Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections:The ORCHESTRA Prospective Cohort Study

The clinical impact of anti-spike monoclonal antibodies (mAb) in Coronavirus Disease 2019 (COVID-19) breakthrough infections is unclear. We present the results of an observational prospective cohort study assessing and comparing COVID-19 progression in high-risk outpatients receiving mAb according to primary or breakthrough infection. Clinical, serological and virological predictors associated with 28-day COVID-19-related hospitalization were identified using multivariate logistic regression and summarized with odds ratio (aOR) and 95% confidence interval (CI). A total of 847 COVID-19 outpatients were included: 414 with primary and 433 with breakthrough infection. Hospitalization was observed in 42/414 (10.1%) patients with primary and 8/433 (1.8%) patients with breakthrough infection (p &lt; 0.001). aOR for hospitalization was significantly lower for breakthrough infection (aOR 0.12, 95%CI: 0.05–0.27, p &lt; 0.001) and higher for immunocompromised status (aOR:2.35, 95%CI:1.08–5.08, p = 0.003), advanced age (aOR:1.06, 95%CI: 1.03–1.08, p &lt; 0.001), and male gender (aOR:1.97, 95%CI: 1.04–3.73, p = 0.037). Among the breakthrough infection group, the median SARS-CoV-2 anti-spike IgGs was lower (p &lt; 0.001) in immunocompromised and elderly patients &gt;75 years compared with that in the immunocompetent patients. Our findings suggest that, among mAb patients, those with breakthrough infection have significantly lower hospitalization risk compared with patients with primary infection. Prognostic algorithms combining clinical and immune-virological characteristics are needed to ensure appropriate and up-to-date clinical protocols targeting high-risk categories.</p

An innovative technological infrastructure for managing SARS-CoV-2 data across different cohorts in compliance with General Data Protection Regulation

Background: The ORCHESTRA project, funded by the European Commission, aims to create a pan-European cohort built on existing and new large-scale population cohorts to help rapidly advance the knowledge related to the prevention of the SARS-CoV-2 infection and the management of COVID-19 and its long-term sequelae. The integration and analysis of the very heterogeneous health data pose the challenge of building an innovative technological infrastructure as the foundation of a dedicated framework for data management that should address the regulatory requirements such as the General Data Protection Regulation (GDPR). Methods: The three participating Supercomputing European Centres (CINECA - Italy, CINES - France and HLRS - Germany) designed and deployed a dedicated infrastructure to fulfil the functional requirements for data management to ensure sensitive biomedical data confidentiality/privacy, integrity, and security. Besides the technological issues, many methodological aspects have been considered: Berlin Institute of Health (BIH), Charité provided its expertise both for data protection, information security, and data harmonisation/standardisation. Results: The resulting infrastructure is based on a multi-layer approach that integrates several security measures to ensure data protection. A centralised Data Collection Platform has been established in the Italian National Hub while, for the use cases in which data sharing is not possible due to privacy restrictions, a distributed approach for Federated Analysis has been considered. A Data Portal is available as a centralised point of access for non-sensitive data and results, according to findability, accessibility, interoperability, and reusability (FAIR) data principles. This technological infrastructure has been used to support significative data exchange between population cohorts and to publish important scientific results related to SARS-CoV-2. Conclusions: Considering the increasing demand for data usage in accordance with the requirements of the GDPR regulations, the experience gained in the project and the infrastructure released for the ORCHESTRA project can act as a model to manage future public health threats. Other projects could benefit from the results achieved by ORCHESTRA by building upon the available standardisation of variables, design of the architecture, and process used for GDPR compliance.Horizon 2020 Framework Programm

Digital Help for Substance Users (SU): A Systematic Review

The estimated number of Substance Users (SU) globally has currently reached a very high number and is still increasing. This aspect necessitates appropriate interventions for prevention and specific treatments. The literature shows that digital treatments can be useful in the context of health services and substance abuse. This systematic review focuses mainly on research on the effectiveness of digital treatments for SU. Data sources included studies found on PsycINFO, PubMed, SCOPUS, and WebOfScience (WOS) database searches. The following keywords were used: TITLE (digital OR computer OR software OR tablet OR app OR videogame OR seriousgame OR virtualreality) AND ABSTRACT((mental AND health) AND (addiction OR dependence OR substance OR drug)). We focused on peer-reviewed articles published from 2010 through 2021 using PRISMA guidelines. A total of 18 studies met the inclusion criteria (i.e., type of intervention, efficacy in terms of misuse of substances and scored outcomes from questionnaire or toxicology tests, study methodology). The studies included investigations of specific digital treatments for SU of various kinds of drugs. The interventions were administered using personal computers, smartphones, or, in a few cases, tablets. Most of the interventions focused on the cognitive behavior therapy (CBT) model and/or on the use strategies, tips, or feedback. A minority provided information or training programs. The current review shows that digital treatments and interventions are effective in reducing the frequency of use, augmenting abstinence, or reducing the gravity of dependence for most of the studies at post-treatment. However, due to the heterogeneity of the variables (i.e., substance type, digital tool used, and treatment administered), there was a reduced generalizability of the results. This review highlights the need to continue the research in this field, and above all, to create effective digital protocols

Challenges of Preadolescence in the School Context: A Systematic Review of Protective/Risk Factors and Intervention Programmes

Preadolescence is a critical period, characterised by changes in physical, hormonal, cognitive, behavioural, and emotional development, as well as by changes in social and school relationships. These changes are accompanied by the transition from elementary school to middle school. The literature shows that this transition is one of the most stressful events for preadolescents, which can have a negative impact on their well-being. The main objectives of this review, focused on the school context, were to identify protective and risk factors influencing the well-being of preadolescent students and to describe the interventions implemented. A systematic search of peer-reviewed papers published between 2011 and 2021 was conducted following the PRISMA reporting guidelines. A total of 36 full-text articles met the inclusion criteria. Studies converge in identifying risk factors that may affect student well-being in this age group: individual factors (levels of emotional awareness and self-esteem) and relational factors (friendship, teachers’ and parents’ supporting actions and roles). Intervention programs are mainly focused on improving emotional and social regulation skills that also influence academic achievement. Our findings have important implications for both research and intervention in school settings

Challenges of Preadolescence in the School Context: A Systematic Review of Protective/Risk Factors and Intervention Programmes

Preadolescence is a critical period, characterised by changes in physical, hormonal, cognitive, behavioural, and emotional development, as well as by changes in social and school relationships. These changes are accompanied by the transition from elementary school to middle school. The literature shows that this transition is one of the most stressful events for preadolescents, which can have a negative impact on their well-being. The main objectives of this review, focused on the school context, were to identify protective and risk factors influencing the well-being of preadolescent students and to describe the interventions implemented. A systematic search of peer-reviewed papers published between 2011 and 2021 was conducted following the PRISMA reporting guidelines. A total of 36 full-text articles met the inclusion criteria. Studies converge in identifying risk factors that may affect student well-being in this age group: individual factors (levels of emotional awareness and self-esteem) and relational factors (friendship, teachers&rsquo; and parents&rsquo; supporting actions and roles). Intervention programs are mainly focused on improving emotional and social regulation skills that also influence academic achievement. Our findings have important implications for both research and intervention in school settings

Problematic smartphone use and cognitive failures : an explorative study among free different generations (x, y, z)

The present study focuses on smartphone overuse and on problematic behaviors related to it, investigating possible differences at the intergenerational level among the variables considered. Through the administration of self-report questionnaires, the perception of smartphone distraction, smartphone problematic use, phubbing, and cognitive failures were surveyed. Two hundred and twenty subjects took part in the research. The participants, aged between 18 and 57, were divided by generation Z, Y and Z, according to Ristiyono, classification (2022). Data analysis was carried out through the application of Spearman's rho was used to analyze correlations between subscales. The Kruskal-Wallis test was invectively used to analyze differences between participants. The results confirm our hypotheses showing positive correlations between perceptions of smartphone distraction, phubbing behavior, smartphone problematic use, and cognitive failures, and a significant difference was found between generations in perceptions of all variables considered. Generation Z (18-26 years) shows the highest scores in almost all subscales examined

Incidence of diabetes mellitus in Italy in year 2018. A nationwide population-based study of the ARNO Diabetes Observatory

Backgrounds and aims: To assess incidence of diabetes in Italy in 2018 by the use of administrative claims from several million residents. Differences in rates in men and women across decades of age were investigated. Incident rates of insulin or noninsulin treated subjects were also examined. Methods and results: We analyzed administrative healthcare claims of 11,300,750 subjects monitored by the ARNO Diabetes Observatory. Incident cases of diabetes were identified by glucose lowering drug prescriptions, disease-specific co-payment exemptions and hospital discharge codes related to diabetes occurring in 2018 but not in 2017. We identified 697,208 subjects with ascertained diabetes. Incident cases were 65,932, with a rate of 5.83 per 1000 person-years (p-y). Incidence of drug-treated diabetes (n = 60,271) was 5.33 per 1000 p-y. Subjects receiving only insulin prescriptions were 5652 (rate 0.50 per 1000 p-y) and those receiving only prescriptions of noninsulin medications were 51,085 (rate 4.52 per 1000 p-y). Incidence rates progressively increased across decades until age 80 and then dropped by 25-30%. Overall, incident rates were generally higher in women aged 11-40 and in men aged 6551. Conclusions: Recent cases represented ~10% of the population of diabetic subjects. Incidence of noninsulin-treated diabetes was almost 10-fold higher than incidence of insulin-treated diabetes. Substantial differences in incidence rates were observed in men and women of several decades of age: women more affected in adolescence and young adult age, men more affected in mature and advanced age. These data provide further understanding on the epidemiological burden of the disease in Italy

A view on the quality of diabetes care in Italy and the role of Diabetes Clinics from the 2018 ARNO Diabetes Observatory

Backgrounds and aims: To investigate relevant indicators of quality of care in a large population-based sample of people with diabetes representative of clinical practice in Italy in 2018.Methods and results: We analyzed data from 11,300,750 subjects. All administrative healthcare claims collected in 2018 were scrutinized to identify subjects with diabetes and investigate several indicators of quality of care. Subjects with diabetes were identified by anti-hyperglycemic drug prescriptions, disease- specific co-payment exemption and hospital discharge codes. Indicators of quality of care pertained to monitoring (HbA1c, creatinine, lipid profile, microalbuminuria, eye examination, ECG, ultrasonography of carotid and lower limb arteries) and diabetes treatment (anti-hyperglycemic agents in subjects with cardiovascular disease, CVD). Subjects attending and nonattending Diabetes Clinics were compared.We identified 697,208 individuals with diabetes. HbA1c was assessed at least once in the year in 62.7%, creatinine in 62.3%, total cholesterol in 59.6%, microalbuminuria in 34.3%. Frequency of eye examination was 8.2%, ECG 23.5%, carotid ultrasonography 14.3%, lower limb ultrasonography 7.6%. Among anti-hyperglycemic drugs, SGLT-2 inhibitors were prescribed to similar to 5% and GLP-1 receptor agonists to similar to 5% although the proportion of subjects with CVD was similar to 45%. Subjects attending Diabetes Clinics had higher figures for all these monitoring and treatment indicators.Conclusions: The implementation of national and international guidelines regarding disease monitoring and treatment is far from being satisfactory, especially among subjects nonattending Diabetes Clinics. Further efforts and investments are needed for better disseminating guidelines, more efficaciously engaging healthcare professionals and more strongly empowering the healthcare system to improve diabetes care. (C) 2020 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved

Clinical burden of diabetes in Italy in 2018: a look at a systemic disease from the ARNO Diabetes Observatory

INTRODUCTION: Diabetes is a highly prevalent disease worldwide and represents a challenge for patients and healthcare systems. This population-based study evaluated diabetes burden in Italy in 2018 by assessing all aspects of outpatient and hospital care.RESEARCH DESIGN AND METHODS: We investigated data of 11 300 750 residents in local health districts contributing to ARNO Diabetes Observatory (~20% of Italian inhabitants). All administrative healthcare claims were analyzed to gather information on access to medical resources. Subjects with diabetes, identified by antihyperglycemic drug prescriptions, disease-specific copayment exemption and hospital discharge codes, were compared with age, sex and residency-matched non-diabetic individuals.RESULTS: We identified 697 208 subjects with ascertained diabetes, yielding a prevalence of 6.2% (6.5% in men vs 5.9% in women, p&lt;0.001). Age was 69\ub115 (mean\ub1SD). As compared with non-diabetic subjects, patients with diabetes received more prescriptions of any drugs (+30%, p&lt;0.001), laboratory tests, radiologic exams and outpatient specialist consultations (+20%, p&lt;0.001) and were hospitalized more frequently (+86%, p&lt;0.001), with a longer stay (+1.4 days, p&lt;0.001). Although cardiovascular diseases accounted for many hospital discharge diagnoses, virtually all diseases contributed to the higher rate of hospital admissions in diabetic subjects (235 vs 99 per 1000 person-years, p&lt;0.001). Healthcare costs were &gt;2-fold higher in subjects with diabetes, mainly driven by hospitalizations and outpatient care related to chronic complications rather than to glucose-lowering drugs, diabetes-specific devices, or metabolic monitoring.CONCLUSIONS: The burden of diabetes in Italy is particularly heavy and, as a systemic disease, it includes all aspects of clinical medicine, with consequent high expenses in all areas of healthcare