Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial.

BACKGROUND AND AIMS: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. METHODS: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. RESULTS: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, -1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). CONCLUSIONS: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.).

EUS-guided biliary drainage with LAMS for distal malignant biliary obstruction when ERCP fails: single-center retrospective study and maldeployment management.

BACKGROUND: EUS-guided biliary drainage (EUS-BD) with Lumen Apposing Metal Stent (LAMS) is a mini-invasive approach for jaundice palliation in distal malignant biliary obstruction (D-MBO) not amenable to ERCP, with good efficacy and not exiguous adverse events. AIMS AND METHODS: From January 2015 to December 2019, we retrospectively enrolled all the EUS-BD with electrocautery-enhanced LAMS for biliary decompression in unresectable D-MBO and failed ERCP. Primary study aims were to evaluate technical/clinical success and AEs rate. In case of maldeployment, we estimated the efficacy of an intra-operative rescue therapy. Secondary aims were to assess the jaundice recurrence and gastric outlet obstruction symptoms. RESULTS: Thirty-six EUS-BD were enrolled over a cohort of 738 patients (ERCP cannulation failure rate was 2.6%): 31 choledocho-duodenostomy and 5 cholecystogastrostomy. A pre-loaded guidewire through the LAMS was systematically used in case of common bile duct ≤ 15 mm or scope instability for a safe/preventive biliary entryway in case of intra-procedural complications. Technical success was 80.6% (29/36 patients). Seven cases of LAMS maldeployment during EUS-guided choledocho-duodenostomy were successfully treated with RT by an over-the-wire fully-covered Self-Expandable Metal Stent (FC-SEMS). The FC-SEMS was released through the novel fistula tract in endoscopic fashion in 5/7 cases and transpapillary in percutaneous-transhepatic-endoscopic rendezvous (1/7) and laparoscopic-endoscopic rendezvous (1/7) in the two remaining cases. The total efficacy of rescue therapy was 100%. Same-session duodenal SEMS was placed in 17 patients with optimal gastric outlet obstruction management. Final clinical success was 100% and no other late adverse events or FC-SEMS migration were observed. CONCLUSION: EUS-BD with LAMS is effective for jaundice palliation after ERCP failure but with considerable adverse events. Maldeployment remains a serious complication with fatal evolution if not correctly recognized/managed. Rescue therapy must be promptly applied especially in tertiary-care centers with highly skilled endoscopists, interventional radiologist and dedicated surgeon.

Is Transient Elastography Needed for Noninvasive Assessment of High-Risk Varices? The REAL Experience.

INTRODUCTION: The Baveno VI consensus guidelines and an expanded algorithm suggest that transient elastography (TE) and platelet (PLT) count can be used to identify patients with cirrhosis who can avoid esophagogastroduodenoscopy (EGD). The primary aims of this study were to assess the ability of a simple algorithm, which uses only laboratory parameters, to predict medium/large esophageal varices (EV) in patients with hepatitis C virus (HCV) and cirrhosis from the Rete Sicilia Selezione Terapia-HCV (RESIST-HCV) cohort and to compare the performance of the algorithm with Baveno VI and Expanded Baveno VI criteria. The secondary aim was to assess the role of TE in ruling out large EV. METHODS: In total, 1,381 patients with HCV-associated cirrhosis who had EGD and TE within 1 year of starting treatment with direct-acting antivirals were evaluated. Using multivariate logistic analysis, laboratory variables were selected to determine which were independently associated with medium/large EV to create the RESIST-HCV criteria. These criteria were tested in a training cohort with patients from a single center (Palermo) and validated with patients from the 21 other centers of the RESIST-HCV program (validation cohort). RESULTS: In the entire cohort, medium/large EV were identified in 5 of 216 patients (2.3%) using the Baveno VI criteria and 13 of 497 patients (2.6%) using the Expanded Baveno VI criteria. PLT count and albumin level were independently associated with medium/large EV. The best cut-off values were a PLT count greater than 120 × 10 cells/µL and serum albumin level greater than 3.6 g/dL; negative predictive values (NPVs) were 97.2% and 94.7%, respectively. In the training cohort of 326 patients, 119 (36.5%) met the RESIST-HCV criteria and the NPV was 99.2%. Among 1,055 patients in the validation cohort, 315 (30%) met the RESIST-HCV criteria and the NPV was 98.1%. Adding TE to the RESIST-HCV criteria reduced the avoided EGDs for approximately 25% of patients and the NPV was 98.2%. DISCUSSION: The "easy-to-use" RESIST-HCV algorithm avoids EGD for high-risk EV screening for more than 30% of patients and has the same performance criteria as TE. Using these criteria simplifies the diagnosis of portal hypertension.

Point-of-care HCV RNA testing in the setting of DAA therapy: HCV-FiS (HEpatitis C Virus Fingerstick Study).

HCV-RNA assessment during therapy with Direct-Acting Antiviral (DAA) regimens still relies on assays requiring blood collection and transport to a specialised laboratory, which may compromise linkage to care. GeneXpert-HCV Viral Load (GXHVL) (Cepheid) is a plasma-based assay used at point of care (POC) with a sensitivity of ≤10 IU/mL, and, results available within 2 hours. Fifty-nine consecutive HCV-patients ready for DAAs treatment were enrolled. HCV-RNA was simultaneously tested using Roche TaqMan RT-PCR (venous blood sample) and GXHVL (capillary blood collected by fingerstick), at baseline (BL), week 4 (W4) of therapy, end of therapy (EOT) and week 12 of follow-up (W12FU). Both assays demonstrated undetectable HCV-RNA in all patients at EOT and identified the single case of HCV-relapse at W12FU. GXHVL used as a point-of-care assay in the outpatient setting provides results fully comparable to the laboratory-based test. Its excellent performance and ease of use suggest its adoption in non-specialist settings where simplicity of care is paramount to implement HCV eradication campaigns.

Effects of Eradicating Hepatitis C Virus Infection in Patients With Cirrhosis Differ With Stage of Portal Hypertension.

BACKGROUND & AIMS: Clearance of hepatitis C virus (HCV) via antiviral treatment changes the course of liver disease. We evaluated the benefit of sustained virologic response (SVR) in patients with HCV and cirrhosis without (stage 1) and with (stage 2) esophageal varices (EV). METHODS: We performed a prospective cohort study of 444 patients with HCV and compensated cirrhosis (218 with stage 1 and 226 with stage 2 disease) treated with peg-interferon and ribavirin from June 2001 through December 2009 at the University of Palermo, Italy and followed for a median of 7.6 years (range, 1-12.6 years). We used Cox regression analysis to identify variables associated with appearance or progression of EVs, development of hepatocellular carcinoma (HCC), liver decompensation, and overall survival. RESULTS: In the intention-to-treat analysis, 67 patients with stage 1 disease (30.7%) and 41 patients with stage 2 disease (18.1%) achieved an SVR (P = .003). Patients with stage 1 disease and an SVR were less likely to develop EVs than stage 1 patients without an SVR (hazard ratio [HR], 0.23; 95% confidence interval [CI], 0.11-0.48; P < .001). However, SVR did not affect whether patients with stage 2 disease developed further EVs (HR, 1.58; 95% CI, 0.33-1.03; P = .07, by log-rank test). An SVR was associated with lower risk for HCC (HR, 0.25; 95% CI, 0.12-0.55; P < .001). Patients with stage 2 disease, regardless of SVR, were at greater risk than patients with stage 1 disease for liver decompensation (HR, 2.82; 95% CI, 1.73-4.59; P < .001) or death (HR, 1.77; 95% CI, 1.12-2.80; P = .015). A lower proportion of patients with stage 1 disease and an SVR died from HCC (2.9%), compared with those without an SVR (11.9%) (P = .03) or developed liver decompensation (none vs 7.1% without an SVR; P = .009). A lower proportion of patients with stage 2 disease and an SVR died from causes secondary to HCC (2.0%) compared with those without an SVR (18.4%) (P = .003). Death from causes secondary to liver decompensation did not differ significantly between patients with stage 2 disease with or without an SVR (12.1% vs 25.4%; P = .15). CONCLUSIONS: In a prospective study of 444 patients with HCV and compensated cirrhosis, HCV eradication reduced risk for liver decompensation, HCC, and death, regardless of whether the patients had EVs.

Promoting teachers' wellbeing through a serious game intervention: a qualitative exploration of teachers' experiences.

Introduction: Teachers' wellbeing plays a critical role in their overall job satisfaction, motivation, and effectiveness in building supporting learning environments. In today's dynamic educational settings, where teachers often face numerous challenges and stressors, their wellbeing becomes increasingly vital. Consequently, there is an urgent need to innovate and develop targeted training interventions that can support specifically the wellbeing of educators. Methods: This study sought to provide an overview of the "Online Wellbeing Course - OWC," a serious game developed to enhance teachers' wellbeing, and to investigate the participants' feedback after being engaged in the OWC, utilizing a qualitative approach through focus group discussions. A total of 189 in-service teachers took part in the study. To qualitatively explore their experiences with the OWC, participants were involved in focus groups and asked to provide feedback about how and to what extent the course was beneficial for their wellbeing. Results: Teachers reported enhancements in areas such as emotional competence, self-care strategies, social awareness, relationship skills, decision-making, and school climate. Discussion: These outcomes suggested the potential of serious games as an innovative training approach for supporting teachers' wellbeing, offering valuable insights for researchers, policymakers, and educators.

The role of teachers' socio-emotional competence in reducing burnout through increased work engagement.

Introduction: Research has highlighted the relevance of socio-emotional competence in buffering the harmful impacts of perceived stress on the psychological facets of the teaching profession. The purpose of this paper is to innovatively investigate the relationships between perceived stress, work engagement, and burnout in a single comprehensive model, when considering the potential role that socio-emotional competence plays in mitigating the adverse impact of perceived stress on burnout. Methods: A total of 276 Italian in-service teachers (mean age = 46.6 ± 9.9 years) completed quantitative self-report measures of perceived stress, socio-emotional competence, work engagement, and burnout. Data were analyzed by using a structural equation modeling (SEM) approach. Results: All fit indexes supported the model's full acceptance and suggested that teachers' socio-emotional competence reduced the effect of perceived stress on the risk of burnout by increasing their level of work engagement. Discussion: The implications of the findings are discussed in terms of promoting interventions that target not only stress reduction but also foster teachers' socio-emotional competence in order to maintain a good level of work engagement and reduce the effect of stress on burnout.

Validation of Italian students' self-ratings on the SSIS SEL brief scales.

Introduction: Despite increasing interest in measuring social and emotional learning (SEL), there is a lack of European-validated tools for assessing the efficacy of SEL programs. The aim of this study was to validate an Italian version of the social skills improvement system (SSIS) SEL brief scales-student form. Methods: Participants were 1,175 students (mean age: 11.02 years; SD: 2.42; range: 8-16 years; males: 46.8%) recruited at schools in Northern Italy. Statistical analyses and results: Initial confirmatory factor analysis encountered a series of challenges, implying non-convergence of the original five-factor measurement model (self-awareness, self-management, social awareness, relationship skills, and responsible decision-making) based on the Collaborative on Academic Social Emotional Learning (CASEL) competency framework established with students in the United States. Further exploratory and confirmatory analyses supported a four-factor model that remained partially invariant across gender groups. The Italian version of the SSIS SEL brief scales was thus shown to be an efficient measurement tool for estimating social and emotional learning in students. Discussion: We discuss the implications of findings in relation to selecting valid and reliable instruments for assessing children's and adolescents' SEL competencies, while considering the culturally-situated nature of the constructs under study.

Supporting Preschoolers' Mental Health and Academic Learning through the PROMEHS Program: A Training Study.

There is compelling evidence that early school intervention programs enhance children's development of life skills, with a positive knock-on effect on their behaviors and academic outcomes. To date, most universal interventions have displayed gains in children's social-emotional competencies with a limited reduction in problem behaviors. This may depend on programs' curricula focused to a greater extent on preschoolers' social-emotional competencies rather than problem behaviors. Promoting Mental Health at Schools (PROMEHS) is a European, school-based, universal mental health program explicitly focused on both promoting students' mental health and preventing negative conduct by adopting a whole-school approach. In this study, we set out to evaluate the effectiveness of the program for Italian and Portuguese preschoolers. We recruited 784 children (age range = 4-5 years), assigning them to either an experimental group (six months' participation in the PROMEHS program under the guidance of their teachers, who had received ad hoc training) or a waiting list group (no intervention). We found that PROMEHS improved preschoolers' social-emotional learning (SEL) competencies, prosocial behavior, and academic outcomes. The more practical activities were carried out at school, the more children's SEL competencies increased, and the more their internalizing and externalizing behaviors decreased. Furthermore, marginalized and disadvantaged children were those who benefited most from the program, displaying both greater improvements in SEL and more marked decreases in internalizing problems compared to the rest of the sample.

Social and Emotional Learning and Internalizing Problems among Adolescents: The Mediating Role of Resilience.

(1) Background: The high rates of mental disorders in adolescence presented in the literature often exclude internalizing problems. Although there is extensive data on the effectiveness of SEL skills in improving resilience, few studies included evidence in their reports on the relationship between SEL skills and internalizing problems. The present study aims to deepen the understanding of the relationship between SEL, resilience, and internalizing problems, by investigating the mediating effect of resilience between SEL components and internalizing problems. (2) Methods: Adolescents (N = 968 adolescents, aged between 11 and 18 years old; M = 13.30; SD = 1.92) from 30 schools from the NE region of Romania were invited to fill out questionnaires on social and emotional learning, internalizing problems, and resilience. (3) Results: The results show that resilience mediates the link between self-awareness and internalizing problems, between self-management and internalizing problems, between relationship skills and internalizing problems, and between responsible decision-making and internalizing problems. (4) Conclusions: These findings revealed the need for social and emotional learning interventions that include resilience-oriented approaches in order to decrease internalizing problems in adolescents. Moreover, we suggest that more culturally appropriate interventions are required to better investigate the interaction between SEL components, resilience, and internalizing problems.

The effectiveness of a school-based, universal mental health programme in six European countries.

As children and young people today face ever increasing social, emotional and mental health challenges, schools, as one of the primary systems in children's lives, are called to broaden their agenda and help to address these challenges. This paper discusses the evaluation of a school-based, universal mental health promotion programme developed recently for the European context. The programme provides a universal curriculum from early years to high school, aiming to promote social and emotional learning and resilience and prevent social, emotional, and behavioural problems in children and adolescents. A total of 7,789 students (and their teachers and parents) from kindergarten to high school across 6 countries in Europe were recruited from 434 classrooms in 124 schools, making use of cluster sampling. A quasi-experimental longitudinal design was used to evaluate the effectiveness of the programme on students' outcomes by comparing the groups' outcomes within times (pre-test vs. post-test) and between groups (experimental vs. control group). A total of 779 classroom teachers completed pre-and-post scales measuring students' social and emotional learning, mental health and academic achievement. Results indicate that the experimental group had significantly larger increase in social and emotional competence and prosocial behaviour, and a decrease in mental health issues (externalising and internalising problems). No significant impact was found for academic outcomes. The findings are discussed in view of the limitations of the study and areas for further research.

Adolescents' Resilience During COVID-19 Pandemic and Its Mediating Role in the Association Between SEL Skills and Mental Health.

The main purpose of this paper is to investigate the role of social and emotional learning (SEL) skills and resilience in explaining mental health in male and female adolescents, during the COVID-19 pandemic. Three self-report questionnaires were administered to 778 participants aged between 11 and 16 years (mean age = 12.73 years; SD = 1.73) and recruited from 18 schools in Northern Italy. The SSIS-SELb-S and the CD-RISC 10 assessed SEL and resilience skills respectively, while the Strengths and Difficulties Questionnaire (SDQ) was used to measure mental health in terms of internalizing problems, externalizing problems, and prosocial behavior. We found that SEL and resilience skills were positively and significantly associated with each other, negatively associated with internalizing and externalizing problems, and positively related to prosocial behavior. Three linear regression analyses showed the significant role of resilience, age, and gender in explaining the variance of internalizing problems; the significant role of SEL skills, resilience, age, and gender in explaining the variance of externalizing problems; and the role of SEL skills, age, and gender in explaining prosocial behavior. Importantly, we found that resilience fully mediated the relationship between SEL skills and internalizing problems, partially mediated the relationship between SEL skills and externalizing problems and didn't mediate the relationship between SEL skills and prosocial behavior. The paper concludes with a discussion of the limitations of the study as well as its practical implications.