Promoting Vaccinations in Pregnancy: Results of a Systematic Literature Review of Italian Initiatives.

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.

Real world evidence for public health decision-making on vaccination policies: perspectives from an expert roundtable.

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.

Attitudes toward influenza vaccination in healthcare workers in Italy: A systematic review and meta-analysis.

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.

COVID-19 Vaccination Actual Uptake and Potential Inequalities Due to Socio-Demographic Characteristics: A Population-Based Study in the Umbria Region, Italy.

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.

Editorial for the Special Issue "COVID-19 Vaccines: A Public Health Perspective".

Public health is aimed at protecting and promoting citizens' and communities' health through different interventions, including vaccinations [...].

Identifying priority questions regarding rapid systematic reviews' methods: protocol for an eDelphi study.

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.

The Impact of Vaccination on COVID-19 Burden of Disease in the Adult and Elderly Population: A Systematic Review of Italian Evidence.

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.

Exploring the Contribution of Curcumin to Cancer Therapy: A Systematic Review of Randomized Controlled Trials.

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.

Long-Term Propensity-Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair of Complex Abdominal Aortic Aneurysms.

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 m2 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.

Determinants of COVID-19 vaccination acceptance or hesitancy in Italy: an overview of the current evidence.

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.

Evaluation of the prevalence of the most common psychiatric disorders in patients with type 2 diabetes mellitus using the patient health questionnaire: results of the cross-sectional "DIA2PSI" study.

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.

Efficacy of vaccination against equine herpesvirus type 1 (EHV-1) infection: Systematic review and meta-analysis of randomised controlled challenge trials.

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.

Cervical cancer elimination in Italy: Current scenario and future endeavors for a value based prevention.

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.

Planning and Organization of the COVID-19 Vaccination Campaign: An Overview of Eight European Countries.

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.

Long-Term Results of Complex Abdominal Aortic Aneurysm Open Repair.

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.

Quadrivalent Vaccines for the Immunization of Adults against Influenza: A Systematic Review of Randomized Controlled Trials.

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.

Comparative effectiveness of adjuvanted versus high-dose seasonal influenza vaccines for older adults: a systematic review and meta-analysis.

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.

The Value(s) of Vaccination: Building the Scientific Evidence According to a Value-Based Healthcare Approach.

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.