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Purpose: This study investigated the long-term outcomes of patients treated with fenestrated and branched endovascular aneurysm repair (F-BEVAR) or open surgical repair (OSR) for complex abdominal aortic aneurysms (c-AAAs). Complex abdominal aortic aneurysms are defined as aneurysms that involve the renal or mesenteric arteries and extend up to the level of the celiac axis or diaphragmatic hiatus but do not extend into the thoracic aorta. This study compares with a propensity-score matching the outcome of these procedures from 2 high-volume aortic centers., Materials and Methods: All patients with c-AAAs undergoing repair at 2 centers between January 2010 and June 2016 were included. The long-term imaging follow-up consisted in a yearly computed tomography angiography (CTA) in the F-BEVAR group. Yearly abdominal ultrasound examination and 5-year CTA were performed in the OSR group. The primary endpoints were long-term mortality, aneurysm-related mortality, and chronic renal decline (CRD), defined as estimated glomerular filtration rate reduction to <60 mL/min/1.73 m 2 or >20%/de novo dependence on permanent dialysis in patients with normal or abnormal preoperative renal function, respectively. Secondary endpoints included aortic-related reinterventions, target vessel occlusion, proximal aorta degeneration, access-related complications, graft infection, and the composite endpoint of clinical failure during follow-up., Results: After 1:1 propensity matching, 102 consecutive patients who underwent F-BEVAR and OSR, respectively, were included. The median follow-up was 67 months. There was no significant difference in long-term overall mortality (40.2% vs 36.3%; p=0.40) and aneurysm-related mortality (6.8% vs 5.8%; p=0.30), in the F-BEVAR and OSR groups, respectively. During follow-up, late renal function decline occurred in 27 (27.8%) versus 46 patients (47.4%) in the F-BEVAR and OSR groups, respectively (p<0.01). During follow-up, 23 reinterventions (23.5%) were performed in the F-BEVAR group, and 5 (5.1%) in the OSR group (p<0.01)., Conclusions: No differences in overall and aneurysm-related mortality were observed. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the F-BEVAR group. These long-term results reflect the outcomes of a complex procedure performed by a single experienced operator in 2 high-volume centers, and followed with a strict surveillance imaging follow-up., Clinical Impact: Nowadays, F-BEVAR and OSR are considered two established techniques for the treatment of c-AAA. However, long-term comparative outcomes are not well studied, and concerns may rise in terms of durability of the repair, risk of reinterventions and late chronic renal decline. The present study showed, with a median follow-up > 5 years, no differences in overall and aneurysm-related mortality. Chronic renal decline was significantly higher after OSR, while the reintervention rate was higher in the endovascular group. To achieve the best possible long-term outcomes, both techniques should be performed in high volume aortic centres, tailored to the patient, and with an adequate surveillance imaging., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Giovanni Tinelli: consultant for Medtronic and Terumo Aortic; Simona Sica: none; Jonathan Sobocinski: proctor for Cook Medical; Zoé Ribreau: none; Chiara de Waure: none; Marco Ferraresi: none; Francesco Snider: none; Yamume Tshomba: consultant for Medtronic and Terumo Aortic; Stéphan Haulon: consultant for GE Healthcare, Bentley and Cook Medical.

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.

Background: Nowadays minimal residual disease (MRD) and log-reduction of leukemic cells are poorly investigated in elderly patients with acute myeloid leukemia (AML) treated with hypometilating agents (HMAs). Studies focusing on MRD in elderly AML patients who received HMAs are scant and devoid of rigorous criteria for both enrollment and monitoring. Log-reduction has never been investigated in these patients. Thus, the purpose of our study was to compare the prognostic impact of MRD and log-reduction of leukemic cells at the optimal time of assessment in older AML patients., Methods: Elderly patients who completed at least six cycles of HMAs and showed suitable leukemia-associated immunophenotypes (LAIPs) for the MRD and log-reduction assessment by flow cytometry were enrolled in the study., Results: After comparing the times of assessment C4 (4-cycles) and C6 (6-cycles), C6 has been chosen as optimal. Patients who achieved MRD negativity or 2-log-reduction of leukemic cells at C6 had a significantly longer DFS. Particularly, results of 2-log-reduction were confirmed a multivariate analysis. Patients with MRD negativity or 2-log reduction of leukemic cells showed an improvement of their OS, although not significantly., Conclusions: Our data confirmed the predictive role of MRD and 2-log reduction also in older AML patients treated with HMAs., (© 2021 International Clinical Cytometry Society.)

Objective: In a previous work, we found that an Intracranial Elastance Index (IEI) ≥0.3 at ventricular infusion test had a high accuracy in predicting shunt response at 6 and 12 months in idiopathic normal pressure hydrocephalus (iNPH). The aim of this study was to verify the accuracy of IEI to predict response to shunt at both short- and long-term follow-up., Methods: Retrospective evaluation of 64 patients undergoing ventriculo-peritoneal shunting for iNPH between 2006 and 2015 based on a positive ventricular infusion test (IEI≥0.3). Patients were classified according to Krauss scale and mRS preoperatively, at 1-year and at last follow-up. An improvement of at least one point at Krauss score or at mRS was considered as a good outcome; unchanged or worsened patients were grouped as poor outcome., Results: Mean follow-up was 6.6 years. Improvement at Krauss scale was seen in 62.5% and 64.3% of patients at 1-year and last follow-up, respectively. Patients in good functional status (mRS≤2) increased from 25 in the preoperative period to 57% at both 1-year and last follow-up. IEI was significantly associated with Krauss (p=0.041) and mRS (p=0.036) outcome at last follow-up. Patients with worse preoperative Krauss and mRS had higher chance to improve but higher overall scores after treatment. At ROC curves, IEI showed a good long-term prediction of change in mRS from first year to last follow-up., Conclusions: IEI≥0.3 predicts outcomes at both short- and long-term, with more than 50% of patients being able to look after themselves after 6 years from treatment., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

In this article, we examine what the role of the private sector in times of crises is and whether the private sector is, and can be held to be, accountable. COVID-19 has amplified the difficulties with public-private partnerships and this article addresses several aspects concerning business enterprises, in particular transnational corporations, human rights and health sector activities, highlighting the key aspects to understand and address accountability issues. The article also explores accountability for the private sector, the processes to ensure accountability, and the relevance of regulation and self-regulation., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Public Health Association.)

Vaccine hesitancy (VH) in the age of adolescence is a major public health issue, though it has not been widely examined in the scientific literature. This systematic review aims to address the determinants of VH among adolescents aged 10-19. PubMed, Scopus, and Web of Science were searched from the inception until 11 December 2020. Articles in English, assessing adolescents' attitudes toward vaccination in terms of hesitancy and/or confidence were considered eligible. Out of 14,704 articles, 20 studies were included in the qualitative analysis. Quality assessment was performed through the Appraisal tool for Cross-Sectional Studies (AXIS). A better knowledge of vaccine-preventable diseases, a higher confidence in vaccines, as well as an active involvement in the decision-making process showed a positive relationship with adolescents' vaccine uptake. These aspects should be considered to plan tailored interventions for the promotion of vaccination among adolescents and to reduce VH. Major limitations of this review are represented by the high heterogeneity of the tools used in the primary studies and the lack of standardization in outcomes definitions. Future research is needed to disentangle the interrelationship among the different determinants of VH in this age group.

Purpose: The aim of the study was to investigate differences in non-small cell lung cancer (NSCLC) intra-thoracic staging by using contrast-enhanced computed tomography (ce-CT) at the arterial phase (AP), at the arterial plus delayed phases (AP + DEP), and at the delayed phase (DEP), and to evaluate their potential impact on disease staging., Materials and Methods: Two chest radiologists with different level of expertise and a general radiologist independently reviewed the chest CT exams of 150 patients with NSCLC; CT scans were performed 40 s (AP) and 60 s (DEP) after contrast material injection. Image assessment included three reading sessions: session A (AP), session B (AP + DEP) and session C (DEP). CT descriptors for the primary tumour (T), regional nodal involvement (N), and intra-thoracic metastases (M) were evaluated in each reading session. Readers had to assign a confidence level (CL) for the assessment of each descriptor and define the TNM stage. Friedman and Cochran Q test was used to compare the assessments of the 3 reading sessions; inter-reader agreement was determined (Intraclass Correlation Coefficient - ICC)., Results: The CL was significantly higher in sessions B and C than in session A for all descriptors, with the exception of pulmonary arterial invasion. Primary tumour inner necrosis and regional nodal involvement were detected in a significantly higher number of cases in sessions B and C as compared to session A (p ≤ 0.001). DEP significantly changed N stage determination (p < 0.001), particularly N3, and excluded chest wall invasion (p = 0.05) and venous invasion (p = 0.001). The agreement was good among the 3 readers (ICC = 0.761) and excellent between the 2 chest radiologists (ICC ≥ 0.940), regardless of the contrast phase., Conclusions: The 60-second DEP ce-CT for staging NSCLC significantly increased the readers' CL, changed the N stage determination, and helped excluding chest wall invasion and venous invasion., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Competing Interests: Tutti gli autori dichiarano assenza di conflitto di interesse.

Emergency preparedness is a continuous quality improvement process through which roles and responsibilities are defined to effectively anticipate, respond to, and recover from the impact of emergencies. This process results in documented plans that provide a backbone structure for developing the core capacities to address health threats. Nevertheless, several barriers can impair an effective preparedness planning, as it needs a 360° perspective to address each component according to the best evidence and practice. Preparedness planning shares common principles with health technology assessment (HTA) as both encompass a multidisciplinary and multistakeholder approach, follow an iterative cycle, adopt a 360° perspective on the impact of intervention measures, and conclude with decision-making support. Our "Perspective" illustrates how each HTA domain can address different component(s) of a preparedness plan that can indeed be seen as a container of multiple HTAs, which can then be used to populate the entire plan itself. This approach can allow one to overcome preparedness barriers, providing an independent, systematic, and robust tool to address the components and ensuring a comprehensive evaluation of their value in the mitigation of the impact of emergencies.

Background: Vaccination coverages need to be constantly maintained and improved with the implementation of vaccination strategies. This paper describes the development of an evidence-based tool to guide their planning and evaluation. Methods: A scoping review was performed in MEDLINE and institutional websites to search for similar available tools. A first version of the tool was developed considering review results and a four-step method used for the control and continuous improvement of processes and products, namely the Deming cycle. A panel of eight experts was then involved in a Delphi study for the finalization of the tool that was eventually discussed in a face-to-face meeting. Results: The scoping review found only one document and the first version of the tool was composed of 30 items. After the Delphi first round, 11 additional items were suggested and 5 original items amended. After the Delphi second round 41 items were eventually included. During the face-to-face meeting, 7 items were recognized as requisites for setting vaccination strategies, whereas 17 as relevant ones. Conclusions: Current public health challenges impose the need for evidence-based tools to organize effective vaccination strategies. Our tool is a first proposal which aims to reflect this focus., 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 © 2021 Calabrò, Carini, Tognetto, Mancinelli, Sarnari, Colamesta, Ricciardi, de Waure and The BRAVE Project Expert panel.)

Background: To keep a high quality of assistance it is important for hospitals to invest in health technologies (HTs) that have the potential of improving health outcomes. Even though guidance exists on how HTs should be introduced, used and dismissed, there is a surprising gap in literature concerning the awareness of hospitals in the actual utilization of HTs., Methods: We performed a systematic literature review of qualitative and quantitative studies aimed at investigating hospital contextual factors that influence the actual utilization of HTs. PubMed, Scopus, Web of Science, Econlit and Ovid Medline electronic databases were searched to retrieve articles published in English and Italian from January 2000 to January 2019. The quality of the included articles was assessed using the Critical Appraisal Skills Programme checklist for qualitative studies, Newcastle-Ottawa Scale for the cross-sectional studies and the Mixed Methods Appraisal Tool for mixed method studies., Results: We included 33 articles, which were of moderate to high methodological quality. The included articles mostly addressed the contextual factors that impact the implementation of information and communication technologies (ICTs). Overall, for all HTs, the hospital contextual factors were part of four categories: hospital infrastructure, human resource management, financial resources and leadership styles., Conclusion: Our systematic review reported that the contextual factors influencing the HTs utilization at hospital level are mainly explored for ICTs. Several factors should be considered when planning the implementation of a new HTs at hospital level. A potential publication bias might be present in our work, since we included articles published only in English and Italian Language, from January 2000 to January 2019. There remains a gap in the literature on the facilitators and barriers influencing the implementation and concrete utilization of medical and surgical HTs, suggesting the need for further studies for a better understanding.

The last 2019/20 northern hemisphere influenza season overlapped with the first wave of coronavirus disease 2019 (COVID-19) pandemic. Italy was the first western country where severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spread to a significant extent. In this representative cross-sectional survey, we aimed to describe some opinions and attitudes of the Italian general population towards both influenza vaccination and the COVID-19 pandemic, and to identify potential modifiers of the decision-making process regarding the uptake of the 2020/21 influenza vaccine. A total of 2543 responses were analyzed. Although most (74.8%) participants valued influenza vaccination positively and declared that it should be mandatory, some misconceptions around influenza persist. The general practitioner was the main source of trusted information on influenza vaccines, while social networks were judged to be the least reliable. Younger and less affluent individuals, subjects not vaccinated in the previous season, and those living in smaller communities showed lower odds of receiving the 2020/21 season influenza vaccination. However, the COVID-19 pandemic may have positively influenced the propensity of being vaccinated against 2020/21 seasonal influenza. In order to increase influenza vaccination coverage rates multidisciplinary targeted interventions are needed. The role of general practitioners remains crucial in increasing influenza vaccine awareness and acceptance by effective counselling.

Background: Patients' increasing needs and expectations require an overall assessment of hospital performance. Several international agencies have defined performance indicators sets but there exists no unanimous classification. The Impact HTA Horizon2020 Project wants to address this aspect, developing a toolkit of key indicators to measure hospital performance. The aim of this review is to identify and classify the dimensions of hospital performance indicators in order to develop a common language and identify a shared evidence-based way to frame and address performance assessment., Methods: Following the PRISMA statement, PubMed, Cochrane Library and Web of Science databases were queried to perform an umbrella review. Reviews focusing on hospital settings, published January 2000-June 2019 were considered. The quality of the studies selected was assessed using the AMSTAR2 tool., Results: Six reviews ranging 2002-2014 were included. The following dimensions were described in at least half of the studies: 6 studies classified efficiency (55 indicators analyzed); 5 studies classified effectiveness (13 indicators), patient centeredness (10 indicators) and safety (8 indicators); 3 studies responsive governance (2 indicators), staff orientation (10 indicators) and timeliness (4 indicators). Three reviews did not specify the indicators related to the dimensions listed, and one article gave a complete definition of the meaning of each dimension and of the related indicators., Conclusions: The research shows emphasis of the importance of patient centeredness, effectiveness, efficiency, and safety dimensions. Especially, greater attention is given to the dimensions of effectiveness and efficiency. Assessing the overall quality of clinical pathways is key in guaranteeing a truly effective and efficient system but, to date, there still exists a lack of awareness and proactivity in terms of measuring performance of nodes within networks. The effort of classifying and systematizing performance measurement techniques across hospitals is essential at the organizational, regional/national and possibly international levels to deliver top quality care to patients.

Human Papillomavirus (HPV) vaccination is a well-known fundamental strategy in the prevention of cervical cancer, as it is always caused by HPV infection. In fact, primary prevention of the infection corresponds to primary prevention of HPV-related cancers and other diseases. Since an effective prevention at the population level is the final goal, it is mandatory for healthcare systems to achieve a high HPV vaccination coverage among the adolescents to reduce the circulation of the virus and the burden of HPV-related diseases. This research identified, through a systematic literature review, 38 papers on strategies adopted to increase HPV vaccination coverage among adolescents. The evaluated strategies targeted adolescents/parents and/or healthcare providers and could be grouped in three main types: (1) reminder-based, (2) education, information, and communication activities, and (3) multicomponent strategies. Several types of strategy, such as those relied only on reminders and integrating different interventions, showed a positive impact on vaccination coverage. Nonetheless, the heterogeneity of the interventions suggests the importance to adapt such strategies to the specific national/local contexts to maximize vaccination coverage.

Introduction Coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), has quickly spread around the world. Areas covered This review will discuss the available immunologic and clinical evidence to support the benefit of the influenza, pneumococcal, and tuberculosis vaccines in the context of COVID-19 as well as to provide an overview on the COVID-19-specific vaccines that are in the development pipeline. In addition, implications for vaccination strategies from a public health perspective will be discussed. Expert opinion Some vaccines are being considered for their potentially beneficial role in preventing or improving the prognosis of COVID-19: influenza, pneumococcal and tuberculosis vaccines. These vaccines may have either direct effect on COVID-19 via different types of immune responses or indirect effects by reducing the burden of viral and bacterial respiratory diseases on individual patients and national healthcare system and by facilitating differential diagnoses with other viral/bacterial respiratory disease. On the other hand, a large number of candidate vaccines against SARS-CoV-2 are currently in the pipeline and undergoing phase I, II, and III clinical studies. As SARS-CoV-2 vaccines are expected to be marketed through accelerated regulatory pathways, vaccinovigilance as well as planning of a successful vaccination campaign will play a major role in protecting public health.

Cytomegalovirus (CMV) is the most common cause of congenital infection in humans. There are no enough data on long-term outcome of newborns with congenital CMV (cCMV) infection, particularly for those asymptomatic at birth. For this reason, we performed this study to evaluate long-term audiological, visual, neurocognitive, and behavioral outcome in patients with symptomatic and asymptomatic cCMV infection treated with oral Valganciclovir (VGC). Thirty-six newborns with confirmed cCMV infection were evaluated: 12 (33.3%) symptomatic at birth and 24 asymptomatic (66.7%). No one had cognitive impairment. Cognitive assessment scales resulted abnormal in 4/35 patients (11.4%). 11/21 patients (52.4%) achieved abnormal scores in neuropsychological tests. The language evaluation gave pathological results in 6/21 (28.5%) patients. 6/35 patients (17.1%) developed SNHL, all symptomatic at birth except one. None of the 34 patients evaluated developed CMV retinopathy. Our study shows that both symptomatic and asymptomatic newborns with cCMV infection develop long-term sequelae, particularly in the behavioral and communicative areas, independently from the trimester of maternal infection., (Copyright © 2020 Turriziani Colonna, Buonsenso, Pata, Salerno, Chieffo, Romeo, Faccia, Conti, Molle, Baldascino, De Waure, Acampora, Luciano, Santangelo and Valentini.)

The World Health Organization (WHO), the United States (US) Centers for Disease Control and Prevention (CDC), the European Center for Disease Control (ECDC), and the immunization guidelines of many countries issue vaccination recommendations for adults and the elderly. However, the uptake of vaccination in these groups is generally low due to several reasons. The present study aimed to identify strategies implemented in Italy in unconventional settings to promote vaccination against influenza, pneumococcal, and herpes zoster virus (HZV) infections among these subjects, i.e., the at-risk adult population and the elderly. We conducted a literature review and a survey of experts. The literature search yielded seven strategies; all of these concerned influenza vaccination, while three also addressed pneumococcal and HZV vaccination. The survey of experts identified 15 strategies; 10 regarded influenza vaccination, while four regarded pneumococcal vaccination and one regarded HZV vaccination. Most of the strategies were implemented in hospital clinics and rest homes. Regarding influenza and pneumococcal vaccinations, the target population mainly comprised at-risk adults, while the elderly represented the main target population for HZV vaccination. Our results show that, in Italy, there are initiatives aimed at promoting vaccination in unconventional settings, but further efforts are required to assess their effectiveness and to further extend them.

Objectives: Pneumonia still remains a problem from the clinical and public health viewpoint because of the relevant epidemiological burden. The etiological diagnosis is important in the light of avoiding unnecessary antibiotic treatment and choosing the most appropriate therapeutical approach. This study is aimed at providing evidence on the proportion of microbiological ascertainment in pneumonia-related hospitalizations in one of the most important teaching hospitals in Rome., Methods: The study relied on the record linkage of two administrative databases of the same hospital: the electronic hospital discharge register and the microbiology laboratory surveillance database., Results: 2819 records were identified, where 46% had a microbiological ascertainment, significantly higher in males than in females (51% vs 40%) and in cases of pneumonia reported in secondary diagnosis instead of primary diagnosis (52% vs 42%). Medical patients had significantly lower proportion of ascertainment compared to surgical patients (43% vs 67%) whereas there were not differences between patients with emergency and elective admission. The overall mortality was 17%. Mortality was significantly higher: in surgical compared to medical patients (27% vs 15%), in ventilated compared to not ventilated patients (41% vs 11%), in cases with secondary diagnosis of pneumonia compared to a primary diagnosis (23% vs 11% ) and in hospitalized in intensive care unit-ICU- rather than in non-ICU (71% vs 12%)., Conclusion: The proportion of microbiological ascertaiment in pneumonia remains less than 50%. Albeit in line with other evidence, this result should call the attention on the impact of unknown etiological diagnosis on antibiotic treatment and resistance.

The availability of several effective and safe vaccines enables health systems to counteract annual influenza epidemics. However, the criteria of appropriateness and sustainability require that each citizen should receive the right vaccine. The value of each vaccine can be assessed within well-known frameworks, such as the Health Technology Assessment (HTA), a step that is fundamental to the process of allocating resources to vaccination strategies. The paper describes how HTA has been incorporated as an evidence-based tool to support the definition of Italian vaccination strategies, reports the results of the HTA report on the most recently available influenza vaccine in Italy (cell-based quadrivalent vaccine (QIVc)-Flucelvax ® Tetra) and elaborates on current and future recommendations in the field of influenza vaccination. Recommendations issued by the Italian Ministry of Health foster the appropriate use of influenza vaccines from 2018-2019 onwards. Evidence of the value of newly available vaccines will hopefully support future decisions and promote the appropriate use of these vaccines on the basis of the characteristics of the target population. However, the success of influenza vaccination will also depend on citizens' empowerment and engagement in the decision-making process.

Background: Vitamin D is a hot topic in the scientific community. Its deficiency and the implications for the children's health became increasingly discussed during the last 20 years. The main aim of this retrospective study was to determinate the prevalence of vitamin D metabolism disorders in a population of adopted children and their risk factors., Methods: We gathered data from 2140 children observed in five different National Working Group for the Migrant Children of the Italian Society of Pediatrics centers, variously located in Italy. Serum 25-hydroxy (OH)-D concentration was used to determine every child's vitamin D status, defined as severely deficient (serum 25-OH-D < 10 ng/ml), moderately deficient (serum 25-OH-D {≥10 ng/ml U < 20 ng/ml}), mildly deficient (serum 25-OH-D {≥20 ng/ml U < 30 ng/ml}) and normal (serum 25-OH-D ≥ 30 ng/ml)., Results: Mean value of serum 25-OH-D was 22.7 ng/ml (SD ± 12.1). Vitamin D status was deemed as normal in 483 (22.6%) children, mildly deficient in 718 (33.6%) children, moderately deficient in 730 (34.1%) children and severely deficient in 209 (9.8%) children., Conclusions: A very high percentage of migrant children is affected by hypovitaminosis D, with a strong association with age, geographic origin, season of blood sample collection and time spent in Italy after the arrival. This finding highlights the need for corrective measures. However, these measures cannot be applied without increasing the access of migrant populations to healthcare services., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.)