Publications by authors named "Pasquale Stefanizzi"

28 Publications

  • Page 1 of 1

In-hospital and web-based intervention to counteract vaccine hesitancy in very preterm infants' families: a NICU experience.

Ital J Pediatr 2021 Sep 16;47(1):190. Epub 2021 Sep 16.

Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, University of Bari, Bari, Italy.

Background: Vaccine hesitancy is a global problem, carrying significant health risks for extremely vulnerable population as that of preterm infants. Social media are emerging as significant tools for public health promotion. Our aim was to evaluate both the coverage and the timeliness of routine immunizations in a cohort of preterm infants (< 33 weeks of gestational age) at 24 months of age whose families have been subjected to in-hospital and web-based interventions to counteract vaccine hesitancy.

Methods: For a period of 2 years parents of preterm infants were instructed during their follow up visits by a member of the NICU team to get correct informations about vaccines from a social network page. Vaccination rates of preterm infants were assessed at 24 months of chronological age with an electronic database and compared to both general population and historical cohort.

Results: Coverage and timeliness of vaccinations at 24 months of age of 170 preterm infants were analyzed in December 2019. Gestational age and birth weight median (IQR) were, respectively, 31.0 (5.0) weeks and 1475.0 (843.8) g. Coverage rates were similar to those of the regional population (p > 0.05), while timeliness of administration was significantly delayed compared to the recommended schedule (p < 0.001). Age of administration was not correlated with either body weight and gestational age at birth (Spearman rank, p > 0.05). DTaP-IPV-HBV-Hib 2nd and 3rd doses, MMR and Varicella vaccines coverage data were higher compared to historical cohort (p < 0.05).

Conclusion: Increasing vaccine confidence through web-based interventions could have a positive impact on vaccination acceptance of parents of preterm infants, although timeliness results still delayed. There is a strong need to develop different and effective vaccination strategies to protect this very vulnerable population.
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http://dx.doi.org/10.1186/s13052-021-01129-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447703PMC
September 2021

SARS-CoV-2 RNA and Supermarket Surfaces: A Real or Presumed Threat?

Int J Environ Res Public Health 2021 09 6;18(17). Epub 2021 Sep 6.

Department of Biomedical Science and Human Oncology-Hygiene Section, University of Bari Aldo Moro, Piazza G. Cesare 11, 70124 Bari, Italy.

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in March 2020 in Italy, leading to the pandemic of coronavirus disease 2019 (COVID-19) that continues to cause high global morbidity and mortality in human populations. Numerous studies have focused on the spread and persistence of the virus in the hospital setting. New scientific evidence shows that SARS-CoV-2 is present in different community environments. Although aerosol is one of the main routes of transmission for SARS-CoV-2, indirect contact through virus-contaminated surfaces could also play a key role. The survival and persistence of SARS-CoV-2 on surfaces appear to be influenced by the characteristics of the material, temperature, and humidity. In this study, we investigated the presence of SARS-CoV-2 RNA on surfaces in 20 supermarkets throughout the Apulia region during the lockdown period. We collected a total of 300 swab samples from various surfaces including supermarket scales, trolley handles, refrigerator and freezer handles, and keyboards. In total, 13 (4.3%) surfaces were positive for SARS-CoV-2 RNA contamination, with shopping trolley handles being the most frequently contaminated. This study showed that contamination in public spaces can occur, so we remark the importance to adopt adequate preventive measures, including environment ventilation, careful surfaces sanitation, hand hygiene, and correct usage of masks, to reduce the likelihood of virus transmission.
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http://dx.doi.org/10.3390/ijerph18179404DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8430590PMC
September 2021

Postmarketing surveillance of adverse events following meningococcal B vaccination: data from Apulia Region, 2014-19.

Hum Vaccin Immunother 2021 Aug 26:1-6. Epub 2021 Aug 26.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Since the multicomponent meningococcal B vaccine introduction, the Apulian Regional Health Authority implemented postmarketing surveillance program, as provided by Italian laws.From National Pharmacovigilance Network, we selected 4CMenB AEFIs reported in Apulia from 01 January 2014 to 31 December 2019, while the number of 4 cMen B doses administered per year was obtained from the regional immunization database (GIAVA).For each subject who experienced an adverse event following meningococcal B vaccine (AEFIs), a predefined form was filled in.A total of 214 AEFIs (26.5 × 100.000 doses) were reported after any dose of MenB-4 c vaccination of which 58/214 (27.1%) were classified as serious (7.2 × 100,000 doses), 145/214 (67.8%) as not serious (180 × 100,000 doses), and 11/214 (5.1%) as undefined (1.3 × 100,000 doses).The average age of subjects who experimented and AEFI was 30 months. The majority of serious AEFIs were reported in 2- to 11-month-old children (44/57; 77.2%). A total of 31/58 (3.8 × 100,000 doses; 53.4%) serious AEFIs were reported as having a 'consistent causal association' with vaccination. Of these, fever/hyperpyrexia was reported in 21/31 (2.6 × 100,000 doses; 67.7%); hypotonic-hyporesponsive episode was reported in 7/31 (0.9 × 100,000 doses [add %-age]) and was the most frequent adverse event with neurological symptoms. A total of 13/31 (41.9%) serious AEFIs classified as 'consistent causal association' were reported after the first dose of 4cMenB, of these 5/13 (38.5%) children did not complete the vaccination schedule.Our data seemed to confirm, in a large population, the a good safety profile of the universal mass vaccination with 4CMENB.
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http://dx.doi.org/10.1080/21645515.2021.1963171DOI Listing
August 2021

Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study.

Vaccines (Basel) 2021 May 4;9(5). Epub 2021 May 4.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, 70124 Bari, Italy.

Since the influenza season 2018/19, the Italian Ministry of Health recommended a dose of cell-based quadrivalent vaccine (Flucelvax Tetra) for HCWs (healthcare workers), because this vaccine seemed more efficacious in the prevention of AH3N2 virus. Due to the lack of pre-registration data, the safety profile of this new vaccine must be investigated in post-marketing surveillance. The aim of our study is to evaluate, through a post-marketing active surveillance program developed during the 2019/20 influenza season, any Adverse Events Following Immunization (AEFIs) that happened in the 7 days after immunization with Flucelvax Tetra. The study was carried out in a sample of HCWs of Policlinico General University-Hospital (Apulia, South Italy). AEFIs were classified as 'serious' or 'not serious' according to the WHO (World Health Organization) guidelines; the WHO causality assessment algorithm was applied to classify serious AEFIs. A total of 741 HCWs were enrolled, and 430 AEFIs (reporting rate: 58.0 (95%CI: 54.4-61.6) × 100 enrolled) were recorded. Of these, 429 of 430 (99.8%; reporting rate: 57.8 (95%CI: 54.2-61.5) × 100 enrolled) were classified as not serious and one (0.2%; reporting rate: 0.13 (0.03-0.75) × 100 enrolled) was classified as serious. Local reactions were the adverse reaction reported most frequently (88%); regarding the serious AEFI, causality assessment excluded the causal link with the administration of the vaccine. All the AEFIs resolved without sequelae. Flucelvax Tetra showed a profile of high safety. Due to their characteristics of greater sensitivity than passive surveillance, active surveillance programs can be useful in defining the safety profiles of a given vaccine/drug in certain population subgroups.
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http://dx.doi.org/10.3390/vaccines9050456DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147936PMC
May 2021

Long -term persistence of antibodies against varicella in fully immunized healthcare workers: an Italian retrospective cohort study.

BMC Infect Dis 2021 May 25;21(1):475. Epub 2021 May 25.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Piazza Giulio Cesare 11, 70124, Bari, Italy.

Background: Chickenpox is a highly contagious disease caused by the varicella zoster virus (VZV), and in infants, adolescents, adults, pregnant women, and the immunocompromised it can be serious. The best way to prevent chickenpox is immunization with the varicella vaccine. Protective levels of antibodies induced by the varicella vaccine decline over time, but there is currently no formal recommendation for testing anti-varicella zoster virus (VZV) IgG levels in immunized healthcare workers (HCWs).

Methods: The aims of this study were to evaluate the seroprevalence of circulating anti-VZV IgG in a sample a sample of students and residents of the medical school of the University of Bari, the long-term immunogenicity of the varicella vaccine, and the effectiveness of a strategy consisting of a third vaccine booster dose. The study population was screened as part of a biological risk assessment conducted between April 2014 and October 2020. A strategy for the management of non-responders was also examined.

Results: The 182 students and residents included in the study had a documented history of immunization (two doses of varicella vaccine). The absence of anti-VZV IgG was determined in 34% (62/182; 95%CI = 27.2-41.4%), with serosusceptibility more common among males than females (p < 0.05). After a third varicella dose, seroconversion was achieved in 100% of this previously seronegative group. No serious adverse events were recorded.

Conclusions: One-third of the study population immunized against VZV lacked a protective antibody titer, but a third dose of vaccine restored protection. Since it is highly unlikely that VZV will be eliminated in the immediate future, the loss of immunity in a substantial portion of the population implies a risk of varicella outbreaks in the coming years. Screening for varicella immunity in routine assessments of the biological risk of medical students and HCWs may help to prevent nosocomial VZV infections.
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http://dx.doi.org/10.1186/s12879-021-06180-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8152326PMC
May 2021

BNT162b2 mRNA COVID-19 Vaccine Effectiveness in the Prevention of SARS-CoV-2 Infection: A Preliminary Report.

J Infect Dis 2021 08;224(3):431-434

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

In the preregistration trial, data on efficacy of BNT162b2 mRNA vaccine against SARS-CoV-2 infection were not collected. This study aimed to evaluate vaccine effectiveness (VE) against documented infection. Bari Policlinico University Hospital health care workers (HCWs) who completed the vaccination schedule were matched with HCWs who had refused vaccination. VE for documented infection was 61.9% (95% confidence interval [CI], 19.2%-82.0%) 14-20 days after first dose, 87.9% (95% CI, 51.7%-97.0%) 21-27 days after first dose, and 96.0% (95% CI, 82.2%-99.1%) 7 or more days after second dose. Unvaccinated HCWs remain a concern in the context of the pandemic emergency.
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http://dx.doi.org/10.1093/infdis/jiab262DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8194590PMC
August 2021

Long-term persistence of poliovirus neutralizing antibodies in the era of polio elimination: An Italian retrospective cohort study.

Vaccine 2021 05 28;39(22):2989-2994. Epub 2021 Apr 28.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Introduction: The extensive use of oral and inactivated poliovirus (PV) vaccines has driven progress toward the global eradication of wild PV2 and PV3 and the elimination of PV1 in most countries, including Italy. Although the persistence of circulating neutralizing antibodies among the vaccinated is unclear, it is estimated that > 99% of the population vaccinated according to the recommended protocol should be protected for at least 18 years.

Methods: This study evaluated the seroprevalence of anti-PV neutralizing antibodies and the long-term immunogenicity of the oral poliovirus vaccine (OPV) in a sample of medical students and residents of the University of Bari who attended the Hygiene Department for a biological risk assessment between April 2014 and October 2020.

Results: The prevalence of protected vaccinated individuals was > 90% for PV1, PV2, and PV3. Specifically, >99% of the study group was protected against PV1, > 98% against PV2, and almost 93% against PV3. Protective antibodies against all three viruses persisted for at least up to 18 years after administration of the last OPV dose, with PV1 and PV2 antibodies detected in > 95% of the participants > 30 years after the last OPV dose.

Conclusions: The childhood series of four doses of OPV guarantees a long duration of protection, despite the elimination of the virus and therefore the absence of a natural booster. However, until PV1 is completely eradicated, maximum vigilance on the part of public health institutions must be maintained.
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http://dx.doi.org/10.1016/j.vaccine.2021.04.005DOI Listing
May 2021

Off-Label Use of COVID-19 Vaccines from Ethical Issues to Medico-Legal Aspects: An Italian Perspective.

Vaccines (Basel) 2021 Apr 23;9(5). Epub 2021 Apr 23.

Department of Biomedical Sciences and Human Oncology, Aldo Moro University of Bari, 70121 Bari, Italy.

During the COVID-19 outbreak, the lack of official recommendations on the treatment has led healthcare workers to use multiple drugs not specifically tested and approved for the new insidious disease. After the availability of the first COVID-19 vaccines (Comirnaty Pfizer-BioNTech and Moderna COVID19 vaccine), an authorization was issued by national and international Drug Regulatory Agencies in order to speed up their introduction on the market and their administration on a large scale. Despite the authorization, the off-label use of these vaccines may still be possible especially to answer specific concerns as the lack of vaccine doses, the delay in the delivery of planned doses or the pressure from public opinion and political influence also in relation to the evolution of the pandemic. This paper aims to assess the possible off-label use of COVID-19 vaccines and the ethical and medico-legal implications of this eventuality. The scope of this paper is to point out the possible consequences of off-label use of COVID-19 vaccines and possible mitigation and preventive measures to be taken by healthcare workers involved in vaccination procedures.
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http://dx.doi.org/10.3390/vaccines9050423DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8146018PMC
April 2021

Immunization coverage among asplenic patients and strategies to increase vaccination compliance: a systematic review and meta-analysis.

Expert Rev Vaccines 2021 Mar 14;20(3):297-308. Epub 2021 Feb 14.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Background: Asplenic or splenectomized patients have a higher risk (ranging from 10 to 50-fold) than the general population of developing an overwhelming post-splenectomy infection (OPSI). Thus, they should receive specific vaccinations to prevent bacterial infections and influenza. The aim of this meta-analysis was to estimate vaccination coverage (VC) with the recommended vaccines among splenectomized patients; strategies recommended in those studies to improve VC worldwide are considered as well.

Research Design And Methods: Scopus, MEDLINE/PubMed, Google Scholar and ISI Web of Knowledge databases were searched. Research papers, short reports, reviews, and meta-analyses published between January 1, 2010 and July 18, 2020 were included; no geographic restrictions were included. Twenty-four studies were included in the meta-analysis.

Results: For anti-pneumococcal vaccination, coverage was 55.1% (95%CI = 41.0-69.2%), for anti-Hib 48.3% (95%CI = 34.3-52.3%), for anti-meningococcal C/ACYW135 33.7% (95%CI = 23.6-43.9%), for anti-meningococcal B 13.3% (95%CI = 7.0-19.5%) and for anti-influenza 53.2% (95%CI = 22.0-84.4%). Most studies determined a lack of adherence to international guidelines by healthcare workers and suggested the need to better educate health professionals in the management of post-splenectomy patients.

Conclusions: The meta-analysis showed the suboptimal immunization coverage for the vaccines recommended for asplenic patients. Greater efforts must be made by public health professionals to increase VC in this group of patients at risk. Introducing specific prophylaxis protocols in the clinical routine seems to guarantee better immunization compliance in those patients.
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http://dx.doi.org/10.1080/14760584.2021.1886085DOI Listing
March 2021

Large-scale IgM and IgG SARS-CoV-2 serological screening among healthcare workers with a low infection prevalence based on nasopharyngeal swab tests in an Italian university hospital: Perspectives for public health.

Environ Res 2021 04 27;195:110793. Epub 2021 Jan 27.

Department of Biomedical Science and Human Oncology, University of Bari, Bari, Italy.

Background: Healthcare workers (HCWs) are highly exposed to SARS-CoV-2 infection given their specific tasks. The IgG-IgM serological assay has demonstrated good accuracy in early detection in symptomatic patients, but its role in the diagnosis of asymptomatic patients is uncertain. The aim of our study was to assess IgM and IgG prevalence in sera in a large cohort of HCWs previously subjected to Nasopharyngeal swab test (NST) after accurate risk assessment due to positive COVID-19 patient exposure during an observation period of 90 days.

Methods: 2407 asymptomatic HCWs that had close contact with COVID-19 patients in the period between April 8th and June 7th were screened with NST based on the RT-PCR method. In parallel, they underwent large-scale chemiluminescence immunoassays involving IgM-IgG serological screening to determine actual viral spread in the same cohort.

Results: During the 90-day observation period, 18 workers (0.75%) resulted positive for SARS-CoV-2 infection at the NST, whereas the positivity rates for IgM and IgG were 11.51% and 2.37%, respectively (277 workers). Despite high specificity, serological tests were inadequate for detecting SARS-CoV-2 infection in patients with previous positive NST results (IgM and IgG sensitivities of 27.78% and 50.00%, respectively).

Conclusions: These findings indicate a widespread low viral load of SARS-CoV-2 among hospital workers. However, serological screening showed very low sensitivity with respect to NST in identifying infected workers, and negative IgG and IgM results should not exclude the diagnosis of COVID-19. IgG-IgM chemiluminescence immunoassays could increase the diagnosis of COVID-19 only in association with NST, and this association is considered helpful for decision-making regarding returning to work.
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http://dx.doi.org/10.1016/j.envres.2021.110793DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839391PMC
April 2021

Long-term immunogenicity after measles vaccine vs. wild infection: an Italian retrospective cohort study.

Hum Vaccin Immunother 2021 07 27;17(7):2078-2084. Epub 2021 Jan 27.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

The persistence of specific IgG after measles infection and after measles vaccination has not been sufficiently investigated. Current evidence suggests that immunity after the disease is life-long, whereas the response after two doses of measles-containing vaccine declines within 10-15 years. This study evaluated the proportion of individuals with detectable anti-measles IgG in two groups, those vaccinated with two doses of anti-MMR vaccine and those with a self-reported history of measles infection. Among the 611 students and residents who were tested, 94 (15%) had no detectable protective anti-measles IgG. This proportion was higher among vaccinated individuals (20%; GMT = 92.2) than among those with a self-reported history of measles (6%; GMT = 213.3; < .0001). After one or two MMR vaccine booster doses, the overall seroconversion rate was 92%. An important proportion of people immunized for measles did not have a protective IgG titer in the years after vaccination, but among those who had a natural infection the rate was three-fold lower. This finding should be considered in the pre-elimination phase, given the resurgence of measles cases among individuals who after being vaccinated lost their circulating IgG after several years, especially if they failed to receive a natural booster.
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http://dx.doi.org/10.1080/21645515.2020.1871296DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8189124PMC
July 2021

COVID-19 hospital outbreaks: Protecting healthcare workers to protect frail patients. An Italian observational cohort study.

Int J Infect Dis 2021 Jan 4;102:532-537. Epub 2020 Nov 4.

Department of Biomedical Science and Human Oncology, University of Bari, Bari, Italy.

Objectives: To determine the prevalence of SARS-CoV-2 infection among exposed healthcare workers (HCWs) after preventive protocol implementation.

Methods: A total of 5750 HCWs were included in the study. Those in contact with COVID-19 patients were allocated into a high-risk or a low-risk group based on contact type (PPE- or non-PPE-protected); high-risk workers underwent nasopharyngeal swab tests, while among low-risk workers, swab tests were carried out only for symptomatic workers (active surveillance). The prevalence was determined by real-time reverse transcriptase-polymerase chain reaction on nasopharyngeal samples.

Results: 3570 HCWs had contact with 1065 COVID-19 patients. Among them, 3494 were subjected to active surveillance (low-risk group); 2886 (82.60%) were subjected to a swab test; and 15 were positive (0.52%). Seventy-six HCWs (2.13% of exposed) were included in the high-risk group, and a swab test was mandatory for each participant. Overall, 66 (86.84% of high-risk) were negative, and 10 were positive (13.16%), resulting in a higher risk of infection than in the low-risk group [OR = 29.00; 95% CI:12.56-66.94; p < 0.0001].

Conclusion: To date, the SARS-CoV-2 infection prevalence is 0.70% among exposed HCWs and 0.435% among all HCWs working at the examined university hospital. The correct use of PPE and the early identification of symptomatic workers are essential factors to avoiding nosocomial clusters.
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http://dx.doi.org/10.1016/j.ijid.2020.10.098DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610093PMC
January 2021

Resources for assessing parents' vaccine hesitancy: a systematic review of the literature.

J Prev Med Hyg 2020 Sep 6;61(3):E340-E373. Epub 2020 Oct 6.

Post Graduate School of Hygiene and Preventive Medicine, Department of Experimental Medicine, University of Perugia, Italy.

The concept of Vaccine Hesitancy has begun to appear in the scientific landscape, referring to the reluctance of a growing proportion of people to accept the vaccination offer. A variety of factors were identified as being associated with vaccine hesitancy but there was no universal algorithm and currently there aren't any established metrics to assess either the presence or impact of vaccine hesitancy. The aim of this study was to systematically review the published questionnaires evaluating parental vaccine hesitancy, to highlight the differences among these surveys and offer a general overview on this matter. This study offers a deeper perspective on the available questionnaires, helping future researches to identify the most suitable one according to their own aim and study setting.
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http://dx.doi.org/10.15167/2421-4248/jpmh2020.61.3.1448DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595070PMC
September 2020

Incident Reporting System in an Italian University Hospital: A New Tool for Improving Patient Safety.

Int J Environ Res Public Health 2020 08 28;17(17). Epub 2020 Aug 28.

Interdisciplinary Department of Medicine, Section of Legal Medicine, University of Bari, Piazza Giulio Cesare 11, 70100 Bari, Italy.

Clinical risk management constitutes a central element in the healthcare systems in relation to the reverberation that it establishes, and as regards the optimization of clinical outcomes for the patient. The starting point for a right clinical risk management is represented by the identification of non-conforming results. The aim of the study is to carry out a systematic analysis of all data received in the first three years of adoption of a reporting system, revealing the strengths and weaknesses. The results emerged showed an increasing trend in the number of total records. Notably, 86.0% of the records came from the medical category. Moreover, 41.0% of the records reported the possible preventive measures that could have averted the event and in 30% of the reports are hints to be put in place to avoid the repetition of the events. The second experimental phase is categorizing the events reported. Implementing the reporting system, it would guarantee a virtuous cycle of learning, training and reallocation of resources. By sensitizing health workers to a correct use of the incident reporting system, it could become a virtuous error learning system. All this would lead to a reduction in litigation and an implementation of the therapeutic doctor-patient alliance.
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http://dx.doi.org/10.3390/ijerph17176267DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7503737PMC
August 2020

Vaccination coverage among paediatric onco-haematological patients: an Italian cross-sectional study.

Hum Vaccin Immunother 2021 03 26;17(3):818-823. Epub 2020 Aug 26.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Children with onco-hematological diseases are at increased risk of infection. However, this risk can in part be controlled or reduced using currently available vaccines. Despite available evidence, in patients diagnosed with a hematological or oncological disease the vaccination schedule is often inappropriately discontinued. In this study we evaluated whether the diagnosis of an oncological or hematological disease is a determinant of noncompliance with recommended vaccinations.The study was carried out between March and April 2019. The population was composed of a convenience sample of 228 children cared for in the Pediatric Oncology Department and Pediatric Hematology Department of the Policlinico Giovanni XXIII Pediatric Hospital (Bari, Italy) from 2005 to 2015. Information on the immunization status of the patients was obtained from the Apulia regional immunization database (GIAVA). A post-diagnosis adherence score was calculated.The vaccination coverage was 87.7% for the DTaP-IPV-Hep B-Hib vaccine (3 doses), 68.7% for the pneumococcal vaccine (3 doses), 75.8% for the MMR vaccine (2 doses) and 75.1% for the varicella vaccine (2 doses). The average age at vaccination was older than that recommended by the National Vaccination Plan. A diagnosis of oncological disease and an older age at enrollment were risk factors for missing vaccinations. These results showed that the overall vaccination status of pediatric onco-hematological patients is suboptimal. Improving provider communication and establishing the hospital as the primary environment for vaccine administration may lead to better vaccination compliance in this group.
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http://dx.doi.org/10.1080/21645515.2020.1797367DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993150PMC
March 2021

Prevalence and management of measles susceptibility in healthcare workers in Italy: a systematic review and meta-analysis.

Expert Rev Vaccines 2020 07 9;19(7):611-620. Epub 2020 Jul 9.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari , Bari, Italy.

Introduction: The national and international guidelines recommend evaluating all healthcare workers (HCWs) for their measles immune status and possibly vaccinating those who are seronegative.

Areas Covered: We conducted a systematic review and meta-analysis in order to estimate the rate of measles susceptibility among HCWs in Italy and to explore possible options for the management of those found to be susceptible. Twenty-three studies were included in the meta-analysis. The prevalence of HCWs susceptible to measles was 11.5% (95%CI = 8.1-15.4%) and was higher in studies in which prevalence was evaluated by survey (16.7%; 95%CI = 8.9-26.3) than by the direct evaluation of blood specimens (9.1%; 95%CI = 6.2-12.5%). Occupational medicine examinations for measles screening with possible subsequent vaccination of seronegatives and the exclusion of susceptible HCWs from high-risk settings were common management strategies.

Expert Opinion: HCWs susceptible to measles are an important epidemiological concern in Italy, and efforts to identify and actively offer the vaccine to this population should be increased.
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http://dx.doi.org/10.1080/14760584.2020.1791091DOI Listing
July 2020

Long time persistence of antibodies against Mumps in fully MMR immunized young adults: an Italian retrospective cohort study.

Hum Vaccin Immunother 2020 11 18;16(11):2649-2655. Epub 2020 Mar 18.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari , Bari, Italy.

Protective levels of antibodies induced by the MMR vaccine have been shown to decline over time, but actually there is not a formal recommendation about the opportunity of testing immunized HCWs to investigate the persistence of anti-Mumps IgG. This study aims to evaluate the long-time immunogenicity of MMR vaccination in a sample of medical students and residents of the University of Bari who attended the Hygiene Department for the biological risk assessment (April 2014-June 2018). A strategy for the management of non-responder subjects has been experimented and described. Two thousand students and residents, with documented immunization status (two doses of MMR vaccine), have been tested. 120/2,000 (6%; 95%CI = 5.0-7.1%) subjects did not show anti-Mumps IgG. This percentage was similar among males and females. After a third MMR dose, we noted a seroconversion of 90% of seronegative participants. No serious adverse events were recorded. An important proportion of subjects immunized for MMR do not show an antibodies protective titer. The immunogenicity and the safety of the third dose seem confirmed by our data. Including the screening model described in the routine assessment of the biological risk of medical students and HCWs may be a winning strategy in preventing Mumps nosocomial infection.
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http://dx.doi.org/10.1080/21645515.2020.1735861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734140PMC
November 2020

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017.

Hum Vaccin Immunother 2020 08 10;16(8):1875-1883. Epub 2020 Feb 10.

Biomedical Science and Human Oncology, Aldo Moro University of Bari , Bari, Italy.

Since 2006, some Italian Regions introduced the active offer of measles, mumps, rubella, and varicella (MMRV) vaccine for all newborns during the second years of life. In 2011, Italian Drug Authority (AIFA) recommended the discontinuation of the MMRV use for an increased risk of febrile seizures following vaccination; furthermore, some Regions (such as Apulia, that introduced MMRV offer in 2009) chose to continue the use of MMRV and Ministry of Health recommended to guarantee supplemental monitoring of safety of the vaccine. In Italy, the surveillance of Adverse Events following immunization (AEFIs) is currently carried out by AIFA and Regional Health Authorities; this paper aims to summarize the results of MMRV-vaccine surveillance of AEFIs program carried out in Apulia. From the AIFA database, we selected MMRV AEFIs that occurred in Apulia (about 4,000,000 inhabitants) from 2009 to 2017. For serious AEFIs, we applied the WHO causality assessment algorithm, using for cases hospitalized information from individual medical records. In the 8 years of observation, 155 MMRV-AEFIs (reporting rate: 37.9×100,000 doses) occurred of which 26 were classified as serious (6.3×100,000 doses) and 22 led to hospitalization. Performing causality assessment, for 10 the classification was "consistent causal association to immunization" (reporting rate: 2.4×100000 doses), for 2 indeterminate, for 13 "inconsistent causal association to immunization" and for 1 not-classifiable. No case of febrile seizure resulted consistent to vaccination. All consistent serious AEFIs were completely resolved at subsequent follow-up.
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http://dx.doi.org/10.1080/21645515.2019.1704124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7482746PMC
August 2020

Compliance with immunization and a biological risk assessment of health care workers as part of an occupational health surveillance program: The experience of a university hospital in southern Italy.

Am J Infect Control 2020 04 19;48(4):368-374. Epub 2019 Nov 19.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Background: The active immunization of health care workers (HCWs) is a primary measure to prevent nosocomial infection; despite this, vaccine coverage among HCWs in most countries is low. To increase vaccine coverage in the health care setting, the hygiene and occupational medicine departments of Bari Policlinico General University-Hospital implemented a vaccination procedure. This operative procedure requires that during the occupational medical examination, all employees are evaluated for immunity/susceptibility to vaccine-preventable diseases, with vaccination offered to those determined to be susceptible.

Methods: The study sample comprised HCWs who attended the biological risk assessment program from December 2017 to January 2019 (n = 449).

Results: Susceptibility was higher for hepatitis B virus (23%), followed by rubella (11%), varicella (9%), mumps (8%), and measles (7%). The seroconversion rate after the administration of booster dose(s) was >80% for all vaccines. Overall, 15% of the HCWs refused the offered vaccine(s), and the main determinants of vaccination compliance were younger age (P < .0001) and being a physician (P < .05).

Discussion: Despite the several recommendations and campaigns to promote vaccinations, achieving high immunization rates among HCWs is still a challenge.

Conclusions: In this scenario, public health institutions have to choose between the enforcement of the promotion or the adoption of a mandatory policy.
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http://dx.doi.org/10.1016/j.ajic.2019.09.024DOI Listing
April 2020

Immunity to rubella: an Italian retrospective cohort study.

BMC Public Health 2019 Nov 8;19(1):1490. Epub 2019 Nov 8.

Department of Biomedical Science and Human Oncology, "Aldo Moro" University of Bari, Piazza Giulio Cesare 11, 70124, Bari, Italy.

Background: International guidelines recommend that healthcare workers (HCWs) have presumptive evidence of immunity to rubella and that susceptible HCWs and doubt cases receive two doses of the MMR vaccine. However, a small percentage of the fully immunized will remain unprotected against wild viruses. Moreover, protective levels of antibodies induced by the vaccine have been shown to decline over time, but a formal recommendation regarding the testing of immunized HCWs for the persistence of IgG against rubella is lacking.

Methods: The aim of this study was to evaluate the long-term immunogenicity conferred by rubella vaccination and the effectiveness of a strategy for the management of immunized individuals in whom IgG against rubella could not be demonstrated (non-responders). The study enrolled students and medical residents who attended the Hygiene Department of Bari Policlinico University Hospital for biological risk assessment (April 2014 to June 2018).

Results: Two thousand students and residents with documented immunization (≥2 doses of rubella or MMR vaccine) were tested. In 181 (9%), IgG against rubella was not detectable. The seronegative rate was higher among participants vaccinated at age < 2 years (89.6%) and lower among those immunized at age ≥ 2 years (93.6%; p < 0.0001). The administration of a single MMR booster dose resulted in a seroconversion rate of 98% in the seronegative group. The seroconversion rate after a second booster dose was 100%. No serious adverse events in the re-immunized were recorded.

Conclusions: An important proportion of individuals immunized for rubella or MMR do not have a protective titer for the disease(s). Our management strategy (booster followed by re-test and, for those who are still negative, a second booster and re-test) is consistent with the goal of achieving immunological memory.
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http://dx.doi.org/10.1186/s12889-019-7829-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6842203PMC
November 2019

Epidemiology of injuries among amateur athletes who attended fitness activities: the role of the qualification of the trainer.

J Sports Med Phys Fitness 2020 Mar 25;60(3):422-427. Epub 2019 Oct 25.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy -

Background: The fitness trainer could have an important role in the prevention of injuries among fitness attendants. In several Countries, including Italy, there is not a formal regulation about the qualification of fitness trainers. The aim of our study is to estimate the incidence of injuries in a sample of amateur fitness athletes training in Apulia (southern Italy) and evaluate if being the presence of a trainer graduated in Sports and Movement Science could be a protective factor for injuries.

Methods: This is a retrospective, cross-sectional study, carried out in a convenience sample of amateur athletes enrolled in 16 Apulian fitness centers. The survey was carried out by an anonymous self-administered questionnaire distributed and compiled in the gym.

Results: We enrolled 205 amateur athletes, of which 105/205 (51.2%) cared by a trainer graduated in Sports and Movement Science and 100/205 (48.8%) trained by a person with a qualification from Olympic Committee or Sport Federation. The incidence rate of injury ×1000 person-months of training is 6.1 (95%CI=4.4-8.1), 5.5 (95%CI=3.1-9.2) among athletes trained by graduated and 6.3 (95%CI=4.2-9.2) in ones trained by a person with a different qualification (IRR=1.1; 95%CI=0.6-2.3; P=0.348).

Conclusions: Our study showed a mild lifetime prevalence of injury among subjects attending fitness activities (21%), higher among athletes trained by an instructor not graduated in Sports Science. This is a topic poorly investigated previously but very important in the future, in particular in the view of the diffusion of fitness worldwide.
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http://dx.doi.org/10.23736/S0022-4707.19.10068-0DOI Listing
March 2020

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017-2018.

Vaccines (Basel) 2019 Oct 7;7(4). Epub 2019 Oct 7.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari 70124, Italy.

Since 2012, the Italian Ministry of Health has recommended to improve the surveillance of adverse events following the measles-mumps-rubella-varicella (MMRV) tetravalent vaccine that was provided in the official immunization schedule of some Italian regions for children during the second year of life. This recommendation was based on data from some surveys that showed an additional risk of seizure following the administration of this vaccine. Responding to the Ministry commitment, the Puglia Region launched, from May 2017 to November 2018, a post-marketing active surveillance program of adverse events following MMRV immunization (AEFIs). Immunized children (second year of life) were enrolled on a voluntary basis, AEFIs diaries were used, and their parents were interviewed 25 days after the immunization. There were 2540 children enrolled; 2149/2540 (84.6%) completed the post-vaccination follow-up. Of these, 992 AEFIs were registered with a reporting rate of 46.2 × 100 doses: 883/992 (89.0%) AEFIs were not serious, while 109/992 (11.0%) were serious. For serious AEFIs, the evaluation of causality assessment was performed using the algorithm proposed by the World Health Organisation (WHO): 82/109 consistent causal associations to MMRV immunization were detected (reporting rate of consistent AEFIs: 3.8 × 100 follow-up). All serious AEFIs consistently associated with immunization resulted completely resolved at the follow-up. The reporting rate of seizure consistently associated with immunization was 0.05 × 100, lower than data previous published in the literature that did not report the causality assessment. Because no emerging signals were detected, our data from the active surveillance program confirmed the safety profile of the MMRV vaccine.
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http://dx.doi.org/10.3390/vaccines7040140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963278PMC
October 2019

Long-term Immunogenicity of Measles Vaccine: An Italian Retrospective Cohort Study.

J Infect Dis 2020 02;221(5):721-728

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Background: Levels of antibodies induced by the measles virus-containing vaccine have been shown to decline over time, but there is no formal recommendation about testing immunized subjects (in particular, healthcare workers [HCWs]) to investigate the persistence of measles immunoglobulin G (IgG).

Methods: This study aims to evaluate the long-term immunogenicity of measles vaccine in a sample of medical students and residents of the University of Bari who attended the Hygiene Department for a biological risk assessment (April 2014-June 2018).

Results: Two thousand immunized (2 doses of measles-mumps-rubella [MMR] vaccine) students and residents were tested; 305 of these (15%) did not show protective anti-measles IgG. This proportion was higher among subjects who received vaccination at ≤15 months (20%) than in those who received vaccination at 16-23 months (17%) and at ≥24 months (10%) (P < .0001). After an MMR vaccine booster dose, we noted a seroconversion of 74% of seronegative HCWs. The overall seroconversion rate after a second dose (booster) was 93%. No serious adverse events were noted after the booster doses.

Conclusions: An important proportion of subjects immunized for measles do not show a protective IgG titer in the 10 years after vaccination. Our management strategy seems consistent with the purpose of evidencing immunological memory.
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http://dx.doi.org/10.1093/infdis/jiz508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7026886PMC
February 2020

Immunization Campaigns and Strategies against Human Papillomavirus in Italy: The Results of a Survey to Regional and Local Health Units Representatives.

Biomed Res Int 2019 4;2019:6764154. Epub 2019 Jul 4.

Policlinic San Martino Hospital, Genoa, Italy.

The study aimed to assess the impact of HPV immunization campaigns organizational aspects, the characteristics of immunization program (vaccination targets and type of offer), and communicative strategies adopted by four Italian administrative regions on vaccination coverage observed. From November 2017 to March 2018, regional and Local Health Units (LHUs) representatives were invited to complete an online survey including 54 questions evaluating vaccination invite systems, access systems to vaccination centres, reminder and recall systems, and adverse events surveillance. An overall descriptive analysis was conducted. Since observed vaccine coverage (VC) obtained in females (2002-2004 birth cohorts) was lower than objectives fixed by the Italian Ministry of Health, variables were assessed using the national VC mean obtained in the 2003 girls birth cohort as outcome. Twenty-six LHUs belonging to 4 Northern and Southern Italian regions participated in the study. Organizational aspects significantly related to VC lower than the national mean were access to vaccine centres without appointment and parents' reservation as appointment planning system. Recall systems for both the first and the second dose, including the appointment in the invitation letter, the availability of regional immunization registry, and education of healthcare workers on universal HPV immunization strategies, instead, were related to higher VC. As regards preadolescent immunization strategies, both VC obtained in girls and boys were far from the Ministerial goals. Only 20% of LHUs introduced multicohort female strategies while all LHUs adopted copayment targeting both men and women. Immunizations strategies targeting subjects at risk were implemented only in half of participating LHUs. VC observed in participating LHUs are largely lower than the national objectives in all anti-HPV vaccine targets. Both organizational and educational strategies have to be implemented to improve the VC goals.
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http://dx.doi.org/10.1155/2019/6764154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6637711PMC
December 2019

Influenza vaccination in health-care workers: an evaluation of an on-site vaccination strategy to increase vaccination uptake in HCWs of a South Italy Hospital.

Hum Vaccin Immunother 2019 25;15(12):2927-2932. Epub 2019 Jul 25.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Despite the international recommendation and specific programs, and although the vaccination of health-care workers (HCWs) is considered the main measure to prevent nosocomial influenza, vaccination coverage (VC) among HCWs remains low. One of the most important barriers to vaccination uptake is the time required to attend a vaccination clinic. Centers for Disease Control and Prevention (CDC) recommends on-site influenza vaccination as a proven and cost-effective strategy that increases productivity, reduces overall absenteeism and prevents direct health-care costs. In order to increase vaccine compliance in the HCWs, the Hygiene and the Occupational Medicine departments of Bari Policlinico General University-Hospital, in the 2017/18 influenza season, promoted an on-site vaccination program in eight Operative Units (OUs). We investigated the influenza VC among HCWs of Bari Policlinico (n = 3,397), comparing VC after implementation of the on-site strategy by the Hygiene department during the 2017/18 influenza season to VC in 2016/17 season. For 2017/18 season, we also compared VC in OUs target of on-site strategy with data from in eight "control" Units (choose by simple random sampling) not included in the on-site offer. In the 2016/17 influenza season, 295/3,397 HCWs were vaccinated (VC: 8.7%) while in the 2017/18 season 482 HCWs (VC: 14.2%) received the vaccination. In OUs target of on-site vaccination, 71 HCWs (VC: 10.0%) were vaccinated in the 2016/17 season and 126 (18.0%) in the 2017/18 season, of which 101/126 (80.2%) were vaccinated in an on-site clinic. VC in OUs target of on-site vaccination increased between 2016/17 and 2017/18 seasons of 16.8 ± 10.4% (range: 5.5-37.1), while the coverage in OUs of the control group increased of 1.6 ± 2.2% (range: -1.7-4.5), with a significant difference ( < .05). Our study suggests that the offer of on-site vaccination during the 2017/18 season led to an increase of VC in HCWs compared to the classical vaccination clinic approach. The determinants of adhesion and not-adhesion must be analyzed in dept, to experiment, in the future, new good clinical practices to increase the vaccination coverage in HCWs.
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http://dx.doi.org/10.1080/21645515.2019.1625645DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6930094PMC
May 2020

Influenza vaccination coverage among splenectomized patients: an Italian study on the role of active recall in the vaccination compliance.

Hum Vaccin Immunother 2019 7;15(11):2644-2649. Epub 2019 May 7.

Department of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari, Italy.

Patients with anatomical or functional hypo-/a-splenia have a 10- to 50-fold higher risk of developing severe infectious diseases than does the general population. Thus, it is recommended to adhere to a specific vaccination schedule, including receiving influenza vaccine. During 2014, Bari Policlinico General Hospital approved a specific protocol to ensure that vaccines are actively offered to all splenectomized patients during their hospitalizations. The aim of this study is to evaluate the efficacy of this active recall protocol for performing influenza vaccination in the years following splenectomy among patients still involved in a specific vaccination program carried out by the hospital's Hygiene department. From May 2014 to October 2016, 96 patients were involved in the vaccination program of the Hygiene department. In November 2017, 46/96 (48%) of patients received a specific invitation by phone to receive the annual influenza vaccine (intervention group), while 50/96 (52%) did not receive any such invitation (control group). At the end of the 2017 influenza season, 73/96 (76%; 95%CI = 66-84%) of patients reported having received the influenza vaccine; no differences were observed in the extent of vaccine coverage between the groups (intervention group = 80% vs. control group = 72%; = 0.33). Older age, more recent splenectomy, hemo-lymphopathy and receiving the previous years' doses of influenza vaccine are associated with receiving influenza vaccination during the 2017 season. These data indicate how effective communication at the time of the vaccine counseling results in good adherence to the vaccination program even after several years. Indeed, vaccination should be an opportunity not only limited to the administration of the vaccine but also for providing patient care.
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http://dx.doi.org/10.1080/21645515.2019.1599678DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6930075PMC
May 2020

Systematic causality assessment of adverse events following HPV vaccines: Analysis of current data from Apulia region (Italy).

Vaccine 2018 02 19;36(8):1072-1077. Epub 2018 Jan 19.

Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy.

Since 2013, World Health Organization (WHO) recommended that adverse events following immunization (AEFIs) should be evaluated by a standardized algorithm for causality assessment, however the use of WHO procedure is rarely adopted. In Italy, AEFIs (classified only by temporal criteria) are registered in the National Drug Authority (AIFA) database, but causality assessment is not mandatory. Every year AIFA publishes the AEFIs report, that doesn't contain information about causal correlation between events and vaccines. From AIFA database, we selected AEFIs following human papillomavirus vaccination (HPV) reported in Apulia (about 4,000,000 inhabitants) during 2008-2016. For serious AEFIs, we applied WHO causality assessment criteria; for cases hospitalized, we repeated the assessment getting additional information from health documentation. In 2008-2016, 100 HPV AEFIs (reporting rate: 17.8 per 100,000 doses) were registered of which 19 were serious (rate: 3.4 per 100,000 doses) and 12 led to hospitalization. After causality assessment, for 9 AEFIs the classification was "consistent causal association to immunization", for 3 indeterminate, for 5 "inconsistent causal association to immunization" and for 2 not-classifiable. Among hospitalized patients, 5 AEFIs were consistent, 5 inconsistent, 1 not-classifiable and 1 indeterminate; adding information from health documentation, the results were similar except for indeterminate and not classifiable AEFIs that turned into "not consistent". Only half of severe AEFIs could be associated with vaccination and this suggests that AIFA report provides a incomplete picture of HPV vaccine safety, with a risk for readers to confound "post hoc" and "propter hoc" approach without considering the causality assessment results. In the view of the systematic use of WHO causality assessment algorithm in the AEFI surveillance, the efforts of Public Health must be focused on the improvement of the quality of the information provided to reduce conclusions inter-observer variability; the routine follow-up of reports, also to collect additional information, must be guaranteed.
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http://dx.doi.org/10.1016/j.vaccine.2018.01.018DOI Listing
February 2018

Vaccination coverage in patients affected by chronic diseases: A 2014 cross-sectional study among subjects hospitalized at Bari Policlinico General Hospital.

Am J Infect Control 2018 Jan 20;46(1):e9-e11. Epub 2017 Nov 20.

Department of Biomedical Sciences and Human Oncology, University of Bari Aldo Moro, Bari, Italy. Electronic address:

Subjects affected by at least 1 chronic disease are the target of influenza vaccination strategies because they are at high risk of influenza complications or death. The aim of this cross-sectional study is to evaluate flu and pneumococcal vaccination coverage (VC) in a sample of patients hospitalized at Bari Policlinico General Hospital (South Italy). According to national public health guidelines, these patients should have been vaccinated at hospital discharge by general practitioners. There were 540 patients involved in the study, and the average age was of 46.9 ± 13.4 years (range, 0-64 years). We assessed the vaccination status of 412 of 540 (76.3%) patients. The overall VC was 22.8% (94/412) for influenza and 7.2% (30/412) for pneumococcal vaccine. Doctor recommendation has a pivotal importance in vaccine acceptance, and recent experiences seem to show a high efficacy of the vaccination offer during hospitalization. This model could be helpful to improve influenza and pneumococcal vaccination offers to patient with underlying chronic conditions.
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http://dx.doi.org/10.1016/j.ajic.2017.10.004DOI Listing
January 2018
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