The use of 12-item General Health Questionnaire (GHQ-12) in Ukrainian refugees: translation and validation study of the Ukrainian version.

Following the Russian-Ukrainian conflict, the well-being of millions of Ukrainians has been jeopardised. This study aims to translate and test the psychometric features of the Ukrainian version of the General Health Questionnaire 12 (GHQ-12). The study included Ukrainian refugees housed in Verona (Italy) between November/2022 and February/2023. The Ukrainian translation was obtained through a 'forward-backward' translation. Questionnaire was completed by 141 refugees (females: 78.7%). Median age was 36 years (IQR 23-43). Individuals with a score suggestive of psychological distress were 97 (68.8%). Cronbach's coefficient was 0.84 (0.95CI 0.80-0.88). According to confirmatory factor analysis, both single- (modelB1) and two-factor (model B2) structures with bimodal scoring method fitted the data satisfactorily. The two factors of model B2 had a 0.88 correlation. Pearson coefficient showed a positive significant correlation between the GHQ-12 and International Trauma Questionnaire scores (ρ = 0.53, 0.95CI 0.40-0.64, p < 0.001). The GHQ-12 Ukrainian translation showed good psychometric features being a reliable and valid instrument to assess Ukrainian refugees' general well-being.

A stepped-wedge randomised controlled trial to assess efficacy and cost-effectiveness of a care-bundle to prevent falls in older hospitalised patients.

BACKGROUND: Patient accidental falls in a hospital environment are a serious problem for patient safety, and for the additional costs due to associated medical interventions. OBJECTIVE: The endpoints of this study were the assessment of the fall incidence in the hospital before and after the implementation of a multidisciplinary care-bundle, along with a cost-effectiveness evaluation. DESIGN: A stepped-wedge trial was conducted between April 2015 and December 2016 in Bologna University Hospital. METHODS: Incidence rates (IRs) of falls in both the control and intervention periods were calculated. A multilevel mixed-effects generalised linear model with logit link function, adjusted for age, sex, cluster cross-over timing and patients' clinical severity was used to estimate odds ratios (OR) of fall risk of patients of the intervention group respect to the controls.Intervention costs associated with the introduction of the care-bundle intervention were spread between patients per cluster-period-group of exposure. Incremental cost-effectiveness ratio was evaluated using total costs in the intervention and control groups. RESULTS: IRs of falls in control and intervention periods were respectively 3.15 and 2.58 for 1,000 bed-days. After adjustment, the subjects receiving the intervention had a statistically significant reduced risk of falling with respect to those who did not (OR = 0.71, 95% confidence interval: 0.60-0.84). According to the cost-effectiveness analysis, the incremental cost per fall prevented was €873.92 considering all costs, and €1644.45 excluding costs related falls. CONCLUSIONS: Care-bundle had a protective effect on patients, with a statistically significant reduction of the fall risk. This type of intervention appears cost-effective compared to routine practices.

Comparing swab- and different symptoms-based strategies to ascertain COVID-19 recovery in healthcare workers: a cost-effectiveness analysis.

OBJECTIVE: Given the human and economic cost of the COVID-19 pandemic, protecting healthcare workers (HCW) and ensuring continuity of care is critical. The aim of this study is to evaluate the cost-effectiveness of different strategies to ascertain COVID-19 recovery in HCWs. METHODS: Data were collected from the hospital health surveillance program on HCWs at the University Hospital of Verona between 29/02/2020 and 14/04/2021. The diagnosis of SARS-CoV-2 infection and the assessment of the recovery were made through RT-PCR on oro-nasopharyngeal swab-sample. Recovery time and probability were estimated through Kaplan-Meier estimate. For each recovery assessment strategy costs (laboratory diagnostics and human resources), expressed in local currency (euro-€), and working days saved (WDS-effectiveness) were estimated. A decision-tree was created where each knot was a time point scheduled by the different recovery assessment strategies. A Monte Carlo simulation method was used, and probabilistic sensitivity analysis assessed the effect of input uncertainty. RESULTS: In the study period 916 (9.9%) HCWs tested positive. Recovery time through symptom-based strategy (21 days 0.95 CI 16-24) was significantly lower compared to swab-based one (25 days 0.95 CI 23-28, p < 0.001). The swab-based strategy was dominated by all symptoms-based ones. Symptoms-based with a swab on days 14 and 17 had an ICER of 2 €/WDS and 27 €/WDS compared to the one scheduled on days 10 and 17 and with only one swab on the 17th day. CONCLUSIONS: Scheduling swabs on days 14 and 17 in a symptom-based strategy was the most cost-effective, saving 7.5 more working days than the standard one with swabs on days 10 and 17.

Improving the culture of safety among healthcare workers: Integration of different instruments to gain major insights and drive effective changes.

The Safety Attitude Questionnaire (SAQ) and Manchester Patient Safety Framework (MaPSaF) are known as effective tools to assess patient safety culture and climate and develop targeted strategies. However, they are seldom applied in an integrated way. The aim of this study was to conduct an implementation project through a novel use of both instruments to gain unique insights. The Italian version of MaPSaF and SAQ were administered to 1,759 healthcare workers from three Italian hospitals (response rate: MaPSaF 70.5%, SAQ 61.6%). MaPSaF evaluation proved an overall bureaucratic level of patient safety culture. SAQ scores showed a predominance of neutral scores (75.99%). The dimension perception of management gained the lowest mean score (53.32), while Stress recognition obtained the highest (75.17). Safety climate perception differed significantly among groups: working in a small hospital, in a medical department, and being a physician were associated with the most positive results. The majority (67.1%) of responders to both MaPSaF and SAQ considered the two instruments as providing with different and complementary information. Overall, results showed that an integrated approach in the evaluation of an organisation's safety culture may result useful for an in-depth analysis of the criticalities and the adoption of appropriate improvement strategies.

Effect of a tailored home-based exercise program in patients with systemic sclerosis: A randomized controlled trial.

OBJECTIVE: The aim was to evaluate the effect of a home-based exercise program on functional capacity, health-related quality of life (HRQoL), and disability, in patients with systemic sclerosis (SSc). METHODS: A 6-month randomized controlled trial was conducted on SSc patients by comparing a home-based minimally supervised exercise program (exercise on a stationary cycle and strengthening of upper limbs; stretching of the hands) with usual care. At baseline and after 3 and 6 months, the patients underwent: 6 minutes walking test; hand mobility in scleroderma test; maximal exercise test on an ergocycle; strength measures (handgrip, quadriceps, and biceps). HRQoL (short-form 36 [SF-36]) and disability (health assessment questionnaire disability index [HAQ-DI]) were measured at the same time. RESULTS: Forty-four patients participated in the study. Twenty-two were randomly assigned to the intervention group (IG, mean age 63.60 ± 10.40 years) and 22 to the control group (CG, 61.80 ± 14.40 years). At 6 months, the distance walked in 6 minutes increased by 46 m (baseline 486, 95% CI 458-513 m; 6 months 532, 95% CI 504-561 m) in IG, whereas it decreased by 5 m (baseline 464, 95% CI 431-497 m; 6 months 459, 95% CI 427-490 m) in CG with a significantly different temporal trend at the between-groups comparison (P < .001). An improvement was also observed for strength measures (handgrip, P = .003; quadriceps, P < .001; biceps, P < .001), for the SF-36 physical component score (P < .001) and for the HAQ-DI (P = .011). CONCLUSIONS: This study indicates that in SSc patients, a minimally supervised home-based exercise program improves physical performance, quality of life, and disability in comparison with usual care.

Reducing interruptions during medication preparation and administration.

PURPOSE: According to literature, interruptions during drug administration lead to a significant proportion of medication errors. Evidence on the effectiveness of interventions to reduce interruption is still limited. The purpose of this paper is to explore main reasons for interruptions during drug administration rounds in a geriatric ward of an Italian secondary hospital and test the effectiveness of a combined intervention. DESIGN/METHODOLOGY/APPROACH: This is a pre and post-intervention observational study based on direct observation. All nurse staff (24) participated to the study that lead to observe a total of 44 drug dispensing rounds with 945 drugs administered to 491 patients in T0 and 994 drugs to 506 patients in T1. FINDINGS: A significant reduction of raw number of interruptions (mean per round from 17.31 in T0 to 9.09 in T1, p<0.01), interruptions/patient rate (from 0.78 in T0 to 0.40 in T1, p<0.01) and interruptions/drugs rate (from 0.44 in T0 to 0.22 in T1, p<0.01) were observed. Needs for further improvements were elicited (e.g. a greater involvement of support staff). PRACTICAL IMPLICATIONS: Nurse staff should be adequately trained on the risks related to interruptions during drug administration since routine activity is at high risk of distractions due to its repetitive and skill-based nature. ORIGINALITY/VALUE: A strong involvement of both MB and leadership, together with the frontline staff, helped to raise staff motivation and guide a bottom-up approach, able to identify tailored interventions and serve concurrently as training instrument tool.

Control and prevention measures for legionellosis in hospitals: A cross-sectional survey in Italy.

Risk assessment, environmental monitoring, and the disinfection of water systems are the key elements in preventing legionellosis risk. The Italian Study Group of Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine, and Public Health and the Italian Multidisciplinary Society for the Prevention of Health Care-Associated Infections carried out a national cross-sectional survey to investigate the measures taken to prevent and control legionellosis in Italian hospitals. A multiple-choice questionnaire was developed, comprising 71 questions regarding hospital location, general characteristics, clinical and environmental surveillance, and control and preventive measures for legionellosis in 2015. Overall, 739 hospitals were enrolled from February to June 2017, and 178 anonymous questionnaires were correctly completed and evaluated (response rate: 24.1%). The survey was conducted using the SurveyMonkey® platform, and the data were analyzed using Stata 12 software. Of the participating hospitals, 63.2% reported at least one case of legionellosis, of which 28.2% were of proven nosocomial origin. The highest case numbers were reported in the Northern Italy, in hospitals with a pavilion structure or cooling towers, and in hospitals with higher numbers of beds, wards and operating theaters. Laboratory diagnosis was performed using urinary antigen testing alone (31.9%), both urinary antigen testing and single antibody titer (17.8%), or with seroconversion also added (21.5%). Culture-based or molecular investigations were performed in 28.8% and 22.1% of the clinical specimens, respectively. The water systems were routinely tested for Legionella in 97.4% of the hospitals, 62% of which detected a positive result (> 1000 cfu/L). Legionella pneumophila serogroup 2-15 was the most frequently isolated species (58.4%). The most common control measures were the disinfection of the water system (73.7%), mostly through thermal shock (37.4%) and chlorine dioxide (34.4%), and the replacement (69.7%) or cleaning (70.4%) of faucets and showerheads. A dedicated multidisciplinary team was present in 52.8% of the hospitals, and 73% of the hospitals performed risk assessment. Targeted training courses were organized in 36.5% of the hospitals, involving nurses (30.7%), physicians (28.8%), biologists (21.5%), technicians (26.4%), and cleaners (11%). Control and prevention measures for legionellosis are present in Italian hospitals, but some critical aspects should be improved. More appropriate risk assessment is necessary, especially in large facilities with a high number of hospitalizations. Moreover, more sensitive diagnostic tests should be used, and dedicated training courses should be implemented.

Factors precipitating the risk of aspiration in hospitalized patients: findings from a multicentre critical incident technique study.

OBJECTIVE: To elucidate factors, other than those clinical, precipitating the risk of aspiration in hospitalized patients. DESIGN: The Critical Incident Technique was adopted for this study in 2015. SETTING: Three departments located in two academic hospitals in the northeast of Italy, equipped with 800 and 1500 beds, respectively. PARTICIPANTS: A purposeful sample of 12 registered nurses (RN), all of whom (i) had reported one or more episodes of aspiration during the longitudinal survey, (ii) had worked ≥3 years in the department, and (iii) were willing to participate, were included. MAIN OUTCOME MEASURE(S): Antecedent factors involved in episodes of aspiration as experienced by RNs were collected through an open-ended interview, and qualitatively analysed. RESULTS: In addition to clinical factors, other factors interacting with each other may precipitate the risk of aspiration episodes during hospitalization: at the nursing care level (misclassifying patients, transferring tasks to other healthcare professionals and standardizing processes to remove potential threats); at the family level (misclassifying patients, dealing with the cultural relevance of eating) and at the environmental level (positioning the patient, managing time pressures, distracting patient while eating, dealing with food consistency and irritating oral medication). CONCLUSIONS: At the hospital level, an adequate nursing workforce and models of care delivery, as well as time for initial and continuing patient and family assessment are required. At the unit level, patient-centred models of care aimed at reducing care standardization are also recommended; in addition, nursing, family and environmental factors should be recorded in the incident reports documenting episodes of aspiration.

Serological and molecular identification of Legionella spp. isolated from water and surrounding air samples in Italian healthcare facilities.

BACKGROUND: Legionella is an intracellular microorganism living in natural and artificial aquatic environments. Although its transmission to humans is linked to the inhalation of contaminated aerosols, there is no validated air sampling method for the control and prevention of the disease. The aim of the present study was to provide more information on the distribution of Legionella spp. in indoor environments and to determine whether the same Legionella strains are isolated from air and water samples. METHODS: Ten healthcare facilities located in seven regions of Italy were enrolled. The serological typing of Legionella spp. from water samples and the surrounding air by active and passive sampling was assessed using polyvalent and monovalent antisera. Subsequently, the strains identified as Legionella pneumophila (Lpn) underwent molecular typing by sequence-based typing (SBT) using seven genes (flaA, pilE, asd, mip, mompS, proA, and neuA). The allelic profile number was assigned using the European Working Group for Legionella Infections-SBT database. RESULTS: Lpn serogroup 6 was the most prevalent serogroup; it was found simultaneously in the air and water samples of three different healthcare facilities. In the remaining seven hospitals, Lpn serogroups 1, 6, 7, 9, and 12 were isolated exclusively from water samples. The molecular investigation showed that Lpn strains in the water and air samples of each positive healthcare facility had the same allelic profile. Strains, identified as sequence types (STs) 728 and ST 1638+ST 1324, were isolated in two respective healthcare facilities, and a new strain, identified as ST 1989, was obtained in one healthcare facility. CONCLUSION: The application of the SBT method allowed to verify the homology among Legionella strains from water samples and the surrounding air. The results showed that the same Lpn strains were present in the air and water samples, and a new Legionella strain was identified.

Clinical Assessment of Risk Management: an INtegrated Approach (CARMINA).

Purpose - The European Union recommendations for patient safety calls for shared clinical risk management (CRM) safety standards able to guide organizations in CRM implementation. The purpose of this paper is to develop a self-evaluation tool to measure healthcare organization performance on CRM and guide improvements over time. Design/methodology/approach - A multi-step approach was implemented including: a systematic literature review; consensus meetings with an expert panel from eight Italian leader organizations to get to an agreement on the first version; field testing to test instrument feasibility and flexibility; Delphi strategy with a second expert panel for content validation and balanced scoring system development. Findings - The self-assessment tool - Clinical Assessment of Risk Management: an INtegrated Approach includes seven areas (governance, communication, knowledge and skills, safe environment, care processes, adverse event management, learning from experience) and 52 standards. Each standard is evaluated according to four performance levels: minimum; monitoring; outcomes; and improvement actions, which resulted in a feasible, flexible and valid instrument to be used throughout different organizations. Practical implications - This tool allows practitioners to assess their CRM activities compared to minimum levels, monitor performance, benchmarking with other institutions and spreading results to different stakeholders. Originality/value - The multi-step approach allowed us to identify core minimum CRM levels in a field where no consensus has been reached. Most standards may be easily adopted in other countries.

Complex alpine extrication: case report of mountain and speleological rescue cooperation.

Mountain sporting activities are an increasingly popular practice that exposes mountaineers to a high risk of adverse events. This report describes a unique case of recovery in an austere environment that involved explosives. In June 2012, a 52-year-old man ascended a cliff tower in the Eastern Alps, Italy. A landslide occurred, and a boulder crushed the climber against a large stone located farther down the cliff, causing compression of the lower limbs and the pelvis with consequent severe musculoskeletal trauma. The National Alpine and Cave Rescue Unit (NACRU) arrived and proceeded with stabilization of the injured climber, which took 6 hours and involved a difficult extrication supported by the Cave Rescue division of NACRU. Unfortunately, during transport to the trauma center of Borgo Trento, Verona, the patient exhibited signs of progressive traumatic shock because of crush syndrome, hypovolemia, and acidosis, which led to cardiac arrest and death. Based on an extensive literature review, this report was determined to be the only one of a mountain rescue using explosives for the extrication of a victim in the Northeast Italian Alps. This case describes how a rescue in austere environments can represent a high-risk situation, and it shows how improvisation and cooperation between rescue teams are crucial for a successful recovery.

Antibiotic consumption and resistance: results of the SPIN-UTI project of the GISIO-SItI.

OBJECTIVE: To evaluate trends and association between antibiotic consumption and resistance during an eight-year period, from 2006 to 2013. DESIGN: Prospective multicenter study. SETTING AND PARTICIPANTS: Intensive Care Units (ICUs) participating in the four editions of the Italian nosocomial infections surveillance in the ICU Network (Sorveglianza Prospettica delle Infezioni Nosocomiali nelle Unità di Terapia Intensiva, SPIN-UTI project). MAIN OUTCOME MEASURES: The isolation density of selected species of microorganisms, antibiotic resistance rates (RRs), incidence density of resistant isolates and antimicrobial usage density were calculated. RESULTS: RRs of carbapenem-resistant Acinetobacter baumannii, of carbapenem-resistant Klebsiella pneumoniae, of third-generation cephalosporin (3GC)-resistant K. pneumoniae and of 3GC-resistant Escherichia coli showed significant increasing trends (p ≤0.001). The consumption of each antibiotic class varied with years, although not significantly. Significant strongly positive correlations were detected between RRs and antibiotic consumption. CONCLUSIONS: The present study describes high RRs and increasing trends of resistant microorganisms and highlights the need for continuous comprehensive strategies targeting not only the prudent use of antibiotics, but also infection control measures to limit the epidemic spread of resistant isolates.

Knowledge about tuberculosis among undergraduate health care students in 15 Italian universities: a cross-sectional study.

BACKGROUND: The Italian Study Group on Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine and Public Health conducted a multicentre survey aiming to evaluate undergraduate health care students' knowledge of tuberculosis and tuberculosis control measures in Italy. METHODS: In October 2012-June 2013, a sample of medical and nursing students from 15 Italian universities were enrolled on a voluntary basis and asked to complete an anonymous questionnaire investigating both general knowledge of tuberculosis (aetiology, clinical presentation, outcome, screening methods) and personal experiences and practices related to tuberculosis prevention. Data were analysed through multivariable regression using Stata software. RESULTS: The sample consisted of 2,220 students in nursing (72.6%) and medicine (27.4%) courses. Our findings clearly showed that medical students had a better knowledge of tuberculosis than did nursing students.Although the vast majority of the sample (up to 95%) answered questions about tuberculosis aetiology correctly, only 60% of the students gave the correct responses regarding clinical aspects and vaccine details. Overall, 66.9% of the students had been screened for tuberculosis, but less than 20% of those with a negative result on the tuberculin skin test were vaccinated. Multivariable regression analysis showed that age and type of study programme (nursing vs. medical course) were determinants of answering the questions correctly. CONCLUSIONS: Although our data showed sufficient knowledge on tuberculosis, this survey underlines the considerable need for improvement in knowledge about the disease, especially among nursing students. In light of the scientific recommendations concerning tuberculosis knowledge among students, progress of current health care curricula aimed to develop students' skills in this field is needed.

[Control of intubator associated pneumonia in intensive care unit: results of the GISIO-SItI SPIN-UTI Project]. / Controllo del rischio di polmonite associata a intubazione in terapia intensiva: risultati del Progetto SPIN-UTI del GISIO-SItI.

OBJECTIVE: To document reported Intubator Associated Pneumonia (IAP) prevention practices in Intensive Care Units (ICUs) and attitudes towards the implementation of a measurement system. DESIGN: In the framework of the SPIN-UTI project the «Italian Nosocomial Infections Surveillance in ICUs network¼, two questionnaires were made available online. The first was filled out by physicians working in ICUs in order to collect data on characteristics of physicians and ICUs, on clinical and measurement practices for IAP prevention, and attitudes towards the implementation of a measurement system. The second questionnaire was filled out for each intubated patient in order to collect data on prevention practices during ICU stay. SETTING AND PARTICIPANTS: ICUs participating to the fourth edition (2012-2013) of the SPIN-UTI project. MAIN OUTCOME MEASURES: Compliance to the component of the European bundle. RESULTS: The components of the bundle for the prevention of IAP are implemented, although to a different level, in the 26 participating ICUs. Overall compliance to all five practices of the European bundle has been reported in 21.1% of the 768 included patients. CONCLUSIONS: The present survey has documented a large potential for improvement in clinical and non-clinical practices aimed at preventing IAP in ICUs.

[Legionella spp. contamination in indoor air: preliminary results of an Italian multicenter study]. / La contaminazione indoor da Legionella spp: risultati preliminari di una indagine multicentrica italiana.

OBJECTIVE: To propose a standardized protocol for the evaluation of Legionella contamination in air. DESIGN: A bathroom having a Legionella contamination in water >1,000 cfu/l was selected in 10 different healthcare facilities. Air contamination was assessed by active (Surface Air System, SAS) and passive (Index of Microbial Air, IMA) sampling for 8 hours, about 1 m away from the floor and 50 cm from the tap water. Two hundred liters of air were sampled by SAS every 12 min, after flushing water for 2 min. The IMA value was calculated as the mean value of colony forming units/16 plates exposed during sampling (2 plates/hour). Water contamination was evaluated at T0, after 4 and 8 hours, according to the standard methods. RESULTS: Air contamination by Legionella was found in three healthcare facilities (one with active and two with passive sampling), showing a concomitant tap water contamination (median=40,000; range 1,100-43,000 cfu/l). The remaining seven hospitals isolated Legionella spp. exclusively from water samples (median=8,000; range 1,200-70,000 cfu/l). CONCLUSIONS: Our data suggest that environmental Legionella contamination cannot be assessed only through the air sampling, even in the presence of an important water contamination.

Unpacking Perceptions on Patient Safety: A Study of Nursing Home Staff in Italy.

Nursing homes (NHs) are crucial for de-hospitalization and addressing the needs of non-self-sufficient individuals with complex health issues. This study investigates the patient safety culture (PSC) in NHs within a northern Italian region, focusing on factor influencing overall safety perceptions and their contributions to subjective judgements of safety. A cross-sectional study was conducted on 25 NHs in the Autonomous Province of Trento. The Nursing Home Survey on Patient Safety Culture (NHSPSC) was utilized to assess PSC among NH staff. Multilevel linear regression and post hoc dominance analyses were conducted to investigate variabilities in PSC among staff and NHs and to assess the extent to which PSC dimensions explain overall perceptions of PS. Analysis of 1080 questionnaires (44% response rate) revealed heterogeneity in PSC across dimensions and NHs, with management support, organizational learning, and supervisor expectations significantly influencing overall safety perceptions. Despite some areas of concern, overall safety perceptions were satisfactory. However, the correlation between individual dimensions and overall ratings of safety was moderate, suggesting the need to enhance the maturity level of PSCs. Promoting a shift in PSC could enhance transparency, prioritize resident safety, empower nursing staff, and increase family satisfaction with care provided in NHs. The support provided by management to PSC appears essential to influence NH staff perceptions of PS.

Diabetes mellitus in stroke unit: prevalence and outcomes-the Verona acute coronary syndrome and stroke in diabetes outcome (VASD-OUTCOME) study.

BACKGROUND: Cerebrovascular accidents (CVA) represent a major complication in diabetes (DM). Real-life evidence as to whether modern management of CVA and DM have softened this relationship is limited. Therefore, we estimated prevalence and impact of DM on in-hospital survival and complications in a contemporary cohort of subjects with CVA. METHODS: We retrospectively evaluated the records of 937 patients admitted for CVA at the Stroke Unit of Verona University Hospital during a 3-year period. Pre-existing or de novo DM was ascertained by prior diagnosis, glucose-lowering therapy at admission/discharge or admittance plasma glucose ≥ 200 mg/dL. Multiple regressions were applied to test DM as predictor of in-hospital mortality, complications (composite of infections, cardio- and cerebrovascular complications, major bleeding and pulmonary complications), duration and costs of hospitalization. RESULTS: Diabetes prevalence was 21%, of which 22% de novo diagnoses. Compared to non-DM, diabetic individuals were older and carried an increased burden of cardiovascular risk factors. Compared to known DM, de novo DM individuals were younger, had higher admittance plasma glucose and poorer cardiovascular comorbidities. Overall, DM versus non-DM individuals did not show significantly increased risk of death (14.0 vs. 9.3%; crude-OR 1.59 95% CI 0.99-2.56). Controlling for confounders did not improve significance. DM resulted independent predictor for in-hospital complications (36.2% vs. 26.9%; adj-OR 1.49, 1.04-2.13), but not for duration and costs of hospitalization. CONCLUSION: DM frequently occurs in patients admitted for stroke and carries an excess burden of adverse in-hospital complications, urgently calling for strategies to anticipate DM diagnosis and tailored treatment in high-risk individuals.

Adverse events following Measles-Mumps-Rubella and varicella immunization: A safety profile analysis and comparison of different vaccination schedules based on the Italian Pharmacovigilance Network in the Veneto Region.

Objective: The vaccines for measles, mumps, rubella and varicella (MMR and V) have been mandatory in Italy since 2017. Two different vaccination strategies are suggested for the first dose: trivalent MMR and a separate V vaccine or the tetravalent MMRV vaccine. Our aim is to compare the safety profile of MMRV and MMR-V vaccines through the passive adverse event reporting system in the Veneto region and to perform a case-by-case review of a few conditions of interest (febrile and afebrile seizures, ataxia, encephalitis, Guillain-Barré Syndrome, thrombocytopenia, neutropenia and Henoch-Schönlein Purpura). Age and sex differences were also explored. Methods: We identified all reports following MMRV or MMR-V vaccination in the Veneto Region and received into the National Pharmacovigilance Network between 2007 and April 30, 2022. Results: 9,510 reports were retrieved, of which 5,662 (59.5 %) were related to MMRV and 3,848 (40.5 %) to MMR-V. No safety signals were detected supporting the evidence that MMRV and MMR-V vaccinations have a good safety profile. The reporting rate (RR) for serious events between 2007 and 2022 resulted in 13.67 per 10,000 administered doses for MMRV and 10.90 for MMR-V. Conclusion: Passive surveillance data show a significantly higher rate of serious events for males 0-2 years old, both overall and stratified per vaccination strategy. Further studies are needed to confirm this observation. The analyses suggest that retrieved differences do not have a significant impact on the overall safety of both formulations.

Safety profile assessment of HPV4 and HPV9 vaccines through the passive surveillance system of the Veneto Region (Italy) between 2008 and 2022: A 15-year retrospective observational study.

In Veneto Region, HPV vaccine has been actively offered to 12 year-old females since 2008, and to 12 year-old males since 2015. The study aims to analyze the safety profile of HPV4v and HPV9v vaccines and perform a case-by-case review of conditions of interest. Spontaneous reports related to HPV uploaded to the database of the Regional Pharmacovigilance Center between 2008-2022 were included. HPV vaccine doses administered until April 2022 in the Veneto Region were considered to calculate the reporting rate (RR). Potential "safety concerns" examined as conditions of interest were included through Standardized MedDRA or preferred terms searching queries. The level of diagnostic certainty was evaluated as per the Brighton Collaboration case definition criteria. A total of 637 reports and 1316 Adverse Events Following Immunizations (AEFI) were retrieved: 469 for HPV4v (73.6 %) and 168 for HPV9v (26.4 %). Serious reports were 71 (11.1 %): 49 (10.4 %) for HPV4v and 22 (13.1 %) for HPV9v. The RR for serious events between 2008-2022 was 6.9/100,000 administered doses, with no differences by vaccine type. Females and adults showed higher overall RR compared to males and to children and adolescents (p < 0.001), this result was confirmed by stratifying analysis by vaccine type. One case of Guillain Barré syndrome, anaphylactic shock, thrombocytopenia, Henoch Schoenlein purpura and four generalized seizures were reviewed. Vaccinovigilance data from the Veneto Region reaffirm a good safety profile for HPV vaccination and found no vaccine-related unexpected events. Such a detailed analysis may assist healthcare providers to advocate properly for HPV vaccination.

Prevalence of urinary colonization by extended spectrum-beta-lactamase Enterobacteriaceae among catheterised inpatients in Italian long term care facilities.

BACKGROUND: Long Term Care Facilities (LTCFs) play a key role in guaranteeing care to patients in developed countries. Many patients, mostly elderly, access LTCFs at some time in their lives, and their healthcare pathways often require them to move back and forth between hospital and outpatient settings. These patterns bring about new challenges regarding infection control, especially healthcare associated infections. METHODS: A point prevalence study was conducted in 23 Italian LTCFs, to identify colonization in patients with urinary catheter (>24 hours). Species identification, susceptibility tests and extended spectrum beta lactamase (ESBL) production screenings were performed using Vitek 2 System. Enterobacteria identified by Vitek 2 System as ESBL-producers or suspected AmpC hyperproducers on the basis of cephamycin resistance, were sent to a research laboratory where they underwent a double-disk synergy test. Finally, ESBL-producers were screened for bla resistance genes by PCR assay. RESULTS: 211 patients with catheter were screened, 185 out of 211 patients showed positive samples for the presence of Enterobacteriaceae, 114 of these 185 patients were colonized by extended spectrum cephalosporins resistant microorganisms. We identified a total of 257 Gram negative pathogens, of which 51.8% (133/257) were extended spectrum cephalosporins resistant. 7 out of 133 cephamycin not susceptible strains proved to be AmpC-type beta-lactamases and 125/133 ESBL-producers; 1 was not further characterized. 43 out of 257 (16.7%) E. coli, 37/257 (14.4%) P. mirabilis, 20/257 (7.8%), P. stuartii, 14/257 (5.4%) M. morganii, 7/257 (2.7%), K. pneumoniae, 4/257 (1.6%) C. koseri proved to be overall ESBL-producers by double-disk synergy test. Third and fourth generation cephalosporin resistant P. mirabilis, P. stuartii and M. morganii strains mainly harboured a blaTEM gene (95.9%), while 89.1% of E. coli were positive for the blaCTX-M determinant by PCR and sequencing. Patients with decubitus had a higher risk of colonization by at least one resistant isolate (p < 0.01). Samples of patients undergoing antibiotic therapy and patients with decubitus showed a higher risk (p < 0.05) of colonization by beta-lactam resistant microorganisms. CONCLUSIONS: These data confirm the presence of high percentages of ESBL-positive Enterobacteria in Italian LTCFs and the predominance of CTX-M type ESBL in E. coli. The alarming presence of ESBL-producing Enterobacteriaceae in Italian LTCFs can seriously compromise the effectiveness of antibiotic therapy.acilities (LTCFs), Antimicrobial resistance.