Occupational heat stress, heat-related effects and the related social and economic loss: a scoping literature review.

Introduction: While there is consistent evidence on the effects of heat on workers' health and safety, the evidence on the resulting social and economic impacts is still limited. A scoping literature review was carried out to update the knowledge about social and economic impacts related to workplace heat exposure. Methods: The literature search was conducted in two bibliographic databases (Web of Science and PubMed), to select publications from 2010 to April 2022. Results: A total of 89 studies were included in the qualitative synthesis (32 field studies, 8 studies estimating healthcare-related costs, and 49 economic studies). Overall, consistent evidence of the socioeconomic impacts of heat exposure in the workplace emerges. Actual productivity losses at the global level are nearly 10% and are expected to increase up to 30-40% under the worst climate change scenario by the end of the century. Vulnerable regions are mainly low-latitude and low- and middle-income countries with a greater proportion of outdoor workers but include also areas from developed countries such as southern Europe. The most affected sectors are agriculture and construction. There is limited evidence regarding the role of cooling measures and changes in the work/rest schedule in mitigating heat-related productivity loss. Conclusion: The available evidence highlights the need for strengthening prevention efforts to enhance workers' awareness and resilience toward occupational heat exposure, particularly in low- and middle-income countries but also in some areas of developed countries where an increase in frequency and intensity of heat waves is expected under future climate change scenarios.

Brand-specific estimates of influenza vaccine effectiveness for the 2021-2022 season in Europe: results from the DRIVE multi-stakeholder study platform.

Introduction: Development of Robust and Innovative Vaccine Effectiveness (DRIVE) was a European public-private partnership (PPP) that aimed to provide annual, brand-specific estimates of influenza vaccine effectiveness (IVE) for regulatory and public health purposes. DRIVE was launched in 2017 under the umbrella of the Innovative Medicines Initiative (IMI) and conducted IVE studies from its pilot season in 2017-2018 to its final season in 2021-2022. Methods: In 2021-2022, DRIVE conducted four primary care-based test-negative design (TND) studies (Austria, Italy, Iceland, and England; involving >1,000 general practitioners), nine hospital-based TND studies (France, Iceland, Italy, Romania, and Spain, for a total of 21 hospitals), and one population-based cohort study in Finland. In the TND studies, patients with influenza-like illness (primary care) or severe acute respiratory infection (hospital) were enrolled, and laboratory tested for influenza using RT-PCR. Study contributor-specific IVE was calculated using logistic regression, adjusting for age, sex, and calendar time, and pooled by meta-analysis. Results: In 2021-2022, pooled confounder-adjusted influenza vaccine effectiveness (IVE) estimates against laboratory-confirmed influenza (LCI) overall and per type and subtype/lineage was produced, albeit with wide confidence intervals (CI). The limited circulation of influenza in Europe did not allow the network to reach the optimal sample size to produce precise IVE estimates for all the brands included. The most significant IVE estimates were 76% (95% CI 23%-93%) for any vaccine and 81% (22%-95%) for Vaxigrip Tetra in adults ≥65 years old and 64% (25%-83%) for Fluenz Tetra in children (TND primary care setting), 85% (12%-97%) for any vaccine in adults 18-64 years (TND hospital setting), and 38% (1%-62%) in children 6 months-6 years (population-based cohort, mixed setting). Discussion: Over five seasons, DRIVE collected data on >35,000 patients, more than 60 variables, and 13 influenza vaccines. DRIVE demonstrated that estimating brand-specific IVE across Europe is possible, but achieving sufficient sample size to obtain precise estimates for all relevant stratifications remains a challenge. Finally, DRIVE's network of study contributors and lessons learned have greatly contributed to the development of the COVID-19 vaccine effectiveness platform COVIDRIVE.

Reproductive Events and Risk of Women's Cancers: From Parturition to Prevention.

Reproductive events beginning with pregnancy and ending with remodeling of the breast after cessation of breastfeeding alter breast structure and function and produce dramatic changes in systemic biology. In aggregate, these processes lower overall risk for breast, tubo-ovarian and endometrial cancers, albeit differentially by molecular subtypes of these tumors. Herein, we explore opportunities for research on protective mechanisms operative during this period of the life course, with the goal of encouraging studies to advance cancer prevention. See related article by Getz et al., p. 353.

Time-Trends in Air Pollution Impact on Health in Italy, 1990-2019: An Analysis From the Global Burden of Disease Study 2019.

Objectives: We explored temporal variations in disease burden of ambient particulate matter 2.5 µm or less in diameter (PM2.5) and ozone in Italy using estimates from the Global Burden of Disease Study 2019. Methods: We compared temporal changes and percent variations (95% Uncertainty Intervals [95% UI]) in rates of disability adjusted life years (DALYs), years of life lost, years lived with disability and mortality from 1990 to 2019, and variations in pollutant-attributable burden with those in the overall burden of each PM2.5- and ozone-related disease. Results: In 2019, 467,000 DALYs (95% UI: 371,000, 570,000) were attributable to PM2.5 and 39,600 (95% UI: 18,300, 61,500) to ozone. The crude DALY rate attributable to PM2.5 decreased by 47.9% (95% UI: 10.3, 65.4) from 1990 to 2019. For ozone, it declined by 37.0% (95% UI: 28.9, 44.5) during 1990-2010, but it increased by 44.8% (95% UI: 35.5, 56.3) during 2010-2019. Age-standardized rates declined more than crude ones. Conclusion: In Italy, the burden of ambient PM2.5 (but not of ozone) significantly decreased, even in concurrence with population ageing. Results suggest a positive impact of air quality regulations, fostering further regulatory efforts.

Development of a Prototype Observatory of Heat-Related Occupational Illnesses and Injuries through the Collection of Information from the Italian Press, as Part of the WORKLIMATE Project.

Exposure to heat is a recognized occupational risk factor. Deaths and accidents at work caused by high temperatures are underestimated. With the aim of detecting and monitoring heat-related illnesses and injuries, a prototype database of occupational events attributable to critical thermal conditions reported in Italian newspapers was created. Information was analyzed from national and local online newspapers using a web application. The analysis was conducted from May to September during the three-year period 2020-2022. Articles concerning 35 occupational heat-related illnesses and injuries were selected; 57.1% of the events were reported in 2022, and 31.4% of total accidents occurred in the month of July 2022, when the Universal Thermal Climate Index daily mean values corresponded to "moderate heat stress" (51.0%) and "strong heat stress" (49.0%). Fatal heat-related illnesses were the most frequent conditions described. In most cases, workers had been involved in outdoor activities in the construction sector. A comprehensive report was created by compiling all relevant newspaper articles to enhance awareness of this issue among relevant stakeholders and promote heat-risk prevention strategies in the current context where heatwaves are becoming increasingly frequent, intense and long-lasting.

Case-Control Study on the Routes of Transmission of SARS-CoV-2 after the Third Pandemic Wave in Tuscany, Central Italy.

The emergence of hyper-transmissible SARS-CoV-2 variants that rapidly became prevalent throughout the world in 2022 made it clear that extensive vaccination campaigns cannot represent the sole measure to stop COVID-19. However, the effectiveness of control and mitigation strategies, such as the closure of non-essential businesses and services, is debated. To assess the individual behaviours mostly associated with SARS-CoV-2 infection, a questionnaire-based case-control study was carried out in Tuscany, Central Italy, from May to October 2021. At the testing sites, individuals were invited to answer an online questionnaire after being notified regarding the test result. The questionnaire collected information about test result, general characteristics of the respondents, and behaviours and places attended in the week prior to the test/symptoms onset. We analysed 440 questionnaires. Behavioural differences between positive and negative subjects were assessed through logistic regression models, adjusting for a fixed set of confounders. A ridge regression model was also specified. Attending nightclubs, open-air bars or restaurants and crowded clubs, outdoor sporting events, crowded public transportation, and working in healthcare were associated with an increased infection risk. A negative association with infection, besides face mask use, was observed for attending open-air shows and sporting events in indoor spaces, visiting and hosting friends, attending courses in indoor spaces, performing sport activities (both indoor and outdoor), attending private parties, religious ceremonies, libraries, and indoor restaurants. These results might suggest that during the study period people maintained a particularly responsible and prudent approach when engaging in everyday activities to avoid spreading the virus.

Investigating confounding in network-based test-negative design influenza vaccine effectiveness studies-Experience from the DRIVE project.

BACKGROUND: Establishing a large study network to conduct influenza vaccine effectiveness (IVE) studies while collecting appropriate variables to account for potential bias is important; the most relevant variables should be prioritized. We explored the impact of potential confounders on IVE in the DRIVE multi-country network of sites conducting test-negative design (TND) studies. METHODS: We constructed a directed acyclic graph (DAG) to map the relationship between influenza vaccination, medically attended influenza infection, confounders, and other variables. Additionally, we used the Development of Robust and Innovative Vaccines Effectiveness (DRIVE) data from the 2018/2019 and 2019/2020 seasons to explore the effect of covariate adjustment on IVE estimates. The reference model was adjusted for age, sex, calendar time, and season. The covariates studied were presence of at least one, two, or three chronic diseases; presence of six specific chronic diseases; and prior healthcare use. Analyses were conducted by site and subsequently pooled. RESULTS: The following variables were included in the DAG: age, sex, time within influenza season and year, health status and comorbidities, study site, health-care-seeking behavior, contact patterns and social precautionary behavior, socioeconomic status, and pre-existing immunity. Across all age groups and settings, only adjustment for lung disease in older adults in the primary care setting resulted in a relative change of the IVE point estimate >10%. CONCLUSION: Our study supports a parsimonious approach to confounder adjustment in TND studies, limited to adjusting for age, sex, and calendar time. Practical implications are that necessitating fewer variables lowers the threshold for enrollment of sites in IVE studies and simplifies the pooling of data from different IVE studies or study networks.

The value of public-private collaborative real-world evidence platforms to monitor vaccine performance post authorization: DRIVE - a European initiative.

INTRODUCTION: Fighting pandemics requires an established infrastructure for pandemic preparedness, with existing, sustainable platforms ready to be activated. This includes platforms for disease surveillance, virus circulation, and vaccine performance monitoring based on Real-World data, to complement clinical trial evidence. AREAS COVERED: Because of its complexity, this can best be done by combining efforts between public and private sectors, developing a multi-stakeholder approach. Public-Private-Partnerships increasingly play a critical role in combating infectious diseases but are still looked at with hesitancy. The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project, which established a platform for measuring brand-specific influenza vaccine effectiveness in Europe, exemplifies how to build a collaborative platform with transparent governance, state-of-the-art methodology, and a large network of participating sites. Lessons learned from DRIVE have been cardinal to set up COVIDRIVE, a platform for brand-specific COVID-19 vaccine effectiveness monitoring. EXPERT OPINION: The DRIVE partners propose that a debate on the benefits of Public-Private-Partnership-generated real-world evidence for vaccine effectiveness monitoring should be pursued to clarify roles and responsibilities, set up expectations, and decide the future environment for vaccine monitoring in Europe. In parallel, the driving factors behind PPP hesitancy should be studied.

Workers' Perception Heat Stress: Results from a Pilot Study Conducted in Italy during the COVID-19 Pandemic in 2020.

Many workers are exposed to the effects of heat and often to extreme temperatures. Heat stress has been further aggravated during the COVID-19 pandemic by the use of personal protective equipment to prevent SARS-CoV-2 infection. However, workers' risk perception of heat stress is often low, with negative effects on their health and productivity. The study aims to identify workers' needs and gaps in knowledge, suggesting the adaptation of measures that best comply with the needs of both workers and employers. A cross-sectional online questionnaire survey was conducted in Italy in the hottest months of 2020 (June-October) through different multimedia channels. The data collected were analyzed using descriptive statistics; analytical tests and analysis of variance were used to evaluate differences between groups of workers. In total, 345 questionnaires were collected and analyzed. The whole sample of respondents declared that heat is an important contributor to productivity loss and 83% of workers did not receive heat warnings from their employer. In this context, the internet is considered as the main source of information about heat-related illness in the workplace. Results highlight the need to increase workers' perception of heat stress in the workplace to safeguard their health and productivity. About two-thirds of the sample stated that working in the sun without access to shaded areas, working indoors without adequate ventilation, and nearby fire, steam, and hot surfaces, represent the main injuries' risk factors.

Health vs. wealth: Employer, employee and policy-maker perspectives on occupational heat stress across multiple European industries.

Successful implementation of cooling strategies obviously depends on identifying effective interventions, but in industrial settings, it is equally important to consider feasibility and economic viability. Many cooling interventions are available, but the decision processes affecting adoption by end-users are not well elucidated. We therefore arranged two series of meetings with stakeholders to identify knowledge gaps, receive feedback on proposed cooling interventions, and discuss factors affecting implementation of heat-health interventions. This included four meetings attended by employers, employees, and health and safety officers (n = 41), and three meetings attended primarily by policy makers (n = 74), with feedback obtained via qualitative and quantitative questionnaires and focus group discussions. On a 10-point scale, both employers and employees valued worker safety (9.1 ± 1.8; mean±SD) and health (8.5 ± 1.9) as more important than protecting company profits (6.3 ± 2.3). Of the respondents, 41% were unaware of any cooling strategies at their company and of those who were aware, only 30% thought the interventions were effective. Following presentation of proposed interventions, the respondents rated "facilitated hydration", "optimization of clothing/protective equipment", and "rescheduling of work tasks" as the top-three preferred solutions. The main barriers for adopting cooling interventions were cost, feasibility, employer perceptions, and legislation. In conclusion, preventing negative health and safety effects was deemed to be more important than preventing productivity loss. Regardless of work sector or occupation, both health and wealth were emphasized as important parameters and considered as somewhat interrelated. However, a large fraction of the European worker force lacks information on effective measures to mitigate occupational heat stress. List of abbreviations: OH-Stress: Occupational heat stress; WBGT: Wet Bulb Globe Temperature.

Identification and Management of Traveler's Diarrhea.

Traveler's diarrhea (TD) is a common occurrence when people travel to foreign countries and can affect individuals of all ages, including those who are pregnant. This clinical syndrome is caused by a variety of intestinal pathogens, and treatment is based on the acuity of the patient's symptoms. This case report describes the clinical presentation and management of a pregnant woman with a history of TD who requests an antibiotic prescription for the potential need of empiric self-treatment of TD for an upcoming business trip outside of the United States. The clinical presentation of TD, differential diagnoses, treatment plan options, prevention recommendations, and empiric self-treatment are reviewed. Current evidence-based guidelines are discussed, and high-risk conditions such as pregnancy are considered.

A Web Survey to Evaluate the Thermal Stress Associated with Personal Protective Equipment among Healthcare Workers during the COVID-19 Pandemic in Italy.

The pandemic has been afflicting the planet for over a year and from the occupational point of view, healthcare workers have recorded a substantial increase in working hours. The use of personal protective equipment (PPE), necessary to keep safe from COVID-19 increases the chances of overheating, especially during the summer seasons which, due to climate change, are becoming increasingly warm and prolonged. A web survey was carried out in Italy within the WORKLIMATE project during the summer and early autumn 2020. Analysis of variance (ANOVA) was used to evaluate differences between groups. 191 questionnaires were collected (hospital doctor 38.2%, nurses 33.5%, other healthcare professionals 28.3%). The impact of PPE on the thermal stress perception declared by the interviewees was very high on the body areas directly covered by these devices (78% of workers). Workers who used masks for more than 4 h per day perceived PPE as more uncomfortable (p < 0.001) compared to the others and reported a greater productivity loss (p < 0.001). Furthermore, the study highlighted a high perception of thermal stress among healthcare workers that worn COVID-19-PPE and this enhances the need for appropriate heat health warning systems and response measures addressed to the occupational sector.

The HEAT-SHIELD project - Perspectives from an inter-sectoral approach to occupational heat stress.

OBJECTIVES: To provide perspectives from the HEAT-SHIELD project (www.heat-shield.eu): a multi-national, inter-sectoral, and cross-disciplinary initiative, incorporating twenty European research institutions, as well as occupational health and industrial partners, on solutions to combat negative health and productivity effects caused by working on a warmer world. METHODS: In this invited review, we focus on the theoretical and methodological advancements developed to combat occupational heat stress during the last five years of operation. RESULTS: We outline how we created climate forecast models to incorporate humidity, wind and solar radiation to the traditional temperature-based climate projections, providing the basis for timely, policy-relevant, industry-specific and individualized information. Further, we summarise the industry-specific guidelines we developed regarding technical and biophysical cooling solutions considering effectiveness, cost, sustainability, and the practical implementation potential in outdoor and indoor settings, in addition to field-testing of selected solutions with time-motion analyses and biophysical evaluations. All recommendations were adjusted following feedback from workshops with employers, employees, safety officers, and adjacent stakeholders such as local or national health policy makers. The cross-scientific approach was also used for providing policy-relevant information based on socioeconomic analyses and identification of vulnerable regions considered to be more relevant for political actions than average continental recommendations and interventions. DISCUSSION: From the HEAT-SHIELD experiences developed within European settings, we discuss how this inter-sectoral approach may be adopted or translated into actionable knowledge across continents where workers and societies are affected by escalating environmental temperatures.

Analysis of the excess mortality and factors associated with deaths from COVID-19 versus other causes in Central Tuscany (Italy) in 2020.

OBJECTIVES: to assess the extent of the excess mortality from all causes in 2020 compared to 2015-2019 in Central Tuscany (Italy) as a proxy to estimate COVID-19-related excess mortality and to identify demographic and clinical differences between subjects who died from COVID-19 and those who died from other causes in 2020. DESIGN: descriptive analysis of the temporal trend of general mortality. SETTING AND PARTICIPANTS: the study population is represented by the 1.6 million residents living in the territory of the Central Tuscany Healthcare Authority in Central Italy, i.e., little less than half of the population of Tuscany, in an area of just over one fifth of the entire region, where the provinces of Florence, Pistoia, and Prato are comprised. MAIN OUTCOME MEASURES: using the Italian National Resident Population Registry (ANPR) as a source of mortality data, standardized mortality ratios with 95% confidence intervals were calculated to compare the number of deaths in 2020 with the number of deaths expected on the basis of mortality data from 2015 to 2019. Furthermore, after record linkage with data from the integrated surveillance of cases of SARS-CoV-2 virus infection and with the MaCro dataset of comorbidities, the characteristics of subjects who died from COVID-19 were compared with those of patients who died from other causes using a multivariate logistic regression model; odds ratios with 95% confidence intervals were calculated. RESULTS: a statistically significant excess mortality was observed during the first pandemic wave in March and April, and during the second wave in the fall; it ranged between +9% in March and +51% in November. On the contrary, in January, February, and May, all-cause mortality was significantly lower than in previous years. The male gender, dyslipidaemia, and dementia were positively associated with death from COVID-19 rather than from all other causes. On the contrary, heart failure and recent tumours were more represented among deaths from other causes. CONCLUSIONS: much of the over-mortality observed in spring is attributable to the harvesting effect COVID-19 exerted on a segment of population with serious underlying chronic conditions and who in the previous months had survived a mild winter and a flu season of medium intensity. In the second pandemic wave, in autumn, the impact of both direct and indirect effects of COVID-19 was substantially higher. Consistently with the available evidence, death from COVID-19 was related to the male gender and to clinical conditions such as dyslipidaemia and dementia.

[Reassessment of burden of occupational fatal injuries in Italy, 1951-2017]. / Rivalutazione del carico di danni dovuti agli infortuni mortali sul lavoro in Italia, 1951-2017.

BACKGROUND: occupational injuries in Italy are registered primarily by the Italian National Institute for insurance against accidents at work (Inail); its statistics show the number of events by consequence type (temporary, permanent, fatal). Data prior to 2001 include fatalities only if benefits were paid to survivors entitled to compensation, typically spouse and/or children. OBJECTIVES: to estimate the number of fatal injuries occurred to workers without survivors entitled to compensation, not considered in INAIL statistics for the period 1951-2000; to evaluate years lived with disability (YLD) years of life lost (YLL), disability-adjusted life years (DALY) caused by all occupational injuries occurred in Italy, period 1951-2016. DESIGN: evaluation of the stability of the ratio among fatal accidents with and without survivors, along the period of observation (2001-2017); retrospective application of such ratio to data related to the period 1951-2000; linkage of individual injury data to Global Burden of Disease injury categories and calculation of corresponding YLLs, YLDs, DALYs; calculation of mean values by main type of consequences (temporary, permanent, fatal); application of above means to Italian data 1951-2017. SETTING AND PARTICIPANTS: occupational injuries compensated by Inail in Italy, 1951-2017. MAIN OUTCOME MEASURES: number of injuries, YLDs, YLLs, DALYs. RESULTS: fatal occupational injuries, not considered in official statistics for the period 1951-2000, are estimated to be 26,218 cases, corresponding to 1.4 millions of YLLs. In the same period, total occupational injuries (with temporary, permanent or fatal consequences) correspond to 11.5 millions of DALYs, fatal component corresponded to 5.1 millions of YLLs. CONCLUSIONS: Estimated total number of fatal occupational injuries in 1951-2000 is 28% higher than official Inail data. Considering YLLs, such increase rises up to 37%. Such difference reflects younger mean age and consequent longer life expectancy of workers without survivors. Considering DALYs, the increase is 14%. Throughout the period 1951-2017, a progressive reduction of the burden of injury is observed. At the same time a qualitative change is observed, with reduction from 55% to 30% of YLL/DALY ratio.

Documented early circulation of Coronavirus Disease 2019 (COVID-19) in Florida, USA, since February 2020.

In this Update, we document the circulation of Coronavirus Disease 2019 (COVID-19) in Florida, USA, since February 2020. On 8th March 2020, a confirmed case of COVID-19 was notified to the Health Authority of Central Tuscany, Florence, Italy. The patient developed symptoms on 3rd March while staying in Miami where he arrived on 12th February. The case returned to Italy on 6th March and was admitted to a local hospital of Florence on 7th March with fever (38.2°C/100.4°F), cough and breathing difficulties. First COVID-19 cases in Florida where confirmed by the Centers for Disease Control and Prevention on 2nd March as imported cases. Therefore, this event documents COVID-19 circulation in Florida at least since mid-February 2020.

Predictors of iron-deficiency anemia in primary care older adults: a real-world European multi-country longitudinal study.

BACKGROUND: Iron deficiency is a major cause of anemia in older people. Increasing the knowledge on the predictors of iron-deficiency anemia (IDA) may facilitate its timely diagnosis. AIM: To investigate the predictors of IDA in older people in four European countries. DESIGN AND SETTING: Retrospective longitudinal study. Primary care patients aged 65 or older (N = 24,051) in four European countries. METHODS: IDA predictors were estimated using multivariate Cox regression based on information gathered from national primary care databases: Italy (years 2002-2013), Belgium, Germany and Spain (years 2007-2012). Adjusted hazard ratios (aHR) with 95% confidence intervals (CIs) were estimated. RESULTS: In Spain and Belgium, men were at greater risk of IDA than women, while they had a lower risk in Italy. Weakness, irritability, alopecia and xerostomia were signs and symptoms significantly associated with IDA. Concurrent diseases, potential causes of anemia, positively associated with IDA were small bowel polyposis, stomach cancer, obesity, gastritis and peptic ulcer, esophagitis, Crohn's disease, celiac disease, lymphangiectasis, gastrectomy or gastric atrophy, gut resection or bypass, and cardiac prosthetic valve. Aspirin users had a 12-35% higher hazard of IDA than non-users. Similarly, corticosteroids and anti-acids were positively associated with IDA. A higher level of comorbidity was associated with an increased hazard of IDA in all countries. CONCLUSIONS: Specific signs and symptoms, chronic conditions, a greater comorbidity burden, and specific pharmacological treatments registered in primary care databases represent relevant predictors and correlates of incident IDA in older people in Europe. General practitioners might employ this information to obtain early diagnosis of IDA in community-dwelling older adults.

Italian translation and validation of the Perinatal Grief Scale.

AIMS: The short version of the Perinatal Grief Scale (PGS) has 33 items of Likert type whose answers vary from 1 (strongly agree) to 5 (strongly disagree), and is used to assess the grief after perinatal loss and to identify women at major need of specific support. This is the first attempt to validate an Italian version of PGS. MATERIALS AND METHODS: The English version of PGS by Potvin et al. was translated into Italian by a professional mother tongue English translator. The survey was administered at 3 different times (translated Italian version; original English version after 10 days; and same Italian version after other 10 days) to 16 Italian/English bilingual women who had experienced a perinatal loss. The reproducibility among the three administrations and concordance were assessed using Cronbach's alpha and Cohen's kappa, respectively. RESULTS: Considering the PGS, median score ranged from 74.5 (58.5-94.5) to 78 (64-95), with no significant difference among the three questionnaire administrations (p = 0.616). No significant difference emerged among the three administered questionnaires for subscales (p = 0.095, 0.410 and 0.410 for 'active grief' AG, 'difficulty in coping' DC and 'despair' D scores, respectively). Concordance varied from good to very good among all questionnaire administrations. CONCLUSIONS: This Italian version of the PGS can be used by clinicians to assess Italian women's responses to stillbirth and perinatal loss, as well as by researchers for research purposes.

Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy.

Background: The concern for adverse events following immunization (AEFI) and anti-vaccination movements that lacked scientific evidence-based supports may reduce vaccine uptake in the general population. Thus, the aims of the present study were to characterize AEFI in general population (all age groups), in terms of frequency, preventability, and seriousness and to define predictors of their seriousness in children. Methods: A retrospective study was performed on suspected AEFI reports for children and adults who received any form of vaccinations, collected in Tuscany, Italy, between 1 January and 31 December 2017. Patients' characteristics, suspected vaccines, and AEFI description were collected. Causality and preventability were assessed using WHO and Schumock and Thornton algorithms, respectively. Logistic regression was used to estimate the reporting odds ratios of potential predictors of AEFI seriousness in children. Results: A total of 223 suspected AEFI reports were collected, and the majority of them were defined as non-serious (76.7%). Reports were mostly related to one vaccine, and to a median of two to five strains/toxoids. The total number of simultaneously administered strains/toxoids and the presence of allergens did not correlate with AEFI seriousness. Considering vaccines with a high number of administered doses (≥60,000 doses), the rates estimated for serious AEFI reports were always very low, ranging between 0.01 and 0.2/1,000 doses. Twenty-four vaccines (8,993 doses) were not related to any AEFI. Conclusion: Results of present study showed that AEFI were very rare; the vast majority of them was non-serious and, despite the claims of anti-vaccination movements, the simultaneous administration of vaccines was safe and did not influence the risk of reporting a serious AEFI, particularly in children.