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Background: Rimegepant, a novel oral calcitonin gene-related peptide receptor antagonist, has been recently approved for the acute migraine treatment. While its efficacy was confirmed in randomized clinical trials, no data is available regarding real-life effectiveness and tolerability. GAINER, a prospective, multicentric study, aimed to evaluate rimegepant effectiveness and tolerability in the real-world setting. Methods: Our study involved 16 headache centers across Italy. The main outcomes were: i) 2 h pain freedom, and ii) occurrence of treatment-emergent adverse events after administration. Participants were instructed to treat one migraine attack with rimegepant 75 mg orally disintegrating tablet. Using an ad hoc diary, participants prospectively collected migraine attack features at baseline and every 30 min after rimegepant administration, up to 2 h post dose. A 24 h follow up was also collected. Results: We enrolled 103 participants with migraine (74.8% female, mean age 44.4 [42.0 – 46.7] years, 24.3% with chronic migraine of whom 44.0% presented a concomitant diagnosis of medication overuse headache). The number of previously failed preventive classes was 2.7 [2.3 – 3.2]. Participants presented a mean of 9.6 [8.2 – 10.9] monthly migraine days at baseline. At rimegepant intake, 40.8% of patients rated migraine intensity as severe. Pain freedom 2 h post dose was reported in 44.7% (46/103) of individuals. Pain freedom 2 h post dose was not influenced by baseline pain severity (p = 0.316), but it was associated with timing of intake (p = 0.032) with a higher rate of 2 h pain freedom when rimegepant was taken within 1 h from pain onset. Mild adverse events were reported in 15.5% total attacks (16/103), predominantly fatigue (n = 6), gastrointestinal symptoms (n = 6), somnolence (n = 4), and transient cognitive difficulties (n = 3). Tolerability was rated as good-to-excellent in 85.4% cases (88/103). Conclusions: Our data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants that includes subjects with episodic or chronic migraine, medication overuse and a high number of prior preventive treatment failures. Trial registration: The study was preregistered on clinicaltrial.gov, NCT05903027. [ABSTRACT FROM AUTHOR]

Vicarious stigma shows how indirect stigmatizing experiences can lead people living with HIV (PLWH) to feel discriminated against. We enrolled 350 PLWH, who were administered a 17-item questionnaire to investigate a subjective experience of stigma experienced in the hospital care setting. We found that at least once 215 PLWH (61.4%) did not want the HIV exemption indicated on the prescription for a specialist medical visit, 232 PLWH (66.3%) never used their HIV-related exemption to make a specialist medical visit, 230 PLWH (65.7%) avoided undergoing a medical assessment outside the infectious disease clinics and 241 patients (68.9%) felt unwelcome during a specialist medical visit. Moreover, 241 patients (61.1%) had heard at least once stories of health workers who did not want to touch PLWH, 213 patients (60.9%) had heard stories at least once of PLWH who had been mistreated by hospital staff, 180 patients (51.4%) had at least once heard stories about PLWH being refused treatment and services and 257 patients (73.4%) had at least once heard stories about health workers talking publicly about PLWH. This is a little explored area, especially regarding the vicarious stigma faced by PLWH. Our findings indicate the importance of combating HIV-related stigma for the wellbeing of PLWH. [ABSTRACT FROM AUTHOR]

This article offers insights into what characterises innovative continuous professional development (CPD) in the field of early childhood education and care (ECEC) by analysing similarities and differences from case studies of exemplary approaches to innovative CPD in Denmark, Italy and Poland. The comparative analysis focuses on four features that are particularly relevant for innovation in CPD in the field of ECEC: the social dimension of innovation as a strengthening component; the benefit of dynamic learning processes aimed at integrating theory and practice; the role of key figures in the quality of CPD; and measurements of CPD impact, outcomes and sustainability. This analysis sheds light on the effects of dynamic factors (e.g., regular team-based reflection sessions based on documentation and observation), the importance of work conditions (e.g., contractual obligations to provide time for reflection), the critical role of pedagogical leaders (coordinators, principals and head teachers, supervisors), the importance of inter-organisational networking at a local level and the facilitating role of collaboration with research institutes.

Objective: We aimed to evaluate the clinical usefulness of the systemic score in the prediction of life‐threatening evolution in Still disease. We also aimed to assess the clinical relevance of each component of the systemic score in predicting life‐threatening evolution and to derive patient subsets accordingly. Methods: A multicenter, observational, prospective study was designed including patients included in the Gruppo Italiano Di Ricerca in Reumatologia Clinica e Sperimentale Adult‐Onset Still Disease Study Group and the Autoinflammatory Disease Alliance Network Still Disease Registry. Patients were assessed to see if the variables to derive the systemic score were available. The life‐threatening evolution was defined as mortality, whatever the clinical course, and/or macrophage activation syndrome, a secondary hemophagocytic lymphohistiocytosis associated with a poor prognosis. Results: A total of 597 patients with Still disease were assessed (mean ± SD age 36.6 ± 17.3 years; male 44.4%). The systemic score, assessed as a continuous variable, significantly predicted the life‐threatening evolution (odds ratio [OR] 1.24; 95% confidence interval [CI] 1.07–1.42; P = 0.004). A systemic score ≥7 also significantly predicted the likelihood of a patient experiencing life‐threatening evolution (OR 3.36; 95% CI 1.81–6.25; P < 0.001). Assessing the clinical relevance of each component of the systemic score, liver involvement (OR 1.68; 95% CI 1.48–2.67; P = 0.031) and lung disease (OR 2.12; 95% CI 1.14–4.49; P = 0.042) both significantly predicted life‐threatening evolution. The clinical characteristics of patients with liver involvement and lung disease were derived, highlighting their relevance in multiorgan disease manifestations. Conclusion: The clinical utility of the systemic score was shown in identifying Still disease at a higher risk of life‐threatening evolution in a large cohort. Furthermore, the clinical relevance of liver involvement and lung disease was highlighted. [ABSTRACT FROM AUTHOR]

Concomitant therapy (CT) and bismuth quadruple therapy (BQT) are recommended in geographical areas with high clarithromycin resistance for Helicobacter pylori (H. pylori) eradication. We compared CT and BQT as the first lines of treatment in a randomized controlled trial. Consecutive patients with H. pylori diagnosed by concordance of both a urea breath test and histology were recruited. For BQT, patients received 3 PyleraTM capsules q.i.d.; for CT, 1000 mg of amoxicillin b.i.d, 500 mg of clarithromycin b.i.d and 500 mg of metronidazole b.i.d. As a proton pump inhibitor, 40 mg of pantoprazole b.i.d was administered. Both regimens lasted 10 days. In total, 46 patients received CT and 38 BQT. Both groups were comparable for age (p = 0.27) and sex (p = 0.36). We did not record any drop outs; therefore, the intention to treat and per protocol rates coincided. The most common symptoms were heartburn and post-prandial fullness, which were equally present in both groups. The success rate was 95.6% for CT and 100% for BQT (p = 0.56). Side effects were recorded in 23.9% and 31.6% of patients in the CT and BQT arms, respectively (p = 0.47). The most common ones were abdominal pain (8) and diarrhea (6). In conclusion, CT and BQT are equally effective in our area with high clarithromycin resistance, southern Italy, and showed comparable safety. [ABSTRACT FROM AUTHOR]

Objective: To describe the pattern of anti‐calcitonin gene–related peptide monoclonal antibodies (anti‐CGRP mAbs) utilization in the Tuscany region, Italy, and the variation of triptan consumption after treatment initiation. Background: Given the recent commercialization of anti‐CGRP mAbs as migraine preventive medications, real‐world evidence on their patterns of utilization and their impact on migraine abortive medication use is still limited. Methods: A retrospective, descriptive, cohort study on the real‐world utilization of anti‐CGRP mAbs was performed using the population‐based regional administrative database of Tuscany. Patients with ≥1 anti‐CGRP mAb dispensing (namely erenumab, galcanezumab, fremanezumab) between April 1, 2019, and September 30, 2021, were identified. The first dispensing was the cohort entry (CE). New users (NUs) were patients with no anti‐CGRP mAb dispensing before CE. Kaplan–Meier (KM) curves were plotted to describe the cumulative probability of remaining with the initial anti‐CGRP mAb during a 15‐month follow‐up period as a measure of treatment persistence. Among NUs with ≥2 triptan dispensings during the 6 months before CE (i.e., baseline), the mean monthly number of triptan dosage units dispensed was measured in five consecutive follow‐up time windows (months 1–3, 4–6, 7–9, 10–12, 13–15) and the difference from the baseline was calculated. Results: A total of 624 NUs (erenumab = 295, galcanezumab = 223, fremanezumab = 106) were identified, of whom 188 (78%) were women. Mean age was 49.2 years (standard deviation [SD] = 12.6). The survival to discontinuation at 6, 12, and 15 months was about 69%, 48%, and 6%, respectively. The survival to switch was about 6% at 15 months. The observed variation of triptan consumption at 3/6/9/12/15 months and the corresponding SD was −4.4 [8.2]/−5.2 [9.0]/−5.5 [9.2]/−5.4 [9.2]/−4.5 [10.0], respectively. Conclusion: Patient demographics reflect the place of these medications in therapy. Overall, findings seem to indicate a favorable tolerability and effectiveness profile. Further studies are warranted to better establish the long‐term comparative effectiveness, safety, and cost effectiveness of anti‐CGRP mAbs compared to other preventive medications. [ABSTRACT FROM AUTHOR]

Spontaneous HBsAg seroclearance has been mainly studied in populations from Asia, Australia, the Pacific Islands, and Polynesia. For the first time, we evaluated the spontaneous HBsAg seroclearance and its possible associated factors and the risk of disease progression in HBeAg-negative patients with inactive infection all coming from the same region in South Italy. In this multicenter retrospective study, 146 patients were selected after 18 months of observation and followed for a median of 82 months (IQR 60–107). For our analyses, they were divided into three groups based on their HBsAg levels: <100 IU/mL, 100–1000 IU/mL, and >1000 IU/mL. Crude and adjusted hazard ratios (HRs) for HBsAg seroclearance were determined. During the follow-up period, three patients (2.0%) showed a disease progression with an increased liver stiffness, whereas 17 (11.6%) cleared the HBsAg. Patients with HBsAg levels <100 IU/mL had the highest probability of HBsAg seroclearance compared to the other two groups (p = 0.009). In the multivariate analysis, the HBsAg level <100 IU/mL was the only parameter independently associated with HBsAg seroclearance (adjusted HR = 3.53; CI 1.29–9.69; p = 0.01). In patients with chronic HBV inactive infection, HBsAg levels <100 IU/mL predicted the highest probability of HBsAg seroclearance. [ABSTRACT FROM AUTHOR]

Evidence accumulated during past years confirm that people living with HIV (PLWH) still have to deal with comorbidities and chronic complications that can increase physical and psychological issues and can affect daily functioning, quality of life and mental health. Moreover, during the COVID-19 pandemic PLWH proved to be a population at increased risk of psychological distress. We explored the ongoing issues and the characteristics of the mental health interventions for which a cohort of Italian PLWH interacted with a psychologist over the past five years. We analysed a dataset that included 61 PLWH who underwent a psychological intervention between 2018 and 2022. We compared different frequencies in characteristics of mental health interventions according to different demographic and clinical variables, psychopathological symptoms and time of the request for intervention. We showed that psychopathological symptoms most frequently reported by patients were anxiety (55.7%), and depression (49.2%). Furthermore, we reported that most our patients undertook occasional psychological support meetings (31%), sought an intervention after the outbreak of the COVID-19 pandemic (62.3%) and complained about disclosure issues (48.5%). Disclosure issues were mainly reported by younger PLWH (p = 0.002) with a shorter disease (p = 0.031) and treatment history (p = 0.032), and higher interpersonal sensitivity (p = 0.042). It seems fundamental to integrate psychological interventions into the care of PLWH, to give particular attention to PLWH with risky demographic, clinical and mental health factors and to pay special attention to emergency conditions (such as the COVID-19 pandemic) and the most widespread issues to create ad hoc interventions. [ABSTRACT FROM AUTHOR]

Objective: To describe the pattern of triptan use by gender in Tuscany, Italy, focusing on special user populations in which evidence on triptan safety is still not conclusive. Background: Growing evidence supports the role of gender differences in migraine pathophysiology and treatment. However, gender impact on triptan real‐word utilization has been poorly investigated. Methods: A retrospective, descriptive, cohort study was performed using the population‐based Administrative Healthcare Database of Tuscany region (Italy). Subjects registered in the database on the January 1 of each year between 2008 and 2018 were identified. New users (NU) of triptans (ATC:N02CC*) were patients with one or more triptan dispensation during the year of interest and none in the past. Age, cardiovascular comorbidities representing an absolute or a possible contraindication to triptan utilization, concomitant serotonergic medications, and pattern of triptan use during 1‐year follow‐up were described by gender. Results: A total of 86,109 patients who received one or more triptan dispensing were identified. Of 64,672 NU (men = 17,039; women = 47,633), 10.2% (6823/64,672) were aged >65 years, who were mostly women (n = 4613). Among NU, men and women with absolute cardiovascular contraindications were 4.3% (740/17,039) and 2.1% (1022/47,633), respectively, while those concomitantly taking serotonergic medications were 17.2% (267/1549) and 21.9% (949/4330), respectively (949/4330). Regular users (two or more dispensing with ≥3 months between first and last observed dispensing) accounted for 26.4% of women (12,597/47,633) and 19.11% of men (3250/17,039); frequent users (≥15 dosage units/month during ≥3 consecutive months) were overall 0.1% (94/64,672) and 62.0% (58/94) of them concomitantly received serotonergic medications. Conclusion: Considering gender differences in triptan use highlighted here, large scale observational studies are warranted to better define what populations are safe to use triptans and whether it is appropriate to tighten or relax certain recommendations on triptan use. In the meantime, any suspected adverse drug reaction observed in the special user populations highlighted in this study should be promptly reported. [ABSTRACT FROM AUTHOR]

Background: Psoriatic arthritis (PsA) is a chronic, immune-mediated, spondyloarthropathy characterised by musculoskeletal signs and symptoms with associated joint pain and tenderness. The average worldwide PsA prevalence is 133/100,000, while in the Italian population is 90–420/100,000. Traditionally, nonsteroidal anti-inflammatory drugs, glucocorticoid, and disease-modifying antirheumatic drugs have been used in the treatment of PsA. However, for those patients who are not adequately controlled with conventional therapies, the new biologics compounds represent a valid option. Biologic therapies have been shown to be more effective but also more expensive than conventional systemic treatments. Based on the CHRONOS study, the economic analyses presented in this paper aim to assess the annualised direct costs and the cost-per-responder of biologics in a real-world context assuming the Italian National Health System perspective. Methods: The economic assessments were carried out on the overall cohort of patients, and on the tumour necrosis factor alpha inhibitors (TNFi) and the secukinumab subgroup, the most prescribed biologic therapies within the CHRONOS study. Results: The annual economic impact of PsA in the overall group was €12,622, €11,725 in the secukinumab subgroup, and €12,791 in the TNFi subgroup. Biologics absorbed the main expenditure costs in the treatment of PsA accounting for about the 93% of total costs. At 6 months, secukinumab performed better in all the considered outcomes: cost-per-responder according to EULAR DAS28 and ACR50 response criteria were €12,661- €28,975, respectively, while they were €13,356 - €33,368 in the overall cohort and €13,138 - €35,166 in the TNFi subgroup. At 12 months secukinumab remained the subgroup with the lowest cost-per-responder ratio in EULAR DAS28 and ACR50 response criteria, while TNFi subgroup was the lowest one considered the ACR20. Conclusion: Despite some potential methodological limitations, our cost-per-response analysis provides physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions. [ABSTRACT FROM AUTHOR]

Cabotegravir and rilpivirine are the first drugs to be approved as injectable therapy to treat individuals with HIV. Despite encouraging results, the guidelines specify strict criteria for eligibility that could limit the feasibility of this strategy. We collected the clinical data of HIV‐positive patients who were being treated at a single, third‐level center in Italy. All patients were on stable therapy and showed suppressed viral load on their most recent analyses. We performed a cross‐sectional analysis of the clinical and viro‐immunological characteristics of this population and excluded patients who had previous virological failures, resistance‐associated mutations (RAMs) to rilpivirine or integrase inhibitors in the historical genotype, hepatitis B infection, absence of previous genotypes, and the coexistence of HIV‐subtype A and obesity. Our aim was to evaluate the proportion of patients who could be eligible for switching to this strategy. one thousand seven hundred fifty‐two patients were eligible. One hundred and forty‐eight were excluded because of a detectable viral load. With regard to the exclusion criteria, 48 patients had coinfection with hepatitis B virus, and 744 had a history of previous virological failures. Of the 896 patients with at least one genotypic resistance test, 161 had one or more RAMs to rilpivirine and 3 had RAMs to cabotegravir. None of the patients presented the combination of obesity and the A viral subtype. Overall, 31.2% of the patients were ineligible for cabotegravir–rilpivirine, and the proportion increased to 47.3% when we considered only patients with all available information concerning resistance tests. Approximately half of our cohort of patients did not fulfill the criteria and even more patients were potentially ineligible for cabotegravir–rilpivirine due to the lack of genotypic resistance tests. Also, fertile women had to be excluded due to the lack of data about this combination during pregnancy and breastfeeding. [ABSTRACT FROM AUTHOR]

The dark matter interpretation of the DAMA/LIBRA annual modulation signal represents a long-standing open question in astroparticle physics. The SABRE experiment aims to test such claim, bringing the same detection technique to an unprecedented sensitivity. Based on ultra-low background NaI(Tl) scintillating crystals like DAMA, SABRE features a liquid scintillator Veto system, surrounding the main target, and it will deploy twin detectors: one in the Northern hemisphere at Laboratori Nazionali del Gran Sasso (LNGS), Italy and the other in the Stawell Underground Physics Laboratory (SUPL), Australia, first laboratory of this kind in the Southern hemisphere. The first very-high-purity crystal produced by the collaboration was shipped to LNGS in 2019 for characterization. It features a potassium contamination, measured by mass spectroscopy, of the order of 4 ppb, about three times lower than DAMA/LIBRA crystals. The first phase of the SABRE experiment is a Proof-of-Principle (PoP) detector featuring one crystal and a liquid scintillator Veto, at LNGS. This contribution will present the results of the stand-alone characterization of the first SABRE high-purity crystal, as well as the status of the PoP detector, commissioned early in the summer of 2020. [ABSTRACT FROM AUTHOR]

A new radiological risk containment procedure, developed to manage the radiological risk in potentially contaminated areas, is presented here. This new methodological approach, systematically employed in sampling and site inspection activities in unknown areas from an environmental point of view, allowed the discovery of eight 226Ra orphan sources buried under the road surface, in a good state of conservation, in an industrial area of the Calabrian territory, southern Italy, and they are reported here as a case study. For workers performing sampling activities in areas for which information regarding the possible presence of contaminated material is missing, an in situ radiometric check is usually carried out as a potential radiological risk prevention, by measuring the levels of environmental radioactivity. Other than this, the procedure described in this article includes, as novelty, a series of progressive operations never carried out before all together for outdoor activities: the assessment of the presence (if any) of hot spots by recording radiometric anomalies, outdoor gamma spectrometry measurements in order to identify the radionuclides generating those anomalies, the sources unearthing activities, the management of the material found and the application of a risk containment protocol. [ABSTRACT FROM AUTHOR]

Background: Adult body fatness is a convincing risk factor for postmenopausal breast cancer. With the aim to compare the different breast cancer (BC) features in Northern and Southern Italy, we investigated the relationship between BMI and BC characteristic in two groups of patients referred in the Modena and Lecce breast units. Materials and Methods: A retrospective analysis of a continuous series of BC patients referred to the Città di Lecce Hospital and the Modena Cancer Center, from January 2019 to December 2020 was performed. We identified four groups of BMI at BC diagnosis: underweight, BMI <18.5 kg/m2; normal weight, BMI ≥ 18.5–24.9 kg/m2; overweight, BMI ≥ 25.0–29.9 kg/m2; obese, BMI ≥30.0 kg/m2. BC characteristics and clinical outcomes were analyzed by the Kolmogorov-Smirnov test and Mann-Whitney U test; categorical data were compared using Pearson's chi-square test, and dicotomic data were compared by odds ratio. Results: Nine hundred seventy-seven BC patients were included in the analysis. Overall, 470 were from Modena and 507 from Lecce. No differences were observed in the mean age of BC patients of Modena (61,42) and Lecce (62,08). No statistical differences between the two populations were shown in terms of tumor characteristics and pathological stage. Conversely, a statistical difference of BMI between the BC patients coming from Modena and Lecce (25.87 and 27.81, respectively; p = 0.000001) was found. BC patients diagnosed in Lecce at age ≥70 years had higher median BMI compared with the ones from Modena (p = 0.000002). The increased BMI in this aged population was also associated to larger tumor size (p = 0.040). Conclusion: The rate of overweight and obesity was higher in BC women living in Southern Italy, despite the presumed nutrition according to the so-called Mediterranean type dietary pattern. Unexpectedly, an increased BMI rate and a relationship with larger tumor size were found in Southern BC patients aged ≥70 years. Our findings strongly support the need for promoting a healthier lifestyle model in Italy, with the aim of reducing the rate of the obesity and, consequently, the increased risk of BC. [ABSTRACT FROM AUTHOR]

Objective The aim of our study was to investigate clinical and histopathological findings in adult DM patients positive for anti-Mi2 (anti-Mi2+) antibodies compared with DM patients negative for anti-Mi2 (anti-Mi2–). Methods Clinical data of adult DM patients, who fulfilled EULAR/ACR 2017 classification criteria, were gathered from electronic medical records of three tertiary Rheumatology Units. Histopathological study was carried out on 12 anti-Mi2+ and 14 anti-Mi2– muscle biopsies performed for diagnostic purpose. Nine biopsies from immune mediated necrotizing myopathy (IMNM) patients were used as control group. Results Twenty-two anti-Mi2+ DM [90.9% female, mean age 56.5 (15.7) years] were compared with 69 anti-Mi2– DM patients [71% female, mean age 52.4 (17) years]. Anti-Mi2+ patients presented higher levels of serum muscle enzymes than anti-Mi2– patients [median (IQR) creatine-kinase fold increment: 16 (7–37) vs 3.5 (1–9.9), P  <0.001] before treatment initiation. Moreover, a trend towards less pulmonary involvement was detected in anti-Mi2+ DM (9.1% vs 30.4%, P  =0.05), without any case of rapidly progressive interstitial lung disease. At muscle histology, anti-Mi2+ patients showed more necrotic/degenerative fibres than anti-Mi2– patients [mean 5.3% (5) vs 0.8% (1), P  <0.01], but similar to IMNM [5.9% (6), P  >0.05]. In addition, the endomysial macrophage score was similar between anti-Mi2+ and IMNM patients [mean 1.2 (0.9) vs 1.3 (0.5), P  >0.05], whereas lower macrophage infiltration was found in anti-Mi2– DM [mean 0.4 (0.5), <0.01]. Conclusions Anti-Mi2+ patients represent a specific DM subset with high muscle damage. Histological hallmarks were a higher prevalence of myofiber necrosis, endomysial involvement and macrophage infiltrates at muscle biopsy. [ABSTRACT FROM AUTHOR]

The aim of this document is to provide a set of indications on the national best practice management of knee osteoarthritis based on an analysis of the existing literature and the contribution of experts in the field. During the first phase of the project, in agreement with the multidisciplinary panel of experts, the main guidelines on the topic were selected. Each guideline was assessed through the AGREEII system to identify their strong/weak points and a summary of the recommendations contained in the various documents was drawn up. The panel drew up a list of therapeutic options to be included in the document and some of these topics were selected for in-depth analysis and review. The search strategy for the required literature reviews was constructed using the PICOS approach. The results obtained from the literature reviews, the in-depth analyses conducted by the members of the scientific societies involved and the analysis of the existing guidelines enabled an initial draft of the consensus document to be elaborated. This document was examined at the consensus conference held on 28 May 2019, in the presence of a multidisciplinary group consisting of members of the various scientific societies involved. Single recommendations were discussed in work groups with a view to combining the indications given by the literature examined with the experience of the specialists involved. The recommendations discussed were then put to the vote in a plenary assembly. The final document contains 26 practice recommendations which leading specialists involved in the management of knee OA in Italy agree upon. [ABSTRACT FROM AUTHOR]

Several studies have evidenced inadequate knowledge about epilepsy and inappropriate seizure management, influencing quality of life and social inclusion of patients with epilepsy. Aim of the study was to estimate the knowledge and the attitudes toward epilepsy in schoolteachers and students in Italy. Custom-designed and validated questionnaires in Italian on general and specific knowledge, and social impact of epilepsy have been administered in a random sample of schoolteachers and students. Overall, 667 schoolteachers and 672 students have been included. Among teachers and students, consider epilepsy a psychiatric disorder (16.8% and 26.5%) or an incurable disease (43.9% and 33%). The 47.5% of teachers declared to be unable to manage a seizing student, 55.8% thought it requires specific support and 21.6% reported issues in administer antiseizure medications in school. Healthcare professionals should have an active role in the educational system, dispelling myths, preparing educators and students with appropriate attitudes in the event of a seizure and prevent over limitations in patients with epilepsy. These findings highlight still poor knowledge and attitudes about epilepsy among teachers and students although the 99.4% claimed to have heard/read something about epilepsy. Therefore, improving existing dedicated educational/training interventions could be necessary. [ABSTRACT FROM AUTHOR]

Purpose: Poor maintenance management leads to non-negligible economic, environmental and social impacts and obstacles to the sustainable manufacturing paradigm. Studies evaluating maintenance impacts on sustainability underline growing interest in the topic, but reports on the industrial field are lacking. Therefore, this paper investigates the industrial environment and the indicators that manufacturing companies use for measuring their maintenance impacts. Design/methodology/approach: In this pilot survey study, several stakeholders of production enterprises in the south of Italy were interviewed to unveil the spread of the measurement of maintenance impacts on sustainability and the indicators used by those companies. Findings: The interview results showed a low level of awareness among stakeholders about maintenance impacts on sustainability. Maintenance stakeholders are mainly focused on technical and economic factors, whereas environmental, quality and safety stakeholders are becoming more aware of maintenance impacts on environmental and social factors. However, both groups need guidelines to define sustainability indicators to assess such impacts. Originality/value: This exploratory study allowed us to investigate the current situation in industrial organisations and achieve the first variegated and diversified vision of the awareness of company stakeholders on maintenance impacts on the sustainability of several business functions. This paper provides a valuable contribution to "maintenance and sustainability" research area in production contexts and sheds light on non-negligible maintenance impacts on sustainability, providing preliminary insights on the topic and an effective basis for defining future research opportunities. Moreover, this study enables increased awareness among internal and external manufacturing company stakeholders on the role of maintenance in sustainable production. [ABSTRACT FROM AUTHOR]

Inflammatory bowel diseases (IBDs) are a public health issue with over 3.5 million patients in Europe, but the advent of several biologic agents has completely changed their management. Pharmacovigilance is needed to early detect expected/unexpected adverse events (AEs) to assess the safety of drugs in a real-world setting. Aim of this prospective pharmacovigilance study was to evaluate the occurrence of AEs in patients treated with biologic drugs in gastroenterology units in Southern Italy. All consecutive patients treated with one biologic drug during a 2-years period (2017–2018) in six gastroenterology tertiary units and satisfying inclusion criteria were enrolled. Demographic and clinical characteristics of patients, type of treatment used, therapy discontinuation, failures, switch/swap to another biologic, and possible onset of AEs were collected. Adverse events have been compared to the number of AEs reported in the same centres in the two years before the protocol. Overall, 623 patients (253 females) with Crohn's disease (352; 56.5%) or ulcerative colitis (271; 43.5%) have been included. Infliximab (IFX) was the most commonly used (308, 49.4%), followed by adalimumab (ADA; 215, 34.5%), vedolizumab (VED; 73, 11.7%), golimumab (GOL; 26, 4.2%) and ustekinumab (UST; 0.2%). Ninety-two patients have experienced AEs (14.8%) and 10 serious adverse events (SAEs) (1.6%) were recorded. Adverse events and SAEs have been reported with GOL (7/26; p =.88), IFX (51/308; p =.54), ADA (28/125; p =.40) and VED (6/73; p =.11), no AEs occurred with UST (0/1). Overall, considering the low rate of AEs reported and discontinuation from therapy, our data seems to confirm the positive beneficial/risk ratio of biologic treatment for IBDs and provide useful data on biologic drugs in gastroenterology. [ABSTRACT FROM AUTHOR]

Behçet's syndrome (BS) is a multisystemic disorder displaying a marked variability across different geographic areas. The main aim of this study was to analyze demographic and clinical features of a cohort of BS patients diagnosed in three tertiary referral centers in Italy and detect potential associations between the different manifestations. Medical records of 396 patients (218 females, 178 males) were retrospectively analyzed. Mean age at onset was 30.00 ± 18.75 years with a female-to-male ratio of 1.22:1. Mucocutaneous features were the most frequent starting manifestations of BS, followed by eye inflammation. Erythema nodosum (p = 0.007), arthritis/arthralgias (p = 0.0115), and central nervous system (CNS) signs (p = 0.014) were significantly over-represented in female patients, whereas male gender was associated with lower mean age at onset (p = 0.031), higher frequency of pseudofollicular lesions, and uveitis (p = 0.00134 and p < 0.0001 respectively), particularly for posterior segment involvement and panuveitis (p < 0.0001). Regarding the association between disease features, genital ulcers were negatively associated with uveitis (p < 0.0001) and vascular involvement (p < 0.0001). Other negative associations were detected between uveitis and gastrointestinal involvement (p = 0.008), pseudofolliculitis and CNS signs (p = 0.031), vascular involvement (p = 0.002) and erythema nodosum (p = 0.013). Logistic regression identified male gender and genital ulcers, respectively, with a higher (OR 2.199 [1.397-3.461], p < 0.001) and lower risk (OR 0.157 [0.090-0.273], p < 0.0001) of developing major organ involvement. Our evaluations found that the disease had started mostly in the second and third decade with most severe features in the male gender, and that patients presenting with mucocutaneous manifestations were less prone to develop major organ involvement. [ABSTRACT FROM AUTHOR]

The immune system of patients infected by SARS-CoV-2 is severely impaired. Detailed investigation of T cells and cytokine production in patients affected by COVID-19 pneumonia are urgently required. Here we show that, compared with healthy controls, COVID-19 patients' T cell compartment displays several alterations involving naïve, central memory, effector memory and terminally differentiated cells, as well as regulatory T cells and PD1+CD57+ exhausted T cells. Significant alterations exist also in several lineage-specifying transcription factors and chemokine receptors. Terminally differentiated T cells from patients proliferate less than those from healthy controls, whereas their mitochondria functionality is similar in CD4+ T cells from both groups. Patients display significant increases of proinflammatory or anti-inflammatory cytokines, including T helper type-1 and type-2 cytokines, chemokines and galectins; their lymphocytes produce more tumor necrosis factor (TNF), interferon-γ, interleukin (IL)-2 and IL-17, with the last observation implying that blocking IL-17 could provide a novel therapeutic strategy for COVID-19. COVID-19 is a serious pandemic threat to public health, but insights on the pathophysiological and immunological conditions are only emerging. Here the authors use multi-color flow cytometry to characterize CD4+ and CD8+ T cells in peripheral blood from 39 COVID-19 patients in Italy to report altered T cell activation, function and polarization. [ABSTRACT FROM AUTHOR]

The article discusses the correlation between liver fibrosis and lower levels of prostate-specific antigen (PSA) in men with Human Immunodeficiency Virus (HIV). Data from a study involving men with HIV and liver fibrosis were analyzed to explore if PSA is similarly reduced in this population. The results showed that PSA levels are lower in men with HIV and more severe liver fibrosis.

• Remote control of a pellet facility has been proved repeatable and reliable. • E3S platform has been successfully tested in remote control of a pellet injector. • Performance tests indicate that, for massive I/O data flow, E3S should be scaled-up. The four-barrel, two-stage gun Ignitor Pellet Injector (IPI) was developed in collaboration between ENEA and ORNL. The prototype injector is presently located at Oak Ridge (TN, USA), and is normally operated locally through a control and data acquisition system developed in LabVIEW. More recently, a remote-control system has been set up, based on RealVNC®, which allows to operate the IPI from a control room in Italy. Tools for data transfer and storage into ENEA ICT area have also been provided. A Staging, Storage and Sharing system, named E3S, developed using OwnCloud as architectural component, is used for file synchronization and sharing of the data acquired by the diagnostic systems. It provides a homogeneous platform able to store and share heterogeneous data produced by many data acquisition systems in large nuclear fusion experiments. This paper reports about the implementation of the IPI remote control, and presents the application of E3S to this specific case, allowing easy storage and sharing of experimental data onto a wide-area distributed file-system, as well as remote data access via web-services based on MDS+ tool, integrated with MySQL metadata. A performance analysis of the architectural components is also introduced. [ABSTRACT FROM AUTHOR]

Rheumatoid arthritis is the most common autoimmune arthritis in adult population. This disease is characterized by joint damage and systemic involvement that lead to general physical and mental impairment with consequent worsening of quality of life. Rheumatoid arthritis is also associated with a large economic burden to healthcare systems. The evidence from the literature indicates that, despite available treatments, several unmet needs still interfere with rheumatoid arthritis management. Based on this evidence, some of the unmet medical needs currently present in the management of the rheumatoid arthritis were identified and a Delphi questionnaire was submitted to 60 Italian Rheumatologists. The aim of this Delphi was to achieve a broad consensus on the most relevant unmet needs identified, in order to present the Italian reality in view of the availability of new molecules that could provide an effective therapeutic option in the treatment of patients with rheumatoid arthritis. [ABSTRACT FROM AUTHOR]

To assess the long-term effectiveness and safety of tocilizumab, abatacept, and tumor necrosis factor-α inhibitors (TNFi), in the Italian real-world setting of rheumatoid arthritis (RA). The records of adult RA patients from the Italian biologics' registry Gruppo Italiano Studio Early Arthritis (GISEA) were analyzed. Demographic and clinical data were obtained at entry. The disease remission rate (28-joint disease activity score calculated using the erythrocyte sedimentation rate [DAS28-ESR] ≤ 2.6) and frequency of adverse events (AEs) were evaluated at 2 years. From 1999 to 2014, 7539 patients were treated with biologics (61.3% in first- and 22.6% in second-line), 68% of cases received TNFi, 9.1% tocilizumab, and 8.6% abatacept. Treatment groups showed a similar DAS28 at entry. As first-line, tocilizumab induced a significantly higher remission rate than abatacept or TNFi at 6 (51 vs 23.3 and 26.2%, respectively; p < 0.0001) and 24 months (52.3 vs 33.3 and 34.4%, respectively; p < 0.01). A similar pattern was observed in later lines. The most common AEs reported were infections, reactions to biologics (more frequent among TNFi-treated patients), increased transaminase (more frequent among TCZ-treated patients), and cardiovascular events. In clinical practice, TCZ induced a rapid and long-lasting remission and in a higher percentage of patients compared to abatacept and TNFi, with a good safety profile. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to assess whether good EULAR response assessed at 3months may predict the achievement of low disease activity (LDA) at 1year in rheumatoid arthritis (RA) patients on treatment with certolizumab pegol (CZP).Methods: From the nationwide Italian registry, we analysed 278 RA patients (age 54.8±12years, duration of disease 9.8±8years, female 84%) initiating CZP as first line (68%) or≥second line (32%) of biological treatment because of their active disease. Assessment of disease activity was based on 28 joint Disease Activity Score (DAS28). A reduction of DAS28>1.2 (good EULAR response) was assessed at 3months, and the achievement of LDA (DAS28≤3.2) was evaluated at 1year. Multiple regression models were used to estimate predictors of early good EULAR response or LDA.Results: The percentages of patients attaining good EULAR response were 52% at 3, 65% at 6, and 66% at 12months. Furthermore, 51.2% (98/192) of the patients reached LDA at 12months. Patients taking CZP as first biological treatment had adjusted odds ratios (OR) of good EULAR response at 3months 6 folds higher than in those with≥1 prior biological drug (OR 6.7, 95% CI 1.97-23.1). While, the strongest variable correlating with 12months LDA was the achievement of good EULAR response at 3months (OR 11.3, 95% CI 13.1-34.8).Conclusions: Our findings showed that attaining good EULAR response at 3months strongly predicted 1year LDA in RA patients treated with CZP in real-life settings. [ABSTRACT FROM AUTHOR]

Background Management of inflammatory bowel disease (IBD) patients requires a multidisciplinary approach. Among the working team, the role of IBD nurse is expected to be particularly relevant when managing patients receiving biological therapies. We performed a survey to assess the presence of IBD nurse in centers where patients were receiving biologics. Methods For this Italian nationwide survey a specific questionnaire was prepared. IBD nurse was defined as a nurse directly involved in all phases of biological therapy, from pre-therapy screening, administration and monitoring during therapy, to follow up performed by a dedicated helpline, completed a specific training on biological therapy therapy, and observed international guidelines. Results A total of 53 Italian IBD centers participated in the survey, and 91 valid questionnaires were collected. Overall, 34 (37.4%) nurses could be classified as IBD specialists. IBD nurses had a significantly higher educational level than other nurses, they were more frequently operating in Central or Southern than in Northern Italy, they were working in an Academic center rather than in a General hospital, and in IBD centers with >25 patients on biological therapy. On the contrary, mean age, gender distribution, years of nursing, and years working in the IBD unit did not significantly differ between IBD and other nurses. Conclusions Our nationwide survey showed that the presence of an IBD nurse is still lacking in the majority of Italian IBD centers where patients receive biological therapies, suggesting a prompt implementation. [ABSTRACT FROM AUTHOR]

School is potentially one of the most important and effective agencies for the promotion of mental health. For this reason, in Italy, the Mental Health Department of The National Health Institute has developed an intervention based on a structured handbook. The aim of this intervention is to promote the psychological well-being of the students. In this study, we have evaluated the efficacy of this intervention through a quasi-experimental study design of four classes (two were control) of secondary education, including 79 students aged 14 to 16 years (15.35 ± 0.68). Assessments were administered before and after the intervention. The results showed improvement in perceived self-efficacy (p ≤ .001), emotional coping (p = .003), and overall well-being (p < .05). The students’ perception of usefulness was also increased (p < .05); the intervention successfully promoted the idea of life as a continuous process of learning, in change and growth (p < .05). The intervention was effective despite some limitations described by authors related to a lack of involvement of relatives and the team teachers, as well as the absence of homework; however, the adoption of a program promoting life skills, problem solving, and goal definition training is recommended with the use of a revised handbook. [ABSTRACT FROM AUTHOR]

Background. This study aims at comparing the morbidity and oncologic outcomes in normal weight, overweight, and obese women with locally advanced cervical cancers (LACC) submitted to radical surgery after chemoradiation. Methods. A review of LACC patients with body mass index (BMI) ≥18.5 kg/m2 who underwent neoadjuvant chemoradiation followed by radical surgery between January 1996 and December 2010 was performed. BMI categories were created according to the World Health Organization (WHO) classification. Results. Two hundred sixty-eight women met the inclusion criteria: 118 (44.0%) were normal weight, 100 (37.3%) overweight and 50 (18.7%) obese. The median follow-up was 42 months. Higher BMI was associated with older age (p = 0.0041), while there were no differences among the three groups in Charlson comorbidity score, tumor characteristics, radiotherapy dosing, type of surgery, and pathological response. There were no differences among the three groups in the intraoperative and postoperative complications as well as rate of patients requiring adjuvant treatments: 21 (7.8%) patients experienced grade 3-4 toxicity, including six normal weight, 12 overweight and three obese patients (p = 0.14). Only the rate of grade 1-2 skin toxicity was higher in obese (14%) with respect to overweight (1%) and normal women (0%) (p = 0.00001). There were no differences in the five-year DFS (74%, 77%, and 84% for normal weight, overweight, and obese women, respectively, p = n.s.), and five-year OS (76%, 78%, and 78% for normal weight, overweight, and obese women, respectively, p = n.s.). Conclusions. The role of obesity should not be overestimated when evaluating the chance of enrolment of LACC patients into preoperative chemoradiation protocols. [ABSTRACT FROM AUTHOR]

An increased risk of developing severe infections has been evidenced in rheumatic disease (RD) patients, and anti-COVID-19 vaccination is strictly recommended for RD patients. However, up to now, no data are available on safety, immunogenicity and efficacy of COVID-19 vaccinations in RD patients. The possible development of adverse events (AEs), including the flare-up of underlying RD, represents a matter of growing importance. The aim of our study is to assess, in RD patients, the safety profile of different types of approved vaccines and the possible influence of immunosuppressive therapies and clinical or demographic characteristics of RD patients on development of AEs. Participants (n = 185; 30.7%) received anti-COVID-19 vaccinations, 137 with autoimmune/chronic inflammatory RD (Au/cIn-RD) and 48 with nonautoimmune/chronic inflammatory RD (no-Au/cIn-RD). AEs were recorded in 42% of patients after the first dose of vaccine, and in 26% of patients after the second dose. The most common reported AEs after anti-COVID 19 vaccines were site injection pain (17%), headache (12%), fever (12%), myalgia (10%) and fatigue (10%). Relapses of the underlying Au/c-In-RD were recorded in 2.2% of patients after the first dose of vaccine. In Au/c-In-RD the risk of developing AEs after the first dose of vaccine was lower in older patients (OR = 0.95; p = 0.001), and in the group of patients with complete control of RD (OR: 0.2; p = 0.010). A lower percentage of AEs was observed in patients with complete control of their Au/cIn-RD (29%) compared to those with low (57%) or moderate-high disease activity (63%) (p = 0.002 and p = 0.006 respectively). In this study all types of COVID-19 vaccines in use in Italy seemed safe in RD patients. The results of this study might provide reassuring information for Au/cIn RD patients and clinicians and could strengthen the data on vaccine safety to guide the use of COVID-19 vaccines in Au/cIn-RD on immunosuppressive agents. [ABSTRACT FROM AUTHOR]

We performed an epidemiologic study to assess the prevalence of chronic viral hepatitis in inflammatory bowel disease (IBD) and to detect their possible relationships. Methods: It was a single centre cohort cross-sectional study, during October 2016 and October 2017. Consecutive IBD adult patients and a control group of non-IBD subjects were recruited. All patients underwent laboratory investigations to detect chronic hepatitis B (HBV) and C (HCV) infection. Parameters of liver function, elastography and IBD features were collected. Univariate analysis was performed by Student's t or chi-square test. Multivariate analysis was performed by binomial logistic regression and odds ratios (ORs) were calculated. We enrolled 807 IBD patients and 189 controls. Thirty-five (4.3%) had chronic viral hepatitis: 28 HCV (3.4%, versus 5.3% in controls, p = 0.24) and 7 HBV (0.9% versus 0.5% in controls, p = 0.64). More men were observed in the IBD–hepatitis group (71.2% versus 58.2%, p < 0.001). Patients with IBD and chronic viral hepatitis had a higher mean age and showed a higher frequency of diabetes, hypertension and wider waist circumference. They suffered more frequently from ulcerative colitis. Liver stiffness was greater in subjects with IBD and chronic viral hepatitis (7.0 ± 4.4 versus 5.0 ± 1.2 KPa; p < 0.001). At multivariate analysis, only old age directly correlated with viral hepatitis risk (OR = 1.05, 95%CI 1.02–1.08, p < 0.001). In conclusion, the prevalence of HBV/HCV in IBD is low in our region. Age may be the only independent factor of viral hepatitis–IBD association. Finally, this study firstly measured liver stiffness in a large scale, showing higher values in subjects with both diseases. [ABSTRACT FROM AUTHOR]

Antibiotic resistance has become an emerging problem for treating Helicobacter pylori (H. pylori) infection. Clarithromycin and levofloxacin are two key antibiotics used for its eradication. Therefore, we reviewed our experience with genotypic resistance analysis in stools to both clarithromycin and levofloxacin in the last four years to evaluate time trends, both in naive and failure patients. Patients collected a fecal sample using the THD fecal test device. Real-time polymerase chain reaction was performed to detect point mutations conferring resistance to clarithromycin (A2142C, A2142G, and A2143G in 23S rRNA) and levofloxacin (substitutions at amino acid position 87 and 91 of gyrA). One hundred and thirty-five naive patients were recruited between 2017–2020. Clarithromycin resistance was detected in 37 (27.4%). The time trend did not show any significant variation from 2017 to 2020 (p = 0.33). Primary levofloxacin resistance was found in 26 subjects (19.2%), and we observed a dramatic increase in rates from 2017 (10%) to 2018 (3.3%), 2019 (20%), and 2020 (37.8%). Ninety-one patients with at least one eradication failure were recruited. Secondary resistance to clarithromycin and levofloxacin was found in 59 (64.8%) and 45 patients (59.3%), respectively. In conclusion, our geographic area has a high risk of resistance to clarithromycin. There is also a progressive spreading of levofloxacin-resistant strains. [ABSTRACT FROM AUTHOR]

Background obesity and sedentary lifestyle have been shown to negatively affect survival in breast cancer (BC). The purpose of this study was to test the efficacy of a lifestyle intervention on body mass index (BMI) and physical activity (PA) levels among BC survivors in Modena, Italy, in order to show an outcome improvement in obese and overweight patients. Methods: This study is a single-arm experimental design, conducted between November 2009 and May 2016 on 430 women affected by BC. Weight, BMI, and PA were assessed at baseline, at 12 months, and at the end of the study. Survival curves were estimated among normal, overweight, and obese patients. Results: Mean BMI decreased from baseline to the end of the study was equal to 2.9% (p = 0.065) in overweight patients and 3.3% in obese patients (p = 0.048). Mean PA increase from baseline to the end of the study was equal to 125% (p < 0.001) in normal patients, 200% (p < 0.001) in overweight patients and 100% (p < 0.001) in obese patients. After 70 months of follow-up, the 5-year overall survival (OS) rate was 96%, 96%, and 93%, respectively in normal, obese, and overweight patients. Overweight patients had significantly worse OS than normal ones (HR = 3.69, 95%CI = 1.82–4.53 p = 0.027) whereas no statistically significant differences were seen between obese and normal patients (HR 2.45, 95%CI = 0.68–8.78, p = 0.169). Conclusions: A lifestyle intervention can lead to clinically meaningful weight loss and increase PA in patients with BC. These results could contribute to improving the OS in obese patients compared to overweight ones. [ABSTRACT FROM AUTHOR]

• In non-middle eastern patients FMF manifests in mild form. • Chromosomes bearing the R202Q variant might not be completely neutral. • The sensitivity of FMF scores is diminished in a homogenous italian population. Familial Mediterranean Fever (FMF) is linked with the MEFV gene and is the commonest among monogenic autoinflammatory diseases, with high prevalence in the Mediterranean basin. Although the clinical presentation of FMF has a major role in diagnosis, genotype/phenotype correlations and the role of "benign" gene variants (as R202Q) appear highly variable and incompletely clear, making difficult to select the most effective strategy in the management of patients. Aim of the present study was to investigate the clinical presentation and the genetic background in a homogenous cohort of patients from Apulia (south eastern Italy). We investigated 217 patients with a clinical suspect of autoinflammatory diseases, who were characterized for the occurrence of specific symptoms and with next generation sequencing by a 4-gene panel including MEFV, MVK, NLRP3 and TNFRSF1A. A genetic change was identified in 122 (53.7%) patients, with 161 different MEFV variants recorded in 100 individuals, 10 variants in NLRP3 , and 6 each in TNFRSF1A and MVK. The benign variant R202Q was largely prevalent (41.6% of all MEFV variants). When patients were selected according the number of pathogenic MEFV variants (0, 1, or 2 pathogenic variants), results failed to show significant links between the frequency of symptoms and the number of pathogenic variants. Only family history and Pras score (indicative for severity of disease) predicted the presence of pathogenic variants, as compared with carriers of variants considered of uncertain significance or benign. Fever >38 °C and arthralgias appeared more frequently in R202Q-positive patients than in non-R202Q carriers. These two subgroups showed comparable duration of fever, occurrence of myalgia, abdominal and chest pain, Pras, and IFFS scores. In conclusion, results confirm that FMF manifests in mild form in non-middle eastern patients. This possibility partly affects the reliability of clinical criteria/scores. Furthermore, the presence of the R202Q variant might not be completely neutral in selected groups of patients. [ABSTRACT FROM AUTHOR]

Background. Vitamin D (25(OH)D) deficiency is a prevalent condition worldwide. However, the highest prevalence rates of 25(OH)D deficiency have been attributed to regions with higher latitude. A close association between 25(OH)D and cardio-cerebrovascular (CCV) risk factors and major health problems has been identified. Aim. To establish the prevalence of 25(OH)D deficiency and to investigate the relationship between 25(OH)D levels and CCV risk factors (blood cholesterol, triglycerides, glucose concentrations, body mass index, and systolic and diastolic blood pressure) in a cohort representative of Southern Italy. Methods. The prevalence of 25(OH)D levels was evaluated in 1200 subjects aged 25–74 years (600 males and 600 females), enrolled in the "VIP" (from Italian for Irno Valley Prevention) Project, whereas multiple linear regression analysis was used to determine the relationship between 25(OH)D levels and CCV risk factors. Results. Only 13.3% of females and 11.1% of males showed adequate serum concentrations of 25(OH)D (≥30 ng/ml), while 59.3% of females and 55.1% of males showed 25(OH)D deficient levels (<20 ng/ml). We observed an independent association between 25(OH)D concentrations and metabolic syndrome score, LDL cholesterol, HDL cholesterol, and corrected QT (cQT). Conclusions. We report a high prevalence of 25(OH)D deficiency across the largest Italian adult population studied so far and, in particular, the first across Southern Italy; furthermore, we provide data on the association between 25(OH)D deficiency and higher CCV risk factors. [ABSTRACT FROM AUTHOR]

Background: Nutrition exerts a fundamental role in the prevention of obesity (OB). The aim of this study was to assess the extent to which well recognized risk factors for early OB can be associated to overweight (OW) or OB under a standardized nutritional approach and surveillance in toddlers., Methods: The eligible population was represented by 676 toddlers aged 24-36 months, assigned to 18 primary care pediatricians trained on nutritional issues who shared a standardized nutritional approach. Six-hundred-twenty-nine children (333 boys), mean age 27.8 ± 4.2 months were effectively included in this observational study. Parents received nutritional advice with particular emphasis to proteins and sugar composition supported by leaflets and reinforced at each visit. Body mass index was assessed at the age of 24-36 months. The following individual and family risk factors were considered: gestational age, birth weight, eutocic/caesarean delivery, milk feeding history, household smoking or antibiotics exposure, parents' weight, height and educational level. Prevalence of OW/OB was compared to a group of 742 toddlers (373 boys) under usual care., Results: Under a standardized nutritional counselling, 28.1% toddlers were classified as OW/OB compared to 36.9% toddlers under usual care (p = 0.005). In unadjusted models, parental OW/OB was significantly associated to OW/OB in toddlers (p < 0.01), while high birth weight did not reach statistical significance (p = 0.07). In adjusted models, including all the explanatory variables studied, only paternal OW/OB vs. normal weight was significantly associated to OW/OB in toddlers (OR 2.035, 95% confidence interval 1.206-3.436). No protective effect of exclusive breast feeding during the first 6 months of age was demonstrated., Conclusions: Toddlers under a standardized nutrition counselling focused to limit protein and simple sugars, showed lower prevalence of OW/OB compared to usual care. Healthy promotion activities should take into account the influence of paternal BMI on the offspring adiposity., (© 2024. The Author(s).)

Total alpha and beta activities and Rn-222 concentrations were determined in water from different sections of seven aqueducts belonging to the water supply system of Campania region (Italy), known worldwide for its volcanism. Statistical analysis was performed on data to account for their variability across the aqueduct sections, and results were discussed considering the geology of reservoirs, the potential mixing processes occurring along the pipe network, the building/constituting materials of the aqueduct sections, and the integrity of the infrastructure. Guidelines proposed by Italian and international regulation entities were considered to determine if total alpha and beta activities and Rn-222 concentrations found at the taps of the different aqueducts should be considered detrimental to public health. Based on a deterministic and a stochastic approach, a health risk assessment was also tested for Rn-222, assuming direct ingestion and showering as potential exposure pathways. Results showed that applying guidelines returned an absence of hazard, whereas risk assessment returned a high probability of exposure to unacceptable Rn-222 doses for some aqueducts. Beyond the usefulness of obtained results to plan actions to improve the safety of drinking water in Campania, our outcomes represent a warning for bodies dealing with public health at any level: the use of guidelines can bring an underestimation of the risks exerted by the exposure to Rn-222 on human health. Further, using a probabilistic approach in risk assessment accounting for uncertainty can favor risk forecasts based on more "realistic" scenarios., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The treatment of hepatitis C virus (HCV) with direct-acting antivirals (DAA) leads to high sustained virological response (SVR) rates, but hepatocellular carcinoma (HCC) risk persists in people with advanced liver disease even after SVR. We weighted the HCC risk in people with cirrhosis achieving HCV eradication through DAA treatment and compared it with untreated participants in the multicenter prospective Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. Propensity matching with inverse probability weighting was used to compare DAA-treated and untreated HCV-infected participants with liver cirrhosis. Kaplan-Meier analysis and competing risk regression analysis were performed. Within the first 36 months, 30 de novo HCC cases occurred in the untreated group ( n = 307), with a weighted incidence rate of 0.34% (95%CI: 0.23-0.52%), compared to 63 cases among SVR patients ( n = 1111), with an incidence rate of 0.20% (95%CI: 0.16-0.26%). The 12-, 24-, and 36-month HCC weighted cumulative incidence rates were 6.7%, 8.4%, and 10.0% in untreated cases and 2.3%, 4.5%, and 7.0% in the SVR group. Considering death or liver transplantation as competing events, the untreated group showed a 64% higher risk of HCC incidence compared to SVR patients (SubHR 1.64, 95%CI: 1.02-2.62). Other variables independently associated with the HCC occurrence were male sex, increasing age, current alcohol use, HCV genotype 3, platelet count ≤ 120,000/µL, and albumin ≤ 3.5 g/dL. In real-life practice, the high efficacy of DAA in achieving SVR is translated into high effectiveness in reducing the HCC incidence risk.

Aims: The impact of reperfusion delay in ST-elevation myocardial infarction (STEMI) is well known. We aimed to describe the specific reasons for delay to primary percutaneous coronary intervention (pPCI), and their impact on mortality after adjusting for confounders, using the first-medical-contact-to-device (FMCTD) time to measure the delay., Methods: Between January 2006 and December 2019, 2149 STEMI patients underwent pPCI at our centre. Delayed pPCI was defined as FMCTD > 90 min or > 120 min in the case of inter-hospital transfer. The causes of delay were classified as system-related (related to the network organization) or patient-related (related to the clinical condition of the patient). Primary outcome was 1-year all-cause mortality., Results: The pPCI was timely in 69.9% of patients, delayed for system-related causes in 16.4% or for patient-related causes in 13.7%. Different patient-related causes induced variable median FMCTD time (from 114 min for technically difficult pPCI to 159 min for ECG and/or symptom resolution). By multivariable Cox-regression models, the main independent risk factors for mortality were delay due to comorbidities [hazard ratio (HR) 2.19 (1.22-3.91)], or hemodynamic instability [HR 2.05 (1.25-3.38)], after adjusting for Global Registry of Acute Coronary Events risk score tertiles and angiographic success. The difference in risk of mortality is maintained over the entire spectrum of time from symptom onset., Conclusions: Different causes of delay had different impacts on mortality, generally more important than the length of the delay. Causes of delay such as hemodynamic instability and comorbidities should prompt specific programs of performance improvement. Timely pPCI maintains prognostic advantages after several hours from symptom onset, mandating prompt reperfusion also in late-presenter patients., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: Liver disease progression after Hepatitis C Virus (HCV) eradication following direct-acting antiviral (DAA) treatment in the real-life setting according to Human Immunodeficiency Virus (HIV) coinfection was evaluated., Methods: Patients consecutively enrolled in PITER between April 2014 and June 2019 and with at least 12-weeks follow-up following treatment were analysed. Cox regression analysis were used to evaluate HIV coinfection and factors independently associated with liver disease outcomes following viral eradication in DAA treated patients with pre-treatment liver cirrhosis., Results: 93 HIV/HCV coinfected and 1109 HCV monoinfected patients were evaluated during a median follow-up of 26.7 (range 6-44.6) and 24.6 (range 6.8-47.3) months, respectively. No difference in the cumulative HCC incidence and hepatic decompensation was observed between coinfected and monoinfected patients. Age (Hazard Ratio [HR] = 1.08; 95% CI 1.04-1.13), male sex (HR = 2.76; 95% CI 1.28-5.96), lower albumin levels (HR = 3.94; 95% CI 1.81-8.58), genotype 3 (HR = 5.05; 95% CI 1.75-14.57) and serum anti-HBc positivity (HR = 1.99, 95% CI 1.01-3.95) were independently associated with HCC incidence. Older age (HR = 1.03; 95% CI 1.00-1.07), male sex (HR = 2.13; 95% CI 1.06-4.26) and lower albumin levels (HR = 3.75; 95% CI 1.89-7.46) were independently associated with the appearance of a decompensating event after viral eradication., Conclusion: Different demographic, clinical and genotype distribution between HIV coinfected vs those monoinfected, was observed in a representative cohort of HCV infected patients in Italy. Once liver cirrhosis is established the disease progression is decreased, but still persists regardless of viral eradication in both coinfected and monoinfected patients. In patients with cirrhosis, HIV coinfection was not associated with a higher probability of liver complications, after viral eradication.

Objective: To assess the frequency of adverse events associated with periendoscopic management of direct oral anticoagulants (DOACs) in patients undergoing elective GI endoscopy and the efficacy and safety of the British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) recommendations (NCT02734316)., Design: Consecutive patients on DOACs scheduled for elective GI endoscopy were prospectively included. The timing of DOAC interruption and resumption before and after the procedures were recorded, along with clinical and procedural data. Procedures were stratified into low-risk and high-risk for GI-related bleeding, and patients into low-risk and high-risk for thromboembolic events. Patients were followed-up for 30 days for major and clinically relevant non-major bleeding events (CRNMB), arterial and venous thromboembolism and death., Results: Of 529 patients, 38% and 62% underwent high-risk and low-risk procedures, respectively. There were 45 (8.5%; 95% CI 6.3% to 11.2%) major or CRNMB events and 2 (0.4%; 95% CI 0% to 1.4%) thromboembolic events (transient ischaemic attacks). Overall, the incidence of bleeding events was 1.8% (95% CI 0.7% to 4%) and 19.3% (95% CI 14.1% to 25.4%) in low-risk and high-risk procedures, respectively. For high-risk procedures, the incidence of intraprocedural bleeding was similar in patients who interrupted anticoagulation according to BSG/ESGE guidelines or earlier (10.3%vs10.8%, p=0.99), with a trend for a lower risk as compared with those who stopped anticoagulation later (10.3%vs25%, p=0.07). The incidence of delayed bleeding appeared similar in patients who resumed anticoagulation according to BSG/ESGE guidelines or later (6.6%vs7.7%, p=0.76), but it tended to increase when DOAC was resumed earlier (14.4%vs6.6%, p=0.27). The risk of delayed major bleeding was significantly higher in patients receiving heparin bridging than in non-bridged ones (26.6%vs5.9%, p=0.017)., Conclusion: High-risk procedures in patients on DOACs are associated with a substantial risk of bleeding, further increased by heparin bridging. Adoption of the BSG/ESGE guidelines in periendoscopic management of DOACs seems to result in a favourable benefit/risk ratio., Trial Registration Number: NCT02734316; Pre-results., Competing Interests: Competing interests: FR received grants outside the submitted work from BMS/Pfizer and Boehringer Ingelheim. FD received grants outside the submitted work from BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Roche and Sanofi., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background & Aims: Advances in direct-acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only diagnosed and linked-to-care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030., Methods: Using a modelling approach grounded in Italian real-life data of diagnosed and treated patients, different linkage-to-care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals., Results: Under the 40% linked-to-care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948-1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0-F3 cases. Under the 60% linked-to-care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958-1978 birth cohorts could capture 55% of F0-F3 individuals. Under the 80% linked-to-care scenario, screening limited in 1968-1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals., Conclusion: In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Nonalcoholic fatty liver disease (NAFLD) is common in inflammatory bowel diseases (IBD). Herein, NAFLD prevalence and risk factors in a large IBD cohort were evaluated and compared to that of a non-IBD sample., Methods: Crohn's disease/ulcerative colitis outpatients referred to IBD service of our Gastroenterology Unit were enrolled. Subjects affected by functional and motor gastrointestinal disorders, in whom IBD was ruled out, referred to general outpatient service in the same area, were considered as nonIBD group. Exclusion criteria were based on previous diagnosis of nonNAFLD chronic liver diseases and secondary causes of fat liver overload. Characteristics of IBD and liver status were collected. Risk factors for metabolic syndrome were analyzed. Ultrasonographic presence and degree of steatosis were assessed. Data were examined by univariate and multivariate analyses., Results: For this study 465 IBD and 189 non-IBD subjects were consecutively enrolled. NAFLD was found in 28.0% and 20.1% in IBD and non-IBD subjects, respectively (P = 0.04). IBD patients with NAFLD were younger than non-IBD ones. There was no significant difference in steatosis grade and association between NAFLD and IBD behavior, extension, activity, and drugs. In the IBD group, multivariate analysis demonstrated that NAFLD was independently associated to metabolic syndrome (OR=2.24, 95%CI 1.77-28.81), diabetes (OR=1.71, 95%CI 1.43-12.25), fasting blood glucose (OR=1.36, 95%CI 1.13-1.68), and abdominal circumference (OR=1.68, 95%CI 1.15-14.52)., Conclusions: NAFLD is more common and occurs at a younger age in IBD than in nonIBD subjects. However, further investigation is required to ascertain possible NAFLD pathogenic IBD-related factors other than conventional/metabolic ones. 10.1093/ibd/izy051&#95;video1izy051.video15774874877001.

Purpose: Real-time polymerase chain reaction (RT-PCR) is a widely used technique for bacterial and viral infection diagnosis. Herein, we report our preliminary experience in retrieving H. pylori genetic sequences in stools and analyzing genotypic clarithromycin resistance by RT-PCR (noninvasive), with the aim of comparing this procedure with that performed on biopsy samples (invasive)., Materials and Methods: After 'in vitro' demonstration of H. pylori DNA detection from pure and stool-mixed bacteria, 52 consecutive patients at the first diagnosis of infection were investigated. DNA was extracted from biopsy tissue and stool samples (THD ® Fecal Test, Italy). RT-PCR was performed to detect 23S rRNA encoding bacterial subunit gene and search A2143G, A2142C, A2142G point mutations for clarithromycin resistance assessment., Results: RT-PCR showed H. pylori positive DNA in all infected patients with full concordance between tissue and stool detection (100%). We found A2143G mutation in 10 (19.2%), A2142G in 4 (7.7%) and A2142C in 5 (9.6%) patients; there was a full agreement between biopsy and fecal samples. A2143G was found in all the four A2142G positive cases and in three out of the five A2142C positive strains. Overall clarithromycin resistance rate in our series was 23%., Conclusions: Despite the need of confirmation on large sample, stool RT-PCR analysis could represent a feasible tool to detect H. pylori DNA sequences and antibiotic resistance point mutations. As compared to tissue molecular analysis, this technique is noninvasive, with potential advantages such as improvement of patient compliance, reduction of diagnostic procedure time/cost and improvement of therapeutic outcome.

Background: No data about the influence of age and underlying diseases on home enteral nutrition (HEN)-related complications are reported in the literature. Herein, we retrospectively investigated this issue by analyzing HEN-related complications in a cohort of consecutive patients grouped according to the underlying disease and age., Material and Methods: We reviewed the medical records of 101 patients referring to our team in 2007-2010 to obtain patients' demographic data, age, nutrition status, duration of HEN treatment, and type of HEN-related complications. They were divided in cancer and neurologic patients and subgrouped on the basis of their age. HEN-related complications were expressed as complication rates., Results: Patients with neurological diseases suffered a significantly higher number of complications as compared with cancer patients (P = .04). Age did not significantly influence complication rates. The mechanical complications were the most frequent. The majority of HEN-related complications were resolved at home., Conclusion: Our data strongly suggest that HEN-related complications are influenced by underlying diseases and not by age. In neurologic patients, dementia, loss of autonomy, and the different therapies administered by PEG probably play an important role in increasing the number of HEN-related complications as compared with cancer patients. The most frequent complications can be managed at home, reducing the costs of hospitalizations and discomfort for the patient., (© 2013 American Society for Parenteral and Enteral Nutrition.)

The aim of this study was to evaluate the combined influence of several lifestyle, health and housing factors in the occurrence of home injuries (HIs) among the elderly. The subjects were recruited from 10 hospitals in Rome, Italy. This study is a paired case-control study. Cases included subjects, aged 65-85 years, who visited the Emergency Department for an HI and were subsequently hospitalised (15 September 2004-30 June 2005). Controls were the subjects of the same gender, age (±3 years) and area of residence of cases. A conditional logistic regression model was used for analysing the variables obtained. In this study, we enrolled 107 hospitalised cases. It was found that the living room was the place where 33% of the accidents occurred. Eighty-seven per cent of the accidents were falls, and 33% of the accidents were the immediate consequence of sudden malaise. One-half of the cases reported one or more leg fractures. The variables that were independently associated with HI were poor household illumination, poor emotional status, regular physical activities and housekeeping activities. We conclude that this study shows the areas of intervention to target HI prevention activities.

Mother-to-infant transmission of Hepatitis C Virus (HCV) represents the major cause of pediatric HCV infection today. Immunogenetic influence has been poorly investigated and mainly confined to HLA-class II serological polymorphisms. Among 290 parities, 135 from Pavia and 155 from Bergamo, of HCV-RNA-infected Italian women, 21 babies (7.24%) were HCV-RNA positive at birth and steadily positive over 20 months of life. All the 21 infected babies and 44 randomly selected uninfected ones, born to HCV-RNA+ mothers but steadily negative for HCV-RNA during a follow-up of 2 years, and their mothers were investigated for HLA-G, -C, -DRB1, -DQA1 and -DQB1 genomic polymorphisms. Among the different covariates, HLA-Cw*07, -G*010401, -DRB1*0701, -DRB1*1401 and homozygosity for HLA-G 14bp deletion can be considered as risk factors for HCV vertical transmission. On the contrary, protection was conferred by the HLA-DQB1*06, -G*0105N, -Cw*0602, DRB1*1104 and -DRB1*1302 alleles. Our initial question was: has the immunogenetic profile any role in the protection of the fetus growing in an infected milieu and, if so, is it independent from the other non-immunogenetic parameters? The answer to both questions should be yes.