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This is a Brighton Collaboration case definition of thrombosis and thromboembolism to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected expert reviewers prior to submission., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JG, SES, AHN, SA, K(D), DT, JJ, JD, EC, FV BL and FMM declare no conflicts of interest. PKD declares that she now works for Sanofi, India but was an independent consultant when this case definition was developed., (Copyright © 2022. Published by Elsevier Ltd.)

Vaccinations are essential for preventing infectious diseases in children with chronic diseases as they have increased risk of infection from frequent use of biologics. Response to immunizations in this group is not well known., Objective: A systematic review was performed to evaluate three primary outcomes: efficacy; immunogenicity; and safety of vaccines in children with chronic conditions treated with biologics., Methods: The protocol for our systematic review and meta-analysis was registered and published with PROSPERO. We searched electronic bibliographic databases for studies published from 2009 to 2019, focusing on vaccinations in children with chronic conditions treated with biologics., Results: We retrieved 532 records. Thirty-one full-text articles were selected, and 14 were included in the meta-analysis. No significant publication bias was found., Efficacy: limited data are available regarding the efficacy of vaccination, as most studies have focused on immunogenicity as surrogate outcome for efficacy. Immunogenicity: patients receiving anti-TNF-alpha therapy had a statistically significant risk of poor seroconversion (p = 0.028) and seroprotection by the serotype B influenza vaccine [inflammatory bowel disease (IBD) p = 0.013; juvenile idiopathic arthritis (JIA) p = 0.004]. We found adequate responses with H1N1 and H3N2 serotypes. Few studies existed for pneumococcal, hepatitis A virus, hepatitis B virus, varicella-zoster virus, Measles Mumps Rubella virus, and multiple vaccine administration., Safety: vaccine administration was not associated with serious side effects, but JIA patients on anti-TNF alpha therapy had a statistically significant risk of presenting with myalgia or arthralgia postinfluenza vaccine (p = 0.014)., Conclusions: More evidence concerning efficacy, immunogenicity, and safety of vaccinations is needed to guide physicians in the vaccine decision process for this pediatric population., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Updated data on epidemiology of tuberculosis are needed in Italy. The aim of this study is to evaluate trends in incidence and associated lethality of tuberculosis in immigrants compared with Italians., Methods: All tuberculosis cases diagnosed from 2000 to 2018 in 31 Tuscan hospitals were retrospectively identified., Results: In 10,827 tuberculosis cases 6715 were males (62%), 4312 (60%) were Italian-born. Hospitalization rate was 15.37/100,000 population/year. The most common comorbidity were liver disease (832/10,827; 7.7%), COPD (675/10,827; 6.2%), cancer (614/10,827; 5.7%). HIV was more frequent in the immigrants (p < 0.001). Extra-pulmonary tuberculosis cases (EPTB) were mainly localized in pleura (740/3,894, 19%) and lymph nodes (449/3,894, 11,5%). HIV was associated with an increased risk of EPTB (OR 3.51 95% CI 2.92-4.23, p < 0.0001). EPTB risk was increased in South Asian-born patients (OR 1.77, 95% CI 1.46-2.15, p < 0.0001) as well in African-born patients (OR 1.13, 95% CI 1.03-1.24, p = 0.0091), who were at risk for gastroenteric tuberculosis (OR 3.74, 95% CI 2.69-5.22, p < 0.0001). Overall mortality rate was 0.006 per 1000. Most of death cases (89%) were Italians (p < 0.02) and mainly affected by pulmonary tuberculosis (PTB)., Conclusions: In Tuscany, tuberculosis is still a health concern in terms of both morbidity and mortality., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Enteric parasite infections are underestimated due to the limited sensitivity and specificity of microscopy, which remains the diagnostic gold standard in routine clinical practice. This could be a major problem in high-income countries, where the burden of parasitic diseases is low. In recent years, Multiplex Real-Time polymerase chain reaction (RT-PCR) based methods have been implemented. Therefore, the aim of this study was to evaluate the prevalence of four enteric protozoan species detected by RT-PCR in non-native children in Italy, and to describe their clinical characteristics., Methods: Adopted and immigrant children, evaluated for migration health assessment between 2017 and 2020 in a tertiary care children's hospital in Italy, were enrolled. Molecular analysis for Giardia lamblia, Dientamoeba fragilis, Blastocystis hominis, and Entamoeba histolytica, was conducted by in-house RT-PCR., Results: Overall, 209 children were enrolled and 70% of them resulted positive by RT-PCR for at least one enteric parasite. B. hominis (47.8%) was the most commonly identified protozoa, followed by D. fragilis (44.5%). Co-infections with multiple pathogens were detected in 35.4% of the samples. Almost 80% of parasite-positive children were asymptomatic and the most common symptom was flatulence (60.7% of symptomatic children). Eosinophils were significantly increased in RT-PCR positive children compared to the negative ones and children with D. fragilis presented the highest eosinophils count., Conclusions: The In-house Multiplex RT-PCR assay provides a valid molecular detection system for selected enteric parasites. This novel and accurate diagnostic method can help in increasing the detection rate of parasite infection, especially in high-risk population., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Updated data regarding the epidemiology of imported malaria in Italy are needed. The aim of this study is to evaluate trends in incidence and associated lethality of malaria episodes and to consider if there has been an increase in paediatric cases in the region of Tuscany., Methods: All malaria cases diagnosed from 2000 to 2017 in 31 Tuscan hospitals were retrospectively identified. Epidemiological data regarding hospitalization rates and lethality for malaria in paediatric and adult population were described., Results: Among the 1102 retrieved cases of malaria (134 children and 968 adults). Plasmodium falciparum was the most commonly reported species (67%). The overall hospitalization rate was of 1.69 cases per 100,000 population/year. Hospitalization rate in the total population decreased from 2000 to 2009 (p < 0.01) and increased from 2009 to 2017 (p < 0.01), similar trends were observed in adults and children. However, in 2010-2017, the cumulative child group incidence of 1.78 per 100,000 surpassed that of the adult group of 1.53 per 100,000 (p < 0.01). Fifteen deaths occurred, all of them in adults, giving a crude lethality rate of 1.36%., Conclusions: In Tuscany, malaria is still a health concern in terms of both morbidity and mortality. Educational actions and pre-travel advice must be promoted., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: Most of internationally adopted children (IAC) come from countries in which tuberculosis (TB) is endemic. Interpretation of discordant Tuberculin Skin Test (TST) and Quantiferon-Gold In Tube (QFT) results is under debate., Methods: Children consecutively referred to our IAC Center between 2009-2017 were prospectively evaluated and screened with protocol recommended by the America Academy of Pediatrics, including TST and QFT. TB infection prevalence was evaluated and possible risk factors associated with discordant TST/QFT results were investigated., Results: 1775 IAC were enrolled (median age: 5.8; IQR:3.3-8.2; 1065 [60.0%] males). Most of the children came from a European country (715; 40.3%) and, among them, 428 (59.9%) from Russia. Active pulmonary TB was diagnosed in 7 (0.4%) children while LTBI was diagnosed in 255 (14.4%) children. Concordant TST-/QFT-result was observed in 1520 (85.6%) children, concordant TST+/QFT + result in 63 children (3.5%), while 169 children (9.5%) displayed TST+/QFT-result and the remaining 23 children (1.3%) TST-/QFT+. Factor significantly associated with discordant TST+/QFT-result was BCG vaccination (aOR:2.62; 95%CI. 1.12-6.12; P = 0.026) and age <5 years (aOR: 5.59; 95%CI:2.27-12.18; P < 0001). . No significant association was evidenced with, continent of origin, eosinophilia or gender., Conclusions: Our data suggest that QFT might be used as unique screening assay in IAC, but further studies are needed at this regard., (Copyright © 2018. Published by Elsevier Ltd.)

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting., (Copyright © 2016. Published by Elsevier Ltd.)

Objective: To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children., Methods: We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children., Results: Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%)., Discussion: This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children., (Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Linezolid is a new drug from the oxazolidinone class of antibiotics used against mycobacteria and multi-drug resistant (MDR) Gram-positive bacterial infections, which may are also glycopeptide-resistant. The drug usage in pediatric age needs an accurate drug monitoring for effective patient management. The aim of this study was to evaluate the use of dried blood spot (DBS) specimens to determinate linezolid levels during treatment. Advantages of DBS include short collection time, low invasiveness, ease and low cost of sample collection, transport and storage. The analysis was performed in LC-MS/MS operating in positive ion mode and multiple reaction monitoring (MRM) mode. The calibration curve in matrix was linear in the concentration range of 1-100 mg/L with correlation coefficient value of 0.9987. Intraday and interday coefficients of variation were within 3.6% and 13.0%, respectively. We also tested the thermal and temporal drug stability in dried blood spots at four different temperatures to evaluate the risks of sample delivery in different conditions. The short term stability studies showed that linezolid concentration remained stable for at least one month under all the conditions tested. This new assay has favorable characteristics being highly precise and accurate and allows a fast linezolid analysis with a total run time 22 min long, in gradient analysis. Concentration data for plasma and DBS samples from patients after treatment were compared showing a good correlation. Correlation between DBS data and serum samples measured by HPLC-UV was satisfactory. The benefit for patients is the ability to monitor the treatment with a simple and convenient sample collection at home., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Background: The most frequent noncutaneous site of involvement of chickenpox is the central nervous system (CNS) and complications include cerebellar ataxia, encephalitis, and meningitis., Objectives: We have recently observed an unusually high number of children with chickenpox CNS complications in our university children's hospital. A study to evaluate the incidence of these complications over time in children living in Tuscany was carried out., Study Design: We evaluated all cases of chickenpox and chickenpox complications leading to hospitalization in children aged 1 month-14 years reported to the Tuscany public health centre between 1997 and 2004. The International Classification of Disease Ninth Revision-CM hospital discharge diagnostic codes and medical records were used., Results: The incidence (95% confidence interval) of CNS complications/1000 chickenpox cases was stable between 1997 and 2001 [1997: 0.80 (0.29-1.74); 1998: 0.73 (0.29-1.50); 1999: 0.67 (0.25-1.46); 2000: 0.56 (0.15-1.44); 2001: 0.59 (0.16-1.50)] but increased significantly (chi(2) for trend: 9.401; p=.0021) in 2002 [1.56 (0.83-2.66)], in 2003 [1.73 (0.95-2.90)] and in 2004 [1.51 (0.74-2.27)]. Non-CNS complications remained stable over time., Conclusions: Possible factors biasing the result were taken into account. Reasons of increased CNS complications remain unknown, but the possible emergence of a particularly neurotropic strain of varicella-zoster virus should be further investigated.