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Utilization of Emergency Medical Services (EMS) declined during COVID-19 pandemic, but most of the studies analyzed components of the EMS system individually. The study aimed to evaluate the indirect impact of COVID-19 pandemic on the utilization of all the components of the EMS system of Tuscany Region (Italy) during the first pandemic wave. Administrative data from the health care system of Tuscany were used. Changes in utilization for out-of-hospital emergency calls and emergency vehicle dispatched, emergency department (ED) visits, and patients being admitted from the ED to an inpatient hospital bed (hospitalizations from ED) during the first pandemic wave were analyzed in relation with corresponding periods of the previous two years. Percentage changes and 95%CI were calculated with Poisson models. Standardized Ratios were calculated to evaluate changes in in-hospital mortality and hospitalizations requiring ICU. Significant declines were observed in the utilization of all the EMS considered starting from the week in which the first case of COVID-19 was diagnosed in Italy till the end of the first pandemic wave. During the epidemic peak, the maximum decreases were observed: -33% for the emergency calls, -45% for the dispatch of emergency vehicles, -71% for ED admissions. Furthermore, a decline of 37% for hospitalizations from ED was recorded. Significant decreases in ED admissions for life threatening medical conditions were observed: acute cerebrovascular disease (-36%, 95% CI: -43, -29), acute myocardial infarction (-42%, 95% CI: -52, -31) and renal failure (-42%, 95% CI: -52, -31). No significant differences were found between the observed and the expected in-hospital mortality and hospitalizations requiring ICU during the epidemic peak. All the components of the EMS showed large declines in their utilization during COVID-19 pandemic; furthermore, major reductions were observed for admissions for time-dependent and life-threatening conditions. Efforts should be made to ensure access to safe and high-quality emergency care during pandemic.

Cancer, chronic heart failure (CHF), and chronic obstructive pulmonary disease (COPD) in the advanced stages have similar symptom burdens and survival rates. Despite these similarities, the majority of the attention directed to improving the quality of end-of-life (EOL) care has focused on cancer. To assess the extent to which the quality of EOL care received by cancer, CHF, and COPD patients in the last month of life is diagnosis-sensitive. This is a retrospective observational study based on administrative data. The study population includes all Tuscany region residents aged 18 years or older who died with a clinical history of cancer, CHF, or COPD. Decedents were categorized into two mutually exclusive diagnosis categories: cancer (CA) and cardiopulmonary failure (CPF). Several EOL care quality outcome measures were adopted. Multivariable generalized linear model for each outcome were performed. The sample included 30,217 decedents. CPF patients were about 1.5 times more likely than cancer patients to die in an acute care hospital (RR 1.59, 95% C.I.: 1.54-1.63). CPF patients were more likely to be hospitalized or admitted to the emergency department (RR 1.09, 95% C.I.: 1.07-1.10; RR 1.15, 95% C.I.: 1.13-1.18, respectively) and less likely to use hospice services (RR 0.08, 95% C.I.: 0.07-0.09) than cancer patients in the last month of life. CPF patients had a four- and two-fold higher risk of intensive care unit admission or of undergoing life-sustaining treatments, respectively, than cancer patients (RR 3.71, 95% C.I.: 3.40-4.04; RR 2.43, 95% C.I.: 2.27-2.60, respectively). The study has highlighted the presence of significant differences in the quality of EOL care received in the last month of life by COPD and CHF compared with cancer patients. Further studies are needed to better elucidate the extent and the avoidability of these diagnosis-related differences in the quality of EOL care.

Background: Low coverage of influenza vaccination in nursing home (NH) staff may be attributed to factors such as vaccine confidence (VC) and vaccine literacy (VL). Our study aimed to evaluate the role of VL and VC in predicting the intention to get the influenza vaccine in a sample of employees of NHs in Tuscany, Italy. Methods: Data from staff members in Tuscany were collected using an online questionnaire that examined influenza vaccination history, intentions, demographic information, health status, and VL. Statistical analyses explored the relationships between VC, VL, and vaccination intentions. Results: The study included 1794 respondents, (86.3%) and assistants/aides (58.1%), with a median age of 46 years. The intention to get vaccinated was significantly higher among those with health risk conditions, and there was a positive association between VC and VL, specifically its interactive/critical component. The mediation analysis showed that VC completely mediated the relationship between VL and the intention to get vaccinated, with significant effects observed in different subgroups. Conclusions: VC is a key factor that mediates the effect of VL on vaccine intention. These results suggest that interventions aimed at improving VL alone may not be sufficient to increase vaccine uptake unless VC is also addressed.

With the introduction of elexacaftor/tezacaftor/ivacaftor (ETI), more women with cystic fibrosis (CF) are likely to grow families. Hence, an understanding long-term safety and effects of CFTR modulators on fertile women and children while monitoring their concentrations is crucial. Here, we report on the development of an improved LC–MS/MS methodology to measure ETI concentrations in maternal and child blood and breastmilk, applied in one case of successful pregnancy of a 30-year-old woman with CF (F508del/R334W). We observed that ETI remains stable in breastmilk, is absorbed by the infant and can be detected in child plasma. Our results confirm accumulating evidence of a successful pregnancy in women treated with CFTR modulators without significant side effects on the child and provide valuable analytical procedures suitable for the post-marketing evaluation of CFTR modulators in pregnant and lactating women, as well as in their infants.

The aim of this cross-sectional study is to address whether health literacy (HL) and vaccine confidence are related with influenza vaccination uptake among staff of nursing homes (NHs). It was conducted in Tuscany (Italy) in autumn 2018, including the staff of 28 NHs. A questionnaire was used to collect individual data regarding influenza vaccination in 2016–2017 and 2017–2018 seasons; the intention to be vaccinated in 2018–2019; as well as demographic, educational, and health information. It included also the Italian Medical Term Recognition (IMETER) test to measure HL and eight Likert-type statements to calculate a Vaccine Confidence Index (VCI). The number of employees that fulfilled the questionnaire was 710. The percentage of influenza vaccination uptake was low: only 9.6% got vaccinated in 2016–2017 and 2017–2018 and intended to vaccinate in 2018–2019. The VCI score and the IMETER-adjusted scores were weakly correlated (Rho = 0.156). At the multinomial logistic regression analysis, the VCI was a positive predictor of vaccination uptake. In conclusion, vaccine confidence is the strongest predictor of influenza vaccination uptake among the staff of NHs. The development of an adequate vaccine literacy measurement tool could be useful to understand whether skills could be related to vaccine confidence.

(1) Background: Influenza vaccination uptake in nursing home (NH) workers is uncommon. The aim of this study was to understand the choice architecture of influenza vaccination acceptance or refusal among them and to promote vaccination acceptance using the nudge approach. (2) Methods: In autumn 2019, a nudge intervention with a contextual qualitative analysis of choice architecture of vaccination was performed among the staff of eight Tuscan NHs. In summer 2020, a cross-sectional study including the staff of 111 NHs (8 in the nudge, 103 in the comparison group) was conducted to assess the impact of the nudge intervention in promoting vaccination uptake. (3) Results: Macro-categories of motivations for vaccination uptake that emerged from the qualitative analysis were risk perception, value dimension, and trust, while those regarding refusal were risk perception, distrust, value dimension, and reasons related to one’s health. Considering the cross-sectional study, influenza vaccination uptake in the 2018–2019 season was similar in the two groups (23.6% vs. 22.2% respectively, in the nudge and comparison group), but significantly different in the 2019–2020 season: 28% in the nudge vs. 20% in the comparison group. Also, the intention to get the vaccine in the 2020–2021 season was significantly different in the two groups: 37.9% in the nudge and 30.8% in the comparison group. (4) Conclusions: Nudge interventions-simple, fast, low cost-could be effective in promoting vaccination acceptance among NH workers and the analysis of choice architecture could be useful in improving tailored, new nudge interventions aimed at modifying irrational biased and cognitive errors.

Background: CardioMEMS is a device suitable for telemedicine that is currently being evaluated by the Regional Health Technology Assessment (HTA) Committee of Tuscany. Two detailed HTA reports are available in the specialized literature, the results of which need to be transferred to our regional setting. These decisions in Tuscany are made by the so-called Centro Operativo HTA. Aim: To validate, with local cost-effectiveness data, the decision on CardioMEMS that will be made in the Tuscany region. Methods: Two detailed international HTA reports were rearranged and adapted to our regional setting to generate a simplified analysis that could form the basis of our decision. Two willingness-to-pay (WTP) thresholds of €20,000/quality-adjusted life year (QALY) and €50,000/QALY were considered. Results: Based on epidemiological and regulatory information, the target population in Tuscany for this device is 166 cases. The value-based price of CardioMEMS is estimated to be €4,332 and €16,662 at WTP thresholds of 20,000/QALY and 50,000/QALY, respectively. Its current price in Italy is €12,000. Conclusion: In our region, the introduction of CardioMEMS is likely to be gradual, around 50 patients/year (or €0.60 million/year at current price). This example highlights the need to adapt the information published in the international literature to the local context in which the approval decision is made. In this context, simplified analyses are easier to apply than complex Markov models.

Cystic Fibrosis (CF) is a genetic disease due to loss-of-function mutations of the CFTR channel. F508del is the most frequent mutation (70% of alleles in Italy), while other mutations have much lower frequency. Among them, G85E (0.4% frequency globally, 1.13% in Italy) emerges as a mutation characterized by a severe CFTR folding and trafficking defect. To investigate the pharmacological responsiveness of the G85E-CFTR variant, we performed a functional and biochemical characterization in heterologous expression systems and models based on patient-derived human nasal epithelial cells (HNEC). Our study demonstrated that treatment of primary airway cells with elexacaftor and tezacaftor causes a significant (although modest) rescue of CFTR function, that reaches 15%-25% of the activity measured in non-CF epithelia. A detrimental effect of chronic treatment with ivacaftor, further limiting G85E rescue, was also observed. A higher rescue of CFTR function, up to 25%-35% of the normal CFTR activity, with no evidence of negative effects upon chronic potentiator treatment, can be achieved by combining elexacaftor with ARN23765, a novel type 1 corrector endowed with very high potency. Importantly, dose-response relationships suggest that G85E might alter the binding of type 1 correctors, possibly affecting their affinity for the target. In conclusion, our studies suggest that novel combinations of modulators, endowed with higher efficacy leading to increased rescue of G85E-CFTR, are needed to improve the clinical benefit in patients for this variant.

Vaccine literacy (VL) mediates the transfer of information and facilitates vaccination acceptance. The aims of this study are to validate the HLVa-IT (Health Literacy Vaccinale degli adulti in Italiano—Vaccine health literacy for adults in Italian language) for the staff of nursing homes (NHs), to measure VL in such a peculiar target group, and to assess its relationship with the sources used to obtain information about vaccines and vaccinations. A survey has been conducted in a sample of Tuscan NHs using an online questionnaire. Eight-hundred and fifty-three questionnaires were analyzed. Two dimensions of the HLVa-IT appeared (functional and interactive/communicative/critical VL). The HLVa-IT interactive/communicative/critical subscale score was slightly higher than the functional subscale, although with no statistical significance. General practitioners (GPs) or other professionals have been reported as the main source of information by most of the respondents (66.1%). The HLVa-IT total score was significantly higher among those who have declared to use official vaccination campaigns (mean score: 3.25 ± 0.49; p < 0.001), GPs or other health professionals (3.26 ± 0.47; p < 0.001), and search engines (3.27 ± 0.48; p = 0.040) as the main sources of information. In conclusion, the HLVa-IT could be reliable test to investigate VL for staff of NHs, and also to highlight criticalities related to information sources.

Six minute walk test (6MWT) is a field exercise test widely used in clinical practice, both in adults and in pediatric patients. The primary aim of the study is to evaluate the physical performance of the subjects and compare them with the predicted Italian values. The secondary aim is to verify the possible relationship between the 6MWT distance (6MWD) and the clinical variables of the sample. Italian children between 6-11 years affected by CF were recruited from 9 regiol centers for CF. Short questionire assessments about their health state and physical activity routine was administered. Anthropometric characteristics were measured before the test and, peripheral oxygen saturation (SpO2), heart and respiratory rate were measured before and after a 6-minute walk test. The tests were performed according to the American Thoracic Society (ATS) guidelines. 6MWD was compared with the predicted distance calculated by the reference equation for healthy subjects of the same age. A total of 132 children were recruited (70 male) and completed the assessment. The mean (±SD) for 6MWD was 557.4 (±69.9), male = 551.4 (±80.0), female = 560.4 (±63.3), however the predicted distance mean was 605 m. A total of 101(76.5%) subjects practice regular physical activity. A total of 31 (23%) had a FEV1 lower than their lower limits of normal (LLN). Functiol performance on the 6MWT was poorer among the CF patients than among the predicted distance estimated with Italian values. The correlation with the amount of physical activity and 6MWD has been verified.