23-valent pneumococcal polysaccharide vaccine (PPV23) for the prevention of invasive pneumococcal diseases (IPDs) in the elderly: is it really effective?

Introduction. Incidence of invasive pneumococcal diseases (IPDs) in Italy is constantly increasing and that is particularly true among the elderly. 23-valent polysaccharide pneumococcal vac- cine (PPV23) is recommended to this age group and offered in all Italian regions. However, efficacy of PPV23 on preventing IPDs is debated. We therefore performed a review of the most recent avail- able meta-analyses in order to assess the efficacy of PPVs. Methods. The literature search was conducted using PubMed and Scopus search engines. We used the following keywords: ?pneu- mococcal?, ?polysaccharide?, ?vaccine?, ?efficacy?, ?elderly?, ?meta analysis?. Only meta-analyses published in the last 7 years were selected. We examined the results of the selected meta-anal- yses and assessed their quality according to the PRISMA recom- mendations. Results. The search returned 16 results in PubMed and 12 in Scopus: among them we selected 3 meta-analyses. According to our quality assessment, all meta-analyses showed generally posi- tive results and almost all items of the PRISMA checklist were respected. However, the research protocol and the registration number were absent in all the 3 revisions and the flow-chart was not shown in Moberley?s and Melegaro?s works. In the study by Huss et al. the relative risk of developing IPDs among vaccinated subjects was 0.90 (95%CI: 0.46-1.77, I2 4.9%), indicating a very slight benefit after vaccination. This contrasts with the results of the Cochrane Review by Moberley et al., in which the PPVs showed a protective efficacy in reducing the risk of IPDs of 74% (OR 0.26, 95%CI: 0.15-0.46) with no statistical heterogeneity (I2 0%). Melegaro et al. found a reduction not statistically signifi- cant of the incidence of IPD of 65% (OR 0.35; 95%CI 0.08-1.49) among healthy elderly, while the global estimate of vaccine efficacy among high risk elderly was minimal (OR 0.80; 95%CI 0.22-2.88). Conclusions. Most of the studies suggest that the PPVs confer low protection against IPDs. Anyhow, their methodological het- erogeneity does not allow definitive conclusions. While waiting to see the results of new trials about the efficacy of PPVs, in particular of PPV23, and the extension of the use of conjugate vaccine among the population over 65, stakeholders should be aware of the results of the meta-analyses discussed in this paper during the implementation of the vaccination programs for the elderly in Public Health. The full article is free available on www.jpmh.or

Vaccine market access pathways in the EU27 and the United Kingdom-analysis and recommendations for improvements

Background: Vaccine market access (VMA) pathways across the European Union (EU) and the United Kingdom (UK) are complex, lengthy, and heterogeneous, particularly when compared with pharmaceuticals. The knowledge base to inform recommendations for optimization of VMA is lacking. We therefore conducted a comprehensive evaluation of EU VMA pathways. Methods: Research in two phases included: (1) mapping VMA pathways in each EU member state (including the UK) based on a literature review, expert interviews, and mathematical archetyping; and (2) interviews with vaccine experts to identify barriers, drivers, and recommendations for regional VMA alignments. Results: Key steps in VMA across the EU include horizon scanning, early advice, National Immunization Technical Advisory Group (NITAG) recommendation for inclusion in national immunization programs, health technology assessment (HTA), final decision and procurement. We found significant complexity and heterogeneity, particularly for early advice, and in the roles, decision-making criteria, and transparency of NITAGs and HTA bodies. The most important drivers for rapid VMA included demonstration of disease burden and vaccine benefit (e.g., efficacy, safety, economic). Key barriers were budget limitations and complexity/clarity of VMA processes (e.g., need for national-regional consensus, clarity on process initiation, and clarity on the role of HTA). Recommendations for alignment at EU and member-state levels include information sharing, joint clinical assessment, initiatives to address funding and political barriers, and improved transparency by decision-making bodies. Early engagement with vaccine stakeholders was a key recommendation for manufacturers. Conclusions: There is significant potential for alignment, collaboration, and improvement of VMA across the EU. Roles, responsibilities, and transparency of key bodies can be clarified. The COVID-19 pandemic response should stimulate policies to improve access to all vaccines, including routine ones, and form the foundation upon which a consistent vaccine ecosystem can be created for the EU, one that is resilient, consistent between member states, and fit for purpose

recommendations to optimise reporting of epidemiological studies on antimicrobial resistance and informing improvement in antimicrobial stewardship

Objectives To explore the accuracy of application of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) tool in epidemiological studies focused on the evaluation of the role of antibiotics in selecting resistance, and to derive and test an extension of STROBE to improve the suitability of the tool in evaluating the quality of reporting in these area. Methods A three-step study was performed. First, a systematic review of the literature analysing the association between antimicrobial exposure and acquisition of methicillin-resistant Staphylococcus aureus and/or multidrug-resistant Acinetobacter baumannii was performed. Second, articles were reviewed according to the STROBE checklist for epidemiological studies. Third, a set of potential new items focused on antimicrobial-resistance quality indicators was derived through an expert two-round RAND-modified Delphi procedure and tested on the articles selected through the literature review. Results The literature search identified 78 studies. Overall, the quality of reporting appeared to be poor in most areas. Five STROBE items, comprising statistical analysis and study objectives, were satisfactory in <25% of the studies. Informative abstract, reporting of bias, control of confounding, generalisability and description of study size were missing in more than half the articles. A set of 21 new items was developed and tested. The new items focused particularly on the study setting, antimicrobial usage indicators, and patients epidemiological and clinical characteristics. The performance of the new items in included studies was very low (<25%). Conclusions Our paper reveals that reporting in epidemiological papers analysing the association between antimicrobial usage and development of resistance is poor. The implementation of the newly developed STROBE for antimicrobial stewardship (AMS) tool should enhance appropriate study design and reporting, and therefore contribute to the improvement of evidence to be used for AMS programme development and assessment

Knowledge, attitudes and behaviour about Sexually Transmitted Infections: a survey among Italian university female students

Aims: Improvements have been made in terms of STIs mortality, but young women still have a lack of attention to the STIs prevention. We investigated the knowledge and attitudes about STIs and their prevention among a sample of Italian university female students. Methods: We designed a questionnaire about knowledge and attitudes toward STIs, Papanicolau test (Pap test) and Human Papilloma Virus (HPV) and had it filled out by 285 young women. Chi-square test, Mann-Whitney test and a multivariable analysis were performed in order to identify associated factors. &nbsp; Results: Knowledge about STIs seems weak, oppositely to knowledge about preventive measures. In line with the results of the univariate analyses, the multivariable one confirmed a higher probability to answer rightly for women who knew the effective behaviours for preventing STIs, women who took information about STIs from Internet, books and TV and those using natural methods (OR 2.77 - 95%CI 1.47-5.23, OR 2.99 - 95%CI 1.62-5.53 and OR 2.55 - 95%CI 1.05-6.18, respectively) and a lower one for students from Cassino and those who knew is possible to recover from STIs (OR 0.38, 95%CI 0.17-0.87 and 0.42, 95%CI 0.20-0.88, respectively). Furthermore, about Pap test it also confirmed the role of a medium-high STIs level of knowledge (OR 2.11, 95%CI 1.02-4.37) and a lower probability to know about it for women from Cassino (OR 0.25, 95%CI 0.09-0.73). Conclusions: Young women are not completely aware of STIs risks and preventive measures. Informational and educational campaigns should be implemented to reach this target group and lighten the current and future burden of STIs

"Integrating China in the International Consortium for Personalized Medicine": The Coordination and Support Action to Foster Collaboration in Personalized Medicine Development between Europe and China

"Integrating China in the International Consortium for Personalized Medicine" (IC2PerMed) is a coordination and support action funded within the Horizon 2020 work program. Following the guidance of the International Consortium for Personalized Medicine (ICPerMed), the project's overarching aim is to align the European Union and China's research agendas in the field of personalized medicine (PM) to enable a swift development of PM approaches in the EU with strong leverage upon EU-Chinese collaboration. Living in the CO­VID-19 era, we are witnessing how the challenges imposed by the pandemic all around the globe have been acting as a catalyst for collaborations and knowledge sharing among national health systems worldwide. Given the strong interest on behalf of both Europe and China in the advancement of PM approaches, now more than ever, a cross-border collaboration between the 2 powers can accelerate the effective translation of such innovation to healthcare systems, advance research, and ensure that such change follows the directions toward the path of sustainability. IC2PerMed developments will be led by European and Chinese experts equally assembled into 3 Working Groups: (1) people and organization, (2) innovation and market, and (3) research and clinical studies in PM. This complex and dynamic network of actions thrives on dialog, cooperation, and alignment of research at national and global levels; work in the direction taken by IC2PerMed shall pave the way toward the realization of PM's full potential, prevent it from becoming a burden for healthcare systems, and, rather, prove that it provides an essential and irreplaceable contribution to their effectiveness, efficiency, and sustainability

Structural accreditation of healthcare facilities: comparison of the requirements by Italian Presidential Decree 14/01/1997 and regional regulations. A proposal for updating the minimum environmental units at national level

Background and aim: The Decree of the President of the Italian Republic 14/01/1997 is the reference norm related to the accreditation of public and private healthcare structures. This guideline establishes the minimum structural, technological and organizational requirements that each structure operating in the Italian territory must comply with. Methods: In occasion of the project work for the postgraduate training course in healthcare management by ALTEMS School, a team of researchers conducted a survey on the state of updating of the minimum structural requirements indicated in the norm-in particular those relating to hospital facilities- with those adopted by the individual regions through the analysis of the most up-to-date regional regulations. Results: Precisely starting from the comparison of regional references and from the regulations on the subject of structural accreditation which suggest strategic environmental units and which address some key-aspects relating to the contemporary design of healing environments (i.e. semi-intensive care units, hybrid operating theatres, etc.), the outcome of the project work is to define a proposal to update the national reference document, also in the light of the currently changing needs in terms of hospital design. Conclusions: The research aims to become a starting milestone for future investigations. The team investigated - in this first phase - the functional areas listed in the norm, and the next step aims to extend the analysis also to the innovative functions (i.e. buffer spaces, hybrid operating theatres, sub-intensive care units, etc.) and/or introduced only the last years which have only been regulated in some regions

Training needs assessment of European frontline health care workers on vaccinology and vaccine acceptance: a systematic review

Background The issue of reluctance towards vaccination is becoming more worrisome. Health care workers (HCWs) are the primary point of contact with individuals who make decisions about vaccination. Therefore, it is crucial that HCWs receive sufficient training and periodic updates. The main objective of this systematic review is to evaluate the HCWs' training needs in vaccination and vaccine uptake. Methods In February 2022, a search was conducted on MEDLINE, Scopus and Google Scholar databases. The search included papers written in English, Italian, Portuguese, Spanish, French and Romanian, with a publication date ranging from 1 January 2011 to 24 February 2022 and conducted in Europe. To assess the methodological quality of the papers, the Appraisal tool for Cross-Sectional Studies was utilized. Results The search of scientific literature yielded 640 outcomes on PubMed, 556 on Scopus and 15 on Google Scholar, for a total of 1211 records. After eliminating duplicates, screening titles and abstracts and evaluating the full text of the articles, only 25 of them were found suitable for inclusion. The studies' overall quality ranged from moderate to good. The majority of the research emphasized the need for improved knowledge of vaccine-preventable diseases, vaccine efficacy, immunization schedules and vaccine adverse effects. Conclusions It is vital to prioritize educational programmes on vaccinology and vaccine hesitancy for HCWs, with the objective of improving their knowledge, awareness and attitudes. Addressing the diversity of educational backgrounds, roles and training requirements of HCWs involved in vaccination across Europe is a critical issue that must be tackled for future initiatives

Big data and ICT solutions in the European Union and in China: A comparative analysis of policies in personalized medicine

Introduction: Several countries are either planning or implementing national strategies for the development and integration of Personalized Medicine (PM) into their healthcare systems. Personalized Medicine is an undisputed priority of the European Commission (EC), which has funded the project "Integrating China into the International Consortium for Personalized Medicine" (IC2PerMed), in order to ensure a common basis for Sino-European collaborations. By mapping the current PM landscape in the European Union (EU) and in China, IC2PerMed aims to provide key solutions toward a synergistic and coordinated approach in the field of PM. Methods: An extensive desk research was conducted, aimed at identifying documents on PM-related policies, programs, and action plans in the EU and in China, published up to November 2020. The search was conducted by exploring scientific and gray literature, and official institutional repositories. A descriptive summary condensed the information retrieved for both. Results: Since 2013, the year of publication of the first PM policy by the EC "Use of omics technologies in PM development," several documents have been published. PM is a key element of the policy agenda also in China, which in 2016 integrated PM into the 13th National Five-Year Plan, followed by the publication of several policies on technology infrastructure and big data. Both in the EU and China, especially in recent years, these policies addressed in detail the issues of big data, data interoperability and exchange, while defining the standards of information and communication infrastructures. Conclusions: In order to allow optimal collaboration, it is essential to understand similarities and differences between the respective policy strategies, with particular attention to data management and adopted infrastructures. The results of this project may enable the development of joint Sino-European research and innovation initiatives, promoting developments in the field of PM

Knowledge, attitudes, and behaviors toward COVID-19 vaccination in a sample of Italian healthcare workers

Vaccine hesitancy in healthcare workers (HCWs) has been studied for various contagious diseases, but there is still insufficient knowledge about this phenomenon for COVID-19. We developed and validated a knowledge, attitude, and practice survey of 39 questions to assess Italian HCWs' hesitancy toward vaccination in general (general hesitancy), COVID-19 vaccination (COVID-19 hesitancy), and public health injunctive measures (refusal of obligations). The survey was administered through a web platform between July and November 2021. Three multivariable logistic regressions were performed to evaluate the association between the explored dimensions of hesitancy and the potential determinants investigated. Out of 2,132 respondents with complete answers, 17.0% showed to be generally hesitancy toward vaccination, 32.3% were hesitant on COVID-19 vaccination, while 18.8% were categorized as refusing obligations. A significant protective effect against all three dimensions of hesitancy was found for increasing fear of COVID-19, advising COVID-19 vaccination to relatives and patients, having received flu vaccination in the previous year and having higher levels of education. Better self-rated knowledge about COVID-19 vaccines and reading up institutional sources were significantly protective against general and COVID-19 hesitancy, while being a physician rather than another healthcare professional was protective only against COVID-19 hesitancy. Conversely, increasing age and referring to colleagues to expand knowledge about COVID-19 were positively associated with COVID-19 hesitancy. The determinants of general hesitancy, COVID-19 hesitancy and the refusal of obligations are mostly overlapping. Given the great influence they exert on patients and communities, it is pivotal to limit HCWs vaccine hesitancy through appropriate training activities