Management of impacted fetal head at cesarean birth: A systematic review and meta-analysis.

INTRODUCTION: Despite increasing incidence of impacted fetal head at cesarean birth and associated injury, it is unclear which techniques are most effective for prevention and management. A high quality evidence review in accordance with international reporting standards is currently lacking. To address this gap, we aimed to identify, assess, and synthesize studies comparing techniques to prevent or manage impacted fetal head at cesarean birth prior to or at full cervical dilatation. MATERIAL AND METHODS: We searched MEDLINE, Emcare, Embase and Cochrane databases up to 1 January 2023 (PROSPERO: CRD420212750016). Included were randomized controlled trials (any size) and non-randomized comparative studies (n ≥ 30 in each arm) comparing techniques or adjunctive measures to prevent or manage impacted fetal head at cesarean birth. Following screening and data extraction, we assessed risk of bias for individual studies using RoB2 and ROBINS-I, and certainty of evidence using GRADE. We synthesized data using meta-analysis where appropriate, including sensitivity analyses excluding data published in potential predatory journals or at risk of retraction. RESULTS: We identified 24 eligible studies (11 randomized and 13 non-randomized) including 3558 women, that compared vaginal disimpaction, reverse breech extraction, the Patwardhan method and/or the Fetal Pillow®. GRADE certainty of evidence was low or very low for all 96 outcomes across seven reported comparisons. Pooled analysis mostly showed no or equivocal differences in outcomes across comparisons of techniques. Although some maternal outcomes suggested differences between techniques (e.g., risk ratio of 3.41 [95% CI: 2.50-4.66] for uterine incision extension with vaginal disimpaction vs. reverse breech extraction), these were based on unreliable pooled estimates given very low GRADE certainty and, in some cases, additional risk of bias introduced by data published in potential predatory journals or at risk of retraction. CONCLUSIONS: The current weaknesses in the evidence base mean that no firm recommendations can be made about the superiority of any one impacted fetal head technique over another, indicating that high quality training is needed across the range of techniques. Future studies to improve the evidence base are urgently required, using a standard definition of impacted fetal head, agreed maternal and neonatal outcome sets for impacted fetal head, and internationally recommended reporting standards.

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.

Operational failures in general practice: a consensus-building study on the priorities for improvement.

BACKGROUND: System problems, known as operational failures, can greatly affect the work of GPs, with negative consequences for patient and professional experience, efficiency, and effectiveness. Many operational failures are tractable to improvement, but which ones should be prioritised is less clear. AIM: To build consensus among GPs and patients on the operational failures that should be prioritised to improve NHS general practice. DESIGN AND SETTING: Two modified Delphi exercises were conducted online among NHS GPs and patients in several regions across England. METHOD: Between February and October 2021, two modified Delphi exercises were conducted online: one with NHS GPs, and a subsequent exercise with patients. Over two rounds, GPs rated the importance of a list of operational failures (n = 45) that had been compiled using existing evidence. The resulting shortlist was presented to patients for rating over two rounds. Data were analysed using median scores and interquartile ranges. Consensus was defined as 80% of responses falling within one value below and above the median. RESULTS: Sixty-two GPs responded to the first Delphi exercise, and 53.2% (n = 33) were retained through to round two. This exercise yielded consensus on 14 failures as a priority for improvement, which were presented to patients. Thirty-seven patients responded to the first patient Delphi exercise, and 89.2% (n = 33) were retained through to round two. Patients identified 13 failures as priorities. The highest scoring failures included inaccuracies in patients' medical notes, missing test results, and difficulties referring patients to other providers because of problems with referral forms. CONCLUSION: This study identified the highest-priority operational failures in general practice according to GPs and patients, and indicates where improvement efforts relating to operational failures in general practice should be focused.

Why is safety in intrapartum electronic fetal monitoring so hard? A qualitative study combining human factors/ergonomics and social science analysis.

BACKGROUND: Problems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, we sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk. METHODS: Human factors/ergonomics (HF/E) experts and social scientists conducted 325 hours of observations and 23 interviews in three maternity units in the UK, focusing on how CTG tasks were undertaken, the influences on this work and the cultural and organisational features of work settings. HF/E analysis was based on the Systems Engineering Initiative for Patient Safety 2.0 model. Social science analysis was based on the constant comparative method. RESULTS: CTG monitoring can be understood as a complex sociotechnical activity, with tasks, people, tools and technology, and organisational and external factors all combining to affect safety. Fetal heart rate patterns need to be recorded and interpreted correctly. Systems are also required for seeking the opinions of others, determining whether the situation warrants concern, escalating concerns and mobilising response. These processes may be inadequately designed or function suboptimally, and may be further complicated by staffing issues, equipment and ergonomics issues, and competing and frequently changing clinical guidelines. Practice may also be affected by variable standards and workflows, variations in clinical competence, teamwork and situation awareness, and the ability to communicate concerns freely. CONCLUSIONS: CTG monitoring is an inherently collective and sociotechnical practice. Improving it will require accounting for complex system interdependencies, rather than focusing solely on discrete factors such as individual technical proficiency in interpreting traces.

How to co-design a prototype of a clinical practice tool: a framework with practical guidance and a case study.

Clinical tools for use in practice-such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts-are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or 'FRESCO') offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed-one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied.

Definition, management, and training in impacted fetal head at cesarean birth: a national survey of maternity professionals.

INTRODUCTION: This study assessed views, understanding and current practices of maternity professionals in relation to impacted fetal head at cesarean birth, with the aim of informing a standardized definition, clinical management approaches and training. MATERIAL AND METHODS: We conducted a survey consultation including the range of maternity professionals who attend emergency cesarean births in the UK. Thiscovery, an online research and development platform, was used to ask closed-ended and free-text questions. Simple descriptive analysis was undertaken for closed-ended responses, and content analysis for categorization and counting of free-text responses. Main outcome measures included the count and percentage of participants selecting predefined options on clinical definition, multi-professional team approach, communication, clinical management and training. RESULTS: In total, 419 professionals took part, including 144 midwives, 216 obstetricians and 59 other clinicians (eg anesthetists). We found high levels of agreement on the components of an impacted fetal head definition (79% of obstetricians) and the need for use of a multi-professional approach to management (95% of all participants). Over 70% of obstetricians deemed nine techniques acceptable for management of impacted fetal head, but some obstetricians also considered potentially unsafe practices appropriate. Access to professional training in management of impacted fetal head was highly variable, with over 80% of midwives reporting no training in vaginal disimpaction. CONCLUSIONS: These findings demonstrate agreement on the components of a standardized definition for impacted fetal head, and a need and appetite for multi-professional training. These findings can inform a program of work to improve care, including use of structured management algorithms and simulation-based multi-professional training.

Training for managing impacted fetal head at caesarean birth: multimethod evaluation of a pilot.

BACKGROUND: Implementation of national multiprofessional training for managing the obstetric emergency of impacted fetal head (IFH) at caesarean birth has potential to improve quality and safety in maternity care, but is currently lacking in the UK. OBJECTIVES: To evaluate a training package for managing IFH at caesarean birth with multiprofessional maternity teams. METHODS: The training included an evidence-based lecture supported by an animated video showing management of IFH, followed by hands-on workshops and real-time simulations with use of a birth simulation trainer, augmented reality and management algorithms. Guided by the Kirkpatrick framework, we conducted a multimethod evaluation of the training with multiprofessional maternity teams. Participants rated post-training statements about relevance and helpfulness of the training and pre-training and post-training confidence in their knowledge and skills relating to IFH (7-point Likert scales, strongly disagree to strongly agree). An ethnographer recorded sociotechnical observations during the training. Participants provided feedback in post-training focus groups. RESULTS: Participants (N=57) included 21 midwives, 25 obstetricians, 7 anaesthetists and 4 other professionals from five maternity units. Over 95% of participants agreed that the training was relevant and helpful for their clinical practice and improving outcomes following IFH. Confidence in technical and non-technical skills relating to managing IFH was variable before the training (5%-92% agreement with the pre-training statements), but improved in nearly all participants after the training (71%-100% agreement with the post-training statements). Participants and ethnographers reported that the training helped to: (i) better understand the complexity of IFH, (ii) recognise the need for multiprofessional training and management and (iii) optimise communication with those in labour and their birth partners. CONCLUSIONS: The evaluated training package can improve self-reported knowledge, skills and confidence of multiprofessional teams involved in management of IFH at caesarean birth. A larger-scale evaluation is required to validate these findings and establish how best to scale and implement the training.

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

INTRODUCTION: While 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. METHODS: We 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. RESULTS: Beyond 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. CONCLUSION: Nonparticipants 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 CONTRIBUTION: The 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.

Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure.

BACKGROUND: Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The participatory and informed consent (PIC) measure was developed for application to recruitment discussions to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial. METHODS: This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio-recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility. RESULTS: Application of the PIC to 18 audio-recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure. CONCLUSION: The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.

What dietary interventions have been tested in heart failure with preserved ejection fraction? A systematic scoping review.

AIMS: To determine what dietary interventions have been tested in heart failure with preserved ejection fraction (HFpEF), the modulation method, and outcomes employed and to summarize any evidence for benefit. METHODS AND RESULTS: We performed key word searches in five bibliographic databases from 2001 to 2021, to identify randomized or experimental dietary interventions tested in HFpEF or mixed heart failure (HF) samples. Study characteristics were summarized according to population, intervention, comparator, outcome categories and intervention complexity was assessed. Twenty-five clinical investigations were retrieved; only 10 (40%) were conducted exclusively in HFpEF; the remainder enrolled mixed HF samples. Most studies employed either highly tailored prescribed diets (n = 12, 48%) or dietary supplementation (n = 10, 40%) modalities. Dietary pattern interventions (n = 3, 12%) are less well represented in the literature. CONCLUSION: Heterogeneity made pooling studies challenging. Better reporting of baseline characteristics and the use of standardized HF lexicon would ensure greater confidence in interpretation of studies involving mixed HF populations. The field would benefit greatly from explicit reporting of the biological mechanism of action (e.g. the causal pathway) that an intervention is designed to modulate so that studies can be synthesized via their underlying mechanism of action by which diet may affect HF. An extension of the current set of core outcomes proposed by the European Society of Cardiology Heart Failure Association would ensure dietary clinical endpoints are more consistently defined and measured. REGISTRATION: PROSPERO: CRD42019145388.

What are the outcomes of dietary interventions in Heart Failure with preserved Ejection Fraction? A systematic review and meta-analysis.

AIMS: To determine the efficacy of dietary interventions in Heart Failure with preserved Ejection Fraction (HFpEF). METHOD AND RESULTS: Keyword searches were performed in five bibliographic databases to identify randomized or controlled studies of dietary interventions conducted in HFpEF or mixed heart failure (HF) samples published in the English language. Studies were appraised for bias and synthesized into seven categories based on the similarity of the intervention or targeted population. The quality of the body of evidence was assessed via the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) framework. Twenty-five unique interventions were identified; 17 were considered for meta-analysis. Most studies were judged to be at high risk of bias. There was moderate-quality evidence that caloric restriction led to clinically meaningful improvements in blood pressure and body weight. There was moderate-quality evidence that carbohydrate restriction resulted in meaningful reductions in blood pressure. There was very low-quality evidence that protein supplementation improved blood pressure and body weight and moderate-quality evidence for clinically meaningful improvements in function. CONCLUSIONS: While some types of dietary interventions appeared to deliver clinically meaningful change in critical outcomes; the study heterogeneity and overall quality of the evidence make it difficult to make firm recommendations. Greater transparency when reporting the nutritional composition of interventions would enhance the ability to pool studies. REGISTRATION: PROSPERO CRD42019145388.

Cumulative complexity: a qualitative analysis of patients' experiences of living with heart failure with preserved ejection fraction.

AIMS: To investigate how heart failure with preserved ejection fraction (HFpEF), within the context of limited clinical services, impacts patients' lives. METHODS AND RESULTS: Secondary thematic analysis informed by the cumulative complexity model (CCM), of interview transcripts from 77 people diagnosed with HFpEF and their carers. Four themes corresponding to the core concepts of workload, capacity, access, and outcome described in the CCM were generated. Theme 1: Shouldering a heavy workload described the many tasks expected of people living with HFpEF. Theme 2: The multiple threats to capacity described how patients and carers strived to engage with this work, but were often faced with multiple threats such as symptoms and mobility limitations. Deficient illness identity (Theme 3) reflects how HFpEF either was not recognized or was perceived as a more benign form of HF and therefore afforded less importance or priority. These themes contributed to a range of negative physical, social, and psychological outcomes and the perception of loss of control described in Theme 4: Spiraling complexity. CONCLUSIONS: The constellation of HFpEF, multi-morbidity, and ageing creates many demands that people with HFpEF are expected to manage. Concurrently, the same syndromes threaten their ability to physically enact this work. Patients' recollections of their interactions with health professionals suggest that there is a widespread misunderstanding of HFpEF, which can prohibit access to care that could potentially reduce or prevent deterioration.

Guiding organisational decision-making about COVID-19 asymptomatic testing in workplaces: mixed-method study to inform an ethical framework.

BACKGROUND: Workplace programmes to test staff for asymptomatic COVID-19 infection have become common, but raise a number of ethical challenges. In this article, we report the findings of a consultation that informed the development of an ethical framework for organisational decision-making about such programmes. METHODS: We conducted a mixed-method consultation - a survey and semi-structured interviews during November-December 2020 in a UK case study organisation that had introduced asymptomatic testing for all staff working on-site in its buildings. Analysis of closed-ended survey data was conducted descriptively. An analysis approach based on the Framework Method was used for the open-ended survey responses and interview data. The analyses were then integrated to facilitate systematic analysis across themes. Inferences were based on the integrated findings and combined with other inputs (literature review, ethical analysis, legal and public health guidance, expert discussions) to develop an ethical framework. RESULTS: The consultation involved 61 staff members from the case study organisation (50 survey respondents and 11 interview participants). There was strong support for the asymptomatic testing programme: 90% of the survey respondents viewed it as helpful or very helpful. Open-ended survey responses and interviews gave insight into participants' concerns, including those relating to goal drift, risk of false negatives, and potential negative impacts for household members and people whose roles lacked contractual and financial stability. Integration of the consultation findings and the other inputs identified the importance of a whole-system approach with appropriate support for the key control measure of isolation following positive tests. The need to build trust in the testing programme, for example through effective communication from leaders, was also emphasised. CONCLUSIONS: The consultation, together with other inputs, informed an ethical framework intended to support employers. The framework may support organisational decision-making in areas ranging from design and operation of the programme through to choices about participation. The framework is likely to benefit from further consultation and refinement in new settings.

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.

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.

Blood Pressure Changes Following Antihypertensive Medication Reduction, by Drug Class and Dose Chosen for Withdrawal: Exploratory Analysis of Data From the OPTiMISE Trial.

Aims: Deprescribing of antihypertensive drugs is recommended for some older patients with polypharmacy, but there is little evidence to inform which drug (or dose) should be withdrawn. This study used data from the OPTiMISE trial to examine whether short-term outcomes of deprescribing vary by drug class and dose of medication withdrawn. Methods: The OPTiMISE trial included patients aged ≥80 years with controlled systolic blood pressure (SBP; <150 mmHg), receiving ≥2 antihypertensive medications. This study compared SBP control, mean change in SBP and frequency of adverse events after 12 weeks in participants stopping one medication vs. usual care, by drug class and equivalent dose of medication withdrawn. Equivalent dose was determined according to the defined daily dose (DDD) of each medication type. Drugs prescribed below the DDD were classed as low dose and those prescribed at ≥DDD were described as higher dose. Outcomes were examined by generalized linear mixed effects models. Results: A total of 569 participants were randomized, aged 85 ± 3 years with controlled blood pressure (mean 130/69 mmHg). Within patients prescribed calcium channel blockers, higher dose medications were more commonly selected for withdrawal (90 vs. 10%). In those prescribed beta-blockers, low dose medications were more commonly chosen (87 vs. 13%). Withdrawal of calcium channel blockers was associated with an increase in SBP (5 mmHg, 95%CI 0-10 mmHg) and reduced SBP control (adjusted RR 0.89, 95%CI 0.80-0.998) compared to usual care. In contrast, withdrawal of beta-blockers was associated with no change in SBP (-4 mmHg, 95%CI -10 to 2 mmHg) and no difference in SBP control (adjusted RR 1.15, 95%CI 0.96-1.37). Similarly, withdrawal of higher dose medications was associated with an increase in SBP but no change in BP control. Withdrawal of lower dose medications was not associated with a difference in SBP or SBP control. There was no association between withdrawal of specific drug classes and adverse events. Conclusion: These exploratory data suggest withdrawal of higher dose calcium channel blockers should be avoided if the goal is to maintain BP control. However, low dose beta-blockers may be removed with little impact on blood pressure over 12-weeks of follow-up. Larger studies are needed to confirm these associations.

GPs' mindlines on deprescribing antihypertensives in older patients with multimorbidity: a qualitative study in English general practice.

BACKGROUND: Optimal management of hypertension in older patients with multimorbidity is a cornerstone of primary care practice. Despite emphasis on personalised approaches to treatment in older patients, there is little guidance on how to achieve medication reduction when GPs are concerned that possible risks outweigh potential benefits of treatment. Mindlines - tacit, internalised guidelines developed over time from multiple sources - may be of particular importance in such situations. AIM: To explore GPs' decision-making on deprescribing antihypertensives in patients with multimorbidity aged ≥80 years, drawing on the concept of mindlines. DESIGN AND SETTING: Qualitative interview study set in English general practice. METHOD: Thematic analysis of face-to-face interviews with a sample of 15 GPs from seven practices in the East of England, using a chart-stimulated recall approach to explore approaches to treatment for older patients with multimorbidity with hypertension. RESULTS: GPs are typically confident making decisions to deprescribe antihypertensive medication in older patients with multimorbidity when prompted by a trigger, such as a fall or adverse drug event. GPs are less confident to attempt deprescribing in response to generalised concerns about polypharmacy, and work hard to make sense of multiple sources (including available evidence, shared experiential knowledge, and non-clinical factors) to guide decision-making. CONCLUSION: In the absence of a clear evidence base on when and how to attempt medication reduction in response to concerns about polypharmacy, GPs develop 'mindlines' over time through practicebased experience. These tacit approaches to making complex decisions are critical to developing confidence to attempt deprescribing and may be strengthened through reflective practice.

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.