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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/m2. 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.

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.

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 systematizin

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.

Considering food insecurity is a problem, even in developed countries, and the evidence gap regarding this issue in Italy, we aimed to assess the prevalence of food insecurity in a sample of Italian children and examine socio-economic and health correlates. This cross-sectional study was conducted in paediatric practices. Parents answered to the 18-items of the Household Food Security Module, 8 of which concern children. Paediatricians answered a questionnaire on children’s health. Socio-economic and health correlates of food insecurity in children were assessed using univariable and multivariable logistic regression. Among 573 households with children, 15·4% were food insecure, while 9·1% of children were food insecure. Socioeconomic factors associated to food insecurity were living in south Italy, households with three or more children, lower household yearly income, worse economic situation description and younger parents. Food insecure children were less likely to have a normal relational [ aOR 0.31 (CI 0.11-0.85)] and physical development [aOR 0.32(CI 0.15-0.65) and had more school difficulties [aOR 3.1(CI 1.33-7.24)] compared to their food secure peers. Food insecure children had higher odds of a deterioration in their health since birth and of a worse perceived health status, as reported by their parents. Considering the results in this sample and the lack of research regarding this issues in Italy and Europemore broadly, we call for consistent, nationalmonitoring to determine the magnitude of the problem of food insecurity in households with children in Italy and to examine the socioeconomic variables and health implications in different contexts.

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.

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.

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.

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.

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.

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.

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.

Il vaccino antinfluenzale Fluenz Tetra® (vaccino vivo attenuato quadrivalente, spray nasale, in sospensione) sarà disponibile in Italia per la prevenzione e il controllo dell’influenza per la stagione influenzale 2021-2022. Tale vaccino è indicato per la profilassi dell’influenza in bambini e adolescenti di età compresa tra i 24 mesi e i 18 anni [1]. I decision makers dovranno, quindi, presto valutarne l’utilizzo. Questa decisione potrebbe essere supportata dalla disponibilità di uno specifico rapporto di Health Technology Assessment (HTA). Infatti, l’HTA rappresenta oggi l’approccio valutativo più utile per i decision makers per prendere le più appropriate decisioni in ambito sanitario in base alle prove scientifiche disponibili. Anche il Piano Nazionale Prevenzione Vaccinale 2017-2019 (PNPV 2017-2019) conferma il ruolo rilevante dell’HTA ai fini della valutazione delle potenzialità e dei limiti di un vaccino e auspica un sempre maggiore utilizzo di questa metodologia per favorire le decisioni basate sulle evidenze, in un’ottica di corretto utilizzo delle limitate risorse disponibili [2]. In ambito vaccinale l’HTA si esplica nella valutazione dell’epidemiologia della specifica infezione e delle malattie correlate nella popolazione target, del disease burden della patologia, delle attuali misure preventive e terapeutiche disponibili contro l'infezione e le malattie esaminate, dell’efficacia e sicurezza del vaccino oggetto di studio e degli eventuali altri vaccini disponibili, delle valutazioni economiche, e infine degli aspetti etici, legali, sociali e organizzativi correlati all’introduzione di tale vaccino [3]. Pertanto, tutte le evidenze scientifiche disponibili su questi aspetti dovrebbero essere raccolte e esaminate criticamente all’interno di un rapporto di HTA al fine di eseguire una valutazione completa. Particolare attenzione va posta sul fatto che questa metodologia di valutazione si applica non solo per la valutazione dell’introduzione di nuovi vac

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.

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.

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.

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 systematizin

Nursing documentation is an important proxy of the quality of care, and quality indicators in nursing assessment can be used to assess and improve the quality of care in health care institutions. The study aims to evaluate the completeness and the accuracy of nursing assessment, analyzing the compilation of pain assessment and nutritional status (body mass index (BMI)) in computerized nursing records, and how it is influenced by four variables: nurse to patient ratio, diagnosis related group weight (DRG), seniority of charge nurse, and type of ward (medical, surgical or other). The observational ecological pilot study was conducted between September and October 2018 in an Italian Tertiary-Level Teaching Hospital. The nursing documentation analyzed for the ‘Assessment’ phase included 12,513 records, 50.4% concerning pain assessment, and 45% BMI. The nurse–patient ratio showed a significant direct association with the assessment of nutritional status (p = 0.032). The average weight DRG has a negative influence on pain and BMI assessment; the surgical units positively correlate with the compilation of nursing assessment (BMI and pain). The nursing process is an essential component for the continuous improvement in the quality of care. Nurses need to be accountable to improve their knowledge and skills in nursing documentation.