Incidence and outcome of invasive candidiasis in intensive care units (ICUs) in Europe: results of the EUCANDICU project.

BACKGROUND: The objective of this study was to assess the cumulative incidence of invasive candidiasis (IC) in intensive care units (ICUs) in Europe. METHODS: A multinational, multicenter, retrospective study was conducted in 23 ICUs in 9 European countries, representing the first phase of the candidemia/intra-abdominal candidiasis in European ICU project (EUCANDICU). RESULTS: During the study period, 570 episodes of ICU-acquired IC were observed, with a cumulative incidence of 7.07 episodes per 1000 ICU admissions, with important between-center variability. Separated, non-mutually exclusive cumulative incidences of candidemia and IAC were 5.52 and 1.84 episodes per 1000 ICU admissions, respectively. Crude 30-day mortality was 42%. Age (odds ratio [OR] 1.04 per year, 95% CI 1.02-1.06, p < 0.001), severe hepatic failure (OR 3.25, 95% 1.31-8.08, p 0.011), SOFA score at the onset of IC (OR 1.11 per point, 95% CI 1.04-1.17, p 0.001), and septic shock (OR 2.12, 95% CI 1.24-3.63, p 0.006) were associated with increased 30-day mortality in a secondary, exploratory analysis. CONCLUSIONS: The cumulative incidence of IC in 23 European ICUs was 7.07 episodes per 1000 ICU admissions. Future in-depth analyses will allow explaining part of the observed between-center variability, with the ultimate aim of helping to improve local infection control and antifungal stewardship projects and interventions.

Hospital and economic burden of influenza-like illness and lower respiratory tract infection in adults ≥50 years-old.

BACKGROUND: Influenza-like illnesses (ILIs) and lower respiratory tract infections (LRTIs) cause substantial morbidity and mortality worldwide. The study assessed the health and economic burden of ILI and LRTI according to age and comorbidities, since available evidence is limited and heterogeneous. METHOD: The prevalence of comorbidities, the seasonal incidence rates and the mean and per capita direct costs of ED accesses for ILI/LRTI, whether followed by hospitalization or not, recorded in adults aged ≥50 years over the last 6 years, in the referral hospitals located in the Genoese metropolitan area (Liguria, Italy) where the syndromic surveillance system is active, were evaluated through a retrospective observational study. Comorbidities were estimated through the Chronic Condition Data Warehouse that integrates multiple Medicare data sources. A comparison with the administrative healthcare International Classification of Diseases-9th revision-Clinical Modification (ICD-9-CM)-based data was also conducted. RESULTS: The prevalence of subjects with ≥1 comorbidity ranged from 23.49 to 59.92%. The most prevalent all-age comorbidities were cardiovascular diseases and cancer. The overall ILI/LRTI incidence rate was 6.73/1000 person-years, almost double the value derived from routine data, and increased with age. The highest rates were observed in patients with renal failure and bronchopneumopathies. The mean cost of ED accesses/hospitalization for ILI/LRTI was €3353 and was almost twice as high in the ≥85 years as in the youngest age-group. The highest mean costs were observed in patients with renal failure and cancer. The per capita costs increased from €4 to €71 with age, and were highest in patients with renal failure and bronchopneumopathy. CONCLUSION: The burden of ILIs/LRTIs in terms of ED accesses and hospitalizations in adults aged ≥50 years is heavy, and is related to increasing age and, especially, to specific comorbidities. These results could contribute to revising age- and risk-based anti-influenza and -pneumococcus immunization strategies.

Granulocytes and monocytes apheresis induces upregulation of TGFß1 in patients with active ulcerative colitis: A possible involvement of soluble HLA-I.

Granulocyte and monocyte apheresis has been used in different immune-mediated disorders, mainly inflammatory bowel diseases. The removal of activated leukocytes and several additional immunomodulatory mechanisms have been so far suggested to explain the anti-inflammatory effects of the treatment. Recent data indicate that, during centrifugation based apheresis, sHLA-I adsorbed to plastic circuits is able to induce TGFß1 production in activated leukocytes. On these bases, the present study was aimed at analyzing if this model could be applied to a noncentrifugation based apheresis, such as granulocyte and monocyte apheresis. Ten patients with ulcerative colitis were enrolled. Every patient received 5 weekly apheresis treatments. Cellulose acetate beads removed from the column post-GMA were stained by fluorescent anticlass I mAb and examined by fluorescent microscope. Moreover, sFasL plasma concentration, TGFß1 plasma levels, and the percentage of TGFß1 positive neutrophils were evaluated before and immediately after each single apheresis. Immunofluorescent images revealed a homogeneous layer of a sHLA-I adsorbed to the surface of the beads recovered following the procedure. sFasL plasma concentration progressively increased both following the procedures and during inter-procedure periods. Consistently, also TGFß1 plasma levels and the percentage of TGFß1 positive neutrophils increased during the procedures with a meaningful relationship with sFasL plasma levels. Taken together, these findings suggest that the immunosuppressive effects attributed to granulocyte and monocyte apheresis might depend, at least in part, on the sensitivity of activated leucocytes to the bioactivity of sHLA-I molecules. J. Clin. Apheresis 32:49-55, 2017. © 2016 Wiley Periodicals, Inc.

Pneumococcus and the Elderly in Italy: A Summary of Available Evidence Regarding Carriage, Clinical Burden of Lower Respiratory Tract Infections and On-Field Effectiveness of PCV13 Vaccination.

Streptococcus pneumoniae is currently the leading cause of community-acquired pneumonia (CAP) and lower respiratory tract infections (LRTI) in adults, elderly and high-risk subjects worldwide. The clear benefits of pneumococcal conjugate vaccination in childhood have been accompanied by a decrease of vaccine-serotype invasive diseases among adults in several countries, mainly due to the herd effect mediated by the reduction of vaccine-serotype nasopharyngeal colonization in both age groups, but this reduction in the incidence of pneumonia has not been observed. The "Community Acquired Pneumonia Immunization Trial in Adults" (CAPITA) study provided conclusive evidence about 13-valent pneumococcal conjugate vaccine (PCV13) efficacy in preventing CAP in adults and led Western countries to issue new recommendations for pneumococcal immunization targeting subjects >50 years and high-risk groups, with marked differences with respect to age and/or risk groups immunized, eligibility for reimbursement and national, regional or local implementation. Several Italian regions implemented PCV13 immunization programs in adults and interesting data have been come available in the last years, especially from Liguria, a Northern region with a high and long-lasting pneumococcal vaccine immunological pressure in infants. In this review, currently available evidence from Italy and Liguria regarding pneumococcal carriage, burden of CAP and LRTI, and on-field effectiveness of PCV13 immunization in adults and elderly will be summarized.

The Molecular Epidemiology and Evolutionary Dynamics of Influenza B Virus in Two Italian Regions during 2010-2015: The Experience of Sicily and Liguria.

Molecular epidemiology of influenza B virus remained poorly studied in Italy, despite representing a major contributor to seasonal epidemics. This study aimed to reconstruct the phylogenetic relationships and genetic diversity of the hemagglutinin gene sequences of 197 influenza B strains circulating in both Southern (Sicily) and Northern (Liguria) Italy between 2010 and 2015. Upper respiratory tract specimens of patients displaying symptoms of influenza-like illness were screened by real-time RT-PCR assay for the presence of influenza B virus. PCR-positive influenza B samples were further analyzed by sequencing. Neighbor-joining phylogenetic trees were constructed and the amino-acid alignments were analyzed. Phylogenetic analysis showed clusters in B/Victoria clade 1A/1B (n = 29, 14.7%), and B/Yamagata clades 2 (n = 112, 56.8%) and 3 (n = 56, 28.4%). Both influenza B lineages were found to co-circulate during the study period, although a lineage swap from B/Victoria to B/Yamagata occurred in Italy between January 2011 and January 2013. The most represented amino-acid substitutions were N116K in the 120-loop (83.9% of B/Yamagata clade 3 strains) and I146V in the 150-loop (89.6% of B/Victoria clade 1 strains). D197N in 190-helix was found in almost all viruses collected. Our findings provide further evidence to support the adoption of quadrivalent influenza vaccines in our country.

Trends in the annual incidence of carbapenem-resistant Klebsiella pneumoniae bloodstream infections: a 8-year retrospective study in a large teaching hospital in northern Italy.

BACKGROUND: Bloodstream infections (BSI) due to carbapenem-resistant (C-R) Klebsiella pneumoniae (Kp) are of global concern from both clinical and public health standpoints. This retrospective study aimed to describe C-R Kp BSI epidemiology in a large teaching hospital in northern Italy. METHODS: Between 1 January 2007 and 31 December 2014, annual incidences both of C-R Kp BSI and of carbapenem-susceptible (C-S) Kp BSI were calculated as the number of events per 10,000 patient-days. A Chi square test for linear trend was used to assess the change in the incidence of C-R Kp BSI and C-S Kp BSI over the study period. Crude 30-day mortality rates were provided both for C-R Kp BSI and for C-S Kp BSI. RESULTS: From 2007 to 2014, we observed 511 episodes of Kp BSI, 349 of which were caused by C-R Kp (68.3 %). The incidence of C-R Kp BSI considerably increased from 0.04/10,000 patient-days in 2007 to 1.77/10,000 patient-days in 2014 (Chi square for trend p < 0.001). The highest incidence of C-R Kp BSI was observed in intensive care units (ICUs), with a peak of 22.01 C-R Kp BSI/10,000 patient-days in 2012. A less marked but significant increase of C-S Kp BSI was also observed (Chi square for trend p = 0.004). Crude 30-day mortality was 36.1 % in patients with C-R Kp BSI and 23.5 % in those with C-S Kp BSI. CONCLUSIONS: During the study period, we observed a dramatic increase in the incidence of C-R Kp BSI in our hospital. More concerted infection-control efforts are needed to contain this alarming C-R Kp diffusion.

Hospital admissions for seizure in Italy: a decennial retrospective analysis with a special focus on the burden in the pediatric age.

The aim of the study was to analyze the incidence of hospitalizations for different types of convulsions in Italy during the years 2001-2010, especially in the pediatric age, with a focus on febrile seizures. National hospital discharge records of admissions for any type of convulsion from 2001 to 2010 were analyzed. The incidence rates were calculated considering the pediatric resident population estimated by the Italian Institute of Statistics in the studied years. 675,189 Hospital discharge records were analyzed, 256,126 of which had at least one specific diagnosis code for convulsion. 77 % of seizures were concentrated in the age group 0-3 years (618/100,000 inhabitants). The admission regimen was mainly ordinary (92 %). 97.6 % of admissions were <7 days and 91 % of hospital discharges were ordinary discharges to home. The percentage distribution of seizures showed a constant trend over the considered period. The code "febrile seizures" represented 71.9 % of all seizures in the pediatric population. 94.5 % was concentrated in children aged 0-5 years. The obtained data could be useful to put into the right perspective issues arising from the reports of febrile seizures following the administration of pediatric vaccines.

Do the omeprazole family compounds exert a protective effect against influenza-like illness?

BACKGROUND: Infections by influenza viruses place a heavy burden on public health and economies worldwide. Although vaccines are the best weapons against influenza, antiviral drugs could offer an opportunity to alleviate the burden of influenza. Since omeprazole family compounds block the "proton pump", we hypothesized that they could interfere with the mechanism of fusion of the virus envelope and endosomal membrane, thereby hindering the M2 proton pump mechanism of influenza viruses. METHODS: A matched case-control study was performed in 2010-2011 in Italy. Cases were subjects aged over 18 years with a diagnosis of Influenza-like Illness (ILI); 254 case-control pairs were recruited. A multivariable conditional logistic regression analysis was used to assess the association between the prevention of ILI and the administration of omeprazole family compounds. The interaction between omeprazole family compounds and influenza vaccination was also examined. RESULTS: After control for potential confounders, subjects treated with omeprazole family compounds displayed a lower risk of catching ILI (ORadj = 0.29, 95% CI: 0.15-0.52). The risk of ILI in unvaccinated non-OFC users was about six times than that in vaccinated OFC users. CONCLUSIONS: Although confirmation is necessary, these results suggest that omeprazole family compounds could be profitably used in the prevention of ILI.

Hepatitis a Vaccine as Opportunity of Primary Prevention for Food Handlers: A Narrative Review.

The hepatitis A virus (HAV) is still a leading cause of viral hepatitis worldwide. After a long incubation period, the clinical manifestations range from asymptomatic infection to acute liver failure. The severity of the disease increases with age and pre-existing liver disease. The transmission is mainly via person-to-person contact or ingestion of contaminated food or water. Food contamination can occur at any step of the food chain, especially when infected people handle not-heated or otherwise-treated food. HAV is endemic in low-income countries because of poor sanitary and sociodemographic conditions. The populations of developed countries are highly susceptible, and large outbreaks occur when HAV is introduced from endemic countries due to globalization, travel, and movement of foodstuffs. HAV prevention includes hygiene practices, immunoglobulins, and vaccination. Safe and effective inactivated and live attenuated vaccines are available and provide long-term protection. The vaccine targets are children and subjects at increased risk of HAV exposure or serious clinical outcomes. This review discusses the critical role of food handlers in the spread of HAV and the opportunity for food industry employers to consider food handler immunization a tool to manage both food safety in compliance with HACCP principles and food operators' biologic risk.

Sexual behaviour and risk factors for the acquisition of human papillomavirus infections in young people in Italy: suggestions for future vaccination policies.

BACKGROUND: Human Papillomavirus (HPV) is the most common sexually transmitted infection. The main risk factors correlated with HPV infection are: early sexual debut, the number of partners, frequency and type of sexual contact and partner's sexual histories.We surveyed sexual habits among young people in order to provide information that might orient decision-makers in adopting HPV multi-cohort vaccination policies. METHODS: We administered a questionnaire to students (14-24 years old) in five Italian cities. RESULTS: 7298 questionnaires were analyzed (4962 females and 2336 males); 55.3% of females (95% CI 53.9-56.7) and 52.5% of males (95% CI 50.5-54.5) reported regular sexual activity. The mean age at sexual debut was 15.7 ± 1.6 and 15.6 ± 1.6 for females and males, respectively, and the median age was 16 for both sexes.With regard to contraceptive use during the last year, 63.6% of males and 62.8% of females responded affirmatively; 42.6% of males and 42.8% of females used condoms. CONCLUSION: The results reveal precocious sexual activity among respondents, with the mean age at first intercourse declining as age decreases. Condom use proved to be scant. Considering lifestyle-related risk factors, males appear to have a higher probability of acquiring HPV infection than females.These data support the importance of promoting multi-cohort HPV vaccination strategies for females up to 25 years of age. It is essential to improve vaccination coverage through different broad-spectrum strategies, including campaigns to increase awareness of sexually transmitted diseases and their prevention.

Attitudes of mothers of pre-adolescent girls on HPV vaccine in Italy. Do we need a turning point?

BACKGROUND: To investigate the knowledge, awareness and attitude of mothers of preadolescent girls regarding the HPV vaccination and cervical cancer, and to understand how to improve the efficacy of the Italian vaccination campaign through the gathered data. METHODS: A questionnaire-based survey was conducted in mothers of unvaccinated 9 to 12-year-old (yo) girls in Italy from November 2018 to July 2019, to evaluate their awareness and the attitude toward HPV, its vaccination and the information sources of the vaccination campaign. The selection of the distribution sites of the questionnaire was performed with randomization of 50 major places of aggregation located throughout the Italian territory. RESULTS: Three hundred mothers of unvaccinated girls were included in the study and divided into two groups (191 subjects <45yo, 109 subjects >45yo). Results showed that 79.6% of <45yo knew what HPV is, compared to 60.6% of >45yo (p-value <0.001); only 60.2% (<45yo) and 54.1% (>45yo) showed awareness about the HPV vaccine (p-value 0.03). The percentage of parents against vaccination in pre-adolescent was higher in the >45yo (29.4%); however, most of them appeared favorable to the information campaigns regarding the vaccine (p-value <0.001). CONCLUSIONS: Our study showed that mothers of unvaccinated pre-adolescent girls have suboptimal knowledge on the topic. Moreover, the implementation of communication strategies dedicated to the population segment appears as a central aspect. As HPV vaccination keeps being a public health concern, it is fundamental to understand which trigger should be managed by healthcare decision makers in order to boost the vaccination campaigns.

Leadership Effectiveness in Healthcare Settings: A Systematic Review and Meta-Analysis of Cross-Sectional and Before-After Studies.

To work efficiently in healthcare organizations and optimize resources, team members should agree with their leader's decisions critically. However, nowadays, little evidence is available in the literature. This systematic review and meta-analysis has assessed the effectiveness of leadership interventions in improving healthcare outcomes such as performance and guidelines adherence. Overall, the search strategies retrieved 3,155 records, and 21 of them were included in the meta-analysis. Two databases were used for manuscript research: PubMed and Scopus. On 16th December 2019 the researchers searched for articles published in the English language from 2015 to 2019. Considering the study designs, the pooled leadership effectiveness was 14.0% (95%CI 10.0-18.0%) in before-after studies, whereas the correlation coefficient between leadership interventions and healthcare outcomes was 0.22 (95%CI 0.15-0.28) in the cross-sectional studies. The multi-regression analysis in the cross-sectional studies showed a higher leadership effectiveness in South America (ß = 0.56; 95%CI 0.13, 0.99), in private hospitals (ß = 0.60; 95%CI 0.14, 1.06), and in medical specialty (ß = 0.28; 95%CI 0.02, 0.54). These results encourage the improvement of leadership culture to increase performance and guideline adherence in healthcare settings. To reach this purpose, it would be useful to introduce a leadership curriculum following undergraduate medical courses.

Risk Factors for Intra-Abdominal Candidiasis in Intensive Care Units: Results from EUCANDICU Study.

INTRODUCTION: Intra-abdominal infections represent the second most frequently acquired infection in the intensive care unit (ICU), with mortality rates ranging from 20% to 50%. Candida spp. may be responsible for up to 10-30% of cases. This study assesses risk factors for development of intra-abdominal candidiasis (IAC) among patients admitted to ICU. METHODS: We performed a case-control study in 26 European ICUs during the period January 2015-December 2016. Patients at least 18 years old who developed an episode of microbiologically documented IAC during their stay in the ICU (at least 48 h after admission) served as the case cohort. The control group consisted of adult patients who did not develop episodes of IAC during ICU admission. Matching was performed at a ratio of 1:1 according to time at risk (i.e. controls had to have at least the same length of ICU stay as their matched cases prior to IAC onset), ICU ward and period of study. RESULTS: During the study period, 101 case patients with a diagnosis of IAC were included in the study. On univariate analysis, severe hepatic failure, prior receipt of antibiotics, prior receipt of parenteral nutrition, abdominal drain, prior bacterial infection, anastomotic leakage, recurrent gastrointestinal perforation, prior receipt of antifungal drugs and higher median number of abdominal surgical interventions were associated with IAC development. On multivariate analysis, recurrent gastrointestinal perforation (OR 13.90; 95% CI 2.65-72.82, p = 0.002), anastomotic leakage (OR 6.61; 95% CI 1.98-21.99, p = 0.002), abdominal drain (OR 6.58; 95% CI 1.73-25.06, p = 0.006), prior receipt of antifungal drugs (OR 4.26; 95% CI 1.04-17.46, p = 0.04) or antibiotics (OR 3.78; 95% CI 1.32-10.52, p = 0.01) were independently associated with IAC. CONCLUSIONS: Gastrointestinal perforation, anastomotic leakage, abdominal drain and prior receipt of antifungals or antibiotics may help to identify critically ill patients with higher probability of developing IAC. Prospective studies are needed to identify which patients will benefit from early antifungal treatment.

Economic Burden of Pneumococcal Disease in Individuals Aged 15 Years and Older in the Liguria Region of Italy.

Despite the availability of vaccines against Streptococcus pneumoniae, the global incidence and economic cost of pneumococcal disease (PD) among adults is still high. This retrospective cohort analysis estimated the cost of emergency department (ED) visits/hospitalizations associated with non-invasive pneumonia and invasive pneumococcal disease among individuals ≥15 years of age in the Liguria region of Italy during 2012-2018. Data from the Liguria Region Administrative Health Databases and the Ligurian Chronic Condition Data Warehouse were used, including hospital admission date, length of stay, discharge date, outpatient visits, and laboratory/imaging procedures. A ≥30-day gap between two events defined a new episode, and patients with ≥1 ED or inpatient claim for PD were identified. The total mean annual number of hospitalizations for PD was 13,450, costing ~€49 million per year. Pneumonia accounted for the majority of hospitalization costs. The median annual cost of hospitalization for all-cause pneumonia was €38,416,440 (per-capita cost: €26.78) and was €30,353,928 (per-capita cost: €20.88) for pneumococcal and unspecified pneumonia. The total number and associated costs of ED visits/hospitalizations generally increased over the study period. PD still incurs high economic costs in adults in the Liguria region of Italy.

Has Clinical and Epidemiological Varicella Burden Changed over Time in Children? Overview on Hospitalizations, Comorbidities and Costs from 2010 to 2017 in Italy.

According to WHO estimates, varicella disease is responsible of a worldwide significant burden in terms of hospitalizations, complications, and deaths, with more than 90% of cases under 12 years old. This study aims at evaluating the clinical, epidemiological, and economic burden of varicella in Ligurian children, about comorbidities, organizational variables, and vaccination coverages from 2010 to 2017, in terms of Emergency Department accesses and hospitalizations. The overall hospitalization rate was 179.76 (per 100,000 inhab.), with a gradual but significant decline since 2015, when universal varicella vaccination was introduced in Liguria (p < 0.0001). The risk of being hospitalized for complicated varicella in subjects with at least one comorbidity was significantly higher than in subjects without comorbidities (p = 0.0016). The economic analysis showed higher costs in subjects with complicated varicella who were 0-3 years old. This age group showed higher costs also considering extra-hospital costs for both outpatient procedures and pharmaceutical costs (p < 0.0001). The results confirm the relevant burden of varicella, especially in the 0-3 age group and in children with comorbidities. Thus, vaccination with the achievement of adequate vaccination coverages is confirmed to be a necessary control strategy to reduce hospitalizations and associated complications with important economic benefits.

Lowering the recommended age for the free and active offer of influenza vaccination in Italy: clinical and economic impact analysis in the Liguria region.

OBJECTIVE: we estimated the epidemiological and budget impact of lowering the recommended age for influenza immunization with quadrivalent vaccine actively offered and administered free of charge to persons over 50 years old by public immunization services. METHODS: a multi-cohort, deterministic, static Markov model was populated by real-world data on the clinical and economic impact of Influenza-Like Illness and Lower Respiratory Tract Infection over 1 year. Four scenarios featuring different vaccine coverage rates were compared with the base case; coverage rates in subjects with and without risk factors were considered separately. RESULTS: compared with the base case, adopting scenarios 1-4 would reduce the annual number of influenza cases by 6.5%, 10.8%, 13.8% and 3.4%, Emergency Department accesses by 10.7%, 9.1%, 15.4% and 4.6%, complications by 8.9%, 9.9%, 14.7% and 4.1%, and the hospitalization of complicated cases by 11%, 9.1%, 15.4% and 4.5%, respectively. The four scenarios would require an additional investment (vaccine purchase and administration) of €316,996, €529,174, €677,539, and €168,633, respectively, in comparison with the base case. Scenario 1 proved to be cost-saving in the 60-64-year age-group. The incremental costs of implementing the other hypothetical scenarios ranged from 2.7% (scenario 4) to 13.2% (scenario 3). CONCLUSIONS: lowering the recommended age for influenza vaccination to 60 years would allow a high proportion of subjects at risk for severe influenza to be reached and would save money.

The Unknown Health Burden of Herpes Zoster Hospitalizations: The Effect on Chronic Disease Course in Adult Patients ≥50 Years.

The effect of severe Herpes Zoster (HZ) on chronic diseases is a component of the real burden of this vaccine-preventable disease that is not commonly considered. A retrospective cohort study was conducted to assess the health burden of severe HZ in adults ≥50 years residing in Liguria Region from 2015 to 2017. Subjects hospitalized with and without HZ were matched (1:6 ratio). 437 subjects in the HZ cohort and 2622 subjects in the non-HZ cohort were enrolled. Previous immunodeficiency, autoimmune, and rare diseases are identified as main chronic conditions related to HZ hospitalization. Higher incidences of autoimmune (1.4% vs. 0.22%, p = 0.002) and gastrointestinal (7.04% vs. 3.62%, p = 0.015) diseases after hospitalization were observed in the HZ cohort compared to the non-HZ cohort. Significantly higher incidences were found after hospitalization versus the previous period for cardiovascular diseases (11.17% vs. 2.09%, p < 0.001), cerebral vasculopathy (6.13% vs. 0.60%, p < 0.001), non-arrhythmic myocardiopathy (4.31% vs. 0.59%, p = 0.002), and neuropathy (2.62% vs. 0.56%, p = 0.033). The HZ cohort showed a relative risk 10-fold higher for cerebral vasculopathy, 5-fold higher for cardiovascular diseases, and 7-fold higher for non-arrhythmic myocardiopathy. HZ causes a substantial impact on the chronic conditions. These data could suggest an implementation of HZ vaccination programs in the elderly and in high-risk groups.

Estimating the Clinical and Economic Impact of Switching from the 13-Valent Pneumococcal Conjugate Vaccine (PCV13) to the 10-Valent Pneumococcal Conjugate Vaccine (PCV10) in Italy.

Background: Invasive and non-invasive pneumococcal diseases are significant health and economic burdens, especially in children and the elderly. Italy included the 7-valent (PCV7) and 13-valent pneumococcal conjugate vaccine (PCV13) in the National Immunization Program in 2007 and 2010, respectively, allowing a dramatic reduction in the burden of pneumococcal disease. In the era of budget constraints, decision-makers may consider switching from the higher-valent, more costly PCV13, to the lower-cost PCV10. This study estimated the potential public health and economic impact of changing vaccine programs from PCV13 to PCV10 in Italy. Methods: A decision-analytic forecasting model estimated the impact of PCV programs. Real-world surveillance data were used to forecast serotype distribution and disease incidence among children and the elderly over a specified 5-year time horizon. Costs and outcomes included estimates of cases and deaths avoided, quality-adjusted life years (QALYs) gained, and total costs from a payer perspective, discounted at an assumed rate of 3.0%, and robustness validated through several scenarios and sensitivity analyses. Results: A switch from PCV13 to PCV10 would increase invasive pneumococcal disease (IPD) cases by 59.3% (4317 cases) over a 5-year horizon, primarily due to serotypes 3 and 19A. Pneumonia increased by 8.3% and acute otitis media (AOM) by 96.1%. Maintaining a PCV13 program would prevent a total incremental 531,435 disease cases (1.02M over a 10-year time horizon) and 641 deaths due to invasive pneumococcal disease (IPD), with €23,642 per QALY gained over 5 years versus PCV10. One-way and probabilistic sensitivity analyses showed that a PCV13-based program remained cost-effective in 99.7% of the simulations in Italy as parameters varied within their plausible range; percent vaccinated had the most impact. Conclusions: Maintaining the PCV13 strategy would provide substantial public health and economic benefits in Italy and is cost-effective. Switching from PCV13 to PCV10 would increase the incidence of pneumococcal disease primarily linked to re-emergence of serotypes 3 and 19A.