Antibodies against Receptor Binding Domain of SARS-CoV-2 spike protein induced by BNT162b2 vaccine: results from a pragmatic, real-life study.

BACKGROUND: As part of the fight against SARS CoV2 infection, vaccination program for health workers at Giannina Gaslini pediatric hospital (IGG) in Genoa, Italy, started on December 2020. We evaluated the anti-Spike protein response in healthcare workers after a complete vaccination scheme of 2 doses spaced by 3 weeks. METHODS: Immunoglobulin class G (IgG) against SARS-CoV-2 spike RBD were detected by means of a chemiluminescence immunoassay for quantitative IgG antibodies using Maglumi SARS-CoV-2-S-RBD IgG kit during the 3rd week after vaccination completion. RESULTS: IgG anti SARS-CoV-2 spike protein were detected in 99.88% of 1765 healthcare workers 3 weeks after 2nd dose of BNT162b2. Higher median IgG values were observed in younger subjects (807 UA/mL in under 30 vs 429 UA/mL in over 60; p < 0.001) and those with previous COVID-19 (1284 vs 574 UA/mL; p < 0.001). CONCLUSION: BNT162b2 is effective in inducing anti SARS-CoV-2 antibodies even in real-life setting. The higher antibody title observed in workers with a previous documented SARS CoV2 infection confirms the possibility to carry out only one dose of BNT162b2 in a context of vaccines shortage.

Impact of a diagnostic therapeutic educational pathway program for asthma management in preschool children.

BACKGROUND: Preschool children with clinically-diagnosed asthma have a higher rate of emergency department visits and consume more resources for management than older children. However, no clinical trials have yet been performed measuring the impact of a combined diagnostic, therapeutic and educational pathway regimen for evaluation of wheezing control in children aged less than 6 years. The purpose of the present study was to assess the impact of a pediatric program developed in Italy, the Diagnostic Therapeutic Educational Pathway (DTEP), for asthma management in children less than 6 years old attending an asthma referral center. METHODS: This is a retrospective population-based cohort study performed in children with asthma aged 0-5 years, attending at "Io e l'Asma center", Brescia, Italy between September 2007 and December 2014. The incidence rates (IRs) of hospitalization, emergency room visits, use of outpatient services and drug usage for dyspnea, wheezing, or respiratory symptoms were evaluated for time periods prior to and after DTEP intervention. RESULTS: A total of 741 patients, aged 0-5 years completed the DTEP, including 391 and 350 children aged 0-2 and 3-5 years, respectively. The percentage of children aged 0-2 and 3-5 years showing improved control of wheezing symptoms during the 1st to 3rd visit interval as a result of the DTEP intervention increased from 39.5 to 60.9% and from 25.5 to 75.5%, respectively. During these periods, the IRs showed a significant decrease for all outcomes, from-8.6% to - 80.4%. Although specific IRs for drug prescriptions declined, particularly for LABA plus corticosteroids, antibiotics, and systemic corticosteroids, they increased for SABA, inhaled corticosteroid and leukotriene receptor antagonist usage. CONCLUSIONS: The results suggest that a real-world assessment of the integrated DTEP program for preschool children provides evidence for improved wheezing control and reduction of adverse therapeutic related outcomes.

Use of multiple metrics to assess antibiotic use in Italian children's hospitals.

Quantification of antibiotic utilization is an essential component of antibiotic stewardship programs. In this multicentric study, we used different metrics to evaluate inpatient antibiotic use in children. The study objectives were to describe point prevalence of antibiotic use by indication and patient characteristics, to evaluate DOTs, LOTs and PDDs, and to compare PDDs to DDDs, which assume average maintenance dose per day in adults. All children hospitalized on the days of the study were included. Trained personnel collected demographic and clinical data from patients' clinical records. We recorded information about antibiotics administered on the date of data collection, and in the previous 30 days of hospitalization. Of 810 patients, 380 (46.9%; CI 95%: 43.4-50.4) received one or more antibiotics; prevalence of use was 27.0% for prophylaxis (219/810), and 20.7% (168/810) for treatment. Overall, 587 drugs were issued to the 380 patients receiving antibiotics (1.5 antibiotic per patient). When considering treatments, DOT and LOT per 100 patient-days were 30.5 and 19.1, respectively, resulting in a DOT/LOT ratio of 1.6. PDDs increased with age and approached DDDs only in children aged ≥ 10 years; the ratio between PDDs estimated in children aged ≥ 10 years and in 0-11 month-old infants ranged from 2 for sulfamethoxazole and trimethoprim, to 25 for meropenem. Our results confirm that DOT, LOT and PDD are better alternatives to DDD in children.

Evaluation of a Diagnostic Therapeutic Educational Pathway for Asthma Management in Children and Adolescents.

Background: Limited evidence exists for the effectiveness of educational programs that improve pediatric asthma control in real-world settings. We aimed to assess the impact of a diagnostic, therapeutic, and educational pathway (DTEP) for asthma management in children and adolescents attending an asthma referral center. Methods: This is a retrospective population-based cohort study, including two groups of patients with asthma, aged 6-17 years and residing in the Local Health Authority (LHA) of Brescia, Italy: (a) the children who followed a DTEP (intervention group) and (b) all the children residing in the LHA who did not follow DTEP (control group). The incidence rates (IRs) of hospitalization, emergency room visit, use of outpatient services, and drug prescription for dyspnea, wheezing, or respiratory symptoms were computed for time before and after attending DTEP in the intervention group and for "early" and "late" time since asthma diagnosis in the control group. Results: There were 9,191 patients included in the study, 804 of whom followed DTEP. In the before-DTEP/early time, the intervention and control groups showed similar IRs for all the outcomes apart from emergency room visits (IRs of 138.6 and 60.3 per 1,000 person-years, respectively). The IRs decreased from before to after DTEP and from early to late time in both groups. The IR decrease for emergency room visits was significantly higher in the intervention than in the control group (-51.3 and -28.2%, respectively; IRR = 0.61, P = 0.001). Conclusion: The DTEP can increase patients' capability in managing asthma and preventing asthma attacks.

Medicine and humanism in the time of COVID-19. Ethical choices.

The Covid-19 pandemic has been the most defining event of our era. The world of healthcare has experienced first-hand the dramatic situation of treating patients in the face of the dangers of contagion and limited resources. Difficult choices have everywhere been made alongside ethical reflection. Now that, at least in our part of the world, viral infection seems to be broadly on the decline, there is an urgent need for fresh, anthropological, ethical reflection. It is important to avoid being unprepared in the event of further occasions, but above all, to now think in global terms. This is because the pandemic has forced us to recognise the urgency of building alliance in healthcare and a balanced relationship with the environment.

A collaborative intervention to improve surgical antibiotic prophylaxis in children: results from a prospective multicenter study.

PURPOSE: The use of surgical antibiotic prophylaxis (SAP) in children is poorly characterized. Our aim was to evaluate the effectiveness of a quality improvement (QI) intervention targeting SAP in children, by means of a multicenter prospective intervention study, with a before and after design. METHODS: We prospectively investigated elective surgical procedures performed in children <18 years, prior to the QI intervention, after the intervention and at 9-month follow-up. The primary outcomes were adherence to SAP indications and SAP appropriateness, defined considering antibiotic choice, timing of first dose and duration of administration. We compared SAP adherence and appropriateness prior the QI intervention, to the post-intervention and the follow-up. We considered patient and procedure characteristics as covariates in two logistic regression models to assess the effect of the QI intervention on SAP adherence and appropriateness. RESULTS: We collected information on 2383 procedures (pre-intervention: 784; post-intervention: 790; follow-up: 809). The QI intervention had a significant impact on the adherence to SAP indications (86.6% in the post-intervention, compared to 82.0% prior to the intervention; p < 0.05), and on its appropriateness (35.7% compared to 19.9%; p < 0.01). The impact of the intervention on SAP appropriateness was maintained at follow-up (38.3%; p < 0.01 compared to pre-intervention). All components of SAP appropriateness significantly improved after the intervention and at follow-up. The logistic regression analyses confirmed the effect of intervention in improving adherence to SAP indications and appropriateness. CONCLUSIONS: Following the QI intervention, there was a significant improvement in quality of SAP in pediatric surgery, though more efforts are needed to increase SAP appropriateness.

Surgical antibiotic prophylaxis in children: a mixed method study on healthcare professionals attitudes.

BACKGROUND: Qualitative and quantitative research investigating determinants of adherence to clinical guidelines (GLs) on surgical antibiotic prophylaxis (SAP) are scarce. We conducted a mixed-method study aimed at investigating barriers and at describing attitudes of healthcare professionals (HCPs) regarding SAP in three Italian children's hospitals. METHODS: The study comprised two sequential phases: 1) collection of qualitative data through focus groups; 2) conduction of a survey on HCPs attitudes towards SAP. Focus groups were carried out in each hospital with a theoretical convenience sample of 10-15 HCPs. Categorical analysis was conducted. Emerging categories and additional topics derived by literature search were used to develop the survey questionnaire, which included 13 questions expressed through a 4-point Likert scale. Members of surgical teams were invited by e-mail to fill in the questionnaire. We summed up the points assigned to each 4-point Likert scale response and calculated a cumulative score expressing overall concordance to expected HCPs attitudes on SAP. We conducted univariate and multivariate analysis to evaluate the relationship among characteristics of respondents and concordance with expected attitudes. RESULTS: The main categories identified in the qualitative phase included determinants of general adherence to GLs (e.g., relevance of clinical judgment), individual determinants (e.g., poor knowledge on hospital data) and organizational/structural determinants (e.g., patient flows). A total of 357 HCPs participated in the survey (response rate: 82.1%). Among respondents, 75% reported that SAP should be performed with first or second-generation cephalosporins, 44% that 2-3 days of antibiotic administration are useful as a precaution after surgery, 32% that SAP is needed for all surgical procedures. At multivariate analysis, professional category (physicians vs nurses; OR: 3.31; 95%CI: 1.88-5.82), and hospital (hospital 1 and 2 vs hospital 3; ORs: 2.79, 95%CI: 1.22-6.36; 2.40, 95%CI: 1.30-4.43, respectively) were significantly and independently associated with higher concordance with expected attitudes on SAP. CONCLUSIONS: Results from this study were useful to identify obstacles to appropriate SAP use in children. In our setting, findings support that a quality-improvement intervention should take into account local contexts, with development of hospital policies, education on SAP recommendations, and dissemination of data on adherence to recommendations.

Surgical antibiotic prophylaxis in children: adherence to indication, choice of agent, timing, and duration.

PURPOSE: Surgical antibiotic prophylaxis (SAP) in children is poorly characterized. We investigated SAP for children undergoing elective surgical procedures. METHODS: We prospectively investigated elective surgical procedures performed in children <18 years, from November 2012 to February 2013, in three tertiary-care children's hospitals in Italy. Data were derived from clinical records. Antibiotics were considered prophylactic if given by parenteral route during the same day of the procedure. SAP indication was defined according to international guidelines. Whenever SAP was indicated, it was defined appropriate if antibiotic choice was different from third-/fourth-generation cephalosporins, carbapenems, or piperacillin/tazobactam; timing of first dose was within 60 min before incision; and duration of administration was ≤24 h. Multivariable logistic regression model was used to assess independent predictors of adherence to SAP administration, for procedures with SAP indication performed in all hospitals. RESULTS: Data on 765 procedures were collected. SAP was administered in 81% of 206 procedures with SAP indication and in 18% of 559 procedures with no indication. Type of procedure and hospital were significantly associated with adherence of administration to SAP indication. In the 206 procedures where SAP was indicated, overall appropriateness of antibiotic choice, timing, and duration was 8%. CONCLUSIONS: The SAP rate observed in procedures with SAP indication and the appropriateness of drug choice, timing, and duration are reasons of concern. Quality improvement interventions for implementing SAP recommendations in children are strongly needed, and their impact should be evaluated at hospital level.

Application and implementation of the GINA asthma guidelines by specialist and primary care physicians: a longitudinal follow-up study on 264 children.

AIMS: To implement GINA guidelines and to assess their impact on the management of childhood asthma. METHODS: A working group of primary care physicians (PCPs) and specialists developed a GINA-based clinical pathway. We then monitored the impact on 385 children (aged 0-15 years) referred to the respiratory outpatients clinic at the University Children's Hospital, Brescia, Italy by 179 PCPs between September 2003 and July 2005. RESULTS: Mean follow-up for 264 children with complete datasets was 10 months. Guidelines were followed by 94.6% of the PCPs. 98.6% of children learned to manage exacerbations. Half of the patients with persistent symptoms became intermittently symptomatic. Maintenance treatment was suspended in 47.2%, reduced in 27.6%, and increased in 4.9%. Asthma severity diminished (p<0.0001) and requirement for medication for exacerbations was significantly reduced (p<0.0001). CONCLUSIONS: Regular specialist visits, a website, and a written management plan shared by all those involved, led to clinical improvements as well as a reduction in, and more efficient use of, asthma medication.