Integration of functional and traditional food in emerging markets. Regulatory and substantive aspects of yerba mate and quinoa

Given the rising cost of healthcare, the increase in life expectancy and the wish for a better quality of life, the request for foods and beverages producing a beneficial effect on health has increased worldwide. “Functional food” is a new concept and may play a key role in diseases’ prevention and management. Although its meaning is currently under definition, its role in global health improvement is growing constantly. This article aims at giving a description of existing legislation on functional food in South America, identifying future directions for health and marketing policies. Furthermore, authors provide a literature revision on two products widely consumed in Latin American countries: Yerba Mate and Quinoa. Thanks to their beneficial health effects in terms of disease prevention and promotion of well-being, they may be considered as functional foods with a potential key role in health care

Impact of perfluoroalkylated substances (PFAS) exposure on maternal and newborn health in Veneto region

Background. Perfluoroalkylated substances (PFAS) are persistent organic pollutants that accumulate in the fish, wildlife, and humans. In 2013, it has been discovered an area of the Veneto Region in which ground water, surface water, and drinking water were contaminated by PFAS. Appropriate interventions have been undertaken to contain the water pollution, reducing it effectively. However, it has been estimated that the contamination had started about fifty years before its discovery, leading to the long-term exposure of the population. The long-term exposure to PFAS is worrying because PFAS have been suggested to affect human health. Veneto Region has therefore organized a health surveillance programme of the population living in the polluted area. A specific aspect of such programme concerns the maternal and newborn health, which represents the focus of my PhD research project. The aims of the project were to review animal and human evidence related to this topic and to assess the effects of the exposure to PFAS on maternal and newborn health in the population living in the polluted area of Veneto Region. Methods. The systematic review included relevant studies in the English language identified through the online database PubMed. Studies were eligible to the review if they assess the effect of PFAS exposure during the reproductive period on the health of the pregnant women and of the infant. The identification of the outcomes of interest assessed in the study about maternal and newborn health in Veneto Region was based on the systematic review. The outcomes investigated were preeclampsia and gestational diabetes mellitus (GDM) (pregnancy complications), and intrauterine growth restriction, evaluated using a proxy of fetal growth, the Small for Gestational Age (SGA) (birth outcomes). The study was performed using an indirect measure of exposure to PFAS, defined as woman’s residence in the contaminated area (including 21 municipalities identified according to a Veneto Region Official Resolution). A control area that included 48 municipalities not exposed to PFAS contamination according to the performance limits of the National Institue of Health was chosen for comparision. The information sources included two administrative datasets, the Veneto Region Birth Registry and the Veneto Region hospital discharge records. For the pregnancy complications (preeclampsia and GDM), a medical chart review of pregnant women hospitalized is ongoing to validate the cases identified from the hospital discharge records. Results. The systematic review led to the retrieval of 1096 records from PubMed. One hundred and thirty-nine records were judged to be eligible to the study. Overall, evidence retrieved suggests that PFAS exposure might affect the health of the pregnant woman and the development of the fetus. The epidemiological study showed that newborns of mothers living in the contaminated area were significantly more likely to be SGA compared to newborns of mothers living in the control area (adjusted Odds Ratio 1.26, 95% C.I. 1.14-1.38). Looking at pregnancy complications (preeclampsia and GDM), preliminary results were available because the review of the medical chart is ongoing. Such preliminary results seem to suggest that the frequency of these pathological conditions is slightly higher in women living in the contaminated area compared to those living in the control ones. However, they must be taken with caution because the validation of preeclampsia and GDM cases is ongoing. Conclusions. The results of the present research project suggest that PFAS exposure might affect maternal and newborn health. The present topic deserves further research, not only from the epidemiological point of view, but also for what concerns the pathophysiological mechanisms potentially involved in the association between PFAS exposure and adverse health outcomes in pregnant women and newborns

Handling missing continuous outcome data in a Bayesian network meta-analysis

Background: A Bayesian network meta-analysis (NMA) model is a statistical method aimed at estimating the relative effects of multiple interventions against the same disease. The method has recently gained prominence, leading to the synthesis of the evidence regarding rank probabilities for each treatment. In several cases, an NMA is performed excluding incomplete data of studies retrieved through a systematic review, resulting in a loss of precision and power.  Methods: There are several methods for handling missing or incomplete data in an NMA framework, especially for continuous outcomes. In certain cases, only baseline and follow-up measurements are available; in this framework, to obtain data regarding mean changes, it is necessary to consider the pre-post study correlation. In this context, in a Bayesian setting, several authors suggest imputation strategies for pre-post correlation. In other cases, a variability measure associated with a mean change score might be unavailable. Different imputation methods have been suggested, such as those based on maximum standard deviation imputation. The purpose of this study is to verify the robustness of Bayesian NMA models concerning different imputation strategies through simulations.  Results: Simulation results show that the bias is notably small for every scenario, confirming that rankings provided by models are robust concerning different imputation methods in several heterogeneity-correlation settings.  Conclusions: This NMA method seems to be more robust to missing data imputation when data reported in different studies are generated in a low-heterogeneity scenario. The NMA method seems to be more robust to missing value imputation if the expectation of the prior distribution, defined on the heterogeneity parameter, approaches the true value of the variability across studies.&nbsp

Endotoxin removal therapy with Polymyxin B immobilized fiber column: a single center experience from EUPHAS2 registry

Continuous renal replacement therapy; Diagnostic markers; InfectionTerapia de reemplazo renal continua; Marcadores de diagnóstico; InfecciónTeràpia de substitució renal contínua; Marcadors diagnòstics; InfeccióAlthough the precise clinical indication for initiation of PMX-HA is widely debated in the literature, a proper patient selection and timing of treatment delivery might play a critical role in the clinical course of a specific subphenotype of septic shock (endotoxic shock). In light of this view, since 2019, we have introduced in our clinical practice a diagnostic-therapeutic flowchart to select patients that can benefit the most from the treatment proposed. In addition, we reported in this study our experience of PMX-HA in a cohort of critically ill patients admitted to our intensive care unit (ICU). We analyzed a single centre, retrospective, observational web-based database (extracted from the EUPHAS2 registry) of critically ill patients admitted to the ICU between January 2016 and May 2021 who were affected by endotoxic shock. Patients were divided according to the diagnostic-therapeutic flowchart in two groups: Pre-Flowchart (Pre-F) and Post-Flowchart (Post-F). From January 2016 to May 2021, 61 patients were treated with PMX-HA out of 531 patients diagnosed with septic shock and of these, fifty patients (82%) developed AKI during their ICU stay. The most common source of infection was secondary peritonitis (36%), followed by community-acquired pneumonia (29%). Fifty-five (90%) out of 61 patients received a second PMX-HA treatment, with a statistically significant difference between the two groups (78% of the Pre-F vs. 100% of the Post-F group, p = 0.005). In both groups, between T0 and T120, the Endotoxin Activity Assay (EAA) decreased, while the SOFA score, mean arterial pressure (MAP), and Vasoactive Inotropic Score (VIS) improved with no statistically significant difference. Furthermore, when performing a propensity score matching analysis to compare mortality between the two groups, statistically significant lower ICU and 90-day mortalities were observed in the Post-F group [p = 0.016]. Although in this experienced centre data registry, PMX-HA was associated with organ function recovery, hemodynamic improvement, and current EAA level reduction in critically ill patients with endotoxic shock. Following propensity score-matched analysis, ICU mortality and 90-day mortalities were lower in the diagnostic-therapeutic flowchart group when considering two temporal groups based on strict patient selection criteria and timing to achieve PMX. Further Randomised Control Trials focused on centre selection, adequate training and a flowchart of action when assessing extracorporeal blood purification use should be performed.This work was supported by IRRIV (The International Renal Research Institute of Vicenza) Foundation

A first estimation of the impact of public health actions against COVID-19 in Veneto (Italy)

Veneto is one of the first Italian regions where the COVID-19 outbreak started spreading. Containment measures were approved soon thereafter. The present study aims at providing a first look at the impact of the containment measures on the outbreak progression in the Veneto region, Italy

AI Cardiac MRI Scar Analysis Aids Prediction of Major Arrhythmic Events in the Multicenter DERIVATE Registry

Scar; MRI; Arrhythmic eventsCicatriu; Ressonància magnètica; Esdeveniments arítmicsCicatriz; Resonancia magnética; Eventos arrítmicosBackground Scar burden with late gadolinium enhancement (LGE) cardiac MRI (CMR) predicts arrhythmic events in patients with postinfarction in single-center studies. However, LGE analysis requires experienced human observers, is time consuming, and introduces variability. Purpose To test whether postinfarct scar with LGE CMR can be quantified fully automatically by machines and to compare the ability of LGE CMR scar analyzed by humans and machines to predict arrhythmic events. Materials and Methods This study is a retrospective analysis of the multicenter, multivendor CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy (DERIVATE) registry. Patients with chronic heart failure, echocardiographic left ventricular ejection fraction (LVEF) of less than 50%, and LGE CMR were recruited (from January 2015 through December 2020). In the current study, only patients with ischemic cardiomyopathy were included. Quantification of total, dense, and nondense scars was carried out by two experienced readers or a Ternaus network, trained and tested with LGE images of 515 and 246 patients, respectively. Univariable and multivariable Cox analyses were used to assess patient and cardiac characteristics associated with a major adverse cardiac event (MACE). Area under the receiver operating characteristic curve (AUC) was used to compare model performances. Results In 761 patients (mean age, 65 years ± 11, 671 men), 83 MACEs occurred. With use of the testing group, univariable Cox-analysis found New York Heart Association class, left ventricle volume and/or function parameters (by echocardiography or CMR), guideline criterion (LVEF of ≤35% and New York Heart Association class II or III), and LGE scar analyzed by humans or the machine-learning algorithm as predictors of MACE. Machine-based dense or total scar conferred incremental value over the guideline criterion for the association with MACE (AUC: 0.68 vs 0.63, P = .02 and AUC: 0.67 vs 0.63, P = .01, respectively). Modeling with competing risks yielded for dense and total scar (AUC: 0.67 vs 0.61, P = .01 and AUC: 0.66 vs 0.61, P = .005, respectively). Conclusion In this analysis of the multicenter CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy (DERIVATE) registry, fully automatic machine learning–based late gadolinium enhancement analysis reliably quantifies myocardial scar mass and improves the current prediction model that uses guideline-based risk criteria for implantable cardioverter defibrillator implantation. ClinicalTrials.gov registration no.: NCT0335264

Impact of a natural versus commercial enteral-feeding on the occurrence of diarrhea in critically ill cardiac surgery patients. A retrospective cohort study

Diarrhea is an important complication in critically ill patients undergoing enteral feeding. The occurrence of diarrhea may lead to systemic and local complications and negatively impacts on nursing workload and patient's wellbeing. An enteral feeding based on blenderized natural food could be beneficial in reducing the risk of diarrhea. No study has compared natural and commercial enteral feedings in critically ill cardiac surgery patients