Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union: Preparing for the European Union's Regulation on Health Technology Assessment for Vaccines.

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

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.

The accountability of the private sector towards citizens in times of crisis: vaccines, medicines and equipment.

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.

Intraventricular infusion test accuracy in predicting short- and long-term outcome of iNPH patients: a 10-year update of a three-decade experience at a single institution.

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.

Hospital contextual factors affecting the implementation of health technologies: a systematic review.

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.

Health technology assessment applied to emergency preparedness: a new perspective.

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.

Identifying people at risk for influenza with low vaccine uptake based on deprivation status: a systematic review.

BACKGROUND: Influenza vaccination is an important public health intervention for controlling disease burden, but coverage rates are still low also in risk groups. In order to identify non-vaccinating subgroups, deprivation and socio-economic indices, i.e. measures used to synthetically describe people's socio-economic status while taking into account several dimensions, may be used. We aimed to synthetize evidence from studies investigating association between deprivation/socio-economic indices and influenza vaccination coverage in population at risk-persons ≥65 years of age, individuals with comorbidities, pregnant women and health-care workers. METHODS: We searched PubMed, ISI WoS, CINAHL and Scopus to identify observational studies published up to October 10th 2017 in English or Italian. Studies reporting quantitative estimates of the association between deprivation/socio-economic indices and influenza vaccination coverage in populations at risk were included. RESULTS: A total of 1474 articles were identified and 12 were eventually included in the final review. Studies were mostly cross-sectional, performed in European countries, from 2004 to 2017. Seven studies focussed on deprivation and five on socio-economic indices. Studies on deprivation indices and vaccination coverage showed that people from the most deprived areas had lower coverage. Regarding socio-economic condition, results were contrasting, even though it may also be concluded that people from lower groups have lower vaccination coverage. CONCLUSIONS: Our work supports the possibility to identify people likely to have lower influenza vaccination coverage based on deprivation/socio-economic indices. Efforts should be performed in order to further strengthen robustness, transferability and suitability of these indices in addressing public health problems.

Vitamin D deficiency in a population of migrant children: an Italian retrospective cross-sectional multicentric study.

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.

Assessing hospital performance indicators. What dimensions? Evidence from an umbrella review.

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.

Adjuvanted influenza vaccine for the Italian elderly in the 2018/19 season: an updated health technology assessment.

BACKGROUND: The elderly, defined here as subjects aged ≥ 65 years, are among at-risk subjects for whom annual influenza vaccination is recommended. For the 2018/19 season, three vaccine types are available for the elderly in Italy: trivalent inactivated vaccine (TIV), adjuvanted TIV (aTIV) and quadrivalent inactivated vaccines (QIV). No health technology assessment (HTA) of seasonal influenza vaccination in the elderly has previously been conducted in Italy. METHODS: An HTA was conducted in 2017 to analyze the burden of influenza illness, the characteristics, efficacy, safety and cost-effectiveness of available vaccines and the related organizational and ethical implications. This was then contextualized to the 2018/19 influenza season. Comprehensive literature reviews/analyses were performed and a static mathematical model developed in order to address the above issues. RESULTS: In Italy, influenza is usually less common in the elderly than in other age-classes, but the burden of disease is the highest; >10% of infected elderly subjects develop complications, and about 90% of all influenza-related deaths occur in this age-class. All available vaccines are effective, safe and acceptable from an ethical standpoint. However, aTIV has proved more immunogenic and effective in the elderly. Furthermore, from the third payer's perspective, aTIV is highly cost-effective and cost-saving in comparison with TIV and QIV, respectively. Nevertheless, vaccination coverage needs to be improved. CONCLUSIONS: According to this HTA, aTIV appeared the vaccine of choice in the elderly. HTA should be reapplied whenever new relevant data become available.

A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.

OBJECTIVE: This study investigated the outcomes of a current series of patients treated with fenestrated and branched endovascular aneurysm repair (F-BEVAR) or open surgical repair (OSR) for pararenal abdominal aortic aneurysms (pr-AAAs), including juxtarenal, suprarenal, and type IV thoracoabdominal aneurysms. This study compares the outcomes of these procedures from two high-volume centers without the bias induced by a learning curve. METHODS: All patients with pr-AAAs undergoing repair at two centers between January 2010 and June 2016 were included in a prospective database. Patients undergoing F-BEVAR and OSR were propensity matched for age, sex, anatomic criteria (aortic clamp site), coronary artery disease, chronic obstructive pulmonary disease, diabetes, smoking, chronic kidney disease, aneurysm diameter, and previous aortic surgery. The primary end points were mortality and dialysis. Secondary end points included any myocardial ischemia, respiratory and early procedural complications, acute kidney injury (AKI) according to RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal failure), spinal cord ischemia, a composite of these complications, and postoperative intensive care unit length of stay. During follow-up, all-cause survival and freedom from reintervention were compared, as was the patency of stented vessels and renal and visceral bypasses. Late renal function deterioration was evaluated. RESULTS: In this period, 157 F-BEVAR patients and 119 OSR patients were operated on. After 1:1 propensity matching, the study cohort consisted of 102 F-BEVARs and 102 OSRs. In the matched population, an average of 2.5 vessels were treated per patient. Univariate analysis demonstrated no significant difference in 30-day mortality (2.9% vs 2.0%; P = .68), dialysis (4.9% vs 3.9%; P = 1), cardiac ischemic complications (3.8% vs 5.9%; P = .52), pulmonary complications (5.9% vs 5.9%; P = 1), or any complications (28.4% vs 30.4%; P = .63) in the F-BEVAR and OSR groups, respectively. AKI was significantly lower in the F-BEVAR group than in the OSR group (19.6% vs 52%; P < .001), as was severe AKI (>50% decrease in glomerular filtration rate, 6.9% vs 16.7%; P = .03). There was no spinal cord ischemia. The median intensive care unit length of stay was 1 day in both groups (P = .33). During follow-up, we found occlusions of five stented vessels and three surgical bypasses. Late renal function deterioration was comparable between the two groups. According to Kaplan-Meier estimates, all-cause survival at 24, 48, and 72 months was 85.6%, 66.8%, and 55.8% after F-BEVAR and 90.5%, 82.9%, and 68.5% after OSR (P = .04). Rates of freedom from reintervention were 97.6% vs 97.5% at 24 months, 90.1% vs 93.4% at 48 months, and 63.9% vs 93.4% at 72 months in the F-BEVAR and OSR groups (P = .05), respectively. Thus, both all-cause survival and freedom from reintervention were lower in the F-BEVAR group. CONCLUSIONS: This propensity score analysis in patients with pr-AAA undergoing F-BEVAR or OSR suggests no difference in terms of 30-day mortality, dialysis, or organ-specific postoperative complications, with the exception of AKI. Postoperative AKI was significantly higher after OSR, although most patients had recovered before discharge. Our data suggest similar outcomes after F-BEVAR or OSR for pr-AAA.

Hospitalization rates and outcome of invasive bacterial vaccine-preventable diseases in Tuscany: a historical cohort study of the 2000-2016 period.

BACKGROUND: Invasive bacterial diseases (IBD) are a serious cause of hospitalization, sequelae and mortality. Albeit a low incidence, an increase in cases due to H. influenzae was registered in the past 4 years and, in the Tuscany region, an excess of cases due to N. meningitidis since 2015 is alarming. The purpose of this study is to deepen the knowledge of IBD epidemiology in Tuscany with particular attention to temporal trends. METHODS: Tuscan residents hospitalized for IBD from January 1st 2000 to March 18th 2016 were selected from the regional hospital discharge database based on ICD-9-CM codes. Age-specific and standardized hospitalization rates were calculated together with case-fatality rates (CFRs). A time-trend analysis was performed; whereas, prognostic factors of death were investigated through univariable and multivariable analyses. RESULTS: The average standardized hospitalization rates for invasive meningococcal diseases (IMD), invasive pneumococcal diseases and invasive diseases due to H. influenzae from 2000 to 2016 were 0.6, 1.8, and 0.2 per 100,000, respectively. The average CFRs were 10.5%, 14.5% and 11.5% respectively with higher values in the elderly. Older age was significantly associated with higher risk of death from all IBD. A significant reduction in hospitalization rates for IMD was observed after meningococcal C conjugate vaccine introduction. The Annual Percentage Change (APC) was -13.5 (95% confidence interval (CI) -22.3; -3.5) in 2005-2013 but has risen since that period. Furthermore, a significant increasing trend of invasive diseases due to H. influenzae was observed from 2005 onwards in children 1-4 years old (APC 13.3; 95% CI 0; 28.3). CONCLUSIONS: This study confirms changes in the epidemiology of invasive diseases due to H. influenzae and IMD. Furthermore, attention is called to the prevention of IBD in the elderly because of the age group's significantly higher rate of hospitalizations and deaths for all types of IBD.

Disinvestment in cancer care: a survey investigating European countries' opinions and views.

Background: The current economic context calls for rationalizing health resources that can be pursued through disinvestment from low value health technologies to invest in the best performing ones, ensuring high healthcare quality. Oncology is a field where, because of high costs of health technologies and rapid innovation, disinvestment is crucial. Methods: On this basis, the research team investigated through a survey, based on a questionnaire, opinions and views of representatives of European countries about disinvestment, in terms of fields of application, potential advocates and barriers, specifically focusing on cancer care. Results: A total of 17 questionnaires were filled in (response rate: 32.1%). The survey showed disinvestment is applied in several countries as a tool for containing health care expenditures and identifying obsolete technologies/ineffective interventions. Clinicians' resistance to change and industries' opposition are recognized as the most important barriers to the implementation of disinvestment policies. Potential targets of disinvestment in cancer are seen in diagnostic and therapeutic areas. Conclusion: Despite the agreement on fields of waste and of disinvestment policies, operational methods to put disinvestment in place are lacking. Since they should rely on an inclusive assessment of the technology, Health Technology Assessment may represent a good approach.

HEALTH TECHNOLOGY ASSESSMENT EVIDENCE ON E-HEALTH/M-HEALTH TECHNOLOGIES: EVALUATING THE TRANSPARENCY AND THOROUGHNESS.

OBJECTIVES: Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement. METHODS: PubMed, ISI-WOS, and University of York - Centre for Reviews and Dissemination-electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model. RESULTS: Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects. CONCLUSIONS: E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

Application and advantages of monoenergetic reconstruction images for the reduction of metallic artifacts using dual-energy CT in knee and hip prostheses.

OBJECTIVE: The study aimed to assess image quality when using dual-energy CT (DECT) to reduce metal artifacts in subjects with knee and hip prostheses. METHODS: Twenty-two knee and 10 hip prostheses were examined in 31 patients using a DECT protocol (tube voltages 100 and 140 kVp). Monoenergetic reconstructions were extrapolated at 64, 69, 88, 105, 110, 120, 140, 170, and 190 kilo-electron volts (keV) and the optimal energy was manually selected. The B60-140 and Fast DE reconstructions were made by CT. The image quality and diagnostic value were subjectively and objectively determined. Double-blind qualitative assessment was performed by two radiologists using a Likert scale. For quantitative analysis, a circular region of interest (ROI) was placed by a third radiologist within the most evident streak artifacts on every image. Another ROI was placed in surrounding tissues without artifacts as a reference. RESULTS: The inter-reader agreement for the qualitative assessment was nearly 100%. The best overall image quality (37.8% rated "excellent") was the Fast DE Siemens reconstruction, followed by B60-140 and Opt KeV (20.5 and 10.2% rated excellent). On the other hand, DECT images at 64, 69 and 88 keV had the worse scores. The number of artifacts was significantly different between monoenergetic images. Nevertheless, because of the high number of pairwise comparisons, no differences were found in the post hoc analysis except for a trend toward statistical significance when comparing the 170 and 64 keV doses. CONCLUSIONS: DECT with specific post-processing may reduce metal artifacts and significantly enhance the image quality and diagnostic value when evaluating metallic implants.

[The Adherence's indicators of cancer patients to oral chemotherapy. A sistematic literature review]. / Gli indicatori di aderenza dei pazienti oncologici alla chemioterapia orale. Evidenze empiriche da una revisione sistematica della letteratura.

INTRODUCTION: Adherence has a key role in treating patients as influences the effectiveness of therapeutic treatment for improving overall survival, life expectancy, quality of life and reducing healthcare costs. There are gaps in identifying indicators to be used to evaluate adherence and ways in which these indicators should be adopted. The aim of this paper is to identify adherence's indicators in literature. METHODS: Systematic review was carried out in, Cinhal-EBSCO, Medline-PUBMED and Scopus including studies of measure patient's adherence in English and published from 2010 to 2016. Inclusion and exclusion criteria were used. The quality of the articles was assessed with the NewCastle Ottawa Scale for observational studies and the Cochrane Collaboration Risk of Bias for experimental studies. RESULTS: Of the 7,368 papers initially retrieved, 15 met the inclusion criteria (11 observational studies, 4 RCTs), for a total of 1,396 patients. The indicators found are: self-report tools, pill counts, drug recharge rate, continuous measures, metabolic dosage. A patient is considered adherent to the treatment if he or she assumes a percentage of drugs ≥ 80% of the prescribed medications. DISCUSSION: A better adherence rating is obtained by using multiple instruments at the same time. The objective indicators derive from the direct measurement methods of adherence, the subjective ones from the indirect.

Helicobacter pylori infection contributes to placental impairment in preeclampsia: basic and clinical evidences.

BACKGROUND: Preeclampsia (PE) is a major cause of maternal and neonatal morbidity and mortality. Epidemiological association between Helicobacter pylori (Hp) infection and PE onset has been widely shown. The aim of this study was to analyze a possible correlation between Hp infection and the severity of clinical presentation of PE and to identify an immunologic mechanism triggered by Hp infection potentially contributing to the pathogenesis of PE. MATERIALS AND METHODS: Sera from 93 preeclamptic women and 87 healthy pregnant women were tested for Hp infection by immunoassay and for anti-CagA antibodies by Western blot assay. The serologic results were correlated with the clinical features of PE. The functional effect of serum IgG fractions, positive or negative for Hp, from preeclamptic women or controls were tested on trophoblast and endothelial cell cultures and in a murine model of angiogenesis. RESULTS: Preeclamptic women showed higher seroprevalence of Hp infection (57.0%) compared to controls (33.3%) (P<.001). The seropositivity for CagA-positive strains of Hp was 45.2% in preeclamptic women vs 13.7% in controls (P<.001). In PE women, Hp infection was associated with abnormality of uterine arteries Doppler (P<.001). Hp+ IgG fractions from preeclamptic women bound to trophoblast and endometrial endothelial cell cultures, reducing in vitro invasiveness and angiogenesis, respectively, and inhibited angiogenesis in mice. CONCLUSIONS: Our data show, for the first time, an association between Hp infection and PE with abnormal uterine arteries Doppler velocimetry, suggesting a role for Hp infection in impairing placental development and increasing the risk to develop PE. This study opens the new perspective of a potential screening and treatment for Hp infection in pregnancy.

Cost-effectiveness analysis of the nine-valent HPV vaccine in Italy.

BACKGROUND: In Italy HPV vaccination with the quadrivalent vaccine (Gardasil®) is offered actively and free of charge to girls aged 12 since 2007. A nine-valent vaccine (Gardasil 9®) received the European market authorization in 2015 to protect, with only 2 doses, against around 90% of all HPV positive cancers, over 80% of high-grade precancerous lesions and 90% of genital warts caused by HPV types 6/11. METHODS: A dynamic transmission model simulating the natural history of HPV-infections was calibrated to the Italian setting and used to estimate costs and QALYs associated with vaccination strategies. The analyses compared two strategies with the nine-valent vaccine (cervical cancer screening and vaccination in girls only or vaccination in boys and girls) to four alternative strategies (cervical cancer screening and vaccination with quadrialent vaccine in girls only, in both boys and girls, with bivalent vaccine in girls and screening strategy only). The National Health Service perspective was considered. CONCLUSION: The switch to the nine-valent vaccine in Italy can further reduce the burden associated to cervical cancer and HPV-related diseases and is highly cost-effective. RESULTS: Compared to the current vaccination program with quadrivalent vaccine, the nine-valent vaccine in a programme including girls and boys shows further reductions of 17% in the incidence of cervical cancer, 35 and 14% in anal cancer for males and females, as well as over a million cases of genital warts avoided after 100 years. The new technology is associated with an ICER of 10,463€ per QALY gained in universal vaccination, decreasing to 4483€ when considering the vaccine switch for girls-only.

Fostering Flu Vaccination in Healthcare Workers: Forum Theatre in a University Hospital.

The World Health Organization recommends flu vaccination as the most effective way to prevent the disease and its severe outcomes and has established the minimum vaccination coverage for people at risk at 75%. Even though healthcare workers (HCWs) represent a strongly recommended target group for flu vaccination campaigns, the average coverage among them is still inadequate. In flu season 2015/2016, our University Hospital tested Forum Theatre (FT) as a new participative strategy to foster HCWs engagement regarding flu vaccination. The aim of this study was to evaluate HCWs' satisfaction with and perceived utility of FT. In 2015, five FT sessions were organized in hospital units which were considered at risk for flu based on the type of admitted patients. After each session, participants were asked to complete an assessment questionnaire. The χ² test or the t-test was used to compare the proportion of participants who were satisfied with the FT and considered it useful (utility score). Data was analyzed according to gender, profession, and age. In all, 16.5% of HCWs who worked in four out of five of the units identified, participated in the FT sessions. Questionnaire results indicated that 74% of spectators were satisfied with their experience and 70% considered this methodology a useful approach for other health issues. Gender, age, and profession did not influence satisfaction or utility scores. Participative strategies such as FT represent an innovative solution to increasing HCWs' awareness of the importance of flu vaccination and could positively impact their adherence to vaccination recommendations. FT can also be a meaningful HCW teaching tool for learning about and changing attitudes toward other clinic and public health issues.

Health assessments for health governance-concepts and methodologies.

Background: For better supporting the science-governance interface, the potential of health assessments appears underrated. Aims: To identify what various types of health assessment have in common; how they differ; which assessment(s) to apply for which purpose; and what needs and options there are for future joint development. Methods: This review is based on five types of health assessment: monitoring/surveillance/reporting, assessment of health impact, of health technology, of health systems performance, health-related economic assessment. The approach is exploratory and includes: applying an agreed set of comparative criteria; circulating and supplementing synoptic tables; and interpreting the results. Results: Two of the assessments deal with the question 'Where do we stand?', two others with variants of 'What if' questions. Economic Assessment can take place in combination with any of the others. The assessments involve both overall 'procedures' and a variety of 'methods' which inescapably reflect some subjective assumptions and decisions, e.g. on issue framing. Resources and assistance exist for all these assessments. The paper indicates which type of assessment is appropriate for what purpose. Conclusions: Although scientific soundness of health assessments is not trivial to secure, existing types of health assessment can be interpreted as a useful 'toolkit' for supporting governance. If current traces of 'silo' thinking can be overcome, the attainability of a more unified culture of health assessments increases and such assessments might more widely be recognized as a prime, 'tried and tested' way to voice Public Health knowledge and to support rational governance and policy-making.