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Search Results for: Ipotesi sull’origine di Omicron e sua evoluzione
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Accuracy of the Canadian COVID-19 Mortality Score (CCMS) to predict in-hospital mortality among vaccinated and unvaccinated patients infected with Omicron: a cohort study
Objective
The objective is to externally validate and assess the opportunity to update the Canadian COVID-19 Mortality Score (CCMS) to predict in-hospital mortality among consecutive non-palliative COVID-19 patients infected with Omicron subvariants at a time when vaccinations were widespread.
Design
This observational study validated the CCMS in an external cohort at a time when Omicron variants were dominant. We assessed the potential to update the rule and improve its performance by recalibrating and adding vaccination status in a subset of patients from provinces with access to vaccination data and created the adjusted CCMS (CCMSadj). We followed discharged patients for 30 days after their index emergency department visit or for their entire hospital stay if admitted.
Setting
External validation cohort for CCMS: 36 hospitals participating in the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN). Update cohort for CCMSadj: 14 hospitals in CCEDRRN in provinces with vaccination data.
Participants
Consecutive non-palliative COVID-19 patients presenting to emergency departments.
Main outcome measures
In-hospital mortality.
Results
Of 39 682 eligible patients, 1654 (4.2%) patients died. The CCMS included age, sex, residence type, arrival mode, chest pain, severe liver disease, respiratory rate and level of respiratory support and predicted in-hospital mortality with an area under the curve (AUC) of 0.88 (95% CI 0.87 to 0.88) in external validation. Updating the rule by recalibrating and adding vaccination status to create the CCMSadj changed the weights for age, respiratory status and homelessness, but only marginally improved its performance, while vaccination status did not. The CCMSadj had an AUC of 0.91 (95% CI 0.89 to 0.92) in validation. CCMSadj scores of 56.8%.
Conclusions
The CCMS remained highly accurate in predicting mortality from Omicron and improved marginally through recalibration. Adding vaccination status did not improve the performance. The CCMS can be used to inform patient prognosis, goals of care conversations and guide clinical decision-making for emergency department patients with COVID-19.
Abstract 4139661: Usefulness of High-sensitive Troponin I and N-terminal pro-B-type Natriuretic Peptide in Coronavirus Disease 2019 Risk Stratification on and after Omicron Variant Waves: COVID-MI Registry Cohort-2 Analysis
Circulation, Volume 150, Issue Suppl_1, Page A4139661-A4139661, November 12, 2024. Introduction:Troponin-defined myocardial injury or N-terminal pro-B-type natriuretic peptide (NT-proBNP) elevation frequently coincides with coronavirus disease 2019 (COVID-19). Our prior study (COVID-MI Registry Cohort-1) confirmed that high-sensitive troponin I (HsTnI) and NT-proBNP effectively stratified mortality risk. However, variants of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) change rapidly, and it remains unclear whether these biomarkers are consistently effective in predicting prognosis of COVID-19 patients irrespective of epidemic periods.Research Questions:Can HsTnI or NT-proBNP stratify mortality risk in recent COVID-19 cohorts?Aims:To assess the potential of HsTnI and NT-proBNP levels for risk stratification in the recent COVID-19 waves.Methods:In the COVID-MI Registry Cohort-2, we enrolled 1115 consecutive COVID-19 patients admitted between October 2021 and October 2022, during the Omicron variant endemic. We collected data of HsTnI or NT-proBNP levels from hospital charts or using the samples in our hospital’s serum/plasma bank if the data were not available. The primary outcome measure was all-cause mortality.Results:On admission, more than one-third of patients were classified as having severe COVID-19. HsTnI and NT-proBNP levels were available for 427 and 414 patients, respectively. The median HsTnI and NT-proBNP levels were 16 (interquartile range [IQR]: 5-57) ng/L and 524 (IQR: 140-2056) pg/mL, respectively. We stratified the patients into three groups by HsTnI level:
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Patients surviving COVID-19 had lower risk for long COVID in the Omicron vs. earlier eras
Annals of Internal Medicine, Ahead of Print.
Patients surviving COVID-19 had lower risk for long COVID in the Omicron vs. earlier eras
Annals of Internal Medicine, Volume 177, Issue 11, Page JC131, November 2024.
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Development and validation of predictive models for mortality of cases with COVID-19 (Omicron BA.5.2.48 and B.7.14): a retrospective study
Objectives
With the emergence of new COVID-19 variants (Omicron BA.5.2.48 and B.7.14), predicting the mortality of infected patients has become increasingly challenging due to the continuous mutation of the virus. Existing models have shown poor performance and limited clinical utility. This study aims to identify the independent risk factors and develop practical predictive models for mortality among patients infected with new COVID-19 variants.
Design
A retrospective study.
Setting and participants
We extracted data from 1029 COVID-19 patients in the respiratory disease wards of a general hospital in China between 22 December 2022 and 15 February 2023.
Outcome measures
Mortality within 15 days after hospital discharge.
Results
A total of 987 cases with new COVID-19 variants (Omicron BA.5.2.48 and B.7.14) were eventually included, among them, 153 (15.5%) died. Non-invasive ventilation, intubation, myoglobin, international normalised ratio, age, number of diagnoses, respiratory rate, pulse, neutrophil count and albumin were the most important predictors of mortality among new COVID-19 variants. The area under the curve of logistic regression (LR), decision tree (DT) and Extreme Gradient Boosting (XGBoost) models were 0.959, 0.883 and 0.993, respectively. The diagnostic accuracy was 0.926 for LR, 0.918 for DT and 0.977 for XGBoost. XGBoost model had the highest sensitivity (0.908) and specificity (0.989).
Conclusion
Our study developed and validated three practical models for predicting mortality in patients with new COVID-19 variants. All models performed well, and XGBoost was the best-performing model.
Assessing the safety and pharmacokinetics of casirivimab and imdevimab (CAS+IMD) in a cohort of pregnant outpatients with COVID-19: results from an adaptive, multicentre, randomised, double-blind, phase 1/2/3 study
Objective
Pregnant women with COVID-19 are at elevated risk for severe outcomes, but clinical data on management of these patients are limited. Monoclonal antibodies, such as casirivimab plus imdevimab (CAS+IMD), have proven effective in treating non-pregnant adults with COVID-19, prompting further evaluation in pregnant women.
Methods
A phase 3 portion of an adaptive, multicentre, randomised, double-blind, placebo-controlled trial evaluated the safety, clinical outcomes, pharmacokinetics and immunogenicity of CAS+IMD (1200 mg or 2400 mg) in the treatment of pregnant outpatients with COVID-19 (NCT04425629). Participants were enrolled between December 2020 and November 2021, prior to the emergence of Omicron-lineage variants against which CAS+IMD is not active. Safety was evaluated in randomised participants who received study drug (n=80); clinical outcomes were evaluated in all randomised participants (n=82). Only two pregnant participants received placebo, limiting conclusions regarding treatment effect. Infants born to pregnant participants were followed for developmental outcomes ≤1 year of age.
Results
In pregnant participants, CAS+IMD was well tolerated, with no grade ≥2 hypersensitivity or infusion-related reactions reported. There were no participant deaths, and only one COVID-19–related medically attended visit. Although two pregnancies (3%) reported issues in the fetus/neonate, they were confounded by maternal history or considered to be due to an alternate aetiology. No adverse developmental outcomes in infants ≤1 year of age were considered related to in utero exposure to the study drug. CAS+IMD 1200 mg and 2400 mg rapidly and similarly reduced viral loads, with a dose-proportional increase in concentrations of CAS+IMD in serum. Pharmacokinetics were consistent with that reported in the general population. Immunogenicity incidence was low.
Conclusion
CAS+IMD treatment of pregnant outpatients with COVID-19 showed similar safety, clinical outcomes and pharmacokinetic profiles to that observed in non-pregnant adults. There was no evidence of an impact on developmental outcomes in infants ≤1 year of age.
Trial registration number
NCT04425629.
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