Epidemiologia, Volume 5, Issue 1 (March 2024) – 9 articles

Phase I clinical trials represent a critical point in drug development because the investigational medicinal product is being tested in humans for the first time. For this reason, it is essential to evaluate and identify the Maximum Tolerated Dose (MTD) and the safety of the new compound. To mitigate the possible risks associated with drug administration and treatment, the European Competent Authority issued various guidelines to provide provisions and harmonize risk management processes. In the UK and Italy, particular attention should be paid to the Medicines & Healthcare Products Regulatory Agency (MHRA) phase I accreditation scheme and the specific rules set by the Italian Drug Authority through the AIFA Determination no. 809/2015. Both reference documents are based on the concept of quality risk management while conducting phase I clinical studies. Moreover, the AIFA determination outlines specific requirements for those sites that want to conduct non-profit phase I clinical trials. Indeed, the document reports peculiar activities to the “Clinical Trial Quality Team”, which is a team that should support the clinical site researchers in designing, starting, performing, and closing non-profit phase I studies. In this paper, we provide a general overview of the main European guidelines concerning the management of risks during phase I trials, focusing on the main peculiarities of the schemes and rules set by the MHRA and AIFA. Full article

Background: Nurses are essential members of the healthcare workforce and were among the first-line carers for patients in community and hospital settings during the COVID-19 pandemic. As a result, they were at a heightened risk of infection, resulting in several reported deaths among nursing staff. Several preventive measures were adopted to contain the spread of the COVID-19 virus. This study aims to explore the knowledge, attitudes, and practices (KAP) of nurses regarding hand hygiene, mask wearing, and social distancing measures in healthcare settings in Barbados during the COVID-19 pandemic. Method: An online survey of nurses working in public hospitals and polyclinics (public primary care clinics) in Barbados from March 2021 to December 2021 was conducted. A nonsystematic convenience sampling method was employed to recruit nurses who were readily available and willing to participate. A questionnaire captured the sociodemographic information and knowledge and practices related to hand hygiene, the use of face masks, and social distancing. Each correct response received one mark. Overall knowledge scores were categorized as poor (<60%), average (60–80%), or good (>80–100%). Results: Of the 192 participants, the majority were female (82.8%) and had >5 years of experience (82%). The findings revealed that 45.8% had poor knowledge of hand hygiene, and that the knowledge of 43.8% of respondents was average. Multivariable logistic regression showed that, after adjustment for age and gender, registered nurses had 2.1 times increased odds (95% confidence interval 1.0, 4.2) of having good knowledge compared to other nursing categories. Regarding mask wearing, 53.6% of nurses had average knowledge, and 27.1% had good knowledge. Multivariable logistic regression showed that, after adjustment for age and gender, registered nurses had 3.3 times increased odds (95% confidence interval 1.5, 7.4) of having good knowledge compared to nursing assistants. A total of 68.6% of respondents followed the correct steps of handwashing every time, and 98.3% wore a mask in public places. More than half of the nurses (51.2%) kept a safe distance from others to avoid spreading SARS-CoV-2; one-third were in a crowded place(s) in the past three months, and 55.8% usually followed guidelines for social isolation as recommended by the WHO. Conclusions: The study identified knowledge deficiencies related to hand hygiene and wearing masks among nurses. It is imperative to provide additional training on infection control measures. Full article

Cannabis is a widely used substance among the youth population, with an estimated 2.8% currently smoking cannabis. Its popularity is growing due to the perception of its harmless nature and lack of dependence. However, this increase in use has been linked to mental health issues, especially since its partial decriminalisation in some part of the United States and Australia. The objective of this scoping review was to investigate the mental health impact of cannabis use among young people in Australia and the United States. A scoping review was conducted according to the Joanna Briggs Institute (JBI) protocol, and articles were searched from ProQuest Central and EBSCO Host (MEDLINE and CINAHL databases). A total of 24 articles were analysed, including systematic reviews, meta-analyses, and cohort, longitudinal, and cross-sectional studies. The findings indicate that cannabis use is associated with depression, psychosis, suicide, cannabis use disorder, dependence, decline in cognitive function, and the development of externalising behaviour, particularly attention deficit hyperactivity disorder. However, the relationship between cannabis use and anxiety is equivocal. Mental health issues were more prevalent with increased frequency, duration, intensity, and type of use. Female, minority, LGBTQI, African American, Aboriginal, and Torres Strait Islander youth and the age of onset of cannabis use were significant factors for the development of mental health problems. The increasing prevalence of cannabis use among high school and college students suggests the need for intervention by teachers, parents, and community health professionals to make them aware of its potential negative mental health outcomes. Moreover, policy-level interventions by the government are required to discourage young people from using cannabis. Full article

Epizootic hemorrhagic disease (EHD) is an infectious, non-contagious viral disease seriously affecting cattle and some wild ruminants and has a worldwide distribution. All viruses can be subdivided into “Eastern” and “Western” topotypes according to geographic distribution via the phylogenetic analysis of internal genes. In Israel, during the last decade, three outbreaks were registered: caused by EHDV-6 in 2015, by EHDV-1 in 2016, and by EHDV-7 in 2020. Additionally, RNA of EHDV-8 was found in imported calves from Portugal in 2023. During the same period in other countries of the region, non-Israeli-like EHDV-6 and EHDV-8 were identified. Full genome sequencing, BLAST, and phylogenetic analyses of the locally and globally known EHDV genomes allowed us to presume the probable route and origin of these viruses detected in Israel. Thus, EHDV-6 has probably been circulating in the region for a long period when EHDV-1 and -8 appeared here for the last years, while their route of introduction into the new areas was probably natural; all of them belonged to the “Western” topotype. In contrast, EHDV-7 probably had the “Eastern”, anthropogenic origin. Data from the study can facilitate the evaluation of the appearance or reappearance of EHDVs in the Mediterranean area and enhance the planning of prevention measures. Full article

Due to the emergence of the SARS-CoV-2 B.1.1.7 (Alpha) variant in the UK in 2020 and its risk of increased transmission, the Ministry of Health in Tunisia implemented a sequencing surveillance strategy for SARS-CoV-2. The aim of this study was to analyze SARS-CoV-2 genomic surveillance data in Tunisia (January 2021–February 2022) and to assess the implementation of the sequencing strategy for SARS-CoV-2 in accordance with national recommendations and the guidance for SARS-CoV-2 genomic surveillance for public health goals. A descriptive study of all sequenced RT-PCR samples sequenced (January 2021–February2022). An internal audit was also done to assess the compliance against standards covering national recommendations and the Guidance for SARS-CoV-2 genomic surveillance for public health goals. A total of 12 simple or composite requirements related to the following areas were included in the audit standards: sampling (one requirements); data collection/analysis (six requirements); partnership (one requirement); and ethical considerations (one requirement). A total of 4819 samples were sent to laboratories and 4278 samples were sequenced. A total of 3648 samples were classified. Positive variants of concern (VOC) samples were 80.92%, differentiated as follows: Alpha, 40.24%; Beta, 0.24%; Gamma, 0.03%; Delta, 45.26%; and Omicron, 14.19%. Three principal phases of VOCs per ISO-week were shown: Alpha 3/2021–25/2021; Delta 26/2021–2/2022; and Omicron 3/2022–6/2022. Levels of compliance were identified; from a total of 12 requirements, 7 were considered as “not met”, 4 as “partially met”, and 1 as “fully met” but including not totally achieved objectives. In conclusion, the internal audit of the national SARS-CoV-2 sequencing strategy revealed an overall “not met” level of compliance. The results offered a trigger to collaborate with all stakeholders to develop a surveillance strategy for early detection and response to outbreaks caused by VOCs. Full article

Homeless people (HP) are disproportionally affected by respiratory disorders, including pneumococcal and mycobacterial infections. On the contrary, more limited evidence has been previously gathered on influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and very little is known about the occurrence of human respiratory syncytial virus (RSV), a common cause of respiratory tract infections among children and the elderly. The present systematic review was designed to collect available evidence about RSV, influenza and SARS-CoV-2 infections in HP, focusing on those from urban homeless shelters. Three medical databases (PubMed, Embase and Scopus) and the preprint repository medRxiv.org were therefore searched for eligible observational studies published up to 30 December 2023, and the collected cases were pooled in a random-effects model. Heterogeneity was assessed using the I² statistics. Reporting bias was assessed by funnel plots and a regression analysis. Overall, 31 studies were retrieved, and of them, 17 reported on the point prevalence of respiratory pathogens, with pooled estimates of 4.91 cases per 1000 HP (95%CI: 2.46 to 9.80) for RSV, 3.47 per 1000 HP for influenza and 40.21 cases per 1000 HP (95%CI: 14.66 to 105.55) for SARS-CoV-2. Incidence estimates were calculated from 12 studies, and SARS-CoV-2 was characterized by the highest occurrence (9.58 diagnoses per 1000 persons-months, 95%CI: 3.00 to 16.16), followed by influenza (6.07, 95%CI: 0.00 to 15.06) and RSV (1.71, 95%CI: 0.00 to 4.13). Only four studies reported on the outcome of viral infections in HP: the assessed pathogens were associated with a high likelihood of hospitalization, while high rates of recurrence and eventual deaths were reported in cases of RSV infections. In summary, RSV, influenza and SARS-CoV-2 infections were documented in HP from urban shelters, and their potential outcomes stress the importance of specifically tailored preventive strategies. Full article

Theories of myopia etiology based on near work and lack of outdoor exposure have had inconsistent support and have not prevented the rising prevalence of global myopia. New scientific theories in the cause and prevention of myopia are needed. Myopia prevalence is low in native people consuming traditional diets lacking in sodium chloride, and nutritional epidemiological evidence supports the association of rising myopia prevalence with dietary sodium intake. East Asian populations have among the highest rates of myopia associated with high dietary sodium. Similar associations of sodium and rising myopia prevalence were observed in the United States in the late 20th century. The present perspective synthesizes nutritional epidemiology evidence with pathophysiological concepts and proposes that axial myopia occurs from increased fluid retention in the vitreous of the eye, induced by dietary sodium chloride intake. Salt disturbs ionic permeability of retinal membranes, increases the osmotic gradient flow of fluid into the vitreous, and stretches ocular tissue during axial elongation. Based on the present nutritional epidemiology evidence, experimental research should investigate the effect of sodium chloride as the cause of myopia, and clinical research should test a very low-salt diet in myopia correction and prevention. Full article

Background: The Mediterranean diet (MD) has been related with a decreased probability of overweight/obesity as well as central obesity at all stages of the human life, decreasing the risk of diverse disease states and improving quality of life. Over the last few years, the prevalence of childhood overweight/obesity and especially abdominal obesity has highly increased worldwide, being associated with a higher likelihood of overweight/obesity as well as central obesity at the next stages of the life during adulthood. The purpose of the present study was to explore the relationship of MD compliance with sociodemographic, anthropometry and lifestyle features in pre-school children aged 2–5 years old. Methods: This is a cross-sectional study, which includes 5188 pre-school children from diverse regions of Greece. Relevant questionnaires were applied to evaluate the sociodemographic features of the enrolled children. Anthropometric parameters were measured by relevant techniques. Qualified questionnaires were utilized for assessing several lifestyle factors such as physical activity, quality of life, breastfeeding practices, MD adherence, as well as the prevalence of childhood asthma and diabetes mellitus type I. Results: Of the enrolled children, 41.7% showed low MD compliance and 36.4% of them indicated moderated compliance, while only 21.9% of them showed a high MD adherence. Overweight/obesity was noted in 24.2% of the assigned children, while abdominal obesity was noticed in 18.2% of them. Higher MD compliance was related with an elevated prevalence of sex (boys, p = 0.0005), Greek nationality (p = 0.0088), rural type of residence (p = 0.0099), childhood overweight/obesity (p < 0.0001) and abdominal obesity (p < 0.0001), lower childbirth weight (p < 0.0001), increased physical activity (p = 0.0041), improved quality of life (p = 0.0008), exclusive breastfeeding (p < 0.0001), childhood asthma (p = 0.0001) and diabetes mellitus type 1 (p = 0.0002). Conclusions: A higher MD adherence is associated with specific sociodemographic, better anthropometric, and beneficial lifestyle factors in pre-school children. However, MD compliance remains low or moderate in the vast majority of children aged 2–5 years old. Thus, future public strategies and policies should be performed to inform parents of the potential beneficial effects of MD against obesity and related chronic diseases at the next stage of their children’s lives. Full article

Background and Objectives: Non-melanoma skin cancers (NMSCs) include basal cell carcinoma (BCC) and squamous-cell carcinoma (SCC), as well as a wide range of rare skin tumors. NMSCs is the most frequently diagnosed type of tumor among Caucasians. We aimed at estimating the incidence and mortality of NMSCs in the Salento area (Lecce province, Southern Italy), whose population is assumed to experience heavy and frequent sun exposure due to climatic/environmental factors, both for working and leisure activities. Materials and Methods: We computed the incidence of NMSCs in the Province of Lecce by examining the comprehensive real-world data collected by the local cancer registry, which covers all the 830,000 inhabitants, over a period of fifteen years (from 2003 to 2017), with a focus on the latest 5 years (2013–2017) for the analysis of the different histologic morphologies of these tumors. The incidence of NMSCs has been described in terms of absolute frequencies, crude rates and age-adjusted direct standardized rates (DSR). Joinpoint analysis was used to examine temporal trends in the incidence of NMSCs and estimate annual percent changes (APCs). Results: During the period of 2003–2017, the incidence of NMSCs reached a direct standardized rate (DSR) of 162.62 per 100,000 in men (mortality 1.57 per 100,000) and 89.36 per 100,000 in women (mortality 0.52 per 100,000), respectively. The incidence significantly increased among both men and women across the entire period. Basal cell carcinoma (BCC), with its different morphologies, represented about 67.6% of the NMSCs in men (n = 2139 out of a total of 3161 tumors observed between 2013 and 2017) and about 75.8% of the NMSCs in women (n = 1718 out of a total of 2264 tumors from 2013 to 2017), thus accounting for the vast majority of NMSCs. The results are consistent with the literature data carried out both at national and international level. Conclusions: Proper monitoring of this phenomenon through timely reporting and recording of all new NMSC cases is necessary to develop new preventive strategies. Full article