Immunogenicity of a third dose with mRNA-vaccines in the ChAdOx1-S/BNT162b2 vaccination regimen against SARS-CoV-2 variants.

CombiVacS study has demonstrated a strong immune response of the heterologous ChAdOx1-S/BNT162b2 vaccine combination. The primary outcomes of the study were to assess the humoral immune response against SARS-CoV-2, 28 days after a third dose of a mRNA vaccine, in subjects that received a previous prime-boost scheme with ChAdOx1-S/BNT162b2. Secondary outcomes extended the study to 3 and 6 months.

Prediction of individual lifetime cardiovascular risk and potential treatment benefit: development and recalibration of the LIFE-CVD2 model to four European risk regions.

Aims: The 2021 European Society of Cardiology prevention guidelines recommend the use of (lifetime) risk prediction models to aid decisions regarding initiation of prevention. We aimed to update and systematically recalibrate the LIFEtime-perspective CardioVascular Disease (LIFE-CVD) model to four European risk regions for the estimation of lifetime CVD risk for apparently healthy individuals.

Methods And Results: The updated LIFE-CVD (i.

Extremely missing numerical data in Electronic Health Records for machine learning can be managed through simple imputation methods considering informative missingness: A comparative of solutions in a COVID-19 mortality case study.

Background And Objective: Reusing Electronic Health Records (EHRs) for Machine Learning (ML) leads on many occasions to extremely incomplete and sparse tabular datasets, which can hinder the model development processes and limit their performance and generalization. In this study, we aimed to characterize the most effective data imputation techniques and ML models for dealing with highly missing numerical data in EHRs, in the case where only a very limited number of data are complete, as opposed to the usual case of having a reduced number of missing values.

Methods: We used a case study including full blood count laboratory data, demographic and survival data in the context of COVID-19 hospital admissions and evaluated 30 processing pipelines combining imputation methods with ML classifiers.

TransFAIR study: a European multicentre experimental comparison of EHR2EDC technology to the usual manual method for eCRF data collection.

Purpose: Regulatory authorities including the Food and Drug Administration and the European Medicines Agency are encouraging to conduct clinical trials using routinely collected data. The aim of the TransFAIR experimental comparison was to evaluate, within real-life conditions, the ability of the Electronic Health Records to Electronic Data Capture (EHR2EDC) module to accurately transfer from EHRs to EDC systems patients' data of clinical studies in various therapeutic areas.

Methods: A prospective study including six clinical trials from three different sponsors running in three hospitals across Europe has been conducted.

Geographical and Temporal Variability of Ultra-Processed Food Consumption in the Spanish Population: Findings from the DRECE Study.

The consumption of ultra-processed foods (UPFs) has increased in recent decades, worldwide. Evidence on the negative impacts of food processing on health outcomes has also been steadily increasing. The aim of this study is to describe changes in consumption patterns of ultra-processed foods in the Spanish population over time and their geographical variability.

The health status: the ignored risk factor in dementia incidence. NEDICES cohort.

Background: The causes of the dementia decrease in affluent countries are not well known but health amelioration could probably play a major role. Nevertheless, although many vascular and systemic disorders in adult life are well-known risk factors (RF) for dementia and Alzheimer disease (AD), health status is rarely considered as a single RF.

Aim: To analyse whether the health status and the self-perceived health (SPH) could be RF for dementia and AD and to discuss its biological basis.

Two Dimensions of Nutritional Value: Nutri-Score and NOVA.

Front-of-pack labels can improve the ability of consumers to identify which foods are healthier, making them a useful public health tool. Nutri-Score is a front-of-pack labelling system adopted by several European countries. This system ranks foods according to their nutritional quality, but does not consider other dimensions such as the degree of food processing.

Ultra-processed food intake and all-cause mortality: DRECE cohort study.

Objective: To determine the association between ultra-processed food (UPF) intake and all-cause mortality in a representative sample of Spanish population.

Design: Prospective cohort design in which follow-up lasted from baseline (1991) to mortality date or 31 December 2017, whichever was first. Dietary information was collected using a validated frequency questionnaire and categorised following the NOVA classification according to the extent of food processing.

Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial.

Background: To date, no immunological data on COVID-19 heterologous vaccination schedules in humans have been reported. We assessed the immunogenicity and reactogenicity of BNT162b2 (Comirnaty, BioNTech, Mainz, Germany) administered as second dose in participants primed with ChAdOx1-S (Vaxzevria, AstraZeneca, Oxford, UK).

Methods: We did a phase 2, open-label, randomised, controlled trial on adults aged 18-60 years, vaccinated with a single dose of ChAdOx1-S 8-12 weeks before screening, and no history of SARS-CoV-2 infection.

[Detection of adverse events in thyroid and parathyroid surgery using trigger tool and Minimum Basic Data Set (MBDS)].

Objectives: To compare the ability of the trigger tool) and the Minimum Basic Data Set (MBDS) in detecting adverse events (AE) in hospitalized surgical patients with thyroid and parathyroid disease.

Methods: A descriptive, cross-sectional observational study, retrospective and cross-sectional study was conducted from May 2014 to April 2015 analysing retrospectively data on of patients submitted to thyroidectomy and parathyroidectomy in order to detect AE through the identification of triggers (an event often associated to an AE) and the MBDS. triggers and AE were located by systematic review of clinical documentation.

Performances of a Solution to Semi-Automatically Fill eCRF with Data from the Electronic Health Record: Protocol for a Prospective Individual Participant Data Meta-Analysis.

Clinical trial data collection still relies on a manual entry from information available in the medical record. This process introduces delay and error risk. Automating data transfer from Electronic Health Record (EHR) to Electronic Data Capture (EDC) system, under investigators' supervision, would gracefully solve these issues.

Renal function at admission as a prognostic marker for patients hospitalised for a first episode of heart failure. Results of the PREDICE study.

Background And Objective: Heart failure (HF) is a frequent condition that deteriorates quality of life and results in high morbidity and mortality. A considerable number of studies have been implemented in recent years to determine the factors that affect the prognosis of HF; however, few studies have assessed the prognosis of patients hospitalised for their first episode of HF. The aim of our study was to analyse the prognostic impact of renal function on patients hospitalised for a first episode of HF.

Ivabradine for chronic heart rate control in persistent atrial fibrillation. Design of the BRAKE-AF project.

Introduction And Objectives: Ivabradine is an inhibitor of the If channel, the main determinant of the pacemaker function of the sinus node. The drug has been approved for the treatment of angina and heart failure. There is some evidence of its role as an inhibitor of atrial-ventricular node (AVN) conduction.

The prognosis of patients hospitalized with a first episode of heart failure, validation of two scores: PREDICE and AHEAD.

Purpose: Heart failure (HF) is a chronic, frequent and disabling condition but with a modifiable course and a large potential for improving. The aim of this study was to validate the two available clinical prediction rules for mortality at one year in patients with primo-hospitalization for decompensated HF: PREDICE and AHEAD. The secondary aim was to evaluate in our setting the changes in the clinical pattern of HF in the last decade in patients hospitalized for a first episode of the disease.

Cardiovascular Risk Factors Associated With Venous Thromboembolism.

Importance: It is uncertain to what extent established cardiovascular risk factors are associated with venous thromboembolism (VTE).

Objective: To estimate the associations of major cardiovascular risk factors with VTE, ie, deep vein thrombosis and pulmonary embolism.

Design, Setting, And Participants: This study included individual participant data mostly from essentially population-based cohort studies from the Emerging Risk Factors Collaboration (ERFC; 731 728 participants; 75 cohorts; years of baseline surveys, February 1960 to June 2008; latest date of follow-up, December 2015) and the UK Biobank (421 537 participants; years of baseline surveys, March 2006 to September 2010; latest date of follow-up, February 2016).

Equalization of four cardiovascular risk algorithms after systematic recalibration: individual-participant meta-analysis of 86 prospective studies.

Aims: There is debate about the optimum algorithm for cardiovascular disease (CVD) risk estimation. We conducted head-to-head comparisons of four algorithms recommended by primary prevention guidelines, before and after 'recalibration', a method that adapts risk algorithms to take account of differences in the risk characteristics of the populations being studied.

Methods And Results: Using individual-participant data on 360 737 participants without CVD at baseline in 86 prospective studies from 22 countries, we compared the Framingham risk score (FRS), Systematic COronary Risk Evaluation (SCORE), pooled cohort equations (PCE), and Reynolds risk score (RRS).

Variability of nutrients intake, lipid profile and cardiovascular mortality among geographical areas in Spain: The DRECE study.

It has often been suggested that cardiovascular mortality and their geographical heterogeneity are associated with nutrients intake patterns and also lipid profile. The large Spanish study Dieta y Riesgo de Enfermedades Cardiovasculares en España (DRECE) investigated this theory from 1991 to 2010. Out of the 4,783 Spanish individuals making up the DRECE cohort, 220 subjects (148 men and 72 women) died (4.

Improvement of serum lipids concentration in a general population historical cohort. Why?

Background: Knowledge about the harmful effects of high levels of low-density lipoprotein cholesterol (cLDL) in adults increased after the publication of various guidelines, leading to closer control and more treatment. We hypothesized that these health care changes would result in an overall improvement in the lipid profile of the population.

Objective: To determine the evolution of the lipid profile in the population of Spain from the Diet and Risk of Cardiovascular Disease in Spain cohort.

Prognostic models for locally advanced cervical cancer: external validation of the published models.

Objective: To externally validate the prognostic models for predicting the time-dependent outcome in patients with locally advanced cervical cancer (LACC) who were treated with concurrent chemoradiotherapy in an independent cohort.

Methods: A historical cohort of 297 women with LACC who were treated with radical concurrent chemoradiotherapy from 1999 to 2014 at the 12 de Octubre University Hospital (H12O), Madrid, Spain. The external validity of prognostic models was quantified regarding discrimination, calibration, measures of overall performance, and decision curve analyses.

Validity Assessment of Low-risk SCORE Function and SCORE Function Calibrated to the Spanish Population in the FRESCO Cohorts.

Introduction And Objectives: To assess the validity of the original low-risk SCORE function without and with high-density lipoprotein cholesterol and SCORE calibrated to the Spanish population.

Methods: Pooled analysis with individual data from 12 Spanish population-based cohort studies. We included 30 919 individuals aged 40 to 64 years with no history of cardiovascular disease at baseline, who were followed up for 10 years for the causes of death included in the SCORE project.

[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery].

Introduction: Surgery is a high risk for the occurrence of adverse events (AE). The main objective of this study is to compare the effectiveness of the Trigger tool with the Hospital National Health System registration of Discharges, the minimum basic data set (MBDS), in detecting adverse events in patients admitted to General Surgery and undergoing surgery.

Material And Methods: Observational and descriptive retrospective study of patients admitted to general surgery of a tertiary hospital, and undergoing surgery in 2012.

Risk of Cause-Specific Death in Individuals With Diabetes: A Competing Risks Analysis.

Objective: Diabetes is a common cause of shortened life expectancy. We aimed to assess the association between diabetes and cause-specific death.

Research Design And Methods: We used the pooled analysis of individual data from 12 Spanish population cohorts with 10-year follow-up.

Circulating Immune Complexes of IgA Bound to Beta 2 Glycoprotein are Strongly Associated with the Occurrence of Acute Thrombotic Events.

Aim: Antiphospholipid syndrome (APS) is characterized by recurrent thrombosis and/or gestational morbidity in patients with antiphospholipid autoantibodies (aPL). Over recent years, IgA anti-beta2-glycoprotein I (B2GPI) antibodies (IgA aB2GPI) have reached similar clinical relevance as IgG or IgM isotypes. We recently described the presence of immune complexes of IgA bounded to B2GPI (B2A-CIC) in the blood of patients with antecedents of APS symptomalology.