Annalisa Rosso

Policy and planning of prevention in Italy: Results from an appraisal of prevention plans developed by Regions for the period 2010–2012

Health policies on disease prevention differ widely between countries. Studies suggest that different countries have much to learn from each other and that significant health gains could be achieved if all countries followed best practice. This paper describes the policy development and planning process relating to prevention activities in Italy, through a critical appraisal of Regional Prevention Plans (RPPs) drafted for the period 2010-2012. The analysis was performed using a specific evaluation tool developed by a Scientific Committee appointed by the Italian Ministry of Health. We appraised nineteen RPPs, comprising a total of 702 projects, most of them in the areas of universal prevention (62.9%) and prevention in high risk groups (27.0%). Italian Regions established prevention activities using an innovative combination of population and high-risk individuals approaches. However, some issues, such as the need to reduce health inequalities, were poorly addressed. The technical drafting of RPPs required some improvement; e.g. the evidence of the effectiveness and cost-effectiveness of the health interventions proposed was seldom reported. There were significant geographical differences across the Regions in the appraisal of RPPs. Our research suggests that continuous assessment of the planning process of prevention may become a very useful tool for monitoring, and ultimately strengthening, public health capacity in the field of prevention. Further research is needed to analyze determinants of regional variation.

Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: a systematic review and meta-analysis

BACKGROUND The multicomponent meningococcal serogroup B vaccine (4CMenB) has been licensed in more than 35 countries. However, uncertainties remain about the lowest number of doses required to induce satisfactory, persistent immune responses. We did a systematic review and meta-analysis to provide quantitative estimates for the immunogenicity, persistence of immunogenicity, and safety of 4CMenB vaccine in children and adolescents. METHODS For this systematic review and meta-analyses (proportion, head to head, and network), we searched MEDLINE, Scopus, Embase, and ClinicalTrials.gov from database inception to June 30, 2017, for randomised trials that compared the immunogenicity or safety of the 4CMenB vaccine with its originator meningococcal B recombinant vaccine or routine vaccines in children or adolescents. For proportion meta-analyses, we also included single arm trials and follow-up studies of randomised controlled trials. Trials that assessed immunogenicity against at least one of four Neisseria meningitidis serogroup B reference strains (44-76/SL, 5/99, NZ98/254, and M10713) and included participants younger than 18 years who had received two or more doses of the 4CMenB vaccine were eligible for inclusion. We requested individual patient-level data from study authors and extracted data from published reports and online trial registries. We did meta-analyses to assess 4CMenB safety and immunogenicity against the four reference strains 30 days after a primary immunisation course (three doses for children, two doses for adolescents), 30 days after the primary course plus one booster dose (children only), 6 months or more after primary course, and 6 months or more after the booster dose. FINDINGS 736 non-duplicate records were screened, and ten randomised trials and eight follow-on extension trials on 4CMenB met the inclusion criteria. In intention-to-treat analyses, the overall proportion of children and adolescents who achieved seroconversion 30 days after the primary course of 4CMenB was 92% (95% CI 89-95 [I2=95%, p<0·0001]) for the 44/76-SL strain, 91% (87-95 [I2=95%, p<0·0001]) for the 5/99 strain, 84% (77-90 [I2=97%, p<0·0001]) for the NZ98-254 strain, and 87% (68-99 [I2=97%, p<0·0001]) for the M10713 strain. 6 months after the primary course, the immunogenicity remained adequate to high against all three tested strains (5/99, 44/76-SL, and NZ98/254) in adolescents (≥77%), and against two of four strains (5/99 and 44/76-SL) in children (≥67%): the proportion of patients who achieved seroconversion substantially declined for M10713 (<50%) and NZ98/254 (<35%). A booster dose re-enhanced the proportion of patients who achieved seroconversion (≥93% for all strains). However, immunogenicity remained high 6 months after the booster dose for strains 5/99 (95%) and M10713 (75%) only, whereas the proportion of patients who achieved seroconversion against strains 44/76-SL and NZ98/254 returned to similar proportions recorded 6 months after the primary course (62% for 44/76-SL, 35% for NZ98/254). The incidence of potentially vaccine-related, acute serious adverse events in individuals receiving 4CMenB was low (5·4 per 1000 individuals), but was significantly higher than routine vaccines (1·2 per 1000 individuals). INTERPRETATION 4CMenB has an acceptable short-term safety profile. The primary course is sufficient to achieve a satisfactory immune response within 30 days of vaccination. A booster dose is required for children to prolong the protection against strain M10713, and the long-term immunogenicity against strain NZ98/254 remains suboptimal. FUNDING None.

The negative effect of financial constraints on planning prevention activities: some evidence from the Italian experience.

This study was aimed to assess the association between regional financial deficits and Recovery Plans and the quality of the 702 projects developed by the Italian Regions within the National Prevention Plan 2010–13. Multivariate analyses showed significant associations between Recovery Plans and low quality of projects, possibly due to weak regional public health capacities. Regions with Recovery Plans are likely to focus mainly on short-term issues with a high impact on health care costs, leaving few resources available for prevention. A different approach to financial deficit focused on long-term strategies, including those for health promotion and disease prevention, is needed.

Predictive genetic testing for complex diseases: a public health perspective

From a public health perspective, systematic, evidence-based technology assessments and economic evaluations are needed to guide the incorporation of genomics into clinical and public health practice. However, scientific evidence on the effectiveness of predictive genetic tests is difficult to obtain. This review first highlights the similarities and differences between traditional screening tests and predictive genetic testing for complex diseases and goes on to describe frameworks for the evaluation of genetic testing that have been developed in recent years providing some evidence that currently genetic tests are not used in an appropriate way. Nevertheless, evidence-based recommendations are already available for some genomic applications that can reduce morbidity and mortality and many more are expected to emerge over the next decade. The time is now ripe for the introduction of a range of genetic tests into healthcare practice, but this will require the development of specific health policies, proper public health evaluations, organizational changes within the healthcare systems, capacity building among the healthcare workforce and the education of the public.

The need to improve implementation and use of lifestyle surveillance systems for planning prevention activities: an analysis of the Italian Regions.

OBJECTIVES To describe the level of use of lifestyle surveillance systems in Italy and to identify predictors of their use by the Italian Regions for planning and monitoring purposes. STUDY DESIGN Data were extracted from the 19 Regional Prevention Plans (RPPs) and the health promotion and prevention projects included in them developed by the Italian Regions within the National Prevention Plan 2010-2013. METHODS The 19 RPPs and the 702 projects were appraised using a tool specifically developed for the purpose. Multiple logistic regression was performed to identify predictors of use of surveillance systems in the 359 projects that could use them. RESULTS The analysis of regional epidemiological contexts does not always rely upon surveillance system data and there were too few projects aimed at the maintenance and the development of these systems. Moreover, fewer than half of projects that could have used surveillance systems for planning and evaluation procedures actually did so, despite the potential value of these data. There was a statistically significant association between Regional Health Care Expenditure (RHCE) and the use of surveillance system data for planning and/or evaluation of the projects (OR 7.81, 95% CI 2.86-21.29). CONCLUSIONS Use of surveillance systems for regional prevention planning in Italy is not optimal due to late implementation, presence of different data collecting systems and RGDP inequalities. There is a pressing need for full implementation of surveillance systems to allow better definition of the priorities and objectives of public health interventions.

How is genetic testing evaluated? A systematic review of the literature

Given the rapid development of genetic tests, an assessment of their benefits, risks, and limitations is crucial for public health practice. We performed a systematic review aimed at identifying and comparing the existing evaluation frameworks for genetic tests. We searched PUBMED, SCOPUS, ISI Web of Knowledge, Google Scholar, Google, and gray literature sources for any documents describing such frameworks. We identified 29 evaluation frameworks published between 2000 and 2017, mostly based on the ACCE Framework (n = 13 models), or on the HTA process (n = 6), or both (n = 2). Others refer to the Wilson and Jungner screening criteria (n = 3) or to a mixture of different criteria (n = 5). Due to the widespread use of the ACCE Framework, the most frequently used evaluation criteria are analytic and clinical validity, clinical utility and ethical, legal and social implications. Less attention is given to the context of implementation. An economic dimension is always considered, but not in great detail. Consideration of delivery models, organizational aspects, and consumer viewpoint is often lacking. A deeper analysis of such context-related evaluation dimensions may strengthen a comprehensive evaluation of genetic tests and support the decision-making process.

Familial Hypercholesterolemia: A Systematic Review of Guidelines on Genetic Testing and Patient Management

Background Familial hypercholesterolemia (FH) is an autosomal-dominant hereditary disorder of lipid metabolism that causes lifelong exposure to increased LDL levels resulting in premature coronary heart disease and, if untreated, death. Recent studies have shown its prevalence to be higher than previously considered, which has important implications for the mortality and morbidity of associated cardiovascular disease (CVD). Several clinical tools are used worldwide to help physicians diagnose FH, but nevertheless most patients remain undetected. This systematic review of guidelines aims to assess the role of genetic testing in the screening, diagnosis, and management of patients affected by heterozygous or homozygous FH and to identify related health-care pathways. Methods We performed a systematic review of the literature; inclusion criteria were English or Italian guidelines focusing on genetic testing. The guidelines were included and evaluated for their content and development process using the Appraisal of Guidelines for Research and Evaluation II instrument. Results Ten guidelines were considered eligible, and all were judged to be of good quality, with slight differences among them. The most common indications for performing genetic tests were high levels of cholesterol, or physical findings consistent with lipid disorder, in the subject or in the family history. Subsequent screening of family members was indicated when a mutation had been identified in the index patient. Regarding patient management, the various guidelines agreed that intensive treatment with lipid-lowering medications should begin as quickly as possible and that lifestyle modifications should be an integral part of the therapy. Conclusion Since the early detection of affected patients is beneficial for effective prevention of CVD, genetic testing is particularly useful for identifying family members via cascade screening and for distinguishing between heterozygous and homozygous individuals, the latter of which require more extreme therapeutic intervention.

Reliability of the telephone-administered International Physical Activity Questionnaire in an Italian pilot sample

Background: the International Physical Activity Questionnaire (IPAQ) is an instrument for crossnational monitoring of physical activity and inactivity. The aim of the study was the reliability evaluation of the Italian telephone-administered IPAQ version in Rome. Methods: the IPAQ short form (IPAQ-SF), consisting of 7 items, was administered. The responses, used to compute Metabolic Equivalent Task (MET in minutes per week), were processed to analyze the internal consistency. Standardized Cronbach’s alpha was used for reliability estimation. Results: a total of 133 adults (51 males and 82 females) participated in the study, with a mean age of 51 years (SD=19). The mean MET was 4 130, corresponding to good physical activity levels. The standardized Cronbach’s alpha on 6 items, concerning time spent on vigorous and moderate activity and walking, was 0.614. Conclusions: according to the findings from other countries, the Italian IPAQ-SF has acceptable measurement properties, as good as other established self-reports. The IPAQ-SF has a questionable reliability as previously reported, but the results of the present pilot study are promising and suggest that these instruments can be used to compare population estimates of physical activity.

Mediterranean diet adherence and synergy with acute myocardial infarction and its determinants: A multicenter case-control study in Italy

Background Cardiovascular diseases are the leading causes of mortality and morbidity in Western countries. The possible synergistic effect of poor adherence to a Mediterranean diet (MD) and other risk factors for acute myocardial infarction (AMI) such as hypertension, cholesterol, ever smoker, BMI> 25, diabetes, has not been deeply studied. Design Case-control study. Methods Patients with first AMI and controls from four tertiary referral Italian centers were screened for enrolment. Dietary information was collected through a questionnaire and a MD adherence score was calculated. Physical activity and smoking habits were also registered. The Synergy Index was calculated according to Rothman. Results 127 cases and 173 controls were enrolled. The analysis was conducted using a dichotomous variable for the MD score with values ≥7 representing good adherence. Multivariate analysis showed the following variables associated to AMI: ever smoker (OR = 2.08), diabetes (OR = 1.42), hypertension (OR = 2.08), hypercholesterolemia (OR = 2.47), BMI> 25 (OR = 1.99), while a protective effect emerged both in subjects scoring > 7 on the MD score (OR = 0.55) and in subjects resident of Southern Italy (OR = 0.38). A synergistic effect does exist between poor adherence to the MD and the following risk factors: hypertension, hypercholesterolemia, BMI >25, diabetes and being a resident in central and northern Italy. Conclusion Synergy between heart disease risk factors and MD underlines the need to enlarge the list of known modifiable cardiovascular risk factors to include and promote adherence to Mediterranean dietary habits.

Identification of Delivery Models for the Provision of Predictive Genetic Testing in Europe: Protocol for a Multicentre Qualitative Study and a Systematic Review of the Literature

Introduction The appropriate application of genomic technologies in healthcare is surrounded by many concerns. In particular, there is a lack of evidence on what constitutes an optimal genetic service delivery model, which depends on the type of genetic test and healthcare context considered. The present project aims to identify, classify, and evaluate delivery models for the provision of predictive genetic testing in Europe and in selected Anglophone extra-European countries (the USA, Canada, Australia, and New Zealand). It also sets out to survey the European public health community’s readiness to incorporate public health genomics into their practice. Materials and equipment The project consists of (i) a systematic review of published literature and selected country websites, (ii) structured interviews with health experts on the genetic service delivery models in their respective countries, and (iii) a survey of European Public Health Association (EUPHA) members’ knowledge and attitudes toward genomics applications in clinical practice. The inclusion criteria for the systematic review are that articles be published in the period 2000–2015; be in English or Italian; and be from European countries or from Canada, the USA, Australia, or New Zealand. Additional policy documents will be retrieved from represented countries’ government-affiliated websites. The results of the research will be disseminated through the EUPHA network, the Italian Network for Genomics in Public Health (GENISAP), and seminars and workshops. Expected impact of the study on public health The transfer of genomic technologies from research to clinical application is influenced not only by several factors inherent to research goals and delivery of healthcare but also by external and commercial interests that may cause the premature introduction of genetic tests in the public and private sectors. Furthermore, current genetic services are delivered without a standardized set of process and outcome measures, which makes the evaluation of healthcare services difficult. The present study will identify and classify delivery models and, subsequently, establish which are appropriate for the provision of predictive genetic testing in Europe by comparing sets of process and outcome measures. In this way, the study will provide a basis for future recommendations to decision makers involved in the financing, delivery, and consumption of genetic services.