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Risultati per: Standard Italiani per la cura del diabete mellito
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Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)
Introduction
Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.
Methods and analysis
The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.
The trial will be delivered by a multidisciplinary research team through a series of five work packages.
The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.
Ethics and dissemination
The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.
Trial registration number
ISRCTN13296529.
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Abstract 19151: Late Gadolinium Enhancement (LGE) in Recurrent Pericarditis Patients on Il-1 Blockers and Standard Anti-Inflammatory Therapy
Circulation, Volume 148, Issue Suppl_1, Page A19151-A19151, November 6, 2023. Introduction:Recurrent pericarditis is defined as the recurrence of pericarditis after a symptom-free interval of 4-6 weeks. Our study aimed to investigate the improvement in the late gadolinium enhancement on cardiac resonance imaging (CMR) in recurrent patients on IL-1 blockers and standard anti-inflammatory therapy.Hypothesis:We hypothesize that patients on IL-1 inhibitor show a better improvement of LGE on CMR in recurrent pericarditis.Methods:This is a retrospective comparative cohort study of 37 recurrent pericarditis patients on IL-1 inhibitor and 107 recurrent pericarditis patients on standard anti-inflammatory therapy. We included patients with LGE tracing and compared both groups. Patients were treated for at least 12 months and were followed for a duration minimum of 12 months.Results:The patients’ mean age in the IL-1 inhibitor group was 51.16 ±16, and the standard therapy group was 54.26 ± 14.32. Patients had a median baseline ESR of 5 mm/hr and median hs-CRP of 2.2 mg/L in the IL-1 inhibitor group and a median baseline ESR of 7.5 mm/hr and median hs-CRP of 1.5 mg/L in the standard therapy group. At baseline, patients in the IL-1 inhibitor group had 5.4% none LGE, 43.24% mild LGE, 37.83% moderate LGE, and 13.5% severe LGE. Over the follow-up of 12-24 months, IL-1 inhibitor patients had improvement in LGE, with 35.13% of patients having none LGE and 64.86% having mild LGE. In the standard group, 27.1% had none LGE, 54.2% had mild LGE, 15.88% had moderate LGE, and 2.8% had severe LGE at baseline. Over 12-24 months follow-up, standard therapy group patients had some improvement as well as worsening of LGE in some patients, with 35.51% having none LGE, 59.81% having mild LGE, and 4.6% having moderate LGE.Conclusions:IL-1 inhibitors serve as a competitive antagonist of IL-1 cytokine and block its pro-inflammatory functions. Pericardial delayed enhancement is significant in determining disease course and improvement in patients with pericarditis.
Abstract 13881: Coronary Artery Calcium as a Risk Marker in Patients With Myocardial Infarction but Without Standard Modifiable Risk Factors (SMuRF-Less)
Circulation, Volume 148, Issue Suppl_1, Page A13881-A13881, November 6, 2023. Introduction:Recent publications have reported that myocardial infarction (MI) patients (pts) without standard modifiable risk factors (SMuRF-less) are surprisingly common (14-27%) and have a notable risk of adverse outcomes. These reports raise the question of how these pts can be identified in advance and provided with effective preventive therapies (e.g., statins, aspirin).Methods:Pts presenting between 2001-2021 to Intermountain Healthcare catheterization laboratories with a diagnosis of MI were included if they also had a coronary artery calcium scan (CACS) by computed tomography within 2 years. SMuRF included a clinical diagnosis of, or treatment for, hypertension, hyperlipidemia, diabetes, and/or smoking. The co-primary endpoints for this study were the proportion of patients with an elevated ( >50%ile) CACS score (MESA criteria) and the presence of an indication for statin therapy with or without aspirin (i.e., >=75%ile score or CAC >=100 AU). Major adverse cardiovascular event (MACE) outcomes at 60-days and long-term were evaluated and compared to MI pts with SMuRF.Results:We identified 429 MI pts with a concurrent CACS, of which 60 were SMuRF-less and 369 had SMuRF. The 2 groups were similar in age, sex, most risk factors, and interventions, but fewer SMuRF-less pts had a history of heart failure or a family history (Table 1). SMuRF-less pts had a high prevalence and an increased percentile of CAC (82% >=50%ile; median, 80%ile;), and 77% met criteria for preventive therapy. Pts with SMuRF, as expected, had high CAC scores and percentiles (Table 1). Outcomes were more favorable for SMuRF-less status (Table 2A) and for lower CAC scores (Table 2B).Conclusions:Despite absence of SMuRF, SMuRF-less pts presenting with an MI have a high prevalence and percentile of CAC. Wider application of CACS, to include those without SMuRF, appears promising as a method to identify an additional at-risk population for consideration of preventive therapy.
Abstract 14701: Agreement Between Handheld and Standard Echocardiography for Diagnosis of Latent Rheumatic Heart Disease in Brazilian Schoolchildren From High-Prevalence Settings
Circulation, Volume 148, Issue Suppl_1, Page A14701-A14701, November 6, 2023. Background:Handheld echocardiography (echo) is the tool of choice for Rheumatic Heart Disease (RHD) screening, based on the 2012 World Heart Federation (WHF) Criteria. We aimed to assess the agreement between screening and standard echo for diagnosis of latent RHD in schoolchildren from an endemic setting.Methods:Over 14 months, 3 non-physicians used handheld machines (GE, VSCAN) and the 2012 WHF Criteria to determine RHD prevalence in low-income public schools in Minas Gerais, Southeast Brazil. Consented children were eligible for participation. Studies were interpreted remotely using a telemedicine cloud-server by 2 experts in Brazil and the US. RHD-positive children (borderline and definite) and those with congenital heart disease (CHD) were referred for standard echo with portable devices (GE, Vivid IQ), with acquisition and interpretation by an expert cardiologist. Agreement between screening and standard echo, by category and according to the WHD criteria, was assessed, and the kappa statistic was applied.Results:A total of 1,390 students were screened in 6 schools and, among these, 110 (7.9%, 95% CI 6.5 – 9.5) were screen-positive and referred for standard echo, with mean age of 14±2 years, 80 (72%) women. Among the 16 cases initially diagnosed as definite RHD, 11 (69%) were confirmed, 4 (25%) reclassified to borderline and 1 to normal. Among the 79 cases flagged as borderline RHD, 19 (24%) were confirmed, 50 (63%) reclassified to normal, 8 (10%) to definite RHD and 2 had mild CHD. Among 11 children with CHD in screening, 4 were confirmed, 5 were reclassified to normal and 2 to RHD. Considering the 4 diagnostic categories, kappa was 0.18. In patients with borderline RHD reclassified to non-RHD, the most frequent WHF criteria was B (isolated mitral regurgitation): 64%, followed by A (2 morphological features of the mitral valve): 31%. In the only patient with definite RHD reclassified to normal, WHF criteria was D (borderline RHD in aortic and mitral valves). After standard echo, RHD prevalence was 3.2% (95% CI 2.3 – 4.2).Conclusions:Although practical, RHD screening with handheld devices tend to overestimate prevalence. Even in endemic settings, continuous education for detection, and application of risk stratification for management are crucial.
Abstract 17590: Association of Intensive vs Standard Blood Pressure Lowering With 1-year and 2-year Changes in Cardiac Biomarker Levels: Findings From SPRINT
Circulation, Volume 148, Issue Suppl_1, Page A17590-A17590, November 6, 2023. Background:The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that intensive systolic blood pressure (SBP) lowering was associated with marked reductions in cardiovascular disease (CVD) endpoints. We recently reported that intensive SBP lowering was also associated with a small increase in high-sensitivity cardiac troponin T (hs-cTnT) and a large decrease in N-terminal pro-B-type natiuretic peptide (NT-proBNP) over 1-year. However, data on longer term biomarker changes with intensive versus standard SBP lowering have not been previously reported.Methods:hs-cTnT and NT-proBNP were measured at baseline, 1 year, and 2 years from stored specimens in SPRINT participants. Changes in biomarkers were evaluated continuously on the log scale with interval censoring of participants with CVD events. The effect of intensive SBP lowering on biomarker changes was assessed using linear regression models with treatment effects reported as geometric mean ratios.Results:Of 9,361 SPRINT participants, hs-cTnT and NT-proBNP were measured in 8,828 (baseline), 7,887 (Year 1), and 7,463 (Year 2) free of CVD events. Intensive SBP lowering led to a 3% increase in log-transformed hs-cTnT from baseline to Year 1, but there was no significant change observed from baseline to Year 2. In contrast, intensive SBP lowering led to a consistent 10% decrease in NT-proBNP from baseline to Year 1 and to Year 2. NT-proBNP levels increased slightly from Year 1 to Year 2 in both treatment arms such that the 1-Year treatment effect for intensive SBP lowering was maintained to Year 2 (see Table).Conclusions:Intensive SBP lowering was associated with a transient, modest increase in hscTnT at Year 1 that was no longer present at Year 2. In contrast, intensive SBP lowering was associated with a persistent reduction in NT-proBNP at both 1 and 2 years follow-up. These findings highlight the complex responses of cardiac biomarkers to intensive SBP lowering.
Abstract 12720: A Nationwide Multi Center Study From China, Comparing Long-Term and Standard Cardiopulmonary Resuscitation: Epidemiology, Risk Factors, and Outcomes
Circulation, Volume 148, Issue Suppl_1, Page A12720-A12720, November 6, 2023. Introduction:The association between the duration of cardiopulmonary resuscitation (CPR) and patient outcomes remains largely unknown.Hypothesis:long-term CPR (LCPR) may benefit certain group of patients.Methods:In this retrospective cohort study, data from the Chinese Emergency Triage Assessment and Treatment database 1.0 (CETAT 1.0) were utilized. The study included CA patients admitted to 14 teaching hospitals in 7 provinces between July 2015 and July 2020. Patients were categorized into SCPR and LCPR groups based on the duration of resuscitation, where SCPR referred to CPR duration less than 60 mins, and LCPR referred to CPR duration equal to or more than 60 mins. The primary outcome measured was ROSC rates between the two groups, while the secondary and tertiary outcomes was 24-hour and 7-day survival rates. A multivariate logistic regression model was employed to analyze the factors influencing ROSC between groups.Results:A total of 529 patients were enrolled in the study, with 372 in the SCPR group and 157 in the LCPR group. Among them, 126 (33.9%) patients in the SCPR group and 56 (35.7%) in the LCPR group achieved ROSC without statistically difference between groups. Furthermore, 31 patients (8.3%) in the SCPR group and 7 patients (4.5%) in the LCPR group survived at 24 hours, while 13 patients (3.5%) in SCPR and 4 patients (2.5%) in LCPR group survived at 7 days, both without statistical difference. Factors associated with SCPR operation included Lower BMI, previous hypertension, daytime admission, hands-only compression, and ventilation. SpO2 and PETCO2 were independent factors associated with ROSC, Moreover, in both groups higher SpO2 and PETCO2 levels were associated with a higher rate of ROSC, suggesting that for this specific patient cohort, longer duration of CPR should be considered.Conclusions:Longer duration of CPR may need to be emphasize for certain group of patients, particularly those with high SpO2 and PET CO2 during CPR.
Abstract 14724: Health Status and Long-Term Outcomes After Acute Myocardial Infarction in Patients Without Standard Modifiable Risk Factors
Circulation, Volume 148, Issue Suppl_1, Page A14724-A14724, November 6, 2023. Background:Prior studies examining patients who experienced acute myocardial infarction (AMI) as their initial presentation of coronary disease have shown that those without Standard Modifiable Risk Factors (SMuRF; diabetes, dyslipidemia, hypertension, and smoking) had worse in-hospital but better long-term survival than those with SMuRFs. However, the health status outcomes, patients’ symptoms, function, and quality of life among those without SMuRF are unknown.Research questions:Are there differences in long-term health status and mortality between patients who survived hospitalization following AMI with and without SMuRFs?Methods:We analyzed data from two prospective registries, PREMIER and TRIUMPH, comprising patients hospitalized to 31 US hospitals with AMI between 2003-2008. We compared the clinical characteristics, 1-year health status (with the Seattle Angina Questionnaire [SAQ]), and 5-year all-cause mortality between patients with and without SMuRFs. Patients with prior coronary artery disease were excluded. We used hierarchical linear mixed models for health status outcomes and Cox-proportional hazard models for mortality, adjusted for clinical and sociodemographic characteristics, including baseline SAQ scores.Results:Among 4076 patients with AMI (mean age 58.4±12.4 years, 34% female, 22% Black), 569 (13.9%) presented without SMuRFs. Despite similar mean age, patients without SMuRFs were more likely to be male, Non-Hispanic White, have higher income and education, fewer depressive symptoms, and higher SAQ Summary Scores at baseline (83.5±13.2 vs. 79.6±16.5). At 1-year follow-up, patients without SMuRFs had higher SAQ Summary Scores (93.9±10.1 vs. 89.9±14.7), although the difference between groups was attenuated after adjustment (1.69 points, 95% CI 0.40-1.97). Furthermore, there were no significant differences in all-cause mortality over 5 years between groups (adjusted HR= 0.83, 95% CI: 0.59-1.16). Notably, besides sex or race category, a higher incomes and better depression status were negative independent predictors for health status and clinical outcomes.Conclusions:AMI survivors, both with and without SMuRFs, had comparable long-term health status and survival after rigorous adjustment.
Abstract 17703: Sequential Validation of a Cuffless Photoplethysmography-Based Wristband for Blood Pressure Measurement: Algorithm Building to Regulatory Standard Trial
Circulation, Volume 148, Issue Suppl_1, Page A17703-A17703, November 6, 2023. Introduction:Hypertension increases cardiovascular risk. Measuring reliable blood pressure (sBP and dBP for systolic and diastolic BP) is challenging. A photoplethysmography (PPG)-based wristband with a custom BP algorithm could provide continuous BP. The algorithm was made by PPG channel aggregation, band-pass filtering and segment creation and evaluated the different PPG colors. Noise and interference were removed. PPG segments were created with a quality factor based on pulse quality. The AI model learned patterns from structured data, including pre-processed features and initialization measurements, ranking their importance.Hypothesis:cuffless PPG-based-wristband method for continuous BP monitoring is compatible with ISO 81060-2:2019.Methods:Compare PPG-guided BP algorithm predictions with subclavian arterial reference measurements during cardiac catheterization. Consecutive patients meeting ISO 81060-2:2019 criteria were included. Reference measurements used a validated invasive BP device (100Hz). PPG signals were collected at 128Hz using six light emission diodes and two photodiodes. Three initialization measurements with a validated cuff were taken before catheterization. Machine learning-based BP algorithm utilized 100+ features. Correlation, mean error, and standard deviation (SD) and sBP and dBP were determined.Results:97 patients provided 420 samples. Mean age, weight, and height were 67 years, 183.7 lbs, and 5’8.5″ respectively. sBP swas ≤100mmHg (11%) and ≥160mmHg (25%). dBP was ≤70mmHg (53%) and ≥85mmHg (24%). BP algorithm predictions correlated strongly with reference measurements for sBP (r = 0.985) and dBP (r = 0.961) BP. Mean error was ±3.7mmHg (SD 4.4 mmHg) for sBP and ±2.5mmHg (SD 3.7 mmHg) for dBP. Results were consistent across gender and skin color categories (Fitzpatrick I-VI), but also for different strata of BP values.Conclusions:Wristband-based PPG with the developed BP algorithm provides accurate continuous BP monitoring across various BP ranges. It offers a valid and less burdensome alternative to cuff BP measurements for in-hospital and at-home monitoring. Further research is needed to evaluate algorithm precision during movement and for long-term prediction stability.