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Objectives: The appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA)., Methods: Literature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines., Results: We found that significant variation exists across the EU member states in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU: (1) support the creation of appropriate terminology and measurements for clinical appraisals of vaccines; (2) develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision making and appraisal; and (3) improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals., Conclusions: Given the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework. The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024. Published by Elsevier Inc.)

Background/Objectives . Many vaccines have been developed in recent decades, and many more will be available in the future. When new safe and effective vaccines are available, decision-makers must extensively assess them before including them in the national immunization plan and issuing recommendations. The Health Technology Assessment (HTA) could be an objective, transparent, and comprehensive approach to guiding the decision-making process for the use of vaccines. Objectives and Methods . The aim of this study was to review the indications for HTA use contained in Italian institutional documents on vaccination, namely the National Immunization Plans (NIPs) and available full Italian HTA reports on vaccines, assessing their availability at the time of national recommendations' introductions. Results . HTA has been recognised as an eligible approach to deciding upon the introduction of vaccines through the NIPs of 2012-2014 and 2017-2019, and the last NIP, of 2023-2025, highlights the lack of funding dedicated to the production of independent HTA reports that can be used for issuing recommendations. In 2007-2023, twenty full HTA reports on vaccines were published in Italy: eight reports on influenza vaccines, five on Human Papilloma Virus (HPV), three each on meningococcal and pneumococcal vaccines, and one on rotavirus vaccine. HTA was applied with different purposes, namely the evaluation of new vaccines or their re-assessment, but it was not always timely with respect to both the marketing authorisation and the issuing of national recommendations for use. Conclusions . As HTA can be considered the best tool to disentangle the overall value of vaccines, it would be desirable for it to be used more and more to provide the evidence for efficient resource use. This calls for action to improve the transfer of HTA results to decision-makers, to try to fill the gap between research and decision and foster evidence-based recommendations.

Leishmaniosis by Leishmania infantum is a zoonotic vector-borne disease transmitted to humans and dogs by the bite of female sand-flies. The domestic dog is the main reservoir and infected dogs may show or not clinical symptoms. The prevalence of infection in dogs varies according to the population studied, the geographic area, and the diagnostics employed. This study aims to estimate the global prevalence, subgrouping per continent, country, diagnostic test and selected risk factors. Cross-sectional studies (n=150; from 1990 to 2020) estimating the prevalence of the infection by Leishmania infantum were extracted from four electronic databases. The pooled global prevalence obtained by random-effects meta-analysis was 15.2 % (95 %CI 13.6-16.9), mostly in rural (19.5 %) and owned dogs (16.5 %). Prevalence varied if the diagnosis was made by western blot (WB, 32.9 %), cellular immunity tests (27.5 %), ELISA (17 %), PCR (16.9 %), IFAT (15.9 %), rapid tests and direct agglutination test (DAT, 11.5 %), cytology/immunohistochemistry (13.1 %), culture (8.6 %). A small studies bias (P<0.005) in the overall prevalence meta-analysis, due to the impact of small-size studies on the overall results was found. Moreover, a continent-related bias was found regarding rapid test, DAT (P=0.021), and WB (P<0.001), as these assays are mainly used in South American studies. A study period bias (P=0.033) and a publication year bias (P=0.002) were detected for PCR, as the test was not employed before the year 2000. In conclusion, a high prevalence of canine leishmaniosis worldwide and high heterogeneity among studies were found., 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 © 2024 Elsevier Ltd. All rights reserved.)

Background: Cardiovascular diseases (CVDs) pose a significant global health challenge, necessitating innovative approaches for primary prevention. Personalized prevention, based on genetic risk scores (PRS) and digital technologies, holds promise in revolutionizing CVD preventive strategies. However, the clinical efficacy of these interventions requires further investigation. This study presents the protocol of the INNOPREV randomized controlled trial, aiming to evaluate the clinical efficacy of PRS and digital technologies in personalized cardiovascular disease prevention., Methods: The INNOPREV trial is a four-arm RCT conducted in Italy. A total of 1,020 participants, aged 40-69 with high 10-year CVD risk based on SCORE 2 charts, will be randomly assigned to traditional CVD risk assessment, genetic testing (CVD PRS), digital intervention (app and smart band), or a combination of genetic testing and digital intervention. The primary objective is to evaluate the efficacy of providing CVD PRS information, measured at baseline, either alone or in combination with the use of an app and a smart band, on two endpoints: changes in lifestyle patterns, and modification in CVD risk profiles. Participants will undergo a comprehensive assessment and cardiovascular evaluation at baseline, with follow-up visits at one, five, and 12 months. Lifestyle changes and CVD risk profiles will be assessed at different time points beyond the initial assessment, using the Life's Essential 8 and SCORE 2, respectively. Blood samples will be collected at baseline and at study completion to evaluate changes in lipid profiles. The analysis will employ adjusted mixed-effect models for repeated measures to assess significant differences in the data collected over time. Additionally, potential moderators and mediators will be examined to understand the underlying mechanisms of behavior change., Discussion: As the largest trial in this context, the INNOPREV trial will contribute to the advancement of personalized cardiovascular disease prevention, with the potential to positively impact public health and reduce the burden of CVDs on healthcare systems. By systematically examining the clinical efficacy of PRS and digital interventions, this trial aims to provide valuable evidence to guide future preventive strategies and enhance population health outcomes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Pastorino, Pezzullo, Agodi, de Waure, Mazzucco, Russo, Bianchi, Maio, Farina, Porcelli, Tona, Di Pumpo, Amore, Wachocka, Pasciuto, Barchitta, Magnano San Lio, Favara, Tuttolomondo, Tramuto, Morello, De Bella, Fruscione, Severino, Liuzzo and Boccia.)

Introduction: Mindful movement is a comprehensive approach that integrates various bodily, emotional and cognitive aspects into physical activity, promoting overall well-being. This study assessed the impact of a mindful movement program, known as Movimento Biologico (MB), on participants psychological well-being (PWB), positive mental health (PMH), sense of coherence (SOC), and interoceptive awareness., Methods: MB program was conducted for students attending the bachelor's degree in Kinesiology and Sport Sciences of University of Perugia over 8 weeks (from October 16 to November 27, 2022). Participants were requested to fill in four questionnaires before and after the MB program: (1) 18-item PWB scale; (2) 9-item PMH scale; (3) 13-item SOC scale; (4) 32-item scale for Multidimensional Assessment of Interoceptive Awareness (MAIA). Wilcoxon signed-rank tests were used to assess changes, with significance set at p  < 0.05., Results: Thirty-eight students (mean age 21.2, 60.5% male) participated. Several MAIA subscales, including noticing ( p  = 0.003), attention management ( p  = 0.002), emotional awareness ( p  = 0.007), self-regulation ( p  < 0.001), body listening ( p  = 0.001), and trusting ( p  = 0.001), showed significant improvements. PMH increased significantly ( p  = 0.015), and there was a significant enhancement in the autonomy subscale of PWB ( p  = 0.036). SOC and overall PWB also improved, though not significantly., Conclusion: The MB program significantly improved participants' positive mental health and interoceptive awareness. This likely resulted from better recognition and management of positive physiological sensations, a stronger link between physical sensations and emotions, enhanced confidence in one's body, and increased autonomy., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Spaccapanico Proietti, Chiavarini, Iorio, Buratta, Pocetta, Carestia, Gobbetti, Lupi, Cosenza, Sorci, Mazzeschi, Biscarini and de Waure.)

Pregnant women and infants inherently face heightened susceptibility to complications resulting from infectious diseases. Within these populations, vaccinations offer numerous advantages. This systematic review endeavors to comprehensively analyze the existing literature concerning interventions designed to promote vaccinations among pregnant women and newborns in Italy. We searched PubMed, Scopus, and Web of Science for primary studies published until 3 August 2023 which assessed the impact of vaccination education interventions targeting pregnant Italian women. Data extraction, pooling, and a quality appraisal of the included studies were conducted according to PRISMA guidelines. Among the 528 articles identified, 3 met the inclusion criteria and focused on pregnant women aged 25 to 40 attending pre-delivery courses. In these studies, the effectiveness of the interventions was assessed using pre- and post-intervention questionnaires that investigated knowledge, attitudes, and behaviors regarding recommended vaccinations. The results reveal significant increases in intention and adherence to vaccination among participants after these interventions. The results underscore the positive influence of health professionals' educational initiatives on pregnant Italian women's vaccination knowledge and attitudes. However, longitudinal studies with larger representative samples are needed to validate these findings and identify potential avenues for improving maternal educational interventions.

Background: Protection provided by seasonal influenza vaccination (SIV) may be measured against numerous outcomes, and their heterogeneity may hamper decision-making. The aim of this study was to explore outcomes used for estimation of SIV efficacy/effectiveness (VE) and obtain expert consensus on their importance., Research Design and Methods: An umbrella review was first conducted to collect and map outcomes considered in systematic reviews of SIV VE. A Delphi study was then performed to reach expert convergence on the importance of single outcomes, measured on a 9-point Likert scale, in principal target groups, namely children, working-age adults, older adults, subjects with co-morbidities and pregnant women., Results: The literature review identified 489 outcomes. Following data reduction, 20 outcomes were selected for the Delphi process. After two Delphi rounds and a final consensus meeting, convergence was reached. All 20 outcomes were judged to be important or critically important. More severe outcomes, such as influenza-related hospital encounters and mortality with or without laboratory confirmation, were generally top-ranked across all target groups (median scores ≥8 out of 9)., Conclusions: Rather than focusing on laboratory-confirmed infection per se, experimental and observational VE studies should include more severe influenza-related outcomes because they are expected to exercise a greater impact on decision-making.

Introduction: Influenza causes significant morbidity and mortality, but influenza vaccine uptake remains below most countries' targets. Vaccine policy recommendations vary, as do procedures for reviewing and appraising the evidence., Areas Covered: During a series of roundtable discussions, we reviewed procedures and methodologies used by health ministries in four European countries to inform vaccine recommendations. We review the type of evidence currently recommended by each health ministry and the range of approaches toward considering randomized controlled trials (RCTs) and real-world evidence (RWE) studies when setting influenza vaccine recommendations., Expert Opinion: Influenza vaccine recommendations should be based on data from both RCTs and RWE studies of efficacy, effectiveness, and safety. Such data should be considered alongside health-economic, cost-effectiveness, and budgetary factors. Although RCT data are more robust and less prone to bias, well-designed RWE studies permit timely evaluation of vaccine benefits, effectiveness comparisons over multiple seasons in large populations, and detection of rare adverse events, under real-world conditions. Given the variability of vaccine effectiveness due to influenza virus mutations and increasing diversification of influenza vaccines, we argue that consideration of both RWE and RCT evidence is the best approach to more nuanced and timely updates of influenza vaccine recommendations.

Healthcare workers (HCWs) are among the at-risk groups for whom influenza vaccination is strongly recommended. To assess the proportion of Italian HCWs with positive attitudes toward influenza vaccination, we conducted a systematic review of relevant literature and a meta-analysis. Our focus was on the influenza seasons from 2017/18 to 2021/22. The prevalence of favorable attitudes toward vaccination varied, ranging from 12% during the 2017/18 influenza season to 59% in the 2020/21 season. The significant increase in the 2020/21 season can be attributed to adaptations necessitated by the COVID-19 pandemic. During the 2021/22 influenza season, there was a decline in vaccination coverage (37%), likely due to the absence of a robust preventive culture. Various strategies have been employed to enhance HCWs' attitudes to achieve higher vaccination rates, but none of them have demonstrated satisfactory results. Policymakers should consider implementing a policy of mandatory vaccination to ensure elevated vaccination coverage among HCWs.

Socio-demographic factors are responsible for health inequalities also in vaccination. The aim of this study was to evaluate their role at the population level through a population-based study performed on the whole population entitled to receive COVID-19 vaccines in the Umbria Region, Italy, and registered to the Regional Healthcare Service as of 28 February 2021. Socio-demographic characteristics and vaccination status in terms of uptake of at least one dose of any available vaccine, completion of the primary vaccination cycle and uptake of the booster doses as of 28 February 2022 were collected from the Umbria regional database. The percentage of eligible population who did not initiate the COVID-19 vaccination, complete the full vaccination cycle and get the booster dose was 11.8%, 1.2% and 21.5%, respectively. A younger age, being a non-Italian citizen, and not holding an exemption for chronic disease/disability and a GP/FP were associated with all the endpoints. Females, as compared to males, were more likely to not initiate the vaccination but less likely to not receive the booster dose. On the contrary, the findings did not show a significant association between the deprivation index and the vaccine uptake. The findings, beyond confirming current knowledge at the population level, provide new inputs for better tailoring vaccination campaigns.

Introduction: Rapid systematic reviews (RRs) have the potential to provide timely information to decision-makers, thus directly impacting healthcare. However, consensus regarding the most efficient approaches to performing RRs and the presence of several unaddressed methodological issues pose challenges. With such a large potential research agenda for RRs, it is unclear what should be prioritised., Objective: To elicit a consensus from RR experts and interested parties on what are the most important methodological questions (from the generation of the question to the writing of the report) for the field to address in order to guide the effective and efficient development of RRs., Methods and Analysis: An eDelphi study will be conducted. Researchers with experience in evidence synthesis and other interested parties (eg, knowledge users, patients, community members, policymaker, industry, journal editors and healthcare providers) will be invited to participate. The following steps will be taken: (1) a core group of experts in evidence synthesis will generate the first list of items based on the available literature; (2) using LimeSurvey, participants will be invited to rate and rank the importance of suggested RR methodological questions. Questions with open format responses will allow for modifications to the wording of items or the addition of new items; (3) three survey rounds will be performed asking participants to re-rate items, with items deemed of low importance being removed at each round; (4) a list of items will be generated with items believed to be of high importance by ≥75% of participants being included and (5) this list will be discussed at an online consensus meeting that will generate a summary document containing the final priority list. Data analysis will be performed using raw numbers, means and frequencies., Ethics and Dissemination: This study was approved by the Concordia University Human Research Ethics Committee (#30015229). Both traditional, for example, scientific conference presentations and publication in scientific journals, and non-traditional, for example, lay summaries and infographics, knowledge translation products will be created., Competing Interests: Competing interests: The authors alone are responsible for the views expressed in this paper and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated. The authors have no conflicts of interest to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

COVID-19 is a major global health threat, with millions of confirmed cases and deaths worldwide. Containment and mitigation strategies, including vaccination, have been implemented to reduce transmission and protect the population. We conducted two systematic reviews to collect nonrandomized studies investigating the effects of vaccination on COVID-19-related complications and deaths in the Italian population. We considered studies conducted in Italian settings and written in English that contained data on the effects of vaccination on COVID-19-related mortality and complications. We excluded studies that pertained to the pediatric population. In total, we included 10 unique studies in our two systematic reviews. The results showed that fully vaccinated individuals had a lower risk of death, severe symptoms, and hospitalization compared to unvaccinated individuals. The review also looked at the impact of vaccination on post-COVID-19 syndrome, the effectiveness of booster doses in older individuals, and nationwide adverse events. Our work highlights the crucial role that vaccination campaigns have played in reducing the burden of COVID-19 disease in the Italian adult population, positively impacting the pandemic trajectory in Italy.

Background: Equid herpesvirus type 1 (EHV-1) infection can cause a range of disease syndromes of variable severity that can result in a lethal outcome and restriction of horse movements, especially in the case of outbreaks involving neurological disease. Vaccination is one of the tools used to control the infection. It is widely known that vaccination is not completely effective in ensuring protection against disease caused by this virus. In fact, the real efficacy of vaccination against EHV-1 related disease has not been measured and no systematic reviews exist on this topic., Objectives: To perform a systematic review and meta-analysis on the efficacy of commercial or candidate vaccines against EHV-1 in randomised controlled trials (RCT) all of which involved experimental challenge of the test subjects., Study Design: Systematic review and meta-analysis., Methods: RCTs were searched using the search algorithm (([equid herpesvirus* OR equine herpesvirus* OR EHV-1]) AND vaccin*) AND (trial OR experimental OR challenge) on PubMed, Science Citation Index Expanded, Scopus, and CAB Abstracts. Where appropriate, meta-analysis was performed using RevMan 5.4., Results: Eight studies were selected and were analysed for their respective characteristics and possible shortcomings. The results of RCTs revealed that there was a general improvement in the clinical and virological outcomes of EHV-1 infection following vaccination, but that the effects were very slight. The reduced beneficial effect is probably amplified by the paucity of detailed data reported in the studies that did not allow for the comparison of parameters in many of the cases analysed., Main Limitations: The remarkable heterogeneity and the poor quality of reporting of the selected studies., Conclusions: Meta-analysis has shown that EHV-1 vaccination generally results in a slight improvement in clinical and virological outcomes, although not to a significant extent. The cumulative results have probably been affected by the lack of information on some parameters not systematically reported in the studies. An improvement in the standard of reporting and better standardisation of the data collected would likely have improved the quality of each study and enabled more effective comparison of the studies with each other., (© 2022 The Authors. Equine Veterinary Journal published by John Wiley & Sons Ltd on behalf of EVJ Ltd.)

Although the anticancer role of curcumin has been extensively addressed in preclinical research, only a few studies were carried out in humans, with conflicting results. The aim of this systematic review is to collate together the results of the therapeutic effect of curcumin in cancer patients. A literature search was carried out in Pubmed, Scopus, and the Cochrane Central Register of Controlled Trials up to 29 January 2023. Only randomized controlled trials (RCTs) designed to evaluate the effects of curcumin on cancer progression, patient survival, or surgical/histological response were included. Seven out of 114 articles, published between 2016 and 2022, were analyzed. They evaluated patients with locally advanced and/or metastatic prostate, colorectal, and breast cancers, as well as multiple myeloma and oral leucoplakia. Curcumin was given as an add-on therapy in five studies. Cancer response was the most investigated primary endpoint and curcumin issued some positive results. On the contrary, curcumin was ineffective in improving overall or progression-free survival. The curcumin safety profile was favorable. In conclusion, available clinical evidence is not strong enough to support the therapeutic use of curcumin in cancer. New RCTs exploring the effects of different curcumin formulations in early-stage cancers would be welcome.

Aims: Common Psychiatric Disorders (CPDs) are associated with the development of overweight and obesity, the strongest risk factors for the onset and maintenance of Type 2 Diabetes mellitus (T2D). To the best of our knowledge, this is the first study to assess the prevalence of CPDs in patients with T2D in Italy., Methods: This is a monocentric cross-sectional study; n = 184 T2D patients were screened for CPDs using the Patient Health Questionnaire (PHQ). Primary outcome was to evaluate the prevalence of CPDs. To assess association between CPDs and risk factors, we have utilized univariable logistic regression models., Results: 64.1% were men, median age was 67 (59-64) and median BMI 27 (25-30) kg/m 2 . The 42.9% tested positive for one or more mental disorders, 25.6% for depression. Patients with higher BMI (p = 0.04) had an increased likelihood of testing positive to the PHQ. Patients who had implemented lifestyle changes (p < 0.01) and were aware that mental health is linked to body health (p = 0.07) had a reduction in the likelihood of testing positive., Conclusions: Prevalence of CPDs in T2D patients is higher than in the general population. Since CPDs favor the onset and subsistence of T2D, integrated diabetic-psychiatric therapy is required for improvement or remission of T2D in patients with comorbid CPDs., (© 2022. The Author(s).)

Cardiovascular diseases (CVDs) represent a major threat to health and primary prevention outstands as the most effective instrument to face this issue, addressing multiple risk factors at a time and influencing behavioral patterns. Community nurses have been involved in many interdisciplinary prevention activities, resulting in effective control of CV risk factors. We conducted a pilot study aiming at describing the impact on the CV risk profile of an 18-month interdisciplinary intervention on lifestyle habits. From September 2018 to May 2020, four general practitioners (GPs) working in the Roman neighborhood of Torresina recruited patients having a cardiovascular risk score (CRS) equal to or higher than 3% and lower than 20%; those patients were included in a nutritional, physical, and psychological counseling program. Assessments of patients' health status were led at baseline, 6, 12, and 18 months by a nutritionist, a physiotherapist, a psychologist, their GPs, and a community nurse. The CRS was estimated at every examination, based on the Italian Progetto Cuore algorithm. A total of 76 patients were included (mean age of 54.6 years; 33 men and 43 women). Mean CRS showed a significant reduction between baseline and 12 months (from 4.9 to 3.8); both total cholesterol and systolic blood pressure (SBP) significantly decreased at 6 months of follow-up (respectively, from 211.1 to 192 and from 133.1 to 123.1). Nonetheless, the reduction was later maintained only for SBP. However, during the last 6 months of the intervention, the COVID-19 pandemic broke out, thus, it is not possible to know how much the results achieved at 18 months were influenced by the restrictive measures introduced by the Italian government. When stratifying according to the presence of hypertension/diabetes and physical activity, no differences in the CRS could be highlighted between the two groups. Our pilot study proved that an interdisciplinary counseling intervention program can improve CV risk profile and could be further spread to people that, according to their CRS, would benefit more from changes in lifestyles., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Lontano, Marziali, Galletti, Mazza, Gambioli, Galasso, Mingarelli, D'Ambrosio, Tamburrano, Paolini, Bande, Damiani, de Waure and Laurenti.)

Objectives: Delaying of policies for immunization of aging adults, low vaccine uptake, and the lack of supportive evidence at the national level could diminish the value in health and economics of such programs. This study aims to develop a "country score tool" to assess readiness and to facilitate evidence generation for aging adult immunization programs in Europe, and examine the comprehensiveness, relevance, acceptability, and feasibility of the tool., Methods: The tool was developed in two phases. First, a modified Delphi process was used to construct the tool. The process included a literature review, stakeholder consultations, and a three-round Delphi study. The Delphi panel included researchers, supra-national and national decision-makers of immunization programs recruited from five countries, using snowball sampling method. The consensus was predefined at the agreement rate of 70%. Pilot testing of the tool was conducted in the Netherlands, Germany, Serbia, and Hungary involving researchers in the field of health technology assessment. After assessing the countries' readiness, researchers evaluated four features, namely comprehensiveness, relevance, acceptability, and feasibility of the tool via an online survey that included 5-scale Likert questions. The percentages of affirmative answers including "agree" and "totally agree" choices were presented., Results: The review identified 16 tools and frameworks that formed the first version of our tool with 14 items. Eight experts were involved in the Delphi panel. Through three Delphi rounds, four items were added, one was dropped, and all others were amended. The consensus was achieved on the tool with 17 items divided into decision-making and implementation parts. Each item has a guiding question, corresponding to explanations and rationales to inform assessment with readiness scores. Eight researchers completed the pilot testing. The tool was rated as comprehensive (75%), relevant (100%), acceptable (75%), and feasible (88%) by participants., Conclusion: Through a thorough and transparent process, a country score tool was developed helping to identify strengths, weaknesses, and evidential requirements for decision-making and implementation of immunization programs of aging adults. The tool is relevant for different European contexts and shows good comprehensiveness, acceptability, and feasibility., Competing Interests: MP reports grants and personal fees from various pharmaceutical industries, all outside the submitted work. EB is an employee of and holds shares in the GSK group of companies. TP was employed by Asc Academics. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Pham, Beck, Postma, Németh, Ágh, de Waure, Salisbury, Nutma and van der Schans.)

Introduction: Vaccine hesitancy is a major public health issue and a challenge for the implementation of COVID-19 immunization campaigns. The objective of this study was to address the determinants of COVID-19 vaccination acceptance or hesitancy in the Italian population., Materials and Methods: We conducted a rapid systematic review by searching PubMed until May 3rd, 2022, according to Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines. Articles assessing determinants of Italians' attitudes towards COVID-19 vaccination in terms of hesitancy and/or acceptance were considered eligible. Quality and risk of bias assessment was performed through the Newcastle Ottawa Scale appraisal tool. Determinants were grouped in three categories: contextual, individual and group, and vaccine/vaccination specific influences., Results: Out of 606 articles, 59 studies were included in the analysis. Included studies demonstrated that, in Italy, COVID-19 vaccination acceptance or hesitancy is mostly influenced by perceived safety, efficacy and usefulness of the vaccine., Conclusion: These findings should be considered to plan tailored interventions for counteracting COVID-19 vaccination hesitancy in Italy.

Background: Cervical Cancer (CC) is a vaccine-preventable disease, and it is treatable if diagnosed early and managed properly. However, it is the fourth most common cancer in women worldwide with about 604,127 cases and 341,831 deaths in 2020. In Italy, it represents the fifth most common cancer in women under 50 years of age with about 2,400 new cases in 2020. The CC elimination is today a global public health goal published by the World Health Organization (WHO) in 2020 and a commitment of the European Union that has included it in Europe's Beating Cancer Plan. Therefore, urgent action is needed, at international and national level, to implement value-based interventions regarding vaccination, screening and timely management of the disease. Our study aims to describe the state of the art of Human Papilloma Virus (HPV) prevention in Italy and to get a consensus on indicators for monitoring the progress toward CC elimination at national level., Methods: The study envisaged the following activities: research and synthesis of the evidence on strategies and actions for CC elimination at regional Italian level; identification of indicators to monitor such strategies/actions; organization of a multi-stakeholder consensus to reach the agreement on main indicators to be used in Italy., Results: As for HPV vaccination coverage, the last Italian available data (December 31st, 2020) showed that it was way below the target (95%) with full cycle vaccination coverage ranging from 6 to 61.7% in female adolescents and from 5.4 to 55.4% in male adolescents (2008 birth cohorts). The coverage rate of CC screening is variable with a range of 61.7-89.6%. Furthermore, coverage rates due to organized screening programs (excluding out-of-pocket screening) shows a range from 20.7 to 71.8%. The mapping of the Italian Regions highlighted an important regional heterogeneity in respect to organizational/operational issue of HPV vaccination and CC screening. Indicators for monitoring CC elimination strategies have been drawn from the Australian experience and distinguished by disease outcomes, vaccination coverage, screening participation and treatment uptake. The highest consensus was reached for the following indicators: CC incidence; detection of high-grade cervical disease; CC mortality; full cycle vaccination coverage; screening participation; high-grade cervical disease treatment rates; CC treatment rates., Conclusions: The assessment of the current status of CC elimination as overarching goal beyond the achievement of vaccine, screening and treatment targets represents the first step for the identification of interventions to be implemented to accelerate the path toward CC elimination. Based on this and following the WHO call, a value-based approach is proposed to untangle the full benefit of HPV-related cancers elimination strategies and identify priority and best practices., Competing Interests: All the authors worked as consultants of VIHTALI (Value in Health Technology and Academy for Leadership & Innovation), Spin-Off of Università Cattolica del Sacro Cuore (Rome, Italy), and which received funds from MSD Italia S.r.l. The sponsor had no role in conducting or designing the study., (Copyright © 2022 Calabrò, Riccardi, D'Ambrosio, Castagna, Sapienza, Millevolte, Pellacchia, Ricciardi, de Vincenzo and de Waure.)

This study investigated the long-term outcomes of patients treated with open surgical repair for complex abdominal aortic aneurysms (c-AAAs). A total of 119 patients with c-AAAs undergoing repair between January 2010 and June 2016 in a high-volume aortic center were included. The long-term imaging follow-up consisted of yearly abdominal ultrasound examinations and 5-year computed tomography angiography. At a median follow-up of 76 months (IQR 38 months), forty-three deaths (37%) and three (2.5%) aortic-related deaths were observed. Long-term chronic renal decline was observed in fifty (43.8%) patients, significantly correlated with post-operative acute kidney injury. During the follow-up, five reinterventions (4.3%) were performed. The present study suggests that open c-AAA repair can be performed with acceptable operative risk with durable results. To achieve the best possible long-term outcome, the open surgery repair of complex AAA should be performed in high-volume aortic centers and tailored to the patient.

The initial progress of the COVID-19 vaccination campaign worldwide depended on several aspects, including programmatic/practical issues. This paper focused on the planning and organization of COVID-19 vaccination campaigns in eight European countries (Sweden, Denmark, Romania, Hungary, Italy, Spain, Germany, and France), from the launch to August 2021. Information on the planning of the vaccination campaign (release and update of a national immunization plan, types of vaccines being used and their limitations/suspensions) and its organization (vaccination target groups, possibility of citizens' choice, vaccination workforce and settings, vaccines procurement) were obtained through desk research of international and national reports, plans, and websites. Eventually, data on vaccination coverage were drawn from Our world in data and analyzed through join point regression. The eight countries showed differences in groups prioritization, limitations/suspensions of use of specific vaccines, citizens' possibility to choose vaccines, and vaccination workforce involved. These issues could have contributed to the different progress towards high levels of vaccination coverage. In respect to vaccination coverage, Romania reached much lower levels than other countries. Further comparative research is needed in order to identify best practices in vaccination campaign that could be useful for the next phases of the COVID-19 pandemic, and be better prepared for future potential pandemic.

Objectives: MF59-adjuvanted standard-dose and nonadjuvanted high-dose seasonal influenza vaccines have been developed to protect the elderly at high risk of severe complications. This study aimed to summarize the available evidence on the comparative efficacy/effectiveness of these two vaccines., Methods: A systematic literature review of experimental and observational studies were conducted according to the preferred reporting items for systematic reviews and meta-analyses guidelines. When possible, the extracted effect sizes were pooled in random-effects meta-analyses., Results: Ten studies were identified. Of these, no head-to-head randomized controlled trials were identified. All available studies had retrospective cohort design and large sample sizes, were conducted in the United States between the 2016-2017 and 2019-2020 seasons, and were at moderate risk of bias. Relative effectiveness estimates were limited to nonlaboratory-confirmed clinical end points, such as medical encounters including hospitalizations. Although most pooled relative effectiveness estimates were close to null, few statistically significant pooled effect sizes were small in magnitude, moved in opposite directions, and depended on the study sponsor and specificity of influenza-related outcomes., Conclusion: At present, MF59-adjuvanted standard-dose and nonadjuvanted high-dose vaccines appear to have similar effectiveness in preventing seasonal influenza in the elderly, and no conclusive recommendations on the preference of one vaccine over another could be drawn., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Pediatric influenza causes significant morbidity annually, resulting in an increased economic burden. Therefore, we aimed to summarize existing literature regarding the costs of pediatric influenza in Europe, paying particular attention to the direct and indirect costs considered in the economic evaluations. Knowing health and social costs of childhood influenza is essential to support value-based health decisions to implement effective immunization strategies., Methods: We searched three databases for articles published to September 3, 2021. Eligible studies were those reporting the economic burden of influenza in the pediatric and youth population in European countries written in English language., Results: Overall, 2225 records were screened, and 9 articles were included. Costs estimates are different across countries and in the age groups considered. Direct costs per episode, whose major expense driver are hospitalizations and pediatric examinations, range from about €74 in Italy to €252 in Germany. Important variations are observed based on age, with the youngest group absorbing in some cases double the resources of the older ones such as (in Italy, in France and in Germany). Regarding indirect costs, workdays lost by parents resulted in higher costs for children <2 years and 2-5 years than those >5 years of age and their economic impact was variable reaching €251 per week in Germany., Conclusion: Evidence obtained in our review strengthened the awareness about the economic impact, in terms of direct and indirect costs, of pediatric influenza requiring, as a priority action in Europe, the implementation of influenza vaccination policies in this target population., (© 2022 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

Vaccination is the most effective intervention to prevent influenza. Adults at risk of complications are among the targets of the vaccination campaigns and can be vaccinated with different types of quadrivalent influenza vaccines (QIVs). In the light of assessing the relative immunogenicity and efficacy of different QIVs, a systematic review was performed. Randomized controlled trials conducted in adults aged 18-64 years until 30 March 2021 were searched through three databases (Medline, Cochrane Library and Scopus). Twenty-four RCTs were eventually included. After data extraction, a network meta-analysis was not applicable due to the lack of common comparators. However, in the presence of at least two studies, single meta-analyses were performed to evaluate immunogenicity and efficacy; on the contrary, data from single studies were considered. Seroconversion rate for H1N1 was higher for standard QIVs, while for the remaining strains it was higher for low-dose adjuvanted QIVs. For seroprotection rate, the recombinant vaccine recorded the highest values for H3N2, while for the other strains, the cell-based QIVs achieved better results. In general, standard and cell-based QIVs showed an overall good immunogenicity profile. Nevertheless, as a relative comparative analysis was not possible, further research would be deserved.

Background: Acute and delayed vasovagal reactions (VVR) are the most frequent adverse reactions (AR) associated with donations. The aim of this study was to provide the data of the Italian donor haemovigilance system and contextualise the VVR data within the international framework, as well as evaluating, among first-time donors, the association of gender and age and the prevalence of VVR compared to other AR., Materials and Methods: The prevalence analysis was performed on VVR and other AR notified to the Italian haemovigilance system from 2016 to 2019. The analysis on the association of gender and age group and VVR prevalence was performed on first-time donations. The definitions and severity of AR were as set out in the 2014 ISBT/IHN international standards., Results: From 2016 to 2019, 34,519 AR were notified, of which 87.1% were VVR. The overall VVR prevalence was 25.0/10,000 donations and the overall prevalence of other AR was 3.7/10,000 donations. All the estimated prevalences of AR were higher for first-time donations than for regular donations and lower for whole blood than for apheresis donations. No difference was noted between whole blood and apheresis donations for VVR with complications or injuries. The prevalence of AR among first-time donors was higher in females than in males. The prevalence of VVR decreased as donor age increased., Discussion: The prevalence of VVR related to blood donation was very low and similar to those calculated by other haemovigilance systems. Among first-time donors, the prevalence of AR was higher in females than in males. The higher prevalence of VVR in young donors and a significant decreasing trend by age group confirmed the results reported in the literature. Finally, no trend by age group in first-time donors was observed for other AR to donations.

Background: The elderly, commonly defined as subjects aged ≥65 years, are among the at-risk subjects recommended for annual influenza vaccination in European countries. Currently, two new vaccines are available for this population: the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose quadrivalent influenza vaccine (hdQIV). Their multidimensional assessment might maximize the results in terms of achievable health benefits. Therefore, we carried out a Health Technology Assessment (HTA) of the aQIV by adopting a multidisciplinary policy-oriented approach to evaluate clinical, economic, organizational, and ethical implications for the Italian elderly., Methods: A HTA was conducted in 2020 to analyze influenza burden; characteristics, efficacy, and safety of aQIV and other available vaccines for the elderly; cost-effectiveness of aQIV; and related organizational and ethical implications. Comprehensive literature reviews/analyses were performed, and a transmission model was developed in order to address the above issues., Results: In Italy, the influenza burden on the elderly is high and from 77.7% to 96.1% of influenza-related deaths occur in the elderly. All available vaccines are effective and safe; however, aQIV, such as the adjuvanted trivalent influenza vaccine (aTIV), has proved more immunogenic and effective in the elderly. From the third payer's perspective, but also from the societal one, the use of aQIV in comparison with egg-based standard QIV (eQIV) in the elderly population is cost-effective. The appropriateness of the use of available vaccines as well as citizens' knowledge and attitudes remain a challenge for a successful vaccination campaign., Conclusions: The results of this project provide decision-makers with important evidence on the aQIV and support with scientific evidence on the appropriate use of vaccines in the elderly.

Objectives: To provide a new value-based immunization approach collating the available scientific evidence on the topic., Methods: Four value pillars (personal, allocative, technical, and societal) applied to vaccination field were investigated. A systematic literature review was performed querying three database from December 24th, 2010 to May 27th, 2020. It included studies on vaccine-preventable diseases (VPDs) that mentioned the term value in any part and which were conducted in advanced economies. An in-depth analysis was performed on studies addressing value as key element., Results: Overall, 107 studies were considered. Approximately half of the studies addressed value as a key element but in most of cases (83.3%) only a single pillar was assessed. Furthermore, the majority of papers addressed the technical value by looking only at classical methods for economic assessment of vaccinations whereas very few dealt with societal and allocative pillars., Conclusions: Estimating the vaccinations value is very complex, even though their usefulness is certain. The assessment of the whole value of vaccines and vaccinations is still limited to some domains and should encompass the wider impact on economic growth and societies., Competing Interests: GEC, EC, AT, IG, EB, MM, and CdW received a fee by VIHTALI (Value in Health Technology and Academy for Leadership & Innovation, Spin-Off of Università Cattolica del Sacro Cuore, Rome, Italy) for the scientific activities of the project entitled “The value (s) of vaccination: building the scientific evidence according to a Value-Based Healthcare approach.” WR was not paid for his time by him. The project was funded by MSD. The funders had no role in the design of the study, the collection, analysis and interpretation of data, or the writing of the manuscript., (Copyright © 2022 Calabro', Carini, Tognetto, Giacchetta, Bonanno, Mariani, Ricciardi and de Waure.)

Reliable country-specific data on influenza burden play a crucial role in informing prevention and control measures. Our purpose was to provide a comprehensive summary of the available evidence on the burden of seasonal influenza in Italy. We performed a systematic literature review of articles published until July 31, 2020. PubMed, Embase, and Web of Science were searched using terms related to burden, influenza, and Italian population. We included studies investigating seasonal influenza-related complications, hospitalizations, and/or mortality. Sixteen studies were included: eight (50%) analyzed influenza-related complications, eight (50%) hospitalizations, and seven (43.8%) influenza-related deaths. Only three studies (19.7%) concerned pediatric age. The synthesis of results showed that patients with chronic conditions have an increased risk for complications up to almost three times as compared with healthy people. Hospitalizations due to influenza can occur in as much as 5% of infected people depending on the study setting. Excess deaths rates were over sixfold higher in the elderly as compared with the rest of population. Although there are still gaps in existing data, there is evidence of the significant burden that influenza places each year especially on high-risk groups. These data should be used to inform public health decision-making., (© 2021 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

Introduction: Health systems worldwide need to pay attention to both sustainability and quality. The explosion of health technologies represents a challenge for health systems' sustainability, and evidence-based tools should support resources allocation to guarantee a continuous quality improvement. The value-based approach could disentangle the full benefit of a health technology, and this is of utmost importance in the vaccination field because of several obstacles still existing in reaching optimal vaccination uptake., Areas Covered: The paper conveys the evidence on the full value of vaccine(s)/vaccination based on the framework suggested by the Expert Panel on Effective Ways of Investing in Health of the European Commission. Indeed, evidence on the personal, technical, allocative, and societal value of vaccine(s)/vaccination published in the last decade was described as foundation of a following consultation with international experts of the field. The result was the issuing of recommendations for research, decision-making, and public engagement that aimed to drive a value-based decision-making on vaccination., Expert Opinion: The development of vaccination programs based on the recognition of the full value of vaccine(s)/vaccination is essential. To achieve this goal, it is necessary to launch intersectoral and multidisciplinary research and implementation initiatives involving all relevant stakeholders.