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The decline in children's vaccination coverage and the resurgence of preventable infectious diseases draw attention to parents' vaccine hesitancy. Our study introduces two validated tools to independently assess vaccine hesitancy and health literacy among parents with school-age children. We developed a Vaccine Confidence Index (VCI) from 10 Likert items, exploring their relationships through exploratory and confirmatory factor analyses. We modified the IMETER (Italian medical term recognition test) to measure health literacy. We assessed the internal consistency of the modified IMETER and the 10 Likert items using Cronbach's alpha test (α) and McDonald's omega total coefficient (ω) with good results (ω = 0.92, α = 0.90; ω = 0.87, α = 0.82 respectively). We used these tools within a questionnaire conducted on 743 parents recruited from pediatric clinic waiting rooms in Italy, collecting demographic data, information sources on vaccines and vaccine-preventable diseases knowledge. The VCI resulting from factor analyses consisted of six items on a ten-point Likert scale, reflecting the ratio of positive to negative items. The survey revealed significant variations in the VCI according to individual features such as education, use of social networks, or Health institutions as sources of information. Multivariate logistic regression identified an association between vaccine intention and the VCI. Health literacy was functional for 91.2% of participants, but knowledge about vaccine-preventable diseases was generally low. The VCI showed no significant association with health literacy and vaccine-preventable diseases knowledge. The VCI and the modified IMETER effectively assess vaccination attitude and health literacy, offering valuable public health tools for tailoring vaccination campaigns to hesitant population subgroups.

(1) Background: vaccination of healthcare workers (HCWs) against seasonal influenza is considered the most effective way to protect HCWs, ensure patient's safety and to maintain essential health care services during influenza epidemics. With the present study we aimed to evaluate the efficacy of incremental bundles of measures implemented during the last three flu campaigns and to assess the attitudes towards influenza vaccination and a potential vaccine against COVID-19 among HCWs, in a large university hospital in Pisa, Italy. (2) Methods: We described measures implemented during 2018/2019, 2019/2020 and 2020/2021 and assessed their impact on flu vaccine coverage (VC) among employees and residents in Pisa university hospital. We considered sex, profession and ward to investigate differences in uptake. In addition, in 2020 a survey was developed and distributed to all employees to evaluate flu and COVID-19 vaccines attitudes. (3) Results: during the 2018/19 and 2019/20 flu campaigns the overall VC rate among HCWs was, respectively, 10.2% and 11.9%. In 2020/21 the overall VC rate jumped to 39.3% (+ 230.6%). Results from the survey indicated a more positive attitude towards flu vaccine as compared to COVID-19 vaccines among the 10.6% of the staff members who responded to the survey. In addition, 70.97% of HCWs totally agreed that being vaccinated against influenza would be more important than the previous years because of COVID-19 emergency. (4) Conclusions: a significant increase in VC was observed in 2020/21, especially among those sub-groups with consistently lower uptake in previous years. The COVID-19 pandemic positively influenced flu vaccination uptake during the 2020/21 season.

In Italy, the coronavirus disease 2019 (COVID-19) emergency took hold in Lombardy and Veneto at the end of February 2020 and spread unevenly among the other regions in the following weeks. In Tuscany, the progressive increase of hospitalized COVID-19 patients required the set-up of a regional task force to prepare for and effectively respond to the emergency. In this case report, we aim to describe the key elements that have been identified and implemented in our center, a 1082-bed hospital located in the Pisa district, to rapidly respond to the COVID-19 outbreak in order to guarantee safety of patients and healthcare workers.

We describe the epidemiology of New Delhi Metallo-Beta-Lactamase-Producing Carbapenem-Resistant Enterobacterales (NDM-CRE) colonization/infection in a cohort of COVID-19 patients in an Italian teaching hospital. These patients had an increased risk of NDM-CRE acquisition versus the usual patients (75.9 vs. 25.3 cases/10,000 patient days). The co-infection significantly increased the duration of hospital stay (32.9 vs. 15.8 days).

The aim of this rat study was to investigate the effect of liquid intake on the oral bioavailability of an amorphous solid dispersion (ASD) containing the poorly water-soluble compound ABT-869. To this end, an ASD was prepared by hot-melt extrusion and administered in form of powder in an open gelatin capsule. The study consisted of three arms: (1) administration of the ASD without any liquid, (2) administration of the ASD with 1.5 mL of water, and (3) administration of a suspension of crystalline drug in water. Administration of the ASD without water resulted in a 4-fold higher exposure as compared to the suspension of crystalline drug. When administered together with water, the in vivo performance of the ASD was dramatically affected and not superior to that of the suspension of crystalline drug. The observed phenomena could not be explained mechanistically, but may be related to the following effects: (I) a faster dissolution in a larger volume of fluid and subsequent precipitation, (II) a change in gastrointestinal transit time that caused a mismatch between dissolution rate and absorption rate, and/or (III) a difference in the mucosal adherence/distribution pattern caused by the gelatin capsule. It remains to be investigated whether the phenomena observed in this study are exceptionally pronounced or even unique for this particular formulation. Yet, our findings emphasize that the amount of liquid co-administered with oral enabling formulations can have an impact on the bioavailability. The administration regime used in animal studies should therefore be considered carefully., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Here we report first experiences with the novel in vitro dissolution/permeation setup PermeaLoop™. It was designed to overcome current limitations of in vivo predictive dissolution testing of enabling formulations, such as lack of relevant absorptive drag to allow for meaningful interplay between dissolution and permeation, as it is occurring in vivo. We propose a novel setup with a high area-to-volume ratio and report as a model case the dissolution/permeation behavior of an enabling formulation of the poorly soluble and poorly permeable drug ABT-869. Mini tablets consisting of an amorphous solid dispersion were tested at a downscaled clinically relevant dose. At room temperature, release was fast, and more than 35% of the employed dose permeated within 6 h. In consequence, the amount in the donor decreased significantly. By contrast, only 9% of the employed dose was released when performing the experiment at 35 °C. Still, most of the released drug permeated into the acceptor (>80%), and the permeation rate was release-dependent and vice versa, i.e. the scenario was highly dynamic. Hence, due to a sufficiently large permeation area the dissolution step became rate-limiting. Therefore, PermeaLoop™ is regarded a promising tool for evaluating enabling formulations., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Combined dissolution/permeation testing is gaining increasing attention as an in vitro tool for predictive performance ranking of enabling oral formulations. The current aim was to study how in vitro drug permeation evolves under conditions, where the donor concentration is changing (non-steady state). To this end, a model case was construed: compacts of pure crystalline hydrocortisone methanolate (HC·MeOH) of slow release rates were prepared, and their dissolution and permeation determined simultaneously in a side-by-side setup, separated by a biomimetic barrier (Permeapad ® ). This was compared to a corresponding setup for a suspension of micronized hydrocortisone (HC). The HC suspension showed constant dissolved HC concentration and constant flux across the barrier, representing the permeation-limited situation. For the HC·MeOH compacts, various dynamic scenarios were observed, where dissolution rate and flux influenced each other. Interestingly, for all the dynamic scenarios, the incremental flux values obtained correlated nicely with the corresponding actual donor concentrations. Furthermore, donor depletion was tested using a HC solution. The dynamic interplay between decrease in donor concentration (down to less than 10% of the initial concentration) and flux was studied. The experiences gained are discussed in terms of further developing combined dissolution/permeation setups., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The aim of the current study was to evaluate a dynamic dissolution-/permeation-system for prediction of gastrointestinal and absorption-behavior of two commercial fenofibrate formulations. To this end, both dissolution and barrier-flux were followed simultaneously for fenofibrate powder, a microparticle formulation (Lipidil® 200mg) and a nanoparticle formulation (LIPIDIL 145 ONE®) using a pair of side-by side diffusion cells separated by a cellulose hydrate membrane. Under such dynamic conditions, transient supersaturation arising from the nanoparticle formulation could be demonstrated for the first time. Furthermore, the dissolution-/permeation-system introduced here allowed for in-depth mechanistic insights: Biomimetic media, despite enhancing the apparent solubility of fenofibrate via micellar solubilization, did not increase permeation rate, irrespective whether the micro-/ or nanoparticle-formulation was tested. Nondissolved nano-/microparticles served as a reservoir helping to maintain high levels of molecularly dissolved drug, which in turn caused high and constant permeation rates. The micelle-bound drug may also serve as a drug-reservoir, yet of subordinate importance as long as there are nano-/microparticles present. Despite the limitations of the current experimental set-up, combined dissolution-/permeation-testing appears a valuable new tool to promote mechanistic understanding during formulation development. Last but not least, the in vitro dissolution and permeation behavior revealed here was in good qualitative agreement with human duodenal and plasma values reported in literature for the same formulations., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Purpose: This study was done to analyse the costs of 64-slice computed tomography (CT) coronary angiography and conventional coronary angiography and determine the cost-effectiveness of the two modalities., Materials and Methods: Detailed activity-based cost analyses of the two modalities were carried out at the departments of radiology and cardiology of a teaching hospital. The differential costs (equipment, variable, personnel), common costs and external costs were estimated. Finally, the full costs of the two procedures were obtained; the full cost of conventional coronary angiography also considered the cost of 1 day in hospital. The cost-effectiveness of the two procedures at different levels of pretest likelihood of coronary artery disease (CAD) was estimated., Results: The costs of multidetector CT (MDCT) coronary angiography were as follows: differential cost 222.23 euro, common cost 5.50 euro, external cost 2.30 euro and full cost 230.03 euro. The costs of conventional coronary angiography were: differential cost 366.18 euro, common cost 0.50 euro, external cost 9.20 euro, hospitalisation cost 1,652 euro and full cost 2,027.88 euro. Cost-effectiveness analysis showed that the cost per correctly identified CAD patient decreased exponentially with increasing pretest likelihoods of CAD. MDCT coronary angiography was more cost effective than conventional coronary angiography up to a pretest likelihood of 86%., Conclusions: MDCT coronary angiography has far lower costs than conventional coronary angiography, and its cost-effectiveness is better in the large majority of patients.

Unlabelled: Cryoglobulinemic Syn&come (CS) is a multi-systemic disease, and its fatal evolution can involve different organs., Aims: To describe the most frequent causes of death in CS, by researching different evolutions between older cases and those of the last 15 years., Patients: The data of 238 patients affected by symptomatic cryoglobulinemia followed by our Medicine Department in the last 30 years are recorded in a database. 54 are presently living and being followed, 70 (36F, 34M) have died. The type II/type III ratio is 5/4. We distinguish between two groups, the oldest, without any data on HCV, and the most recent who were tested for HCV. The follow-up ranges from 0.5 to 16 years., Results: Liver diseases (25 cases, 9 with hepatic carcinomas), lymphomas and myeloproliferative diseases (12), and cardiovascular events (8) are the most reported causes of death. Sepsis, neurological syndromes, nephropathy, other malignancies and diffuse vasculitis are also reported. The median age at death was 67.2 years (58.4 in the oldest group, 71.9 in the other). Hepatic carcinomas are reported only after 1991., Conclusion: Cirrhosis complications are more frequent in patients affected by HCV. The increase in instrumental diagnostic ability and the improved survival of patients with cirrhosis account for the increase in patients with hepatic carcinomas. Improved treatment has resulted in a reduction of deaths from renal failure.

Objective: The noninvasive method for estimating bladder weight (UEBW, Ultrasound Estimated Bladder Weight) can be used as a measure of bladder hypertrophy and may have clinical use for evaluating intravesical obstruction in male patients. The aim of this study was to assess whether, in patients with bladder outlet obstruction (BOO), tamsulosin treatment produced any significant change in UEBW., Methods: 32 male patients with lower urinary tract symptoms (LUTS) suggestive of BOO [benign prostatic hyperflesia (BPH) was the apparent cause of BOO] were enrolled in an open pilot study. At baseline, physical examination, ECG, hematochemical tests, urine analysis, urine culture, urodynamics, urethrocystography, transrectal ultrasound, UEBW and symptom score were performed. Using the International Continence Society (ICS) nomogram, patients were assigned to three different groups: obstructed, not obstructed and equivocal. Only patients in the obstructed and equivocal categories were treated with tamsulosin 0.4 mg once daily for 6 months. Follow-up for all patients took place after 30 days, 3 and 6 months of treatment., Results: In the obstructed group of patients, the decrease in UEBW was observed at 30 days and maintained up to 6 months, with a significantly improved Qmax. A statistically significant correlation was found between UEBW and postvoid residual urine (PVR) and Abrams-Griffith number (AG)., Conclusions: The results of this study suggest a significant change in UEBW during tamsulosin treatment. The change observed might be suggestive of a therapeutic effect of tamsulosin on the detrusor muscle. Further and more extensive studies are needed in order to confirm a possible therapeutic effect of tamsulosin on the detrusor muscle.

We evaluated coagulation and fibrinolytic parameters in both plasma and ascitic fluid of 39 patients with ascites secondary to liver cirrhosis and in 14 cirrhotic patients without ascites, in order to verify if the peritoneal compartment could be involved in the pathogenesis of the hyperfibrinolytic state of the disease. An activation of fibrinolysis, as suggested by increased levels of FDP, D-dimer and tissue plasminogen activator (t-PA) was demonstrated in both ascitic fluid and to a lesser extent in plasma. A positive correlation was also observed between plasma and ascitic fluid plasminogen, anti-plasmin and fibrinogen, while a negative correlation was found between plasma and ascitic fluid plasminogen activator inhibitor-1 (PAI-1). Moreover, plasma PAI-1 was significantly lower in patients with ascites than in those without ascites and among ascitic patients in those who had bleeding into soft tissues when compared to those who did not present haemorrhagic events. Finally, a significant association was also shown between positivity for plasma D-dimer (> 200 ng/ml) and the presence of ascites. Taken together, our data suggest an exchange of some coagulation and fibrinolytic proteins between plasma and ascitic fluid and point out the key role of PAI-1 in regulating plasma fibrinolytic potential and in bleeding complications in cirrhotic patients.

Food sensitization was evaluated in 78 subjects with respiratory allergies, both by skin tests with commercial and fresh allergens, and by specific IgE determination. On the basis of the presence or absence of the latter the population was divided into two groups. The group with food-specific IgE showed more severe features of respiratory allergy, including a greater number of positive skin tests and specific IgE determinations, more class 3 and 4 reactions, and more symptoms. The hypothesis that early food sensitization can predispose to severe inhalant allergy is discussed.