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Why you should read this article: • To gain a greater understanding of key specialist nursing roles in children’s cardiology • To delve into the guidance and standards on nursing roles and competences in children’s cardiac services • To recognise the need for nursing teams to collaborate across congenital heart disease (CHD) networks. Background: Children’s cardiac nursing roles have changed over the past decade. Royal College of Nursing (RCN) guidance and NHS England standards have been published with the aim of standardising and enhancing nursing care for children and young people with congenital heart disease (CHD) and their families. Aim: To explore the breath of implementation of key nursing roles in children’s cardiac services across the UK and Ireland and to determine whether the roles met the RCN guidance and the NHS England standards. Method: A cross-sectional survey design was used. The 150 members of the Congenital Cardiac Nurses Association (CCNA) were invited via email to participate and were sent a link to an online survey. Findings: Of the 150 potential respondents, 31 completed the survey. Overall, respondents believed that the RCN guidance had been implemented effectively and that children’s cardiac nursing roles matched the RCN’s example job descriptions. Respondents’ comments suggested that implementation of the NHS England standards had been challenging and that progress in setting up key roles such as lead nurse, cardiac nurse educator and children’s cardiac nurse specialist had been slow. Respondents felt that political and financial factors adversely affected recruitment. Conclusion: Since publication of the NHS England standards there has been some progress in the implementation, in children’s cardiac services, of key nursing roles such as lead nurse and innovative nursing roles such as advanced nurse practitioner and research nurse. The findings of this study have informed the latest edition of the RCN guidance, which now includes the role of senior research nurse. [ABSTRACT FROM AUTHOR]

Background: Outpatient care for patients with heart valve disease (HVD) is best provided by valve clinics delivered by specialists. Modern day practice in the United Kingdom (UK) is currently poorly understood and has not been evaluated for nearly a decade. Furthermore, the COVID 19 pandemic changed the management of many chronic diseases, and how this has impacted patients with heart valve disease is unclear. Methods: A British Heart Valve Society survey was sent to 161 hospitals throughout the UK. Results: There was a general valve clinic in 46 of the 68 hospitals (68%), in 19 of 23 Heart Centres (83%) and 29 of 45 DGHs (64%). Across all settings, 3824 new patients and 17,980 follow up patients were seen in valve clinics per annum. The mean number of patients per hospital were 197 (median 150, range 48–550) for new patients and 532 (median 400, range 150–2000) for follow up. On the day echocardiography was available in 55% of valve clinics. In patients with severe HVD, serum brain natriuretic peptide (BNP) was measured routinely in 39% of clinics and exercise testing routinely performed in 49% of clinics. A patient helpline was available in 27% of clinics. 78% of centres with a valve clinic had a valve multidisciplinary team meeting (MDT). 45% centres had an MDT co-ordinator and MDT outcomes were recorded on a database in 64%. COVID-19 had a major impact on valve services in 54 (95%) hospitals. Conclusions: There has been an increase in the number of valve clinics since 2015 from 21 to 68% but the penetration is still well short of the expected 100%, meaning that valve clinics only serve a small proportion of patients requiring surveillance for HVD. COVID-19 had a major impact on the care of patients with HVD in the majority of UK centres surveyed. [ABSTRACT FROM AUTHOR]

Physical activity presents an important cornerstone in the management and care of individuals with hypertrophic cardiomyopathy (HCM). Twenty-one individuals with HCM (age: 52±15 years old, body mass index (BMI): 30±7 kg/m2) completed 7-day monitoring using wrist-worn triaxial accelerometers (GENEActiv, ActivInsights Ltd, UK) and were compared to age and sex-matched healthy controls (age: 51±14 years old, BMI: 25±4 kg/m2). For individuals with HCM, clinical parameters (left atrial diameter and volume, peak oxygen consumption, NTproBNP and Minnesota Living with Heart Failure (MLHF)) were correlated with accelerometry. After adjusting for BMI, individuals with HCM spent less time in moderate-vigorous physical activity (MVPA) (86 (55–138) vs. 140 (121–149) minutes/day, p <0.05) compared to healthy controls. Individuals with HCM engaged in fewer MVPA-5 min (6 (2–15) vs. 27 (23–37) minutes/day, p <0.01) and MVPA-10 min bouts (9 (0–19) vs. 35 (17–54) minutes/day, p <0.01) versus healthy controls. For HCM only, peak oxygen consumption was correlated with MVPA (r =0.60, p <0.01) and MVPA-5 min bouts (r =0.47, p <0.05). MLHF score was correlated with slee p duration (r =0.45, p <0.05). Individuals with HCM should be encouraged to engage in moderate-intensity physical activity bouts and reduce prolonged periods of inactivity in order to potentially improve exercise tolerance and reduce disease burden. [ABSTRACT FROM AUTHOR]

Background: Digital health interventions (DHIs) could support prevention and management of cardiometabolic disease. However, those who may benefit most often experience barriers to awareness and adoption of these interventions., Objective: Among South Asian individuals, we evaluated user experience of DHIs for prevention and management of cardiometabolic disease, aiming to understand barriers and facilitators to initial and ongoing use., Methods: Among South Asian individuals recruited via primary care, community organizations, and snowball methods (n=18), we conducted "think-aloud" interviews using a reflective and reactive approach. Participants included nonusers, as well as those that used a range of DHIs as part of monitoring and improving their health. Participants were asked to think aloud while completing a task they routinely do in a familiar DHI, as well as while setting up and completing a search task in a novel DHI; they were encouraged to behave as if unobserved., Results: Lack of cultural specificity was highlighted as reducing relevance and usability, particularly relating to dietary change. Preferred features reflected individual health beliefs and behaviors, digital skills, and trust in DHIs. For example, tracking blood glucose was considered by some to be positive, while for others it caused distress and anxiety. Similarly, some users found the novel DHI to be extremely simple to set up and use, and others grew frustrated navigating through initial interfaces. Many participants raised concerns about data privacy and needing to agree to terms and conditions that they did not understand. Participants expressed that with information and support from trusted sources, they would be interested in using DHIs as part of self-management., Conclusions: DHIs may support South Asians to prevent and manage cardiometabolic disease, but it is important to consider the needs of specific user groups in DHI development, design, and implementation. Despite motivation to make health changes, digital barriers are common. Cultural appropriateness and trusted sources (such as health care providers and community organizations) have roles in increasing awareness and enabling individuals to access and use DHIs., (© Mel Ramasawmy, Dan Roland Persson, David Sunkersing, Paramjit Gill, Kamlesh Khunti, Lydia Poole, Wasim Hanif, Ann Blandford, Madiha Sajid, Fiona Stevenson, Nushrat Khan, Amitava Banerjee. Originally published in JMIR Human Factors (https://humanfactors.jmir.org).)

Objective: We evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary stent implantation., Study Design: The study was a prospective, observational, multicentre, single-arm registry., Study Settings: The study was conducted at 19 NHS Hospitals across the UK, from March 2020 to September 2021., Study Participants: A total of 1904 patients with symptomatic coronary artery disease (age ≥18 years) who underwent percutaneous coronary intervention with at least one Supraflex Cruz SES were enrolled., Primary and Secondary Outcomes Measure: The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated target lesion revascularisation (CI-TLR), at 12 months. Safety endpoints were stent thrombosis, all-cause death and any MI. Prespecified subgroups analysis included patients with diabetes mellitus, bifurcation lesion, type B2/C lesion defined as per ACC/AHA (American College of Cardiology/American Heart Association) lesion classification and long coronary lesions (>20 mm)., Results: A total of 2973 Supraflex Cruz SES were implanted in 1835 patients (mean age: 65.20±11.03 years). Of these, 404 patients had diabetes mellitus (491 lesions), 271 had bifurcation lesions (293 lesions), 1541 had type B2/C lesions (1832 lesions) and 985 had long coronary lesions (>20 mm, 1139 lesions). Among the overall population, device success was achieved in 98.2% of lesions. TLF occurred in 12 (0.7%) patients (0.3% cardiac death, 0.2% TV-MI, 0.2% CI-TLR) at 30 days and in 43 (2.3%) patients (0.8% cardiac death, 0.8% TV-MI, 0.8% CI-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3% in the overall population at 12 months. The incidence of TLF and stent thrombosis was 6.2% and 1% in the diabetic, 1.8% and none in bifurcation lesion, 2.5% and 0.3% in type B2/C lesion, and 2.7% and 0.3% in long coronary lesions (>20 mm) subgroups, respectively. at 12 months follow-up., Conclusion: The S-FLEX UK-II registry confirms the clinical safety and performance of the ultrathin Supraflex Cruz SES in an all-comer population with complex coronary artery disease, demonstrating low rates of TLF and stent thrombosis., Trial Registration Number: ISRCTN39751665 (https://doi.org/10.1186/ISRCTN39751665)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims To evaluate the clinical feasibility of implementing the 2020 ESC 0/1 hr algorithm for rapid rule-out/rule-in of acute coronary syndrome (ACS). Methods and results Data were collected retrospectively from 5496 patients in 2020 and 7363 patients in 2021 who received cardiac troponin measurements through the ACS algorithm in acute care settings within a large tertiary cardiac centre in the United Kingdom. This period overlapped the introduction of the 2020 ESC 0/1 hr algorithm. After exclusion of haemolysis, 1905 patients underwent repeat troponin measurement within the study period in 2020 and 2658 in 2021. Median time to repeat was significantly reduced from 3 h 14 min for intermediate low risk patients (5--12 ng/L) in 2020 to 1 h 22 min in 2021, and from 3 h 30 min to 1 h 59 min in intermediate high-risk patients (12--51 ng/L). Less than 15% of patients requiring repeat testing had dynamic changes in troponin of sufficient magnitude to change their initial risk category. Of all patients, 58.1% of patients in 2020 were ultimately classified as 'low risk', 19.2% deemed 'ACS likely', and 22.7% as 'ACS possible', with similar distributions in 2021. Conclusion Whilst an efficient algorithm, our study demonstrates multi-faceted, practical limitations of achieving the 1 h target for the triage of patients with suspected ACS. Despite challenges predominantly of logistic nature, the algorithm enables rapid, streamlined, and efficient triage of large patient cohorts. Further work is required to streamline this process and achieve the targeted 1 h repeat in a resource-constrained healthcare environment, which would invariably require second blood draw before the result of first, as recommended by the ESC. [ABSTRACT FROM AUTHOR]

Objective: To determine the incidence, clinical correlates and exposure risk of medical encounters during community-based physical activity events in the UK.Methods: An analysis of medical data from weekly, community-based physical activity events (parkrun) at 702 UK locations over a 6-year period (29 476 294 participations between 2014 and 2019) was conducted in order to define the incidence and clinical correlates of serious life-threatening, non-life-threatening and fatal medical encounters.Results: 84 serious life-threatening encounters (overall incidence rate=0.26/100 000 participations) occurred including 18 fatalities (0.056/100 000 participations). Statistical modelling revealed that the probabilities of serious life-threatening encounters were exceptionally low, however, male sex, increasing age, slower personal best parkrun time and less prior running engagement/experience (average number of runs per year and number of years as a parkrun participant) were associated with increased probability of serious life-threatening encounters. These were largely accounted for by cardiac arrest (48/84, 57%) and acute coronary syndromes (20/84, 24%). Non-life-threatening medical encounters were mainly attributed to tripping or falling, with a reported incidence of 39.2/100 000 participations.Conclusions: Serious life-threatening and fatal medical encounters associated with parkrun participation are extremely rare. In the context of a global public health crisis due to inactivity, this finding underscores the safety and corollary public health value of community running/walking events as a strategy to promote physical activity. [ABSTRACT FROM AUTHOR]

Healthcare professionals, including nurses, will be involved in the care and management of patients in cardiac arrest. This highly stressful and demanding situation can lead to breakdowns in communication, difficulty in decision-making and emotional distress for members of the healthcare team. Debriefing is a recommended tool that team members can use to acknowledge what went well, what could be improved and areas for learning or development. However, debriefing is often not prioritised due to pressures in clinical practice. This article discusses the benefits of debriefing and outlines some of the approaches and tools that may be used. The author argues that by recognising the importance of debriefing after cardiac arrests in the hospital setting and committing to best practices, nurses can be better prepared for the challenges of resuscitation and improve patient outcomes., Competing Interests: None declared, (© 2024 RCN Publishing Company Ltd. All rights reserved. Not to be copied, transmitted or recorded in any way, in whole or part, without prior permission of the publishers.)

Objectives: UK single ventricle (SV) palliation outcomes after first postnatal procedure (FPP) are well documented. However, survival determinants from fetal diagnosis to FPP are lacking. To better inform parental-fetal counselling, we examined factors favouring survival at two large UK centres., Design: Retrospective multicentre cohort study., Setting: Two UK congenital cardiac centres: Leeds and Birmingham., Patients: SV fetal diagnoses from 2015 to 2021., Main Outcome Measures: Survival from fetal diagnosis with intention to treat (ITT) to birth and then FPP. Maternal, fetal and neonatal risk factors were assessed., Results: There were 666 fetal SV diagnoses with 414 (62%) ITT. Of ITT, 381 (92%) were live births and 337 (81%) underwent FPP. Survival (ITT) to FPP was notably reduced for severe Ebstein's 14/22 (63.6%), unbalanced atrioventricular septal defect 32/45 (71%), indeterminate SV 3/4 (75%), mitral atresia 8/10 (80%) and hypoplastic left heart syndrome 127/156 (81.4%). Biventricular pathway was undertaken in five (1%). After multivariable adjustment, prenatal risk factors for mortality were increasing maternal age (OR 1.05, 95% CI 1.0 to 1.1), non-white ethnicity (OR 2.6, 95% CI 1.4 to 4.8), extracardiac anomaly (OR 6.34, 95% CI 1.8 to 22.7) and hydrops (OR 7.39, 95% CI 1.2 to 45.1). Postnatally, prematurity was significantly associated with mortality (OR 6.3, 95% CI 2.3 to 16.8)., Conclusions: Around 20% of ITT fetuses diagnosed with SV will not reach FPP. Risk varies according to the cardiac lesion and is significantly influenced by the presence of an extracardiac anomaly, fetal hydrops, ethnicity, increasing maternal age and gestation at birth. These data highlight the need for fetal preprocedure data to be used in conjunction with procedural outcomes for fetal counselling., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To examine the impact of a Patient and Public Involvement exercise on the development of British Congenital Cardiac Association Fetal Cardiology Standards 2021., Design: Open-ended, semi-structured interviews were undertaken to inform the design of a study to improve the quality of parents' experiences during antenatal and perinatal care of their child with CHD. This Patient and Public Involvement exercise was used to inform the final version of the drafted 'Standards'., Setting: One-on-one interviews with parents who responded to a request on the closed Facebook page of the user group "Little Hearts Matter": "Would you be interested in helping us to design a study about parents' experience on learning that their child had CHD"?, Patients: Parents of children with single ventricle CHD., Results: Twenty-one parents (18 mothers, 3 fathers) participated. Parents responses were reported to have variably reinforced, augmented, and added specificity in the later stages of drafting to six of the seven subsections of Section C Information and Support for Parents including: "At the time of the Scan"; "Counselling following the identification of an abnormality"; "Written information/resources"; "Parent support"; "Communication with other teams and ongoing care"; and "Bereavement support"., Conclusions: This Patient and Public Involvement exercise successfully informed the development of Standards after the initial drafting. It contributed to the establishment of face validity of the 'Standards', especially when consistent with what is reported in the literature. Further research is needed to explore approaches to involving and standardising Patient and Public Involvement in the development of clinical standards.

The use of intracoronary imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) can define vessel architecture and has an established role in guidance and optimisation of percutaneous coronary intervention. Additionally intracoronary imaging has an emerging role in diagnosis, afforded by the ability to depict vessel wall characteristics not seen on angiography alone. Use of intracoronary imaging is recommended by international consensus guidelines from the European Society of Cardiology and two recent expert consensus position statements from the European Association of Percutaneous Coronary Interventions (EAPCI). However, uptake in contemporary practice in the United Kingdom appears to lag behind these recommendations. Imaging is particularly advantageous in complex coronary lesions (such as left main stem coronary artery, bifurcation, or heavily calcified lesions) and in complex patients (acute presentations, atypical presentations, and renal dysfunction). Stent detail to the level of individual struts can be appreciated with intracoronary imaging, which facilitates appropriate stent selection and optimisation of the final stent result. We highlight specific subgroups that benefit from an imaging guided approach to percutaneous coronary intervention. We review the evidence and the role of intracoronary imaging and highlight specific subgroups that show particular benefit from imaging guided percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is to understand stakeholder experiences of diagnosis of cardiovascular disease (CVD) to support the development of technological solutions that meet current needs. Specifically, we aimed to identify challenges in the process of diagnosing CVD, to identify discrepancies between patient and clinician experiences of CVD diagnosis, and to identify the requirements of future health technology solutions intended to improve CVD diagnosis., Design: Semistructured focus groups and one-to-one interviews to generate qualitative data that were subjected to thematic analysis., Participants: UK-based individuals (N=32) with lived experience of diagnosis of CVD (n=23) and clinicians with experience in diagnosing CVD (n=9)., Results: We identified four key themes related to delayed or inaccurate diagnosis of CVD: symptom interpretation, patient characteristics, patient-clinician interactions and systemic challenges. Subthemes from each are discussed in depth. Challenges related to time and communication were greatest for both stakeholder groups; however, there were differences in other areas, for example, patient experiences highlighted difficulties with the psychological aspects of diagnosis and interpreting ambiguous symptoms, while clinicians emphasised the role of individual patient differences and the lack of rapport in contributing to delays or inaccurate diagnosis., Conclusions: Our findings highlight key considerations when developing digital technologies that seek to improve the efficiency and accuracy of diagnosis of CVD., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Competing Interests: Competing interests: None declared.

Chronic thromboembolic pulmonary disease (CTEPD) is a complication of pulmonary embolism (PE). We conducted an online survey of UK PE-treating physicians to understand practices in the follow-up of PE and awareness of CTEPD. The physicians surveyed ( N = 175) included 50 each from cardiology, respiratory and internal medicine, plus 25 haematologists. Most (89%) participants had local guidelines for PE management, and 65% reported a PE follow-up clinic, of which 69% were joint clinics. Almost half (47%) had a protocol for the investigation of CTEPD. According to participants, 129 (74%) routinely consider a diagnosis of CTEPD and 97 (55%) routinely investigate for CTEPD, with 76% of those 97 participants investigating in patients who are symptomatic at 3 months and 22% investigating in all patients. This survey demonstrated variability in the follow-up of PE and the awareness of CTEPD and its investigation. The findings support the conduct of a national audit to understand the barriers to the timely detection of CTEPD.

Document Reviewers: Rudolf A. de Boer (CPG Review Co-ordinator) (Netherlands), P. Christian Schulze (CPG Review Co-ordinator) (Germany), Elena Arbelo (Spain), Jozef Bartunek (Belgium), Johann Bauersachs (Germany), Michael A. Borger (Germany), Sergio Buccheri (Sweden), Elisabetta Cerbai (Italy), Erwan Donal (France), Frank Edelmann (Germany), Gloria Färber (Germany), Bettina Heidecker (Germany), Borja Ibanez (Spain), Stefan James (Sweden), Lars Køber (Denmark), Konstantinos C. Koskinas (Switzerland), Josep Masip (Spain), John William McEvoy (Ireland), Robert Mentz (United States of America), Borislava Mihaylova (United Kingdom), Jacob Eifer Møller (Denmark), Wilfried Mullens (Belgium), Lis Neubeck (United Kingdom), Jens Cosedis Nielsen (Denmark), Agnes A. Pasquet (Belgium), Piotr Ponikowski (Poland), Eva Prescott (Denmark), Amina Rakisheva (Kazakhstan), Bianca Rocca (Italy), Xavier Rossello (Spain), Leyla Elif Sade (United States of America/Türkiye), Hannah Schaubroeck (Belgium), Elena Tessitore (Switzerland), Mariya Tokmakova (Bulgaria), Peter van der Meer (Netherlands), Isabelle C. Van Gelder (Netherlands), Mattias Van Heetvelde (Belgium), Christiaan Vrints (Belgium), Matthias Wilhelm (Switzerland), Adam Witkowski (Poland), and Katja Zeppenfeld (Netherlands) All experts involved in the development of this Focused Update have submitted declarations of interest. These have been compiled in a report and simultaneously published in a supplementary document to the Focused Update. The report is also available on the ESC website www.escardio.org/guidelines See the European Heart Journal online for supplementary documents that include evidence tables., (© 2024 European Society of Cardiology.)

Objective: Retrospectively analyze the cardiac assessment process for elite soccer players, and provide team physicians with a systematic guide to managing longitudinal cardiac risk. Design: Descriptive Epidemiology Study. Setting: Cardiac assessments incorporating clinical examination, 12-lead ECG, echocardiography, and health questionnaire. Participants: Soccer players at 5 professional clubs in England, the United Kingdom. Intervention: Data was retrospectively collected, inspected, and analyzed to determine their clinical management and subsequent follow-up. Results: Over 2 years, 265 soccer players, aged 13 to 37 years with 66% of white European ethnicity, were included in the cohort. Eleven percent had "not-normal" assessments, of these assessments, 83% were considered gray screens, falling into three broad categories: structural cardiac features (including valvular abnormalities), functional cardiac features, and electrocardiogram changes. After cardiology consultation, all assessments were grouped into low, enhanced and high-risk categories for ongoing longitudinal risk management. Overall clear-cut pathology was identified in 2%. Conclusions: Cardiovascular assessment is a vital tool in identifying athletes at risk of sudden cardiac death to mitigate their risk through surveillance, intervention, or participation restriction. The decision whether a player is fit to play or not requires a robust risk assessment followed by input from a multidisciplinary team that includes both the team physician and cardiologist. This educational article proposes a clinical management pathway to aid clinicians with this process. Clinical Relevance: Sudden cardiac death is the important medical cause of death during exercise. The team physician should assume responsibility for the management of the longitudinal risk of their players' cardiac assessments in conjunction with sports cardiologist. [ABSTRACT FROM AUTHOR]

We systematically reviewed the evidence on secular trends in main chronic conditions, disability and self-assessed general health among adults in the United Kingdom, as reported in primary/secondary care databases and population-based surveys. Searches were conducted separately for: (1) trends in age-standardised or age-specific prevalence of major non-communicable diseases, disability, and self-reported general health; (2) trends in health expectancy. The databases searched were MEDLINE, EMBASE/EMBASE Classic and Web of Science (all from 1946/7). The evidence was synthesised narratively. There were 39 studies reporting trends in prevalence of health conditions and 15 studies in health expectancy. We did not find evidence for improvement in the age-standardised or age-specific prevalence of any of the studied major chronic conditions over the last few decades, apart from Alzheimer's disease and other dementias. Both increasing or stable prevalence rates with simultaneous rising life expectancy support the expansion of morbidity theory, meaning that people are expected to spend a greater number of years with chronic condition(s). The evidence on disability—expressed as prevalence or health expectancy—was mixed, but also appeared to support the expansion of morbidity among those aged 65 or over. The evidence on trends in disability for younger age is lacking. Across the studied period (1946–2017), the UK population endured more years with chronic morbidity and disability, which may place a serious strain on the health care system, the economy and the society. [ABSTRACT FROM AUTHOR]

Introduction: Readmissions are a recognised challenge for providers of healthcare and incur financial penalties in a growing number of countries. However, the scale of unscheduled hospital contacts including attendances at emergency departments that do not result in admission is not well known. In addition, little is known about the route to readmission for patients recently discharged from an emergency hospital stay. Methods: This is an observational study of national hospital administration data for England. In this retrospective cohort study, we tracked patients for 30 days after discharge from an emergency admission for heart failure (HF) or chronic obstructive pulmonary disorder (COPD). Results: The majority of patients (COPD:79%; HF:75%) had no unscheduled contact with secondary health care within 30 days of discharge. Of those who did have unscheduled contact, the most common first unscheduled contact was emergency department (ED) attendance (COPD:16%; HF:18%). A further 5% of COPD patients and 4% of HF patients were admitted for an emergency inpatient stay, but not through the ED. A small percentage of patients (COPD:<1%, HF:2%) died without any known contact with secondary care. ED conversion rates at first attendance for both COPD and HF were high: 75% and 79% respectively. A quarter of patients who were not admitted during this first ED attendance attended the ED again within the 30-day follow-up period, and around half (COPD:56%; HF:63%) of these were admitted at this point. Patients who live alone, had an index admission which included an overnight stay and were comorbid had higher odds of being admitted through the ED than via other routes. Conclusion: While the majority of patients did not have unscheduled contact with secondary care in the 30 days after index discharge, many patients attended the ED, often multiple times, and many were admitted to hospital, not always via the ED. More frail patients were more likely to be admitted through the ED, suggesting a possible area of focus as discharge bundles are developed. [ABSTRACT FROM AUTHOR]

Background: In recent years, criticism of the percentage range approach for individualised exercise prescription has intensified and we were concerned that sub-optimal exercise dose (especially intensity) may be in part responsible for the variability in the effectiveness of cardiac rehabilitation (CR) programmes in the United Kingdom (UK). The aim was to investigate the fidelity of a structured Phase III CR programme, by monitoring and quantifying exercise training intensity. Design: Observational study. Methods: The programme comprised 16 sessions over 8 weeks, where patients undertook an interval, circuit training approach within national guidelines for exercise prescription (40–70% heart rate reserve [HRR]). All patients wore an Apple Watch (Series 0 or 2, Watch OS2.0.1, Apple Inc., California, USA). We compared the mean % heart rate reserve (%HRR) achieved during the cardiovascular training component (%HRR-CV) of a circuit-based programme, with the %HRR during the active recovery phases (%HRR-AR) in a randomly selected cohort of patients attending standard CR. We then compared the mean %HRR-CV achieved with the minimal exercise intensity threshold during supervised exercise (40% HRR) recommended by national governing bodies. Results: Thirty cardiac patients (83% male; mean age [SD] 67 [] years; BMI 28.3 [4.6] kg∙m-2) were recruited. We captured 332 individual training sessions. The mean %HRR-CV and %HRR-AR were 37 (10) %, and 31 (13) %, respectively. There was weak evidence to support the alternative hypothesis of a difference between the %HRR-CV and 40% HRR. There was very strong evidence to accept the alternative hypothesis that the mean %HRR-AR was lower than the mean %HRR-CV, median standardised effect size 1.1 (95%CI: 0.563 to 1.669), with a moderate to large effect. Conclusion: Mean exercise training intensity was below the lower limit of the minimal training intensity guidelines for a Phase III CR programme. These findings may be in part responsible for previous reports highlighting the significant variability in effectiveness of UK CR services and poor CRF improvements observed from several prior investigations. [ABSTRACT FROM AUTHOR]

Background: Effective management of heart failure is complex, and ensuring evidence-based practice presents a major challenge to health services worldwide. Over the past decade, the United Kingdom introduced a series of national initiatives to improve evidence-based heart failure management, including a landmark pay-for-performance scheme in primary care and a national audit in secondary care started in 2004 and 2007, respectively. Quality improvement efforts have been evaluated within individual clinical settings, but patterns of care across its continuum, although a critical component of chronic disease management, have not been studied. We have designed this study to investigate patients' trajectories of care around the time of diagnosis and their variation over time by age, sex, and socioeconomic status.Methods and Findings: For this retrospective population-based study, we used linked primary and secondary health records from a representative sample of the UK population provided by the Clinical Practice Research Datalink (CPRD). We identified 93,074 individuals newly diagnosed with heart failure between 2002 and 2014, with a mean age of 76.7 years and of which 49% were women. We examined five indicators of care: (i) diagnosis care setting (inpatient or outpatient), (ii) posthospitalisation follow-up in primary care, (iii) diagnostic investigations, (iv) prescription of essential drugs, and (v) drug treatment dose. We used Poisson and linear regression models to calculate category-specific risk ratios (RRs) or adjusted differences and 95% confidence intervals (CIs), adjusting for year of diagnosis, age, sex, region, and socioeconomic status. From 2002 to 2014, indicators of care presented diverging trends. Outpatient diagnoses and follow-up after hospital discharge in primary care declined substantially (ranging from 56% in 2002 to 36% in 2014, RR 0.64 [0.62, 0.67] and 20% to 14%, RR 0.73 [0.65, 0.82], respectively). Primary care referral for diagnostic investigations and appropriate initiation of beta blockers and angiotensin-converting-enzyme inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs) both increased significantly (37% versus 82%, RR 2.24 [2.15, 2.34] and 18% versus 63%, RR 3.48 [2.72, 4.43], respectively). Yet, the average daily dose prescribed remained below guideline recommendations (42% for ACE-Is or ARBs, 29% for beta blockers in 2014) and was largely unchanged beyond the first 30 days after diagnosis. Despite increasing rates of treatment initiation, the overall dose prescribed to patients in the 12 months following diagnosis improved little over the period of study (adjusted difference for the combined dose of beta blocker and ACE-I or ARB: +6% [+2%, +10%]). Women and patients aged over 75 years presented significant gaps across all five indicators of care. Our study was limited by the available clinical information, which did not include exact left ventricular ejection fraction values, investigations performed during hospital admissions, or information about follow-up in community heart failure clinics.Conclusions: Management of heart failure patients in the UK presents important shortcomings that affect screening, continuity of care, and medication titration and disproportionally impact women and older people. National reporting and incentive schemes confined to individual clinical settings have been insufficient to identify these gaps and address patients' long-term care needs. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the potential real-world application of a machine learning (ML) algorithm, developed and trained on heart failure (HF) cohorts in the USA, to detect patients with undiagnosed wild type cardiac amyloidosis (ATTRwt) in the UK., Design: In this retrospective observational study, anonymised, linked primary and secondary care data (Clinical Practice Research Datalink GOLD and Hospital Episode Statistics, respectively, were used to identify patients diagnosed with HF between 2009 and 2018 in the UK. International Classification of Diseases (ICD)-10 clinical modification codes were matched to equivalent Read (primary care) and ICD-10 WHO (secondary care) diagnosis codes used in the UK. In the absence of specific Read or ICD-10 WHO codes for ATTRwt, two proxy case definitions (definitive and possible cases) based on the degree of confidence that the contributing codes defined true ATTRwt cases were created using ML., Primary Outcome Measure: Algorithm performance was evaluated primarily using the area under the receiver operating curve (AUROC) by comparing the actual versus algorithm predicted case definitions at varying sensitivities and specificities., Results: The algorithm demonstrated strongest predictive ability when a combination of primary care and secondary care data were used (AUROC: 0.84 in definitive cohort and 0.86 in possible cohort). For primary care or secondary care data alone, performance ranged from 0.68 to 0.78., Conclusion: The ML algorithm, despite being developed in a US population, was effective at identifying patients that may have ATTRwt in a UK setting. Its potential use in research and clinical care to aid identification of patients with undiagnosed ATTRwt, possibly enabling earlier diagnosis in the disease pathway, should be investigated., Competing Interests: Competing interests: CT is a full-time employee of Pfizer but was employed by HEOR during the study. AH is a full-time employee of Pfizer. JB was a full-time employee of Pfizer during the study. VL was a paid contractor of Pfizer in connection with development of this manuscript. MN and CD are employees of Health Economics and Outcomes Research (HEOR). HEOR received fees from Pfizer in relation to this study. MM received funding for consulting services from Pfizer during preparation of this manuscript. PE received funding for consulting services from Pfizer during preparation of this manuscript and received consulting fees from Pfizer, Novo Nordisk, BMS, Sanofi, DinaQor, Sarepta, Freeline and AstraZeneca., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To study the impact of out-of-hours delivery on outcome for neonates with antenatally diagnosed transposition of the great arteries., Setting: Tertiary paediatric cardiology centre (Yorkshire, United Kingdom), with co-located tertiary neonatal unit., Patients: Neonates with antenatally diagnosed simple transposition of the great arteries delivered out-of-hours (Monday to Friday 17:00-08:00 and weekends) versus in-hours between 2015 and 2020., Outcome: The primary outcome was survival to hospital discharge. Secondary outcomes included neurological morbidity, length of stay, and time to balloon atrial septostomy., Results: Of 51 neonates, 38 (75%) were delivered out-of-hours. All neonates born in the tertiary centre survived to discharge. Time to balloon atrial septostomy was slightly longer for out-of-hours deliveries compared to in-hours (median 130 versus 93 mins, p = 0.33). Neurological morbidity occurred for nine (24%) patients in the out-of-hours group and one (8%) in-hours (OR 3.72, 95% CI: 0.42-32.71, p = 0.24). Length of stay was also similar (18.5 versus 17.3 days, p = 0.59). Antenatal diagnosis of a restrictive atrial septum was associated with a lower initial pH (7.03 versus 7.13; CI: 0.03-0.17, p = 0.01), longer length of stay (22.6 versus 17.3 days; CI: 0.37-10.17, p = 0.04), and increased neurological morbidity (44% versus 14%; OR 4.80, CI 1.00-23.15, p = 0.05). A further three neonates were delivered in surrounding hospitals, with a mortality of 67% (versus 0 in tertiary centre; OR 172, CI 5-5371, p = 0.003)., Conclusion: Neonates with antenatally diagnosed transposition of the great arteries have similar outcomes when delivered out-of-hours versus in-hours. Antenatal diagnosis of restrictive atrial septum is a significant predictor of worse outcomes. In our region, delivery outside the tertiary cardiac centre had a significantly higher risk of mortality.

Introduction: Reflex syncope is the most common subtype of syncope and, despite not being associated with increased mortality, often results in significant morbidity and costly diagnostics. Reflex syncope can be of concern for certain occupational groups and may be exacerbated by some occupations. Reflex syncope in the military is anecdotally common but the extent in the UK Armed Forces (UKAF) is unknown. The aim of this study was to assess the incidence and prevalence of reflex syncope in the UKAF., Methods: A retrospective search of the Defence Medical Information Capability Programme using prespecified read-codes was performed at defence primary healthcare centres over the period of 1 January 2019 to 1 January 2020. Data were obtained on 76 103 service personnel (SP) (53% of the UKAF)., Results: The overall syncope case rate for the UKAF was 10.5 per 1000 person-years (p-yrs). In comparing services there was a significantly increased risk of syncope in the British Army (10.7 per 1000 p-yrs) compared with the Royal Air Force (8.6 per 1000 p-yrs) (p=0.0365), SP who served overseas (16.7 per 1000 p-yrs) in comparison with UK medical centres (10.3 per 1000 p-yrs) (p<0.0001), and British Army units that regularly took part in State Ceremonial and Public Duties (15.8 per 1000 p-yrs vs 10.2 per 1000 p-yrs) (p=0.0035). Army training units conferred a significantly reduced risk of syncope (p<0.0001)., Conclusions: These data are the first to define the incidence and prevalence of syncope in the UKAF. Orthostasis and heat are probable triggers, although recruits are potentially protected. These data offer opportunities to improve the health and well-being of SP, with economic, logistical and reputational benefits for the UKAF. Further research to identify personnel at risk of future syncopal events may allow for targeted use of countermeasures., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To conduct the first prospective surveillance study of Sydenham's chorea (SC) in the UK and Ireland, and to describe the current paediatric and child psychiatric service-related incidence, presentation and management of SC in children and young people aged 0-16 years., Design: Surveillance study of first presentations of SC reported by paediatricians via the British Paediatric Surveillance Unit (BPSU) and all presentations of SC reported by child and adolescent psychiatrists through the Child and Adolescent Psychiatry Surveillance System (CAPSS)., Results: Over 24 months from November 2018, 72 reports were made via BPSU, of which 43 met the surveillance case definition of being eligible cases of suspected or confirmed SC. This translates to an estimated paediatric service-related incidence rate of new SC cases of 0.16 per 100 000 children aged 0-16 per year in the UK. No reports were made via CAPSS over the 18-month reporting period, although over 75% of BPSU cases presented with emotional and/or behavioural symptoms. Almost all cases were prescribed courses of antibiotics of varying duration, and around a quarter of cases (22%) received immunomodulatory treatment., Conclusions: SC remains a rare condition in the UK and Ireland but has not disappeared. Our findings emphasise the impact that the condition can have on children's functioning and confirm that paediatricians and child psychiatrists should remain vigilant to its presenting features, which commonly include emotional and behavioural symptoms. There is a further need for development of consensus around identification, diagnosis and management across child health settings., Competing Interests: Competing interests: MJSM is Honorary President of the Sydenham’s Chorea Association., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Aiming to contribute to prevention of cardiovascular disease (CVD), the National Health Service (NHS) Health Check programme has been implemented across England since 2009. The programme involves cardiovascular risk stratification-at 5-year intervals-of all adults between the ages of 40 and 74 years, excluding any with preexisting vascular conditions (including CVD, diabetes mellitus, and hypertension, among others), and offers treatment to those at high risk. However, the cost-effectiveness and equity of population CVD screening is contested. This study aimed to determine whether the NHS Health Check programme is cost-effective and equitable in a city with high levels of deprivation and CVD.Methods and Findings: IMPACTNCD is a dynamic stochastic microsimulation policy model, calibrated to Liverpool demographics, risk factor exposure, and CVD epidemiology. Using local and national data, as well as drawing on health and social care disease costs and health-state utilities, we modelled 5 scenarios from 2017 to 2040: Scenario (A): continuing current implementation of NHS Health Check;Scenario (B): implementation 'targeted' toward areas in the most deprived quintile with increased coverage and uptake;Scenario (C): 'optimal' implementation assuming optimal coverage, uptake, treatment, and lifestyle change;Scenario (D): scenario A combined with structural population-wide interventions targeting unhealthy diet and smoking;Scenario (E): scenario B combined with the structural interventions as above. We compared all scenarios with a counterfactual of no-NHS Health Check. Compared with no-NHS Health Check, the model estimated cumulative incremental cost-effectiveness ratio (ICER) (discounted £/quality-adjusted life year [QALY]) to be 11,000 (95% uncertainty interval [UI] -270,000 to 320,000) for scenario A, 1,500 (-91,000 to 100,000) for scenario B, -2,400 (-6,500 to 5,700) for scenario C, -5,100 (-7,400 to -3,200) for scenario D, and -5,000 (-7,400 to -3,100) for scenario E. Overall, scenario A is unlikely to become cost-effective or equitable, and scenario B is likely to become cost-effective by 2040 and equitable by 2039. Scenario C is likely to become cost-effective by 2030 and cost-saving by 2040. Scenarios D and E are likely to be cost-saving by 2021 and 2023, respectively, and equitable by 2025. The main limitation of the analysis is that we explicitly modelled CVD and diabetes mellitus only.Conclusions: According to our analysis of the situation in Liverpool, current NHS Health Check implementation appears neither equitable nor cost-effective. Optimal implementation is likely to be cost-saving but not equitable, while targeted implementation is likely to be both. Adding structural policies targeting cardiovascular risk factors could substantially improve equity and generate cost savings. [ABSTRACT FROM AUTHOR]

Background: To describe the development of polypharmacy and its components in a British birth cohort in its seventh decade and to investigate socioeconomic and gender differences independent of disease burden.Methods: Data from the MRC National Survey for Health and Development were analysed to determine the prevalence and composition of polypharmacy at age 69 and changes since ages 60 to 64. Multinomial regression was used to test associations between gender, education and occupational social class and total, cardiological and non-cardiological polypharmacy controlling for disease burden.Results: At age 69, 22.8% of individuals were taking more than 5 medications. There was an increase in the use of 5 to 8 medications (+ 2.3%) and over 9 medications (+ 0.8%) between ages 60-64 and 69. The greatest increases were found for cardiovascular (+ 13.4%) and gastrointestinal medications (+ 7.3%). Men experienced greater cardiological polypharmacy, women greater non-cardiological polypharmacy. Higher levels of education were associated with lower polypharmacy independent of disease burden, with strongest effects seen for over five cardiological medications (RRR 0.3, 95% CI 0.2-0.5 p < 0.001 for advanced secondary qualifications compared with no qualification); there was no additional effect of social class.Conclusions: Polypharmacy increased over the seventh decade. Those with lower levels of education had more polypharmacy (total, cardiological and non-cardiological), even allowing for disease burden. Further analysis of future outcomes resulting from polypharmacy should take into account educational and gender differences, in an effort to identify at-risk populations who could benefit from medication reviews. [ABSTRACT FROM AUTHOR]

Background: Reduced lung function is common and associated with increased cardiovascular morbidity and mortality, even in asymptomatic individuals without diagnosed respiratory disease. Previous studies have identified relationships between lung function and cardiovascular structure in individuals with pulmonary disease, but the relationships in those free from diagnosed cardiorespiratory disease have not been fully explored. Methods: UK Biobank is a prospective cohort study of community participants in the United Kingdom. Individuals self-reported demographics and co-morbidities, and a subset underwent cardiovascular magnetic resonance (CMR) imaging and spirometry. CMR images were analysed to derive ventricular volumes and mass. The relationships between CMR-derived measures and spirometry and age were modelled with multivariable linear regression, taking account of the effects of possible confounders. Results: Data were available for 4,975 individuals, and after exclusion of those with pre-existing cardiorespiratory disease and unacceptable spirometry, 1,406 were included in the analyses. In fully-adjusted multivariable linear models lower FEV1 and FVC were associated with smaller left ventricular end-diastolic (−5.21ml per standard deviation (SD) change in FEV1, −5.69ml per SD change in FVC), end-systolic (−2.34ml, −2.56ml) and stroke volumes (−2.85ml, −3.11ml); right ventricular end-diastolic (−5.62ml, −5.84ml), end-systolic (−2.47ml, −2.46ml) and stroke volumes (−3.13ml, −3.36ml); and with lower left ventricular mass (−2.29g, −2.46g). Changes of comparable magnitude and direction were observed per decade increase in age. Conclusions: This study shows that reduced FEV1 and FVC are associated with smaller ventricular volumes and reduced ventricular mass. The changes seen per standard deviation change in FEV1 and FVC are comparable to one decade of ageing. [ABSTRACT FROM AUTHOR]

Background: The National Health Service (NHS) Health Check programme was introduced in 2009 in England to systematically assess all adults in midlife for cardiovascular disease risk factors. However, its current benefit and impact on health inequalities are unknown. It is also unclear whether feasible changes in how it is delivered could result in increased benefits. It is one of the first such programmes in the world. We sought to estimate the health benefits and effect on inequalities of the current NHS Health Check programme and the impact of making feasible changes to its implementation.Methods and Findings: We developed a microsimulation model to estimate the health benefits (incident ischaemic heart disease, stroke, dementia, and lung cancer) of the NHS Health Check programme in England. We simulated a population of adults in England aged 40-45 years and followed until age 100 years, using data from the Health Survey of England (2009-2012) and the English Longitudinal Study of Aging (1998-2012), to simulate changes in risk factors for simulated individuals over time. We used recent programme data to describe uptake of NHS Health Checks and of 4 associated interventions (statin medication, antihypertensive medication, smoking cessation, and weight management). Estimates of treatment efficacy and adherence were based on trial data. We estimated the benefits of the current NHS Health Check programme compared to a healthcare system without systematic health checks. This counterfactual scenario models the detection and treatment of risk factors that occur within 'routine' primary care. We also explored the impact of making feasible changes to implementation of the programme concerning eligibility, uptake of NHS Health Checks, and uptake of treatments offered through the programme. We estimate that the NHS Health Check programme prevents 390 (95% credible interval 290 to 500) premature deaths before 80 years of age and results in an additional 1,370 (95% credible interval 1,100 to 1,690) people being free of disease (ischaemic heart disease, stroke, dementia, and lung cancer) at age 80 years per million people aged 40-45 years at baseline. Over the life of the cohort (i.e., followed from 40-45 years to 100 years), the changes result in an additional 10,000 (95% credible interval 8,200 to 13,000) quality-adjusted life years (QALYs) and an additional 9,000 (6,900 to 11,300) years of life. This equates to approximately 300 fewer premature deaths and 1,000 more people living free of these diseases each year in England. We estimate that the current programme is increasing QALYs by 3.8 days (95% credible interval 3.0-4.7) per head of population and increasing survival by 3.3 days (2.5-4.1) per head of population over the 60 years of follow-up. The current programme has a greater absolute impact on health for those living in the most deprived areas compared to those living in the least deprived areas (4.4 [2.7-6.5] days of additional quality-adjusted life per head of population versus 2.8 [1.7-4.0] days; 5.1 [3.4-7.1] additional days lived per head of population versus 3.3 [2.1-4.5] days). Making feasible changes to the delivery of the existing programme could result in a sizable increase in the benefit. For example, a strategy that combines extending eligibility to those with preexisting hypertension, extending the upper age of eligibility to 79 years, increasing uptake of health checks by 30%, and increasing treatment rates 2.5-fold amongst eligible patients (i.e., 'maximum potential' scenario) results in at least a 3-fold increase in benefits compared to the current programme (1,360 premature deaths versus 390; 5,100 people free of 1 of the 4 diseases versus 1,370; 37,000 additional QALYs versus 10,000; 33,000 additional years of life versus 9,000). Ensuring those who are assessed and eligible for statins receive statins is a particularly important strategy to increase benefits. Estimates of overall benefit are based on current incidence and management, and future declines in disease incidence or improvements in treatment could alter the actual benefits observed in the long run. We have focused on the cardiovascular element of the NHS Health Check programme. Some important noncardiovascular health outcomes (e.g., chronic obstructive pulmonary disease [COPD] prevention from smoking cessation and cancer prevention from weight loss) and other parts of the programme (e.g., brief interventions to reduce harmful alcohol consumption) have not been modelled.Conclusions: Our model indicates that the current NHS Health Check programme is contributing to improvements in health and reducing health inequalities. Feasible changes in the organisation of the programme could result in more than a 3-fold increase in health benefits. [ABSTRACT FROM AUTHOR]

Background: Application to cardiology specialty training is competitive with uncertainty among candidates as to what the secret recipe for a successful appointment is. We aimed to investigate objective variables, which were demonstrated by successful appointees to cardiology training schemes in the UK.Methods: Data from successful cardiology applicants for the years 2014 to 2016 were obtained from the Joint Royal Colleges of Physicians Training Board under the Freedom of Information Act. These data included basic demographics as well as objective scores awarded for selection categories such as qualifications, academic, teaching and other achievements.Results: There were a total of 976 applicants during the study period, of whom 423 were successfully appointed, generating a competition ratio of 2.3 applicants for each position. There was an increasing proportion of successful female applicants (22% in 2014, 28% in 2015 and 32% in 2016). Median scores for postgraduate exams (14/14), presentations (6/6) and quality improvement (10/10) scores corresponded to maximum possible scores, whereas median scores for additional undergraduate and postgraduate degrees were 0. Median scores for prizes, publications and teaching experience were 6/10, 4/8 and 9/10, respectively.Conclusion: The secret to a successful cardiology training appointment is associated with completion of all postgraduate clinical exams, completion and presentation of quality improvement projects, national presentations and substantial teaching achievements. At least half of the successful candidates had no additional undergraduate or postgraduate degrees but had evidence of some prizes and publications. The ratio of successful female candidates is rising, but remains less than males in cardiology training. [ABSTRACT FROM AUTHOR]

Introduction: Ventolin Nebules® (reference product; GlaxoSmithKline) was the first licensed nebulizer solution containing the rapid-onset, short-acting β2-agonist salbutamol. Salbutamol Steri-Neb™ (comparator; Teva Pharmaceuticals, Inc.) has the same chemical composition as the reference product. This study evaluated whether the effectiveness of the comparator is non-inferior to the reference product alongside concomitant medications during real-life clinical management of COPD exacerbations. Safety in terms of adverse events (AEs) was also examined. Methods: This matched (1:1) historical cohort study evaluated data from 2 UK primary care databases on patients prescribed the salbutamol comparator or reference. The study included a 1-year baseline period, starting 1 year before the index prescription date, and 1-year outcome period. Cohorts were matched for baseline COPD respiratory medications. The primary outcome was analysis of non-inferiority for the comparator versus reference product for the rate of moderate and severe COPD exacerbations. Non-inferiority was satisfied if the 95% confidence interval (CI) upper limit for mean differences in proportions between treatments was <15%. Secondary outcomes were examined through rate ratios (RR) of severe exacerbations and AEs. Results: After matching, 1191 patients were included in each cohort. Adjusted upper 95% CI for the difference in proportion of patients experiencing moderate or severe exacerbations between comparator and reference groups was 0.032 (3.2%), demonstrating non-inferiority. No significant differences were observed in rates of moderate and severe exacerbations (RR: 1.00; 95% CI: 0.91, 1.10), severe exacerbations (RR: 0.76; 95% CI: 0.49, 1.17), or AEs (RR: 0.98; 95% CI: 0.78, 1.22) after adjusting for baseline confounders. No significant differences across cohorts were observed for rates of any AE or death. Conclusion: This matched cohort study of real-life management of COPD patients supports the salbutamol comparator as non-inferior to the reference product, providing an effective treatment alternative for COPD exacerbations. Comparator and reference safety profiles were similar. [ABSTRACT FROM AUTHOR]

Background: In the United Kingdom, the Food Standards Agency-Ofcom nutrient profiling model (FSA-Ofcom model) is used to define less-healthy foods that cannot be advertised to children. However, there has been limited investigation of whether less-healthy foods defined by this model are associated with prospective health outcomes. The objective of this study was to test whether consumption of less-healthy food as defined by the FSA-Ofcom model is associated with cardiovascular disease (CVD).Methods and Findings: We used data from the European Prospective Investigation of Cancer (EPIC)-Norfolk cohort study in adults (n = 25,639) aged 40-79 years who completed a 7-day diet diary between 1993 and 1997. Incident CVD (primary outcome), cardiovascular mortality, and all-cause mortality (secondary outcomes) were identified using record linkage to hospital admissions data and death certificates up to 31 March 2015. Each food and beverage item reported was coded and given a continuous score, using the FSA-Ofcom model, based on the consumption of energy; saturated fat; total sugar; sodium; nonsoluble fibre; protein; and fruits, vegetables, and nuts. Items were classified as less-healthy using Ofcom regulation thresholds. We used Cox proportional hazards regression to test for an association between consumption of less-healthy food and incident CVD. Sensitivity analyses explored whether the results differed based on the definition of the exposure. Analyses were adjusted for age, sex, behavioural risk factors, clinical risk factors, and socioeconomic status. Participants were followed up for a mean of 16.4 years. During follow-up, there were 4,965 incident cases of CVD (1,524 fatal within 30 days). In the unadjusted analyses, we observed an association between consumption of less-healthy food and incident CVD (test for linear trend over quintile groups, p < 0.01). After adjustment for covariates (sociodemographic, behavioural, and indices of cardiovascular risk), we found no association between consumption of less-healthy food and incident CVD (p = 0.84) or cardiovascular mortality (p = 0.90), but there was an association between consumption of less-healthy food and all-cause mortality (test for linear trend, p = 0.006; quintile group 5, highest consumption of less-healthy food, versus quintile group 1, HR = 1.11, 95% CI 1.02-1.20). Sensitivity analyses produced similar results. The study is observational and relies on self-report of dietary consumption. Despite adjustment for known and reported confounders, residual confounding is possible.Conclusions: After adjustment for potential confounding factors, no significant association between consumption of less-healthy food (as classified by the FSA-Ofcom model) and CVD was observed in this study. This suggests, in the UK setting, that the FSA-Ofcom model is not consistently discriminating among foods with respect to their association with CVD. More studies are needed to understand better the relationship between consumption of less-healthy food, defined by the FSA-Ofcom model, and indices of health. [ABSTRACT FROM AUTHOR]