Search

Background The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

BackgroundThe occurrence of a range of health outcomes following myocardial infarction (MI) is unknown. Therefore, this study aimed to determine the long-term risk of major health outcomes following MI and generate sociodemographic stratified risk charts in order to inform care recommendations in the post-MI period and underpin shared decision making.Methods and findingsThis nationwide cohort study includes all individuals aged ≥18 years admitted to one of 229 National Health Service (NHS) Trusts in England between 1 January 2008 and 31 January 2017 (final follow-up 27 March 2017). We analysed 11 non-fatal health outcomes (subsequent MI and first hospitalisation for heart failure, atrial fibrillation, cerebrovascular disease, peripheral arterial disease, severe bleeding, renal failure, diabetes mellitus, dementia, depression, and cancer) and all-cause mortality. Of the 55,619,430 population of England, 34,116,257 individuals contributing to 145,912,852 hospitalisations were included (mean age 41.7 years (standard deviation [SD 26.1]); n = 14,747,198 (44.2%) male). There were 433,361 individuals with MI (mean age 67.4 years [SD 14.4)]; n = 283,742 (65.5%) male). Following MI, all-cause mortality was the most frequent event (adjusted cumulative incidence at 9 years 37.8% (95% confidence interval [CI] [37.6,37.9]), followed by heart failure (29.6%; 95% CI [29.4,29.7]), renal failure (27.2%; 95% CI [27.0,27.4]), atrial fibrillation (22.3%; 95% CI [22.2,22.5]), severe bleeding (19.0%; 95% CI [18.8,19.1]), diabetes (17.0%; 95% CI [16.9,17.1]), cancer (13.5%; 95% CI [13.3,13.6]), cerebrovascular disease (12.5%; 95% CI [12.4,12.7]), depression (8.9%; 95% CI [8.7,9.0]), dementia (7.8%; 95% CI [7.7,7.9]), subsequent MI (7.1%; 95% CI [7.0,7.2]), and peripheral arterial disease (6.5%; 95% CI [6.4,6.6]). Compared with a risk-set matched population of 2,001,310 individuals, first hospitalisation of all non-fatal health outcomes were increased after MI, except for dementia (adjusted hazard ratio [aHR] 1.01; 95% CI [0.99,1.02];p = 0.468) and cancer (aHR 0.56; 95% CI [0.56,0.57];p < 0.001). The study includes data from secondary care only-as such diagnoses made outside of secondary care may have been missed leading to the potential underestimation of the total burden of disease following MI.ConclusionsIn this study, up to a third of patients with MI developed heart failure or renal failure, 7% had another MI, and 38% died within 9 years (compared with 35% deaths among matched individuals). The incidence of all health outcomes, except dementia and cancer, was higher than expected during the normal life course without MI following adjustment for age, sex, year, and socioeconomic deprivation. Efforts targeted to prevent or limit the accrual of chronic, multisystem disease states following MI are needed and should be guided by the demographic-specific risk charts derived in this study.

Abstract Background Online studies offer an efficient method of recruiting participants and collecting data. Whilst delivering an online randomised trial, we detected unusual recruitment activity. We describe our approach to detecting and managing suspected fraud and share lessons for researchers. Methods Our trial investigated the single and combined effects of different ways of presenting clinical audit and feedback. Clinicians and managers who received feedback from one of five United Kingdom national clinical audit programmes were emailed invitations that contained a link to the trial website. After providing consent and selecting their relevant audit, participants were randomised automatically to different feedback versions. Immediately after viewing their assigned feedback, participants completed a questionnaire and could request a financial voucher by entering an email address. Email addresses were not linked to trial data to preserve participant anonymity. We actively monitored participant numbers, questionnaire completions, and voucher claims. Results Following a rapid increase in trial participation, we identified 268 new voucher claims from three email addresses that we had reason to believe were linked. Further scrutiny revealed duplicate trial completions and voucher requests from 24 email addresses. We immediately suspended the trial, improved security measures, and went on to successfully complete the study. We found a peak in questionnaires completed in less than 20 seconds during a likely contamination period. Given that study and personal data were not linked, we could not directly identify the trial data from the 268 duplicate entries within the 603 randomisations occurring during the same period. We therefore excluded all 603 randomisations from the primary analysis, which was consequently based on 638 randomisations. A sensitivity analysis, including all 961 randomisations over the entire study except for questionnaire completions of less than 20 seconds, found only minor differences from the primary analysis. Conclusion Online studies offering incentives for participation are at risk of attempted fraud. Systematic monitoring and analysis can help detect such activity. Measures to protect study integrity include linking participant identifiers to study data, balancing study security and ease of participation, and safeguarding the allocation of participant incentives. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN41584028. Registration date is August 17, 2017.

Abstract Aims Prognosis for ST‐segment elevation myocardial infarction (STEMI) is worse when heart failure is present on admission. Understanding clinical practice in different health systems can identify areas for quality improvement initiatives to improve outcomes. In the absence of international comparison studies, we aimed to compare treatments and in‐hospital outcomes of patients admitted with ST elevation myocardial infarction (STEMI) by heart failure status in two healthcare‐wide cohorts. Methods and results We used two nationwide databases to capture admissions with STEMI in the United Kingdom (Myocardial ischemia National Audit Project, MINAP) and Japan (Japanese Registry of All Cardiac and Vascular Diseases‐Diagnostic Procedure Combination, JROAD‐DPC) between 2012 and 2017. Participants were stratified using the HF Killip classification into three groups; Killip 1: no congestive heart failure, Killip 2–3: congestive heart failure, Killip 4: cardiogenic shock. We calculated crude rate and case mix standardized risk ratios (CSRR) for use of treatments and in‐hospital death. Patients were younger in the United Kingdom (65.4 [13.6] vs. 69.1 [13.0] years) and more likely to have co‐morbidities in the United Kingdom except for diabetes and hypertension. Japan had a higher percentage of heart failure and cardiogenic shock patients among STEMI during admission than that in the United Kingdom. Primary percutaneous coronary intervention (pPCI) rates were lower in the United Kingdom compared with Japan, especially for patients presenting with Killip 2–3 class heart failure (pPCI use in patients with Killip 1, 2–3, 4: Japan, 86.2%, 81.7%, 78.7%; United Kingdom, 79.6%, 58.2% and 79.9%). In contrast, beta‐blocker use was consistently lower in Japan than in the United Kingdom (61.4% vs. 90.2%) across Killip classifications and length of hospital stay longer (17.0 [9.7] vs. 5.0 [7.4] days). The crude rate of in‐hospital mortality increased with increasing Killip class group. Both the crude rate and CSRR was higher in the United Kingdom compared with Japan for Killip 2–3 (15.8% vs. 6.4%, CSRR 1.80 95% CI 1.73–1.87, P

Introduction Atrial fibrillation (AF) is a major public health issue and there is rationale for the early diagnosis of AF before the first complication occurs. Previous AF screening research is limited by low yields of new cases and strokes prevented in the screened populations. For AF screening to be clinically and cost-effective, the efficiency of identification of newly diagnosed AF needs to be improved and the intervention offered may have to extend beyond oral anticoagulation for stroke prophylaxis. Previous prediction models for incident AF have been limited by their data sources and methodologies.Methods and analysis We will investigate the application of random forest and multivariable logistic regression to predict incident AF within a 6-month prediction horizon, that is, a time-window consistent with conducting investigation for AF. The Clinical Practice Research Datalink (CPRD)-GOLD dataset will be used for derivation, and the Clalit Health Services (CHS) dataset will be used for international external geographical validation. Analyses will include metrics of prediction performance and clinical utility. We will create Kaplan-Meier plots for individuals identified as higher and lower predicted risk of AF and derive the cumulative incidence rate for non-AF cardio-renal-metabolic diseases and death over the longer term to establish how predicted AF risk is associated with a range of new non-AF disease states.Ethics and dissemination Permission for CPRD-GOLD was obtained from CPRD (ref no: 19_076). The CPRD ethical approval committee approved the study. CHS Helsinki committee approval 21-0169 and data usage committee approval 901. The results will be submitted as a research paper for publication to a peer-reviewed journal and presented at peer-reviewed conferences.Trial registration number A systematic review to guide the overall project was registered on PROSPERO (registration number CRD42021245093). The study was registered on ClinicalTrials.gov (NCT05837364).

Objective To investigate the association between health-related quality of life (HRQoL) and major adverse cardiovascular and cerebrovascular events (MACCE) in individuals with ischaemic heart disease (IHD).Methods Medline(R), Embase, APA PsycINFO and CINAHL (EBSCO) from inception to 3 April 2023 were searched. Studies reporting association of HRQoL, using a generic or cardiac-specific tool, with MACCE or components of MACCE for individuals with IHD were eligible for inclusion. Risk of bias was assessed using the Newcastle-Ottawa Quality Assessment Scale to assess the quality of the studies. Descriptive synthesis, evidence mapping and random-effects meta-analysis were performed stratified by HRQoL measures and effect estimates. Between-study heterogeneity was assessed using the Higgins I2 statistic.Results Fifty-one articles were included with a total of 134 740 participants from 53 countries. Meta-analysis of 23 studies found that the risk of MACCE increased with lower baseline HeartQoL score (HR 1.49, 95% CI 1.16 to 1.93) and Short Form Survey (SF-12) physical component score (PCS) (HR 1.39, 95% CI 1.28 to 1.51). Risk of all-cause mortality increased with a lower HeartQoL (HR 1.64, 95% CI 1.34 to 2.01), EuroQol 5-dimension (HR 1.17, 95% CI 1.12 to 1.22), SF-36 PCS (HR 1.29, 95% CI 1.19 to 1.41), SF-36 mental component score (HR 1.18, 95% CI 1.08 to 1.30).Conclusions This study found an inverse association between baseline values or change in HRQoL and MACCE or components of MACCE in individuals with IHD, albeit with between-study heterogeneity. Standardisation and routine assessment of HRQoL in clinical practice may help risk stratify individuals with IHD for tailored interventions.PROSPERO registration number CRD42021234638.

Introduction Atrial fibrillation (AF) is associated with a fivefold increased risk of stroke. Oral anticoagulation reduces the risk of stroke, but AF is elusive. A machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation (FIND-AF)) developed to predict incident AF within 6 months using data in primary care electronic health records (EHRs) could be used to guide AF screening. The objectives of the FIND-AF pilot study are to determine yields of AF during ECG monitoring across AF risk estimates and establish rates of recruitment and protocol adherence in a remote AF screening pathway.Methods and analysis The FIND-AF Pilot is an interventional, non-randomised, single-arm, open-label study that will recruit 1955 participants aged 30 years or older, without a history of AF and eligible for oral anticoagulation, identified as higher risk and lower risk by the FIND-AF risk score from their primary care EHRs, to a period of remote ECG monitoring with a Zenicor-ECG device. The primary outcome is AF diagnosis during ECG monitoring, and secondary outcomes include recruitment rates, withdrawal rates, adherence to ECG monitoring and prescription of oral anticoagulation to participants diagnosed with AF during ECG monitoring.Ethics and dissemination The study has ethical approval (the North West—Greater Manchester South Research Ethics Committee reference 23/NW/0180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder’s open access policy.Trial registration number NCT05898165.

Objective Risk-guided atrial fibrillation (AF) screening may be an opportunity to prevent adverse events in addition to stroke. We compared events rates for new diagnoses of cardio-renal-metabolic diseases and death in individuals identified at higher versus lower-predicted AF risk.Methods From the UK Clinical Practice Research Datalink-GOLD dataset, 2 January 1998–30 November 2018, we identified individuals aged ≥30 years without known AF. The risk of AF was estimated using the FIND-AF (Future Innovations in Novel Detection of Atrial Fibrillation) risk score. We calculated cumulative incidence rates and fit Fine and Gray’s models at 1, 5 and 10 years for nine diseases and death adjusting for competing risks.Results Of 416 228 individuals in the cohort, 82 942 were identified as higher risk for AF. Higher-predicted risk, compared with lower-predicted risk, was associated with incident chronic kidney disease (cumulative incidence per 1000 persons at 10 years 245.2; HR 6.85, 95% CI 6.70 to 7.00; median time to event 5.44 years), heart failure (124.7; 12.54, 12.08 to 13.01; 4.06), diabetes mellitus (123.3; 2.05, 2.00 to 2.10; 3.45), stroke/transient ischaemic attack (118.9; 8.07, 7.80 to 8.34; 4.27), myocardial infarction (69.6; 5.02, 4.82 to 5.22; 4.32), peripheral vascular disease (44.6; 6.62, 6.28 to 6.98; 4.28), valvular heart disease (37.8; 6.49, 6.14 to 6.85; 4.54), aortic stenosis (18.7; 9.98, 9.16 to 10.87; 4.41) and death from any cause (273.9; 10.45, 10.23 to 10.68; 4.75). The higher-risk group constituted 74% of deaths from cardiovascular or cerebrovascular causes (8582 of 11 676).Conclusions Individuals identified for risk-guided AF screening are at risk of new diseases across the cardio-renal-metabolic spectrum and death, and may benefit from interventions beyond ECG monitoring.

Summary: Background: Knowledge of post-myocardial infarction (MI) disease risk to date is limited—yet the number of survivors of MI has increased dramatically in recent decades. We investigated temporally ordered sequences of all conditions following MI in nationwide electronic health record data through the application of process mining. Methods: We conducted a national retrospective cohort study of all hospitalisations (145,670,448 episodes; 34,083,204 individuals) admitted to NHS hospitals in England (1st January 2008–31st January 2017, final follow-up 27th March 2017). Through process mining, we identified trajectories of all major disease diagnoses following MI and compared their relative risk (RR) and all-cause mortality hazard ratios (HR) to a risk-set matched non-MI control cohort using Cox proportional hazards and flexible parametric survival models. Findings: Among a total of 375,669 MI patients (130,758 females; 34.8%) and 1,878,345 matched non-MI patients (653,790 females; 34.8%), we identified 28,799 unique disease trajectories. The accrual of multiple circulatory diagnoses was more common amongst MI patients (RR 4.32, 95% CI 3.96–4.72) and conferred an increased risk of death (HR 1.32, 1.13–1.53) compared with matched controls. Trajectories featuring neuro-psychiatric diagnoses (including anxiety and depression) following circulatory disorders were markedly more common and had increased mortality post MI (HR ranging from 1.11 to 1.73) compared with non-MI individuals. Interpretation: These results provide an opportunity for early intervention targets for survivors of MI—such as increased focus on the psychological and behavioural pathways—to mitigate ongoing adverse disease trajectories, multimorbidity, and premature mortality. Funding: British Heart Foundation; Alan Turing Institute.

Summary: Background: Whether the accuracy of the phenotype ascribed to patients in electronic health records (EHRs) is associated with variation in prognosis and care provision is unknown. We investigated this for heart failure (HF, characterised as HF with preserved ejection fraction [HFpEF], HF with reduced ejection fraction [HFrEF] and unspecified HF). Methods: We included individuals aged 16 years and older with a new diagnosis of HF between January 2, 1998 and February 28, 2022 from linked primary and secondary care records in the Clinical Practice Research Datalink in England. We investigated the provision of guideline-recommended diagnostic investigations and pharmacological treatments. The primary outcome was a composite of HF hospitalisation or all-cause death, and secondary outcomes were time to HF hospitalisation, all-cause death and death from cardiovascular causes. We used Kaplan–Meier curves and log rank tests to compare survival across HF phenotypes and adjusted for potential confounders in Cox proportional hazards regression analyses. Findings: Of a cohort of 95,262 individuals, 1271 (1.3%) were recorded as having HFpEF, 10,793 (11.3%) as HFrEF and 83,198 (87.3%) as unspecified HF. Individuals recorded as unspecified HF were older with a higher prevalence of dementia. Unspecified HF, compared to patients with a recorded HF phenotype, were less likely to receive specialist assessment, echocardiography or natriuretic peptide testing in the peri-diagnostic period, or receive angiotensin-converting enzyme inhibitors, beta blockers or mineralocorticoid receptor antagonists up to 12 months after diagnosis (risk ratios compared to HFrEF, 0.64, 95% CI 0.63–0.64; 0.59, 0.58–0.60; 0.57, 0.55–0.59; respectively) and had significantly worse outcomes (adjusted hazard ratios compared to HFrEF, HF hospitalisation and death 1.66, 95% CI 1.59–1.74; all-cause mortality 2.00, 1.90–2.10; cardiovascular death 1.77, 1.65–1.90). Interpretation: Our findings suggested that absence of specification of HF phenotype in routine EHRs is inversely associated with clinical investigations, treatments and survival, representing an actionable target to mitigate prognostic and health resource burden. Funding: Japan Research Foundation for Healthy Aging and British Heart Foundation.

Summary: Background: Understanding and quantifying the differences in disease development in different socioeconomic groups of people across the lifespan is important for planning healthcare and preventive services. The study aimed to measure chronic disease accrual, and examine the differences in time to individual morbidities, multimorbidity, and mortality between socioeconomic groups in Wales, UK. Methods: Population-wide electronic linked cohort study, following Welsh residents for up to 20 years (2000–2019). Chronic disease diagnoses were obtained from general practice and hospitalisation records using the CALIBER disease phenotype register. Multi-state models were used to examine trajectories of accrual of 132 diseases and mortality, adjusted for sex, age and area-level deprivation. Restricted mean survival time was calculated to measure time spent free of chronic disease(s) or mortality between socioeconomic groups. Findings: In total, 965,905 individuals aged 5–104 were included, from a possible 2.9 m individuals following a 5-year clearance period, with an average follow-up of 13.2 years (12.7 million person-years). Some 673,189 (69.7%) individuals developed at least one chronic disease or died within the study period. From ages 10 years upwards, the individuals living in the most deprived areas consistently experienced reduced time between health states, demonstrating accelerated transitions to first and subsequent morbidities and death compared to their demographic equivalent living in the least deprived areas. The largest difference were observed in 10 and 20 year old males developing multimorbidity (−0.45 years (99% CI: −0.45, −0.44)) and in 70 year old males dying after developing multimorbidity (−1.98 years (99% CI: −2.01, −1.95)). Interpretation: This study adds to the existing literature on health inequalities by demonstrating that individuals living in more deprived areas consistently experience accelerated time to diagnosis of chronic disease and death across all ages, accounting for competing risks. Funding: UK Medical Research Council, Health Data Research UK, and Administrative Data Research Wales.

Abstract Background Medicines are often suboptimally managed for heart failure patients across the transition from hospital to home, potentially leading to poor patient outcomes. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme included: understanding the problems faced by patients and healthcare professionals; developing and co‐designing the Medicines at Transitions of care Intervention (MaTI); a cluster randomized controlled trial testing the effectiveness of a complex behavioural MaTI aimed at improving medicines management at the interface between hospitals discharge and community care for patients with heart failure; and a process evaluation. The MaTI included a patient‐held My Medicines Toolkit; enhanced communication between the hospital and the patient's community pharmacist and increased engagement of the community pharmacist postdischarge. This paper reports on the patients' experiences of the MaTI and its implementation from the process evaluation. Design Twenty one‐to‐one semi‐structured patient interviews from six intervention sites were conducted between November 2018 and January 2020. Data were analysed using the Framework method, involving patients as co‐analysts. Interview data were triangulated with routine trial data, the Consolidated Framework for Implementation Research and a logic model. Results Within the hospital setting patients engaged with the toolkit according to whether staff raised awareness of the My Medicines Toolkit's importance and the time and place of its introduction. Patients' engagement with community pharmacy depended on their awareness of the community pharmacist's role, support sources and perceptions of involvement in medicines management. The toolkit's impact on patients' medicines management at home included reassurance during gaps in care, increased knowledge of medicines, enhanced ability to monitor health and seek support and supporting sharing medicines management between formal and informal care networks. Conclusion Many patients perceived that the MaTI offered them support in their medicines management when transitioning from hospital into the community. Importantly, it can be incorporated into and built upon patients' lived experiences of heart failure. Key to its successful implementation is the quality of engagement of healthcare professionals in introducing the intervention. Patient or Public Contribution Patients were involved in the study design, as qualitative data co‐analysts and as co‐authors.

Background: Biventricular pacing (BVP) is recommended for patients with heart failure (HF) who require cardiac resynchronization therapy (CRT). Left bundle branch area pacing (LBBAP) is a novel pacing strategy that appears to ensure better electrical and mechanical synchrony in these patients. Our aim was to systematically review and meta-analyze the existing evidence regarding the clinical outcomes of LBBAP-CRT compared with BVP-CRT. Methods: Medline, Embase, Cochrane Central Register of Controlled Trials and Web of Science databases were searched for studies comparing LBBAP-CRT with BVP-CRT. Outcomes were all-cause mortality, heart failure hospitalizations (HFH) and New York Heart Association (NYHA) class improvement. We included randomized controlled trials (RCTs) and observational studies with participants that had left ventricular ejection fraction (LVEF) ≤40% and (i) symptomatic HF or (ii) expected ventricular pacing >40%. Random and fixed effects models pairwise meta-analysis was conducted. Cochrane Risk of Bias 2 assessment tool (ROB 2.0) and the Newcastle–Ottawa scale (NOS) were used to assess the quality of the studies. Results: Eleven studies (10 observational studies and 1 RCT) with 3141 patients were included in the analysis. Compared with BVP-CRT, LBBAP-CRT was associated with lower risk of all-cause mortality (risk ratio (RR): 0.71, 95% CI: 0.57 to 0.87; p = 0.001), lower risk of HFH (RR: 0.59, 95% CI: 0.50 to 0.71; p < 0.00001) and more improvement in NYHA class (weighed mean difference (WMD): –0.36, 95% CI: –0.59 to –0.13; p < 0.00001) compared with patients who received BVP-CRT. Conclusions: Compared with BVP-CRT, receipt of LBBAP-CRT in patients with HF is associated with a lower risk of mortality, and HFH and greater improvement in NHYA class.

Abstract Background Audit and feedback aims to improve patient care by comparing healthcare performance against explicit standards. It is used to monitor and improve patient care, including through National Clinical Audit (NCA) programmes in the UK. Variability in effectiveness of audit and feedback is attributed to intervention design; separate randomised trials to address multiple questions about how to optimise effectiveness would be inefficient. We evaluated different feedback modifications to identify leading candidates for further “real-world” evaluation. Methods Using an online fractional factorial screening experiment, we randomised recipients of feedback from five UK NCAs to different combinations of six feedback modifications applied within an audit report excerpt: use effective comparators, provide multimodal feedback, recommend specific actions, provide optional detail, incorporate the patient voice, and minimise cognitive load. Outcomes, assessed immediately after exposure to the online modifications, included intention to enact audit standards (primary outcome, ranked on a scale of −3 to +3, tailored to the NCA), comprehension, user experience, and engagement. Results We randomised 1241 participants (clinicians, managers, and audit staff) between April and October 2019. Inappropriate repeated participant completion occurred; we conservatively excluded participant entries during the relevant period, leaving a primary analysis population of 638 (51.4%) participants. None of the six feedback modifications had an independent effect on intention across the five NCAs. We observed both synergistic and antagonistic effects across outcomes when modifications were combined; the specific NCA and whether recipients had a clinical role had dominant influences on outcome, and there was an antagonistic interaction between multimodal feedback and optional detail. Among clinical participants, predicted intention ranged from 1.22 (95% confidence interval 0.72, 1.72) for the least effective combination in which multimodal feedback, optional detail, and reduced cognitive load were applied within the audit report, up to 2.40 (95% CI 1.88, 2.93) for the most effective combination including multimodal feedback, specific actions, patient voice, and reduced cognitive load. Conclusion Potentially important synergistic and antagonistic effects were identified across combinations of feedback modifications, audit programmes, and recipients, suggesting that feedback designers must explicitly consider how different features of feedback may interact to achieve (or undermine) the desired effects. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN41584028

Summary: Background: Direct oral anticoagulants (DOACs) are effective and safe alternatives to warfarin for stroke prophylaxis for atrial fibrillation (AF). Whether this extends to patients at the extremes of body mass index (BMI) is unclear. Methods: Using linked primary and secondary data, Jan 1, 2010 to Nov 30, 2018, we included CHA2DS2-VASC score ≥3 in women and ≥2 in men with AF treated with oral anticoagulants (OACs). Outcomes were ischaemic stroke, major bleeding and all-cause mortality by World Health Organisation BMI classification. Patients who received warfarin were propensity score matched (1:1 ratio) with those who received DOACs and the association of time-varying OAC exposure on outcomes quantified using Cox proportional hazards models. Findings: We included 29,135 (22,818 warfarin, 6317 DOAC); 585 (2.0%) underweight, 8427 (28.9%) normal weight, 10,705 (36.7%) overweight, 5910 (20.3%) class I obesity and 3508 (12.0%) class II/III obesity. Patients treated with DOACs were older and more comorbid. After 3.7 (SD 2.5) years follow up, there was no difference in risk of ischaemic stroke and major bleeding by BMI category between DOACs and warfarin. Normal weight, overweight and obese class I patients had higher risk of all-cause mortality when treated with DOACs compared with warfarin (HR: 1.45 [95% CI 1.24–1.69], p

Objectives To investigate sex-based differences in baseline values and longitudinal trajectories of health-related quality of life (HRQoL) in a large cohort of myocardial infarction (MI) survivors after adjusting for other important factors.Design Longitudinal cohort study.Setting Population-based longitudinal study the Evaluation of the Methods and Management of Acute Coronary Events study linked with national cardiovascular registry. Data were collected from 77 hospitals in England between 1 November 2011 and 24 June 2015.Participants 9551 patients with MI. Patients were eligible for the study if they were ≥18 years of age.Primary and secondary outcome measures HRQoL was measured by EuroQol five-dimension, visual analogue scale (EQ-5D, EQ VAS) survey at baseline, 1, 6 and 12 months after discharge. Multi-level linear and logistic regression models coupled with inverse probability weighted propensity scoring were used to evaluate sex differences in HRQoL following MI.Results Of the 9551 patients with MI and complete data on sex, 25.1% (2,397) were women. At baseline, women reported lower HRQoL (EQ VAS (mean (SD) 59.8 (20.4) vs 64.5 (20.9)) (median (IQR) 60.00 (50.00–75.00) vs 70.00 (50.00–80.00))) (EQ-5D (mean (SD) 0.66 (0.31) vs 0.74 (0.28)) (median (IQR) 0.73 (0.52–0.85) vs 0.81 (0.62–1.00))) and were more likely to report problems in each HRQoL domain compared with men. In the covariate balanced and adjusted multi-level model sex differences in HRQoL persisted during follow-up, with lower EQ VAS and EQ-5D scores in women compared with men (adjusted EQ VAS model sex coefficient: −4.41, 95% CI −5.16 to −3.66 and adjusted EQ-5D model sex coefficient: −0.07, 95% CI −0.08 to −0.06).Conclusions Women have lower HRQoL compared with men at baseline and during 12 months follow-up after MI. Tailored interventions for women following an MI could improve their quality of life.Trial registration number ClinicalTrials.gov (NCT04598048, NCT01808027, NCT01819103

Abstract Background Secondary use of data via integrated health information technology is fundamental to many healthcare policies and processes worldwide. However, repurposing data can be problematic and little research has been undertaken into the everyday practicalities of inter-system data sharing that helps explain why this is so, especially within (as opposed to between) organisations. In response, this article reports one of the most detailed empirical examinations undertaken to date of the work involved in repurposing healthcare data for National Clinical Audits. Methods Fifty-four semi-structured, qualitative interviews were carried out with staff in five English National Health Service hospitals about their audit work, including 20 staff involved substantively with audit data collection. In addition, ethnographic observations took place on wards, in ‘back offices’ and meetings (102 h). Findings were analysed thematically and synthesised in narratives. Results Although data were available within hospital applications for secondary use in some audit fields, which could, in theory, have been auto-populated, in practice staff regularly negotiated multiple, unintegrated systems to generate audit records. This work was complex and skilful, and involved cross-checking and double data entry, often using paper forms, to assure data quality and inform quality improvements. Conclusions If technology is to facilitate the secondary use of healthcare data, the skilled but largely hidden labour of those who collect and recontextualise those data must be recognised. Their detailed understandings of what it takes to produce high quality data in specific contexts should inform the further development of integrated systems within organisations.

Background: National clinical audit programmes aim to improve patient care by reviewing performance against explicit standards and directing action towards areas not meeting those standards. Their impact can be improved by (1) optimising feedback content and format, (2) strengthening audit cycles and (3) embedding randomised trials evaluating different ways of delivering feedback. Objectives: The objectives were to (1) develop and evaluate the effects of modifications to feedback on recipient responses, (2) identify ways of strengthening feedback cycles for two national audits and (3) explore opportunities, costs and benefits of national audit participation in a programme of trials. Design: An online fractional factorial screening experiment (objective 1) and qualitative interviews (objectives 2 and 3). Setting and participants: Participants were clinicians and managers involved in five national clinical audits – the National Comparative Audit of Blood Transfusions, the Paediatric Intensive Care Audit Network, the Myocardial Ischaemia National Audit Project, the Trauma Audit & Research Network and the National Diabetes Audit – (objective 1); and clinicians, members of the public and researchers (objectives 2 and 3). Interventions: We selected and developed six online feedback modifications through three rounds of user testing. We randomised participants to one of 32 combinations of the following recommended specific actions: comparators reinforcing desired behaviour change; multimodal feedback; minimised extraneous cognitive load for feedback recipients; short, actionable messages followed by optional detail; and incorporating ‘the patient voice’ (objective 1). Main outcome measures: The outcomes were intended actions, including enactment of audit standards (primary outcome), comprehension, user experience and engagement (objective 1). Results: For objective 1, the primary analysis included 638 randomised participants, of whom 566 completed the outcome questionnaire. No modification independently increased intended enactment of audit standards. Minimised cognitive load improved comprehension (+0.1; p = 0.014) and plans to bring audit findings to colleagues’ attention (+0.13, on a –3 to +3 scale; p = 0.016). We observed important cumulative synergistic and antagonistic interactions between modifications, participant role and national audit. The analysis in objective 2 included 19 interviews assessing the Trauma Audit Research Network and the National Diabetes Audit. The identified ways of strengthening audit cycles included making performance data easier to understand and guiding action planning. The analysis in objective 3 identified four conditions for effective collaboration from 31 interviews: compromise – recognising capacity and constraints; logistics – enabling data sharing, audit quality and funding; leadership – engaging local stakeholders; and relationships – agreeing shared priorities and needs. The perceived benefits of collaboration outweighed the risks. Limitations: The online experiment assessed intended enactment as a predictor of actual clinical behaviour. Interviews and surveys were subject to social desirability bias. Conclusions: National audit impacts may be enhanced by strengthening all aspects of feedback cycles, particularly effective feedback, and considering how different ways of reinforcing feedback act together. Future work: Embedded randomised trials evaluating different ways of delivering feedback within national clinical audits are acceptable and may offer efficient, evidence-based and cumulative improvements in outcomes. Trial registration: This trial is registered as ISRCTN41584028. Funding details: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 15. See the NIHR Journals Library website for further project information.

Background: National audits aim to reduce variations in quality by stimulating quality improvement. However, varying provider engagement with audit data means that this is not being realised. Aim: The aim of the study was to develop and evaluate a quality dashboard (i.e. QualDash) to support clinical teams’ and managers’ use of national audit data. Design: The study was a realist evaluation and biography of artefacts study. Setting: The study involved five NHS acute trusts. Methods and results: In phase 1, we developed a theory of national audits through interviews. Data use was supported by data access, audit staff skilled to produce data visualisations, data timeliness and quality, and the importance of perceived metrics. Data were mainly used by clinical teams. Organisational-level staff questioned the legitimacy of national audits. In phase 2, QualDash was co-designed and the QualDash theory was developed. QualDash provides interactive customisable visualisations to enable the exploration of relationships between variables. Locating QualDash on site servers gave users control of data upload frequency. In phase 3, we developed an adoption strategy through focus groups. ‘Champions’, awareness-raising through e-bulletins and demonstrations, and quick reference tools were agreed. In phase 4, we tested the QualDash theory using a mixed-methods evaluation. Constraints on use were metric configurations that did not match users’ expectations, affecting champions’ willingness to promote QualDash, and limited computing resources. Easy customisability supported use. The greatest use was where data use was previously constrained. In these contexts, report preparation time was reduced and efforts to improve data quality were supported, although the interrupted time series analysis did not show improved data quality. Twenty-three questionnaires were returned, revealing positive perceptions of ease of use and usefulness. In phase 5, the feasibility of conducting a cluster randomised controlled trial of QualDash was assessed. Interviews were undertaken to understand how QualDash could be revised to support a region-wide Gold Command. Requirements included multiple real-time data sources and functionality to help to identify priorities. Conclusions: Audits seeking to widen engagement may find the following strategies beneficial: involving a range of professional groups in choosing metrics; real-time reporting; presenting ‘headline’ metrics important to organisational-level staff; using routinely collected clinical data to populate data fields; and dashboards that help staff to explore and report audit data. Those designing dashboards may find it beneficial to include the following: ‘at a glance’ visualisation of key metrics; visualisations configured in line with existing visualisations that teams use, with clear labelling; functionality that supports the creation of reports and presentations; the ability to explore relationships between variables and drill down to look at subgroups; and low requirements for computing resources. Organisations introducing a dashboard may find the following strategies beneficial: clinical champion to promote use; testing with real data by audit staff; establishing routines for integrating use into work practices; involving audit staff in adoption activities; and allowing customisation. Limitations: The COVID-19 pandemic stopped phase 4 data collection, limiting our ability to further test and refine the QualDash theory. Questionnaire results should be treated with caution because of the small, possibly biased, sample. Control sites for the interrupted time series analysis were not possible because of research and development delays. One intervention site did not submit data. Limited uptake meant that assessing the impact on more measures was not appropriate. Future work: The extent to which national audit dashboards are used and the strategies national audits use to encourage uptake, a realist review of the impact of dashboards, and rigorous evaluations of the impact of dashboards and the effectiveness of adoption strategies should be explored. Study registration: This study is registered as ISRCTN18289782. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 12. See the NIHR Journals Library website for further project information.

Abstract Background Heart failure affects 26 million people globally, and the optimal management of medicines is crucial for patients, particularly when their care is transferred between hospital and the community. Optimising clinical outcomes requires well-calibrated cross-organisational processes with staff and patients responding and adapting to medicines changes. The aim of this study was to assess the feasibility of implementing a complex intervention (the Medicines at Transitions Intervention; MaTI) co-designed by patients and healthcare staff. The purpose of the intervention was to optimise medicines management across the gaps between secondary and primary care when hospitals handover care. The study objectives were to (1) assess feasibility through meeting specified progression criteria to proceed to the trial, (2) assess if the intervention was acceptable to staff and patients, and (3) determine whether amendment or refinement would be needed to enhance the MaTI. Methods The feasibility of the MaTI was tested in three healthcare areas in the North of England between July and October 2017. Feasibility was measured and assessed through four agreed progression to trial criteria: (1) patient recruitment, (2) patient receipt of a medicines toolkit, (3) transfer of discharge information to community pharmacy, and (4) offer of a community pharmacy medicines review/discussion or medicines reconciliation. From the cardiology wards at each of the three NHS Acute Trusts (sites), 10 patients (aged ≥ 18 years) were recruited and introduced to the ‘My Medicines Toolkit’ (MMT). Patients were asked to identify their usual community pharmacy or nominate a pharmacy. Discharge information was transferred to the community pharmacy; pharmacists were asked to reconcile medicines and invited patients for a medicines use review (MUR) or discussion. At 1 month following discharge, all patients were sent three questionnaire sets: quality-of-life, healthcare utilisation, and a patient experience survey. In a purposive sample, 20 patients were invited to participate in a semi-structured interview about their experiences of the MaTI. Staff from hospital and primary care settings involved in patients’ care were invited to participate in a semi-structured interview. Patient and staff interviews were analysed using Framework Analysis. Questionnaire completion rates were recorded and data were descriptively analysed. Results Thirty-one patients were recruited across three sites. Eighteen staff and 18 patients took part in interviews, and 19 patients returned questionnaire sets. All four progression to trial criteria were met. We identified barriers to patient engagement with the intervention in hospital, which were compounded by patients’ focus on returning home. Some patients described not engaging in discussions with staff about medicines and lacking motivation to do so because they were preoccupied with returning home. Some patients were unable or unwilling to attend a community pharmacy in person for a medicines review. Roles and responsibilities for delivering the MaTI were different in the three sites, and staff reported variations in time spent on MaTI activities. Staff reported some work pressures and staff absences that limited the time they could spend talking to patients about their medicines. Clinical teams reported that recording a target dose for heart failure medicines in patient-held documentation was difficult as they did not always know the ideal or tolerable dose. The majority of patients reported receiving the patient-held documentation. More than two-thirds reported being offered a MUR by their community pharmacists. Conclusions Delivery of the Medicines at Transitions Intervention (MaTI) was feasible at all three sites, and progression to trial criteria were met. Refinements were found to be necessary to overcome identified barriers and strengthen delivery of all steps of the intervention. Necessary changes to the MaTI were identified along with amendments to the implementation plan for the subsequent trial. Future implementation needs to take into account the complexity of medicines management and adaptation to local context.

Abstract Background Atrial fibrillation (AF) is common in older people with frailty and is associated with an increased risk of stroke and systemic embolism. Whilst oral anticoagulation is associated with a reduction in this risk, there is a lack of data on the safety and efficacy of direct oral anticoagulants (DOACs) in people with frailty. This study aims to report clinical outcomes of patients with AF in the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial by frailty status. Methods Post hoc analysis of 20,867 participants in the ENGAGE AF-TIMI 48 trial, representing 98.8% of those randomised. This double-blinded double-dummy trial compared two once-daily regimens of edoxaban (a DOAC) with warfarin. Participants were categorised as fit, living with pre-frailty, mild-moderate, or severe frailty according to a standardised index, based upon the cumulative deficit model. The primary efficacy endpoint was stroke or systemic embolism and the safety endpoint was major bleeding. Results A fifth (19.6%) of the study population had frailty (fit: n = 4459, pre-frailty: n = 12,326, mild-moderate frailty: n = 3722, severe frailty: n = 360). On average over the follow-up period, the risk of stroke or systemic embolism increased by 37% (adjusted HR 1.37, 95% CI 1.19–1.58) and major bleeding by 42% (adjusted HR 1.42, 1.27–1.59) for each 0.1 increase in the frailty index (four additional health deficits). Edoxaban was associated with similar efficacy to warfarin in every frailty category, and a lower risk of bleeding than warfarin in all but those living with severe frailty. Conclusions Edoxaban was similarly efficacious to warfarin across the frailty spectrum and was associated with lower rates of bleeding except in those with severe frailty. Overall, with increasing frailty, there was an increase in stroke and bleeding risk. There is a need for high-quality, frailty-specific population randomised control trials to guide therapy in this vulnerable population. Trial registration ClinicalTrials.gov NCT00781391 . First registered on 28 October 2008

Background Deaths in the first year of the Coronavirus Disease 2019 (COVID-19) pandemic in England and Wales were unevenly distributed socioeconomically and geographically. However, the full scale of inequalities may have been underestimated to date, as most measures of excess mortality do not adequately account for varying age profiles of deaths between social groups. We measured years of life lost (YLL) attributable to the pandemic, directly or indirectly, comparing mortality across geographic and socioeconomic groups. Methods and findings We used national mortality registers in England and Wales, from 27 December 2014 until 25 December 2020, covering 3,265,937 deaths. YLLs (main outcome) were calculated using 2019 single year sex-specific life tables for England and Wales. Interrupted time-series analyses, with panel time-series models, were used to estimate expected YLL by sex, geographical region, and deprivation quintile between 7 March 2020 and 25 December 2020 by cause: direct deaths (COVID-19 and other respiratory diseases), cardiovascular disease and diabetes, cancer, and other indirect deaths (all other causes). Excess YLL during the pandemic period were calculated by subtracting observed from expected values. Additional analyses focused on excess deaths for region and deprivation strata, by age-group. Between 7 March 2020 and 25 December 2020, there were an estimated 763,550 (95% CI: 696,826 to 830,273) excess YLL in England and Wales, equivalent to a 15% (95% CI: 14 to 16) increase in YLL compared to the equivalent time period in 2019. There was a strong deprivation gradient in all-cause excess YLL, with rates per 100,000 population ranging from 916 (95% CI: 820 to 1,012) for the least deprived quintile to 1,645 (95% CI: 1,472 to 1,819) for the most deprived. The differences in excess YLL between deprivation quintiles were greatest in younger age groups; for all-cause deaths, a mean of 9.1 years per death (95% CI: 8.2 to 10.0) were lost in the least deprived quintile, compared to 10.8 (95% CI: 10.0 to 11.6) in the most deprived; for COVID-19 and other respiratory deaths, a mean of 8.9 years per death (95% CI: 8.7 to 9.1) were lost in the least deprived quintile, compared to 11.2 (95% CI: 11.0 to 11.5) in the most deprived. For all-cause mortality, estimated deaths in the most deprived compared to the most affluent areas were much higher in younger age groups, but similar for those aged 85 or over. There was marked variability in both all-cause and direct excess YLL by region, with the highest rates in the North West. Limitations include the quasi-experimental nature of the research design and the requirement for accurate and timely recording. Conclusions In this study, we observed strong socioeconomic and geographical health inequalities in YLL, during the first calendar year of the COVID-19 pandemic. These were in line with long-standing existing inequalities in England and Wales, with the most deprived areas reporting the largest numbers in potential YLL. In a registry-based study, Evangelos Kontopantelis and colleagues examine the excess years of life lost to COVID-19 and other causes of death by sex, neighbourhood deprivation and region in England & Wales during 2020. Author summary Why was this study done? The Coronavirus Disease 2019 (COVID-19) pandemic generated large numbers of excess deaths (additional deaths over those predicted from trends in previous years). These excess deaths were also unevenly distributed across different geographic areas and socioeconomic groups, exacerbating prepandemic inequalities. Up to a quarter of the excess deaths during the pandemic were attributable to coronary heart disease, dementia, and other noninfectious causes, and not directly to COVID-19 infection. Most measures of excess deaths do not fully account for differences in the ages at which people die in different social groups. If the pandemic killed disproportionally more young people in more deprived areas, then inequalities resulting from the pandemic will have been underestimated. Measuring years of life lost (YLL) rather than excess deaths would address this problem. What did the researchers do and find? In England and Wales, there were an estimated 763,550 (95% CI: 696,826 to 830,273) excess YLL during the first 42 weeks of the pandemic, of which 15% were not directly attributed to COVID-19 or another respiratory cause. For all-cause mortality, estimated deaths in the most deprived compared to the most affluent areas were as follows: 11 times as many for 15- to 44-year-olds, 3 times as many for 45- to 64-year-olds, 40% higher in 75- to 84-year-olds, and not significantly higher for those aged 85 or over. This pattern of disproportionately higher mortality in younger age groups exacerbated prepandemic inequalities between the most and least deprived areas, and varied widely across regions, with the North West particularly affected. What do these findings mean? Inequalities between socioeconomic and geographic groups resulting from the COVID-19 pandemic are more pronounced than previously reported. Future plans to manage pandemics, including decisions about vaccination rollout, should include an understanding of regional and socioeconomic variation in YLL and how this has exacerbated long-standing health inequalities. Immediate and longer-term recovery planning for communities and their health and social services should reflect historical disparities as well as the impact of the pandemic on YLL. Limitations of this study include the observational nature of the data and the need for accurate and timely recording of the deaths and their causes.

Abstract Background Comorbidity is common and has a substantial negative impact on the prognosis of patients with acute myocardial infarction (AMI). Whilst receipt of guideline-indicated treatment for AMI is associated with improved prognosis, the extent to which comorbidities influence treatment provision its efficacy is unknown. Therefore, we investigated the association between treatment provision for AMI and survival for seven common comorbidities. Methods We used data of 693,388 AMI patients recorded in the Myocardial Ischaemia National Audit Project (MINAP), 2003–2013. We investigated the association between comorbidities and receipt of optimal care for AMI (receipt of all eligible guideline-indicated treatments), and the effect of receipt of optimal care for comorbid AMI patients on long-term survival using flexible parametric survival models. Results A total of 412,809 [59.5%] patients with AMI had at least one comorbidity, including hypertension (302,388 [48.7%]), diabetes (122,228 [19.4%]), chronic obstructive pulmonary disease (COPD, 89,221 [14.9%]), cerebrovascular disease (51,883 [8.6%]), chronic heart failure (33,813 [5.6%]), chronic renal failure (31,029 [5.0%]) and peripheral vascular disease (27,627 [4.6%]). Receipt of optimal care was associated with greatest survival benefit for patients without comorbidities (HR 0.53, 95% CI 0.51–0.56) followed by patients with hypertension (HR 0.60, 95% CI 0.58–0.62), diabetes (HR 0.83, 95% CI 0.80–0.87), peripheral vascular disease (HR 0.85, 95% CI 0.79–0.91), renal failure (HR 0.89, 95% CI 0.84–0.94) and COPD (HR 0.90, 95% CI 0.87–0.94). For patients with heart failure and cerebrovascular disease, optimal care for AMI was not associated with improved survival. Conclusions Overall, guideline-indicated care was associated with improved long-term survival. However, this was not the case in AMI patients with concomitant heart failure or cerebrovascular disease. There is therefore a need for novel treatments to improve outcomes for AMI patients with pre-existing heart failure or cerebrovascular disease.

BackgroundDashboards can support data-driven quality improvements in health care. They visualize data in ways intended to ease cognitive load and support data comprehension, but how they are best integrated into working practices needs further investigation. ObjectiveThis paper reports the findings of a realist evaluation of a web-based quality dashboard (QualDash) developed to support the use of national audit data in quality improvement. MethodsQualDash was co-designed with data users and installed in 8 clinical services (3 pediatric intensive care units and 5 cardiology services) across 5 health care organizations (sites A-E) in England between July and December 2019. Champions were identified to support adoption. Data to evaluate QualDash were collected between July 2019 and August 2021 and consisted of 148.5 hours of observations including hospital wards and clinical governance meetings, log files that captured the extent of use of QualDash over 12 months, and a questionnaire designed to assess the dashboard’s perceived usefulness and ease of use. Guided by the principles of realist evaluation, data were analyzed to understand how, why, and in what circumstances QualDash supported the use of national audit data in quality improvement. ResultsThe observations revealed that variation across sites in the amount and type of resources available to support data use, alongside staff interactions with QualDash, shaped its use and impact. Sites resourced with skilled audit support staff and established reporting systems (sites A and C) continued to use existing processes to report data. A number of constraints influenced use of QualDash in these sites including that some dashboard metrics were not configured in line with user expectations and staff were not fully aware how QualDash could be used to facilitate their work. In less well-resourced services, QualDash automated parts of their reporting process, streamlining the work of audit support staff (site B), and, in some cases, highlighted issues with data completeness that the service worked to address (site E). Questionnaire responses received from 23 participants indicated that QualDash was perceived as useful and easy to use despite its variable use in practice. ConclusionsWeb-based dashboards have the potential to support data-driven improvement, providing access to visualizations that can help users address key questions about care quality. Findings from this study point to ways in which dashboard design might be improved to optimize use and impact in different contexts; this includes using data meaningful to stakeholders in the co-design process and actively engaging staff knowledgeable about current data use and routines in the scrutiny of the dashboard metrics and functions. In addition, consideration should be given to the processes of data collection and upload that underpin the quality of the data visualized and consequently its potential to stimulate quality improvement. International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2019-033208

Introduction Multimorbidity is widely recognised as the presence of two or more concurrent long-term conditions, yet remains a poorly understood global issue despite increasing in prevalence.We have created the Wales Multimorbidity e-Cohort (WMC) to provide an accessible research ready data asset to further the understanding of multimorbidity. Our objectives are to create a platform to support research which would help to understand prevalence, trajectories and determinants in multimorbidity, characterise clusters that lead to highest burden on individuals and healthcare services, and evaluate and provide new multimorbidity phenotypes and algorithms to the National Health Service and research communities to support prevention, healthcare planning and the management of individuals with multimorbidity.Methods and analysis The WMC has been created and derived from multisourced demographic, administrative and electronic health record data relating to the Welsh population in the Secure Anonymised Information Linkage (SAIL) Databank. The WMC consists of 2.9 million people alive and living in Wales on the 1 January 2000 with follow-up until 31 December 2019, Welsh residency break or death. Published comorbidity indices and phenotype code lists will be used to measure and conceptualise multimorbidity.Study outcomes will include: (1) a description of multimorbidity using published data phenotype algorithms/ontologies, (2) investigation of the associations between baseline demographic factors and multimorbidity, (3) identification of temporal trajectories of clusters of conditions and multimorbidity and (4) investigation of multimorbidity clusters with poor outcomes such as mortality and high healthcare service utilisation.Ethics and dissemination The SAIL Databank independent Information Governance Review Panel has approved this study (SAIL Project: 0911). Study findings will be presented to policy groups, public meetings, national and international conferences, and published in peer-reviewed journals.

BackgroundAlthough many studies have described patient-level risk factors for outcomes in heart failure (HF), health care structural determinants remain largely unexplored. This research reports patient-, hospital- and country-level characteristics associated with 1-year all-cause mortality among patients with chronic HF, and investigates geographic and hospital variation in mortality.Methods and findingsWe included 9,277 patients with chronic HF enrolled between May 2011 and November 2017 in the prospective cohort study European Society of Cardiology Heart Failure Long Term registry across 142 hospitals, located in 22 countries. Mean age of the selected outpatients was 65 years (sd 13.2) and 28% were female. The all-cause 1-year mortality rate per 100 person-years was 7.1 (95% confidence interval (CI) 6.6-7.7), and varied between countries (median 6.8, IQR 5.6-11.2) and hospitals (median 7.8, IQR 5.2-12.4). Mortality was associated with age (incidence rate ratio 1.03, 95% CI 1.02-1.04), diabetes mellitus (1.37, 1.15-1.63), peripheral artery disease (1.56, 1.27-1.92), New York Heart Association class III/IV (1.91, 1.60-2.30), treatment with angiotensin-converting enzyme inhibitor and angiotensin receptor antagonists (0.71, 0.57-0.87) and HF clinic (0.64, 0.46-0.89). No other hospital-level characteristics, and no country-level healthcare characteristics were associated with 1-year mortality, with case-mix standardised variance between countries being very low (1.83e-06) and higher for hospitals (0.372).ConclusionsAll-cause mortality at 1 year among outpatients with chronic HF varies between countries and hospitals, and is associated with patient characteristics and the availability of hospital HF clinics. After full adjustment for clinical, hospital and country variables, between-country variance was negligible while between-hospital variance was evident.

Background Studies have reported significant reduction in acute myocardial infarction–related hospitalizations during the coronavirus disease 2019 (COVID‐19) pandemic. However, whether these trends are associated with increased incidence of out‐of‐hospital cardiac arrest (OHCA) in this population is unknown. Methods and Results Acute myocardial infarction hospitalizations with OHCA during the COVID‐19 period (February 1–May 14, 2020) from the Myocardial Ischaemia National Audit Project and British Cardiovascular Intervention Society data sets were analyzed. Temporal trends were assessed using Poisson models with equivalent pre–COVID‐19 period (February 1–May 14, 2019) as reference. Acute myocardial infarction hospitalizations during COVID‐19 period were reduced by >50% (n=20 310 versus n=9325). OHCA was more prevalent during the COVID‐19 period compared with the pre–COVID‐19 period (5.6% versus 3.6%), with a 56% increase in the incidence of OHCA (incidence rate ratio, 1.56; 95% CI, 1.39–1.74). Patients experiencing OHCA during COVID‐19 period were likely to be older, likely to be women, likely to be of Asian ethnicity, and more likely to present with ST‐segment–elevation myocardial infarction. The overall rates of invasive coronary angiography (58.4% versus 71.6%; P

Aims To (1) Describe the sociodemographic and risk factor profiles of a sample of patients with coronary disease, (2) Explore associations between illness perceptions and health literacy with sociodemographic characteristics and risk factors, health-related quality of life (HRQoL), anxiety, and depression. Methods and results Conducted as part of the ESC Prevention of CVD Project and EUROASPIRE V survey, patients were consecutively and retrospectively identified 6 months to 2 years after an acute event or elective procedure from 12 countries and interviewed. Three thousand four hundred and eight participants (76% male, mean age 64 years) were recruited, 16% were smokers, 38% obese, 60% physically inactive, and 41% hypertensive. Forty percent had attended cardiac rehabilitation. More threatening illness perceptions were associated with female gender (P<0.0001), lower income (P< 0.0001), lower education (P=0.02), obesity (P<0.0001), sedentary behaviour (P<0.0001), and diabetes (P<0.0001). Poorer health literacy was associated with obesity (P=0.02) and sedentary behaviour (P=0.0001). Threatening illness perceptions were strongly associated with anxiety, depression, and poorer ratings of HRQoL after multivariable adjustment (all P<0.001). Poor health literacy was associated with anxiety and depression (P< 0.0001) and poorer ratings of HRQoL (HeartQol scores P= 0.03). Results were consistent across regions of Europe, age, gender, and socio-economic strata. Conclusions Interventions like cardiac rehabilitation should be targeted at vulnerable groups given the strong associations between more threatening illness perceptions, lower health literacy, lower HRQoL, and higher levels of anxiety and depression. The delivery and content of these interventions should be accessible for those with low health literacy. [ABSTRACT FROM AUTHOR]

Background Bleeding risk stratification in acute coronary syndrome is of highest clinical interest but current risk scores have limitations. We sought to develop and validate a new in‐hospital bleeding risk score for patients with acute myocardial infarction. Methods and Results From the nationwide SWEDEHEART (Swedish Web‐System for Enhancement and Development of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies) register, 97,597 patients with acute myocardial infarction enrolled from 2009 until 2014 were selected. A full model with 23 predictor variables and 8 interaction terms was fitted using logistic regression. The full model was approximated by a model with 5 predictors and 1 interaction term. Calibration, discrimination, and clinical utility was evaluated and compared with the ACTION (Acute Coronary Treatment and Intervention Outcomes Network) and CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) scores. Internal and temporal validity was assessed. In‐hospital major bleeding, defined as fatal, intracranial, or requiring surgery or blood transfusion, occurred in 1356 patients (1.4%). The 5 predictors in the approximate model that constituted the SWEDEHEART score were hemoglobin, age, sex, creatinine, and C‐reactive protein. The ACTION and CRUSADE scores were poorly calibrated in the derivation cohort and therefore were recalibrated. The SWEDEHEART score showed higher discriminative ability than both recalibrated scores, overall (C‐index 0.80 versus 0.73/0.72) and in all predefined subgroups. Decision curve analysis demonstrated consistently positive and higher net benefit for the SWEDEHEART score compared with both recalibrated scores across all clinically relevant decision thresholds. The original ACTION and CRUSADE scores showed negative net benefit. Conclusions The 5‐item SWEDEHEART score discriminates in‐hospital major bleeding in patients with acute myocardial infarction and has superior model performance compared with the recalibrated ACTION and CRUSADE scores.