Health promotion at the beach: lessons learned from the “safe beaches” education project

Background. During summer, beach authorities are charged with ensuring the safety of beach visitors, which includes promoting safe behaviour via educational efforts. The purpose of this study was to describe the processes of development and implementation of a promotional project for beach safety.Methods. A multidisciplinary task force developed the informational material and the content to be provided following the principles of the Health Belief Model (HBM). The health promotion addressed a wide range of topics and was delivered at 65 bathing facilities along the Lazio coast (Central Italy) from June 2, 2023, to September 10, 2023. To evaluate the feedback of the promotion activities, the attendees were asked to answer a post-event self-evaluation survey.Results. 1,032 people responded to the questionnaire about satisfaction and utility levels. Participants’ overall satisfaction scores (98% rated “excellent” or “good”) and utility (88%) were high, with higher satisfaction levels for the women, those with higher education, and Italian citizens. Most participants reported that the material was easy to understand; the contents were comprehensive; and the healthcare professionals were prepared, engaging, and available.Conclusions. This project showed that approaching the summer visitors in the place time is a feasible and well-accepted strategy for summer health-related education

Comparison of corticosterone responses to acute stress in mice following different serial blood collection methods

Background. Accurate evaluation of glucocorticoid concentrations during serial blood collection in rodents is often hampered by the stress response elicited by the procedure itself. The optimal method to minimize stress and impact on animal welfare remains debated.Methods. Hence, we compared corticosterone concentrations in adult mice serially bled by using the retro-orbital sinus puncture or the tail vein incision methods, either with or without exposure to an acute restraint stress.Results. Corticosterone concentrations were significantly affected by the sampling method, with higher peaks and sustained hypercortisolemia in mice bled with the retroorbital sinus puncture, pointing to the tail vein incision method as preferable for serial blood collections. Mice bled using the tail vein incision reached similar corticosterone peaks regardless of exposure to acute stress.Conclusions. Our findings suggest that tail vein incision can be used to evaluate neuroendocrine reactivity without exposing mice to restraint procedures. This would improve animal welfare practices in experimental protocols

Psychological distress and its impact on the onset of lasting neurological symptoms during the pandemic: evidence from the Italian Twin Registry

Introduction. Neurocognitive disorders are typical of older people. Psychological distress increased during the pandemic, particularly in young people. Although often underestimated, the impact of psychological distress on neurological disorders should be considered. As part of a longitudinal study conducted by the Italian Twin Registry (ITR) on the health effects of COVID-19 pandemic, we explored the onset of lasting neurological symptoms in relation with pre-existing psychological symptoms and/or SARSCov-2 infection.Methods. Online surveys on adult subjects of the ITR: in June 2020 we investigated symptoms of depression, anxiety and post-traumatic distress and, in December 2021, the onset of six persisting neurocognitive symptoms. SARS-CoV-2 infection was examined in both surveys. Associations of psychological symptoms and of viral infection with subsequent neurological manifestations were tested through logistic regression analysis.Results. Among 1,784 participants (mean age 46.6), 42.8% reported neurological symptoms and 15.7% SARS-Cov-2 infection. Odds of neurological manifestations increased in participants with depressive or anxiety symptoms (ORs: 1.44 to 3.72), and in those with COVID-19 (ORs: 1.73 to 2.32). Anxiety symptoms explained more cases of cognitive symptoms (26.9% to 37.9%) than COVID-19 (9.1% to 15.5%). Smell/taste changes were strongly associated with viral infection (OR: 43.2).Conclusions. During the pandemic, widespread psychological distress contributed more than COVID-19 to the appearance of some cognitive symptoms in a relatively young population. Our findings indicates that preservation of neurological well-being cannot ignore mental health interventions

Visual responses in a transplanted eye: reality or chimera?

not needed for Letters to the Edito

Book Reviews, Notes and Comments

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Awareness of digital tomosynthesis and attitudes towards breast cancer early diagnosis in women at first screening: findings from the IMPETO trial survey

Background. The European guidelines on breast cancer and diagnosis recommend digital mammography (DM) or digital breast tomosynthesis (DBT) for screening asymptomatic women with an average risk of breast cancer. The research project innovationin mammography: tomosynthesis pathways (IMPETO) includes an interventional randomised trial conducted in Tuscany, Italy, aiming to assess the feasibility and impact of DBT in screening. Limited evidence exists on women’s preferences and acceptability ofthis new technology. To address this gap, as part of the IMPETO trial, a questionnaire was administered to 441 women aged 45 at their first inclusion in the screening programme, to investigate women’s awareness of tomosynthesis and their attitudes toward early diagnosis.Methods. This cross-sectional study was nested within the IMPETO trial, whose participants were randomly sampled. From October 2021 to February 2022 all women who  participated in the face-to-face enrolment for the IMPETO trial were asked to fill out a structured questionnaire collecting socio-demographic information and assessing awareness of tomosynthesis, breast density, attitudes toward breast cancer early diagnosis, and sources of information on breast health. Multiple logistic regression was performed to identify predictors of tomosynthesis awareness and attitudes toward early diagnosis.Results. Out of the 441 women surveyed, only 12% knew what tomosynthesis was and this awareness was positively associated with prior mammography experience (OR=2.092; 95% CI: 1.036-4.11). More than half of the participants (56.7%) had undergone mammography before joining the screening programme. Education attainment emerged as a significant predictor, with women holding a secondary degree being more likely to undergo mammography before age 45 (OR=2.18; 95% CI: 1.04-4.56). Amongthose who had undergone mammography before 45, 38.8% were advised by their gynaecologist, 27.6% made the decision independently, and 13.6% followed the advice of their general practitioner.Conclusion. This study highlights the need for improved education on screening appropriateness and associated risks and the importance of tailored communication to reduce knowledge differences across educational levels without increasing inappropriate use

Assessing brain vascular impairment, white matter lesions and ApoE status as predictors of behavioral and psychological symptoms of dementia (BPSD) in a multicentre sample of patients with Alzheimer’s disease: a multidisciplinary retrospective study

Background. Understanding pathogenetic background and risk factors is the primary step to a better behavioral and psychological symptoms of dementia (BPSD) management. To this aim, this exploratory study is designed to sketch some indicative correlationsbetween BPSD severity and vascular, genetic and cognitive variables.Methods. A retrospective cross-sectional study conducted on medical reports of 135 Alzheimer Dementia (AD) patients from two memory clinics. Each subject underwent clinical examination and brain Magnetic Resonance Imaging (MRI), mini mental stateexamination (MMSE) and behavioral assessment using the neuropsychiatric inventory (NPI). This real-world cross-sectional study aimed to correlate the load of white matter lesions and global vascular compromise with clinical assessment. In addition, apolipoprotein E (ApoE) genotype was checked in 92 patients. Data were analysed performing Spearman correlation and principal component analysis (PCA).Results. BPSD severity was independent from cognitive impairment, vascular impairment, white matter lesions and ApoE status.Conclusions. Our results do not confirm the possible role for vascular impairment in BPSD severity as previously reported. Studies focusing on different biological features in relation to other structural, psychosocial and environmental factors are needed in orderto get a more reliable model

Life project: a scoping review of assessment tools for persons with autism spectrum disorder

Background. Persons with autism spectrum disorder (ASD) may face significant challenges during transition from adolescence to adulthood. This phase necessitates tailored support to address all needs, underscoring the importance of a comprehensive life project(LP) planning. This scoping review aims to identify methods and tools used in the development of LP for persons with ASD.Methods. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) extension for scoping reviews was used. The literature search was performed across Embase, Scopus, Web of Science, PubMed, CINAHL, and PsycINFO. The selection process involved screening titles and abstracts, followed by full-text reading, data extraction, and narrative synthesis of findings.Results. A total of 899 records were identified, and 8 studies were included in the review. Preference assessment and ecological balance emerged as crucial elements in developing LP.Conclusions. This review highlights the importance of tools that accurately capture individual preferences and support needs for persons with ASD but also reveals a gap in the literature concerning the development of tailored LP for this population

The authorization process of observational studies in Italy: exploring two decades of Ethics Committee approval data

Introduction. The recent guideline from the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) on observational studies prompts a broader reflection on the impact of regulations on clinical research and real-world evidence. While regulations are necessary to ensure ethical and scientific standards, their effectiveness in improving research quality is unclear. It is also uncertain whether these regulations strengthen clinical research or create bureaucratic obstacles. This quantitative, “before and after” study investigates the impact of the 2008 AIFA guideline and the 2018 General Data Protection Regulation (GDPR) on the complexity of ethical evaluation processes. As a secondary outcome, we also aimed to investigate whether the duration and probability of suspensions were influenced by intrinsic study characteristics (study design, rare disease, genetic data, post-authorization safety study).Materials. The study analyzed the ethical evaluation process of 112 observational multicenter studies with 2,875 submissions from 2002 to 2022, included in the database of Medineos srl. The number of suspensions observed in each evaluation process was a surrogate endpoint of complexity of evaluation process.Methods. Descriptive analyses and survival analysis were used to evaluate the total evaluation time, and a logistic model was applied to assess the probability of receiving a suspension.Results. The median (and interquartile range) evaluation time for “pre-AIFA” submissions was 70 (41-133) days, whereas it was 75 (45-122) days for “post-AIFA” submissions. The median evaluation time was 68 (41-113) days without suspension and 127 (84-180) days with suspension. Post-AIFA submissions had a higher likelihood of suspension. The median evaluation time for “pre-GDPR” submissions was 70 (42-123) days,whereas it was 90 (63-140) days for “post-GDPR” submissions. AIFA guidelines slightly increased evaluation time and the likelihood of suspension, suggesting improved quality control. GDPR increased evaluation time due to privacy evaluations but did not affect suspension probability. Intrinsic study factors did not impact evaluation duration or suspension probability.Conclusions. Although more extensive analyses are necessary, this study suggests that past changes in Italian regulations have affected the evaluation by the Ethics Committee (EC) and have also impacted the conduct of the observational studies. The data generated can be useful for monitoring the future impact of the recently published new AIFA guideline

Ten years after Regulation 536/2014: ethical reflection on the role of Ethics Committees in Italy

Since their institution, Ethics Committees (ECs) dedicated to the ethical evaluation of research protocols have been traditionally entrusted with the role of finding a delicate balance between protecting research participants’ rights and avoiding the hampering ofscientific progress. In Europe, these bodies have evolved significantly over time, shaped by a dynamic regulatory framework culminating in Regulation (EU) 536/2014, which has been fully applied since 2022. Focusing on the Italian scenario, a decade after theadoption of the Regulation (2014-2024), this paper is aimed at shedding light on the extent to which the evolution of the pertinent normative framework has affected ECs’ space for reflection within the ethics review process of clinical trials, essential to protectthe rights of research participants. Although focused on the Italian scenario, the analysis holds relevance for the broader European context, since the Regulation is unique and developments in a single Member State may impact the others