Occupational burnout and job satisfaction among community pharmacists.

Introduction: Community pharmacists (CPs) are the most accessible healthcare professionals in primary care due to pharmacies' open-door policy and convenience, resulting in high patient and prescription volumes, and numerous free-of-charge consultations. Therefore, they are at high risk for burnout. Objectives: The primary objective of this study was to assess the levels of burnout among community pharmacists in Greece, marking the first investigation of its kind within the country. Additionally, this study aimed to explore potential correlations between demographic variables and other health-related factors with burnout scores. Methods: This study used a quantitative cross-sectional design involving two validated questionnaires(the Greek version of Maslach (MBI) questionnaire and the SF-36 questionnaire). Prior to data collection, all the relevant documentation was approved by the Metropolitan College Research Ethics Committee and was adopted under the auspices of the Panhellenic Pharmaceutical Association. Random sampling was used. Data collection period was July to August 2022. Results: A total of 368 responses were included in the analysis, with the majority being pharmacy-owners (n = 292, 79.3%). Notably, a significant proportion of respondents were female practitioners working within community pharmacy settings (n = 230, 62.5%). Analysis revealed that the sample exhibited low levels of personal achievement (M = 30.99, SD = 6.41), high levels of emotional exhaustion (M = 41.73, SD = 6.94), and moderate levels of depersonalization (M = 23.38, SD = 3.78), indicative of substantial occupational burnout. Furthermore, gender had a discernible impact on depersonalization, with women scoring higher than men (t = -3.29, p < 0.01). Pharmacists who identified medicine shortages as their primary challenge in daily practice reported lower emotional burnout and depersonalization, albeit with a diminished sense of accomplishment (t = -2.62, p < 0.01). Conclusions: This study sheds light on burnout levels and health-related quality of life among community pharmacists in Greece.

A systematic review of the effect of semaglutide on lean mass: insights from clinical trials.

INTRODUCTION: Semaglutide, a glucagon-like peptide-1 receptor agonist, is associated with significant weight loss, yet its impact on lean body mass remains insufficiently understood. This review investigates the effect of semaglutide on lean mass in the context of obesity management. METHODOLOGY: This study investigates through different databases (PubMed, Elsevier, and Google Scholar) from 2016 for randomized control trials (RCTs) or observational studies that assessed the use of semaglutide in overweight or obese patients, regardless of whether they have type 2 diabetes or not. The studies compared semaglutide to a placebo or alternative medications. RESULTS: Six studies with 1,541 overweight or obese adults were included, and significant weight reductions were observed primarily due to fat mass loss. While the lean mass remained stable in some cases, notable reductions ranging from almost 0% to 40% of total weight reduction were observed in others. Noteworthy decreases in lean mass were particularly evident in larger trials, yet the proportion of lean mass relative to total body mass increased, suggesting a positive overall outcome. CONCLUSION: Semaglutide displays potential for weight loss primarily through fat mass reduction. However, concerns arise from notable reductions in lean mass, especially in trials with a larger number of patients.

Exploring the Relationship between Mediterranean Diet Adherence and Subjective Well-Being among Greek and Cypriot Adults.

Associations between subjective well-being (SWB) and dietary habits, employment status, and habitual activities are increasingly capturing the focus of researchers as well as policymakers worldwide. This study aimed to explore these associations in a sample of the population in Greece and Cyprus via an online survey. In total, 936 questionnaires (470: Cyprus, 466: Greece) were analyzed to study the associations between the Mediterranean Diet (MD) (using the 14-item MEDAS score, (14-MEDAS)), subjective well-being (SWB), and several socioeconomic factors. Key remarks of this survey highlight the positive impact of MD adherence on some well-being items. Namely, statistically significant differences were found on the following items: Satisfied with life (p < 0.001), Life worthwhile (p < 0.001), Feeling happy (p < 0.001), worried (p = 0.005), and depressed (p = 0.001), when comparing Low MD adherence (14-MEDAS < 5) to High MD adherence (14-MEDAS > 10). Other lifestyle habits such as spending time with friends and family, spending time in nature, and habitual physical activity were associated with aspects of SWB such as Life satisfaction, Life worthwhile, Feeling happy, and energetic. The findings support adherence to the MD, since it is associated with higher life satisfaction and self-reported happiness in this sample and should be considered when developing health policies on well-being.

Public's perspective on COVID-19 adenovirus vector vaccines after thrombosis with thrombocytopenia syndrome (TTS) reports and associated regulatory actions - A cross-sectional study in six EU member states.

OBJECTIVE: In 2021, thrombosis with thrombocytopenia syndrome (TTS) was confirmed by the European Medicines Agency (EMA) as a rare side effect of the COVID-19 adenovirus vector vaccines Vaxzevria® and Jcovden®. This study aimed to describe the public's knowledge of TTS and how it affected the willingness to be vaccinated with COVID-19 vaccines and other vaccines in six European countries. METHODS: From June to October of 2022, a multi-country cross-sectional online survey was conducted in Denmark, Greece, Latvia, Netherlands, Portugal, and Slovenia. The minimum target of participants to be recruited was based on the size of the country's population. The results were analysed descriptively. RESULTS: In total, 3794 respondents were included in the analysis; across the six countries, 33.3 %-68.3 % reported being familiar with signs and symptoms of TTS, although 3.1-61.4 % of those were able to identify the symptoms correctly. The reported changes in willingness to be vaccinated against COVID-19 and with other vaccines varied per country. The largest reported change in the willingness to be vaccinated with Vaxzevria® and Jcovden® was observed in Denmark (61.2 %), while the willingness to be vaccinated with other COVID-19 vaccines changed most in Slovenia (30.4 %). The smallest decrease in willingness towards future vaccination against COVID-19 was reported in the Netherlands (20.9 %) contrasting with the largest decrease observed in Latvia (69.1 %). CONCLUSION: Knowledge about TTS seemed to have influenced the public's opinion in Europe resulting in less willingness to be vaccinated with Vaxzevria® and Jcovden®. Willingness for vaccination against COVID-19 with other vaccines and widespread use of vaccines to prevent other diseases also differed and seemed to be determined by the approaches taken by national health authorities when reacting to and communicating about COVID-19 vaccination risks. Further investigation of optimal risk communication strategies is warranted.

Nutritional interventional studies in patients with multiple sclerosis: a scoping review of the current clinical evidence.

A good nutritional status appears to slow down disease progression and ameliorate symptoms' intensity in patients with multiple sclerosis (MS). Up to date, there are several interventional studies, which have explored the potential beneficial effects of specific dietary patterns as well as specific bioactive nutrients against disease progression and symptomatology of MS patients. This is a thorough, scoping review, which aims to critically summarize and scrutinize the currently available clinical evidence of the potential beneficial effects of nutritional interventional studies against MS progression and symptomatology. This review was conducted to systematically map the research done in this area, as well as to identify gaps in knowledge. For this purpose, we thoroughly explored the most accurate scientific web databases, e.g., PubMed, Scopus, Web of Science, and Google Scholar to achieve the most relevant clinical human studies applying effective and characteristic keywords. There are currently several dietary patterns and specific bioactive nutrients that show promising results by slowing down disease progression and by improving MS symptoms. However, there are also certain conflicting results, while most of the existing studies enrolled a small number of MS patients. Nutritional interventions may exert substantial protective effects against MS progression and symptomatology. However, large, long-term, randomized, double-blind, controlled clinical trials with a prospective design are strongly recommended to delineate whether such nutritional intervention may attenuate disease progression, and improve symptomatology in MS patients.

Assessment of quality of life, job insecurity and work ability among nurses, working either under temporary or permanent terms.

OBJECTIVES: Aim of this study was to assess and compare health, quality of life, well-being, job satisfaction and job insecurity between nurses, in a tertiary hospital in Greece, working either under permanent or temporary contract. MATERIAL AND METHODS: In this cross-sectional study, consecutively recruited nurses answered a structured questionnaire, the WHO-5 Well-being Index (WHO-5), the Job Insecurity Index (JII), the Work Ability Index (WAI), and the Well-Being at Work Scale (WBWS). RESULTS: Included were 323 nurses (87.6% women, age M±SD 43.68±8.10 years). Tem- porary contract employees had worse quality of life (p = 0.009) and higher job insecurity: both in cognitive dimension (p = 0.013) and emotional dimension (p < 0.001). They also scored worse in the positive affect (p < 0.001), negative affect (p = 0.002) and fulfillment of expectations in work environment (p < 0.001) domains of the WBWS. Additionally, they reported less frequently occupational accidents and injuries (p = 0.001), muscu - loskeletal disorders of the spine or neck (p = 0.007), cardiovascular (p = 0.017), and gastrointestinal (p = 0.010) disorders, while they reported more frequently mental disorders (p < 0.001). Multivariate linear regression analysis showed that temporary work predicted high cognitive (p = 0.010) and emotional (p < 0.001) insecurity, low positive emotions and mood index (p = 0.007), low achievement-fulfillment index (p = 0.047) and high index of negative emotions (p = 0.006), regardless of gender and age. CONCLUSIONS: Temporary employment among nurses is associated with a lower sense of job security and well-being, and a higher prevalence of mental disorders, independently of age or gender without a significantly negative effect on their ability to work. Managers, as well as occupational physicians, should recognize the extent of nurses' job insecurity and assess their ability to work, to provide them with the necessary support and to stimulate the sense of occupational security and work capacity, so that they can thrive in their workplace and therefore be more productive and provide high quality healthcare. Int J Occup Med Environ Health. 2024;37(1):98-109.

Does the Simultaneous Introduction of Several Pharmaceuticals in the Post-Lenalidomide Era Translate to Better Outcomes in Relapse Refractory Multiple Myeloma? Findings from the Real-World Innovation in Multiple Myeloma (REAL IMM) Study.

Newer methodologies are needed to assess the real-world comparative effectiveness of a "generation" of pharmaceutical innovation versus the prior standard of care. This chart review study aimed to first evaluate the cumulative clinical benefits of pharmaceutical innovation in everyday relapse/refractory multiple myeloma before analyzing findings in the context of respective real-world outcomes from the bortezomib/lenalidomide era. Study endpoints included the 52-week PFS rate in second and third line of therapy (LOT), mPFS-2 across the first and second LOT, the ORR, reasons for discontinuation, and the treatment duration per therapeutic algorithm. Data from 107 patients were collected. The median follow-up was 2.0 years. Of the subjects who met the selection criteria for the second LOT, 72.2% maintained the PFS at 52 weeks. In the third-line setting, the PFS rate at 52 weeks was 63.5%. The mPFS across the first and second, the second, and the third LOTs were 26, 17, and 15 months, respectively. The ORR was 76.1% in the second and 69.7% in the third LOT. After non-response or progression, the main reason for drug discontinuation was treatment intolerability. The second-line ORR and the 52-week PFS rate were similar to previous real-world findings from the bortezomib/lenalidomide era. The cumulative mPFS across the second and third LOTs was higher than the respective mPFS across the first and second LOTs. Despite its limitations, the methodology and findings from this study may be used in future clinical and economic evaluations across all hematological malignancies.

Sentiment analysis of epidemiological surveillance reports on COVID-19 in Greece using machine learning models.

The present research deals with sentiment analysis performed with Microsoft Azure Machine Learning Studio to classify Facebook posts on the Greek National Public Health Organization (EODY) from November 2021 to January 2022 during the pandemic. Positive, negative and neutral sentiments were included after processing 300 reviews. This approach involved analyzing the words appearing in the comments and exploring the sentiments related to daily surveillance reports of COVID-19 published on the EODY Facebook page. Moreover, machine learning algorithms were implemented to predict the classification of sentiments. This research assesses the efficiency of a few popular machine learning models, which is one of the initial efforts in Greece in this domain. People have negative sentiments toward COVID surveillance reports. Words with the highest frequency of occurrence include government, vaccinated people, unvaccinated, telephone communication, health measures, virus, COVID-19 rapid/molecular tests, and of course, COVID-19. The experimental results disclose additionally that two classifiers, namely two class Neural Network and two class Bayes Point Machine, achieved high sentiment analysis accuracy and F1 score, particularly 87% and over 35%. A significant limitation of this study may be the need for more comparison with other research attempts that identified the sentiments of the EODY surveillance reports of COVID in Greece. Machine learning models can provide critical information combating public health hazards and enrich communication strategies and proactive actions in public health issues and opinion management during the COVID-19 pandemic.

Exploring public knowledge and perceptions regarding per os OTC pain-relieving medications: the case of paracetamol (acetaminophen).

BACKGROUND: Over-the-counter medications (OTC) are safe and effective when patients follow the patient's information leaflet (PIL) instructions and/or the instructions given by healthcare professionals (HCPs). However, OTC medications could be harmful and unsafe when individuals do not follow the given instructions and/or when their understanding about the proper use of OTC medications is incorrect. This study aimed to investigate the knowledge and perceptions of people regarding paracetamol use in the Republic of Cyprus. METHODS: This cross-sectional study, which belongs to quantitative research methods, included participants visiting community pharmacies in the following three cities of the Republic of Cyprus: Nicosia, Limassol and Larnaca. Participation in the study was voluntary and anonymous. Participants responded to the survey-based questionnaire, which concerned their knowledge and views on paracetamol use. After the data collection, responses were tabulated and analysed statistically. RESULTS: The original compound was shown to be more well-known compared to generics. A notable percentage of respondents-ranging between 13.0% (N = 49) and 29.8% (N = 112)-answered incorrectly that broadly used non-steroidal anti-inflammatory drugs (NSAIDs) contain paracetamol. Furthermore, a remarkable percentage of respondents (71.5%, N = 269 and 50.3%, N = 189, respectively) falsely believed that two widely used combination products in the market of Cyprus (Paracetamol and Hyoscine-N-butylbromide; Paracetamol and Codeine and Caffeine) did not contain paracetamol. A notable percentage of participants (27.6%, N = 100) believed that paracetamol causes low toxicity. More than a third of the respondents (40.2%, N = 149) drink alcohol together with or slightly after consuming paracetamol products. This viewpoint was linked with the participants' attitude towards consuming paracetamol medications after drinking alcohol (OR for consuming alcohol versus not consuming alcohol 0.100, 95% CI 0.044-0.225, p = 0.000). CONCLUSIONS: To the best of our knowledge, this is the first study conducted in the Republic of Cyprus on this topic. Paracetamol is frequently consumed by individuals, both in its generic and original forms. However, the study showed that respondents often misperceive NSAIDs and paracetamol-containing medications. In addition, it is identified that there is a lack of education among people about the safe and effective use of paracetamol, namely, indications, potential side effects, maximum daily dose, alcohol consumption, and the potential risks of hepatotoxicity. The study contributed to the current published literature as it showed that there is a significant public health issue, for which appropriate measures can be established by the respective Authorities of Cyprus.

Coastal Water Quality Modelling Using E. coli, Meteorological Parameters and Machine Learning Algorithms.

In this study, machine learning models were implemented to predict the classification of coastal waters in the region of Eastern Macedonia and Thrace (EMT) concerning Escherichia coli (E. coli) concentration and weather variables in the framework of the Directive 2006/7/EC. Six sampling stations of EMT, located on beaches of the regional units of Kavala, Xanthi, Rhodopi, Evros, Thasos and Samothraki, were selected. All 1039 samples were collected from May to September within a 14-year follow-up period (2009-2021). The weather parameters were acquired from nearby meteorological stations. The samples were analysed according to the ISO 9308-1 for the detection and the enumeration of E. coli. The vast majority of the samples fall into category 1 (Excellent), which is a mark of the high quality of the coastal waters of EMT. The experimental results disclose, additionally, that two-class classifiers, namely Decision Forest, Decision Jungle and Boosted Decision Tree, achieved high Accuracy scores over 99%. In addition, comparing our performance metrics with those of other researchers, diversity is observed in using algorithms for water quality prediction, with algorithms such as Decision Tree, Artificial Neural Networks and Bayesian Belief Networks demonstrating satisfactory results. Machine learning approaches can provide critical information about the dynamic of E. coli contamination and, concurrently, consider the meteorological parameters for coastal waters classification.

Mediterranean Diet Adherence Is Associated with Favorable Health-Related Quality of Life, Physical Activity, and Sleep Quality in a Community-Dwelling Greek Older Population.

BACKGROUND: The Mediterranean diet (MD) is a beneficial dietary pattern with strong antioxidant and anti-inflammatory properties that can promote mental and physical human health. This study aims to assess the impact of MD adherence on health-related quality of life, physical activity levels, and sleep quality in a representative Greek elderly population. METHODS: This is a cross-sectional study. A total of 3254 persons ≥65 years from 14 different Greek regions, urban, rural and islands participated in this study, of which 48.4% were female and 51.6% were male. Health-Related Quality of Life (HRQOL) was evaluated utilizing a short form healthy survey, physical activity was determined by the International Physical Activity Questionnaire (IPAQ), sleep quality was assessed utilizing the Pittsburgh Sleep Quality Index (PSQI) and MD adherence was assessed via the Mediterranean Diet Score (MedDietScore). RESULTS: Moderate adherence to the MD and an increased prevalence of poor quality of life, low physical activity levels and inadequate sleep quality among the elderly population were recorded. High MD adherence was independently associated with better quality of life (OR: 2.31, 95% CI: 2.06-2.68, p = 0.0008), higher physical activity (OR: 1.89, 95% CI: 1.47-2.35, p = 0.0141) and adequate sleep quality (OR: 2.11, 95%: 1.79-2.44, p = 0.0018), female sex (OR: 1.36, 95% CI: 1.02-1.68, p = 0.0032) and living with others (OR: 1.24, 95% CI: 0.81-1.76, p = 0.0375), after adjustment for potential confounding factors. In unadjusted analysis, participants' age (p < 0.0001), anthropometric characteristics (p < 0.005), educational (p = 0.0026) and financial status (p = 0.0005) and smoking habits (p = 0.0031) were also identified as indicators of MD adherence; however, their impact on MD adherence was considerably attenuated after adjusting for confounding factors (p > 0.05). CONCLUSION: High MD adherence was correlated with favorable quality of life, higher levels of physical activity, and a more adequate sleep quality score. Strategies and public health policies that facilitate MD adherence and physical activity in older adults may improve sleep and quality of life, impacting overall wellbeing in this age group.

Novel Pyrimidine Derivatives as Antioxidant and Anticancer Agents: Design, Synthesis and Molecular Modeling Studies.

The heterocyclic ring system of pyrido [2,3-d]pyrimidines is a privileged scaffold in medicinal chemistry, possessing several biological activities. The synthesis of the pyrimidine derivatives was performed via the condensation of a suitable α,ß-unsaturated ketone with 4-amino-6-hydroxy-2-mercaptopyrimidine monohydrate in glacial acetic acid. Chalcones were synthesized, as starting materials, via the Claisen-Schmidt condensation of an appropriately substituted ketone and an appropriately substituted aldehyde in the presence of aqueous KOH 40% w/v in ethanol. All the synthesized compounds were characterized using IR, 1H-NMR, 13C-NMR, LC-MS and elemental analysis. The synthesized compounds were evaluated for their antioxidant (DPPH assay), anti-lipid peroxidation (AAPH), anti-LOX activities and ability to interact with glutathione. The compounds do not interact significantly with DPPH but strongly inhibit lipid peroxidation. Pyrimidine derivatives 2a (IC50 = 42 µΜ), 2f (IC50 = 47.5 µΜ) and chalcone 1g (IC50 = 17 µM) were the most potent lipoxygenase inhibitors. All the tested compounds were found to interact with glutathione, apart from 1h. Cell viability and cytotoxicity assays were performed with the HaCaT and A549 cell lines, respectively. In the MTT assay towards the HaCaT cell line, none of the compounds presented viability at 100 µM. On the contrary, in the MTT assay towards the A549 cell line, the tested compounds showed strong cytotoxicity at 100 µM, with derivative 2d presenting the strongest cytotoxic effects at the concentration of 50 µΜ.

How to improve food waste management in hospitals through focussing on the four most common measures for reducing plate waste.

Hospitals have a responsibility to link human health and the environment, but food waste in hospitals has traditionally been much higher than in other areas of food supply. The cause of this situation has many negative impacts on health, economy, society, and environment. As a result, food waste has become a topic of discussion in hospital food departments. Part of this problem is plate waste, the served food that remains uneaten by patients. Given the magnitude of the food problem, this systematic review is aimed to identify the most common measures used to reduce plate waste in hospitals. PubMed, Scopus, and Google Scholar databases were comprehensively searched to identify food waste studies worldwide using related search terms. Many approaches have been recommended to increase patient food intake and minimise plate waste in hospitals. Up to date, the four most common include flexible portion sizes, increased food choices through selective menus, additional nutritional support and a better ordering and delivery system. Among them, the most used and effective are flexible portion sizes which may increase the ability of patients choosing their menus and upgrade ordering and delivery system by electronic format. In most studies, plate waste covers the most significant percentage of food waste produced in hospitals, while more than one approach is recommended to minimise it. In this aspect, further well-design, multicenter, clinical studies are strongly required to highlight and establish novel and effective approaches for improving food waste management in hospitals by reducing plate waste.

Use of Edible, Medicinal, and Aromatic Plants in Various Health Disorders: A Cross-Sectional Evaluation among Inhabitants in the Area of Thrace, North-Eastern Greece.

BACKGROUND: Medicinal and aromatical plants (MAPs) have been historically used as traditional remedies in many cultures in Europe and globally. The aim of this study was to evaluate the use of MAPs in various health disorders in association to dietary habits and other lifestyle factors among residents in Thrace, NE Greece. METHODS: Data were collected through anonymous and voluntary responses to a structured online questionnaire, via convenience (snowball) sampling. RESULTS: The 561 responders (age: 39.7 ± 11.6 y) were mostly female (59.7%), with higher education (69.8%), working as state or private employees (55.4%), and having low/medium income (77.1%). Overall, more than 70% were using MAPs in various symptoms and common health disorders, such as chamomile against common cold and the flu. More than 20 different MAPs were being used in smaller frequencies against various conditions. Key contributing factors to the consumption of MAPs were sex (female over male), employment (employed vs. unemployed), education (higher education vs. lower) and higher Body Mass Index (overweight and obese vs. normal), while consumption of fruit, fish, and vegetables was mainly associated with the use of MAPs as common items of diet and in health disorders. CONCLUSIONS: The use of MAPs as part of the diet and as traditional remedy is present in the examined population, while particular choices seem to be affected by sociodemographic and lifestyle factors.

Prevalence of pharmacologically treated type 2 diabetes mellitus in 2012-2016 in Greece: Real-World Data.

Type 2 diabetes mellitus is a serious health disorder with a global prevalence of 6059 cases per 100,000 in 2017. By analyzing real-world data, our study found an increasing prevalence of type 2 diabetes in Greece, with the peak being 7,40 individuals per 100,000 in 2016.

Systematic analysis of nutrigenomic effects of polyphenols related to cardiometabolic health in humans - Evidence from untargeted mRNA and miRNA studies.

Cardiovascular and metabolic disorders present major causes of mortality in the ageing population. Polyphenols present in human diets possess cardiometabolic protective properties, however their underlying molecular mechanisms in humans are still not well identified. Even though preclinical and in vitro studies advocate that these bioactives can modulate gene expression, most studies were performed using targeted approaches. With the objective to decipher the molecular mechanisms underlying polyphenols cardiometabolic preventive properties in humans, we performed integrative multi-omic bioinformatic analyses of published studies which reported improvements of cardiometabolic risk factors following polyphenol intake, together with genomic analyses performed using untargeted approach. We identified 5 studies within our criteria and nearly 5000 differentially expressed genes, both mRNAs and miRNAs, in peripheral blood cells. Integrative bioinformatic analyses (e.g. pathway and gene network analyses, identification of transcription factors, correlation of gene expression profiles with those associated with diseases and drug intake) revealed that these genes are involved in the processes such as cell adhesion and mobility, immune system, metabolism, or cell signaling. We also identified 27 miRNAs known to regulate processes such as cell cytoskeleton, chemotaxis, cell signaling, or cell metabolism. Gene expression profiles negatively correlated with expression profiles of cardiovascular disease patients, while a positive correlation was observed with gene expression profiles following intake of drugs against cardiometabolic disorders. These analyses further advocate for health protective effects of these bioactives against age-associated diseases. In conclusion, polyphenols can exert multi-genomic modifications in humans and use of untargeted methods coupled with bioinformatic analyses represent the best approach to decipher molecular mechanisms underlying healthy-ageing effects of these bioactives.

A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project.

INTRODUCTION: A large proportion of medicine product labels lack information on safety in pregnancy and breastfeeding. To address this gap, pharmaceutical companies are requested to develop post-approval studies regarding the use of drugs by pregnant and breastfeeding women. OBJECTIVE: Our study aims to review key features of observational studies in pregnancy and breastfeeding and their impact on the respective medicine product labels. METHODS: Observational studies focusing on the safety evaluation of medicines used during pregnancy and breastfeeding were selected from the European Union Register of Post-Authorization Studies (EU PAS register) and ClinicalTrials.gov. We extracted information on the variables of interest and performed an impact assessment on the respective label. RESULTS: A total of 141 observational studies were eligible. Of these, 63 studies (45%) were based on primary data collection and 55 studies (39%) on secondary use of health data. A small number of studies (8%) aimed to evaluate drug safety during breastfeeding. Studies using secondary data collection lasted around 2.9 years as opposed to 7.5 years' duration for studies using primary data collection. Only two product labels were updated based on the study results. CONCLUSION: The duration is significantly longer for studies based on primary data collection, and these are also smaller in size (less power), whereas outcomes of interest are similar. For completed studies, the impact on the label was very low. Given the gap in adequate pregnancy information on product labels, the current process of generating evidence in pregnancy and breastfeeding seems neither efficient nor impactful. To support evidence-based decision making by prescribers, this current process might be redesigned.

Physical Activity, Body Mass Index (BMI) and Abdominal Obesity of Pre-Adolescent Children in the Region of Thrace, NE Greece, in Relation to Socio-Demographic Characteristics.

This study aimed to explore the prevalence of overweight, obesity, and abdominal obesity, and define predictive factors of their occurrence among pre-adolescents in the region of Thrace, NE Greece. A secondary aim was to record physical activity at different times (schooldays, weekends, holidays) and explore associations with characteristics such as gender, overweight and obesity, and socio-demographic conditions. A cross-sectional study was conducted involving children aged 11-12 years. Participating children were measured for height, weight, and waist circumference, and their parents answered a questionnaire. In total, 1929 children were included. Prevalence of overweight was 31.5%, prevalence of obesity 17%, and only 1% of children were underweight. Abdominal obesity was detected in 20.3% of the sample. Overweight and obesity were more frequent in males, who also had higher mean values of Body Mass Index-for-age z-scores (BMIaz) and Waist-to-Height ratio (WtHR). Obesity rates were higher among those not participating in physical activities; however, no significant difference was observed between normal-weight, overweight and obese children in the time spent for organized athletic activities or free play. Logistic regression analysis showed that the probability for overweight/obesity was higher in boys (OR = 1.39, 95% CI = 1.16-1.66) and lower in children whose fathers had a higher educational level (OR = 0.75, 95% CI = 0.60-0.93). The probability for abdominal obesity was also higher in boys (OR = 1.37, 95% CI = 1.10-1.72) and lower in children participating at least one hour/day in an organized physical activity (compared to those with no physical activity (OR = 0.66, 95% CI = 0.51-0.85), and whose father was exercising at least 1-2 times/week (OR = 0.76, 95% CI = 0.591-0.98). In conclusion, the prevalence of overweight and obesity among pre-adolescents in NE Greece was estimated at 48.5%. This is associated with the male gender and not participating in physical activities. The educational level and exercise habits of the father (but not of the mother) affect the probability of obesity and abdominal obesity, respectively.

Exploring Hedonic and Eudaimonic Items of Well-Being in Mediterranean and Non-Mediterranean Countries: Influence of Sociodemographic and Lifestyle Factors.

Increased understanding of subjective well-being (SWB), as well as factors that influence it, are essential to enhance well-being at the individual and national level. We have applied a hedonic and eudaimonic 9-item composed tool (SWB score) to measure SWB across several Mediterranean (MED) and non-Mediterranean (non-MED) countries, and to explore the association between the SWB score and a range of sociodemographic, health and Mediterranean lifestyle factors. A specifically designed web-based questionnaire was distributed to adult participants (N = 2400) from Spain, Italy, Portugal, Bulgaria and Republic of North Macedonia. Results showed that the SWB score was significantly different across the examined countries with the MED participants displaying slightly higher average scores than the non-MED ones (6.3 ± 1.5 vs. 6.1 ± 1.6, p = 0.002). Several sociodemographic, health status and lifestyle factors displayed a significant but limited association with the 9-item SWB score, with a multiple regression model explaining around 17% of the variance. Nevertheless, our results support that a closer adherence to Mediterranean lifestyle habits-the Mediterranean Diet, spending time with friends, family, and in nature, being active, and getting adequate rest at night-has a positive influence on the 9-item SWB score. Further research is needed to advance the understanding of the measuring and differentiating of SWB across different populations and to establish all the factors that influence it.