Perspective: Improving Nutritional Guidelines for Sustainable Health Policies: Current Status and Perspectives.

A large body of evidence supports the notion that incorrect or insufficient nutrition contributes to disease development. A pivotal goal is thus to understand what exactly is appropriate and what is inappropriate in food ingestion and the consequent nutritional status and health. The effective application of these concepts requires the translation of scientific information into practical approaches that have a tangible and measurable impact at both individual and population levels. The agenda for the future is expected to support available methodology in nutrition research to personalize guideline recommendations, properly grading the quality of the available evidence, promoting adherence to the well-established evidence hierarchy in nutrition, and enhancing strategies for appropriate vetting and transparent reporting that will solidify the recommendations for health promotion. The final goal is to build a constructive coalition among scientists, policy makers, and communication professionals for sustainable health and nutritional policies. Currently, a strong rationale and available data support a personalized dietary approach according to personal variables, including sex and age, circulating metabolic biomarkers, food quality and intake frequency, lifestyle variables such as physical activity, and environmental variables including one's microbiome profile. There is a strong and urgent need to develop a successful commitment among all the stakeholders to define novel and sustainable approaches toward the management of the health value of nutrition at individual and population levels. Moving forward requires adherence to well-established principles of evidence evaluation as well as identification of effective tools to obtain better quality evidence. Much remains to be done in the near future.

Public health value of universal HPV vaccination.

BACKGROUND: The story of Human Papillomavirus vaccination demands reflection not only for its public health impact on the prophylactic management of HPV disease, but also for its relevant economic and social outcomes. Greater than ever data confirm the efficacy and support the urge for effective vaccination plans for both genders before sexual debut. METHODS: A review of previous experience in gender-restricted vaccination programs has demonstrated a lower effectiveness. Limiting vaccination to women might increase the psychological burden on women by confirming a perceived inequality between genders; and even if all women were immunized, the HPV chain of transmission would still be maintained through men. RESULTS: The cost-effectiveness of including boys into HPV vaccination programs should be re-assessed in view of the progressive drop of the economic burden of HPV-related diseases in men and women due to universal vaccination. The cost of the remarkable increase in anal and oropharyngeal HPV driven cancers in both sexes has been grossly underestimated or ignored. CONCLUSIONS: Steps must be taken by relevant bodies to achieve the target of universal vaccination. The analysis of HPV vaccination's clinical effectiveness vs. economic efficacy are supportive of the economic sustainability of vaccination programs both in women and men. In Europe, these achievements demand urgent attention to the social equity for both genders in healthcare. There is sufficient ethical, scientific, strategic and economic evidence to urge the European Community to develop and implement a coordinated and comprehensive strategy aimed at both genders and geographically balanced, to eradicate cervical cancer and other diseases caused by HPV in Europe. Policymakers must take into consideration effective vaccination programs in the prevention of cancers.

Steps forward in regulatory pathways for acute and chronic heart failure.

A workshop was organized by the Agenzia Italiana del Farmaco (AIFA) to discuss unmet needs and ways forward in the development of medicines in heart failure, their rationale, and cost-effective use. An integrated, multidisciplinary approach, including patients' needs and perspectives, was advocated by all the participants as the way to the most effective treatment regimens. More work is needed for reaching consensus on clinical and functional endpoints, for validating patient reported outcomes and measurements of well-being. Similarly, the integration into the clinical programmes of the health technology assessment/payers perspective, in particular, the evaluation of 'real-life' treatment effectiveness and of health as a value, would help in shifting the development and authorization of medicines from the molecule paradigm to their evaluation in the context of the whole health care regimen. Through this kind of workshop, AIFA is trying to build a template for meetings devoted to debate unmet needs with all stakeholders towards tentative road maps for the future.

Hearing loss and dementia in the aging population.

For some years, policy makers and medical scientists have both begun to focus more on chronic noncommunicable diseases. It is well known that cardio-cerebrovascular disease, tumors, diabetes, and chronic obstructive pulmonary disease (COPD), are considered areas of major interest in many scientific projects and health programs. The economic impact of cardio-cerebrovascular disease in EU alone is more than EUR 200 billion, while tumors have an impact of EUR 150 billion. The direct and indirect cost of brain disorders exceeds EUR 700 billion a year. Among the brain disorders, the devastating impact of dementia on affected individuals and the burden imposed on their families and society has made prevention and treatment of dementia a public health priority. Interventions that could merely delay the onset of dementia by 1 year would result in a more than 10% decrease in the global prevalence of dementia in 2050. Unfortunately, there are no known interventions that currently have such effectiveness. The manifestations of age-related hearing loss in many older adults are subtle and, thus, hearing loss is often perceived as an unfortunate but inconsequential part of aging. Researchers report that hearing loss seems to speed up age-related cognitive decline. Researchers suggest that treating hearing loss more aggressively could help delay cognitive decline and dementia. Furthermore, there is an increasing interest in better understanding the pathophysiologic correlations between hearing loss and dementia. Hearing loss in older adults, in fact, is associated independently with poorer cognitive functioning, incident dementia, and falls. Further research investigating the basis of this connection as well as the pathomechanism of the two diseases will further our ability to treat dementia.

Steps forward in regulatory pathways for acute and chronic heart failure.

A workshop was organized by the Agenzia Italiana del Farmaco (AIFA) to discuss unmet needs and ways forward in the development of medicines in heart failure, their rationale, and cost-effective use. An integrated, multidisciplinary approach, including patients' needs and perspectives, was advocated by all the participants as the way to the most effective treatment regimens. More work is needed for reaching consensus on clinical and functional endpoints, for validating patient reported outcomes and measurements of well-being. Similarly, the integration into the clinical programmes of the health technology assessment/payers perspective, in particular, the evaluation of 'real-life' treatment effectiveness and of health as a value, would help in shifting the development and authorization of medicines from the molecule paradigm to their evaluation in the context of the whole health care regimen. Through this kind of workshop, AIFA is trying to build a template for meetings devoted to debate unmet needs with all stakeholders towards tentative road maps for the future.

Considerations for early acute myocardial infarction rule-out for emergency department chest pain patients: the case of copeptin.

The evaluation of patients admitted at the emergency department (ED) for chest pain is challenging and involves many different clinical specialists including emergency physicians, laboratory professionals and cardiologists. The preferable approach to deal with this issue is to develop joint protocols that will assist the clinical decision-making to quickly and accurately rule-out patients with non life-threatening conditions that can be considered for early and safe discharge or further outpatient follow-up, rule-in patients with acute coronary syndrome and raise the degree of alert of the emergency physicians on non-cardiac life-threatening emergencies. The introduction of novel biomarkers alongside the well-established troponins might support this process and also provide prognostic information about acute short-term or chronic long-term risk and severity. Among the various biomarkers, copeptin measurement holds appealing perspectives. The utility of combining troponin with copeptin might be cost-effective due to the high negative predictive value of the latter biomarker in the rule-out of an acute coronary syndrome. Moreover, in the presence of a remarkably increased concentration (e.g., more than 10 times the upper limit of the reference range), to reveal the presence of acute life-threatening conditions that may not necessarily be identified with the use of troponin alone. The aim of this article is to review current evidence about the clinical significance of copeptin testing in the ED as well as its appropriate placing within diagnostic protocols.

Assessment of nutritional profiles: a novel system based on a comprehensive approach.

The prevalence of non-communicable diseases (for example, cardiovascular disorders, type 2 diabetes and cancer) is rampant in Western societies, accounting for approximately 60 % of all causes of death. A large proportion of non-communicable diseases can be prevented through appropriate diets and lifestyles. Accordingly, several health authorities and regulatory bodies are assessing the nutritional profiles of food items and whole diets, to implement guidelines aimed at improving the diet of the general population. While a global approach is desirable, the need of individuals to maintain their distinct dietary habits must also be taken into account. The portion sizes of food as well as pattern of food consumption, for example during or between the main meals, are very important in determining the nutritional profile of a diet. A novel method to assess the nutritional profile of foods is being proposed and made available on-line. Its main innovative aspects are (1) the comprehensive manner with which the system analyses and computes a great range of features of individual food items and (2) the distinction among eating occasions, namely during or in-between the main meals. Moreover, this approach allows for rapid modification and great flexibility to suit individual needs and gastronomic habits.