Use of oxygen-ozone therapy to improve the effectiveness of antibiotic treatment on infected arthroplasty: protocol for a superiority, open-label, multicentre, randomised, parallel trial.

INTRODUCTION: Surgical site infections still remain a major public health challenge and have become an increasing universal risk, especially for the implantation of orthopaedic devices.Unfortunately, the discovery and increasingly widespread use (especially the misuse) of antibiotics have led to the rapid appearance of antibiotic-resistant strains today; more and more infections are caused by microorganisms that fail to respond to conventional treatments.Oxygen-ozone therapy has been extensively used and studied for decades across various potential medical applications and has provided consistent effects with minimal side effects.This study aims to determine the superiority of oxygen-ozone therapy in combination with oral antibiotic therapy in patients with wound infections after an orthopaedic device implantation when compared with antibiotic therapy alone. METHODS AND ANALYSIS: This is an open-label, multicentre, randomised, parallel-group study that aims to assess the efficacy and safety of oxygen-ozone therapy in combination with oral antibiotic therapy to treat infections in patients (male or female aged ≥18 years) having undergone surgery for the implant of an orthopaedic device. Patients must have at least one (but no more than three) postoperative wounds in the site of surgery (ulcers, eschars and sores) and at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling and purulent secretion) of infection of at least moderate intensity (score ≥2) in the target lesion at the screening visit (patients with wounds without signs of localised infection or with undermining wounds will be excluded).Patients (n=186) will be recruited from five Italian hospitals and studied for 7 weeks. All will be assigned to one of the two treatment groups according to a web-based, centralised randomisation procedure and placed into either the (1) intervention: oxygen-ozone therapy 2-3 times a week for 6 weeks (for a maximum of 15 sessions) simultaneously with an appropriate oral antibiotic therapy prescribed at baseline or (2) control: oral antibiotic therapy prescribed at baseline.The primary outcome is the efficacy and superiority of the treatment (ozone and oral antibiotic therapies); secondary outcomes include the resolution of signs and symptoms, modifications in lesion size and the treatment's safety and tolerability. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the responsible Independent Ethics Committee (IEC) of COMITATO ETICO CAMPANIA NORD, located at 'Azienda Ospedaliera San Giuseppe Moscati di Avellino'.After completion of the study, the project coordinator will prepare a draft manuscript containing the final results of the study on the basis of the statistical analysis. The manuscript will be derived by the co-authors for comments, and after revision, it will be sent to a major scientific journal. Findings will be disseminated via online and print media, events and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04787575.

The Porto European Cancer Research Summit 2021.

Key stakeholders from the cancer research continuum met in May 2021 at the European Cancer Research Summit in Porto to discuss priorities and specific action points required for the successful implementation of the European Cancer Mission and Europe's Beating Cancer Plan (EBCP). Speakers presented a unified view about the need to establish high-quality, networked infrastructures to decrease cancer incidence, increase the cure rate, improve patient's survival and quality of life, and deal with research and care inequalities across the European Union (EU). These infrastructures, featuring Comprehensive Cancer Centres (CCCs) as key components, will integrate care, prevention and research across the entire cancer continuum to support the development of personalized/precision cancer medicine in Europe. The three pillars of the recommended European infrastructures - namely translational research, clinical/prevention trials and outcomes research - were pondered at length. Speakers addressing the future needs of translational research focused on the prospects of multiomics assisted preclinical research, progress in Molecular and Digital Pathology, immunotherapy, liquid biopsy and science data. The clinical/prevention trial session presented the requirements for next-generation, multicentric trials entailing unified strategies for patient stratification, imaging, and biospecimen acquisition and storage. The third session highlighted the need for establishing outcomes research infrastructures to cover primary prevention, early detection, clinical effectiveness of innovations, health-related quality-of-life assessment, survivorship research and health economics. An important outcome of the Summit was the presentation of the Porto Declaration, which called for a collective and committed action throughout Europe to develop the cancer research infrastructures indispensable for fostering innovation and decreasing inequalities within and between member states. Moreover, the Summit guidelines will assist decision making in the context of a unique EU-wide cancer initiative that, if expertly implemented, will decrease the cancer death toll and improve the quality of life of those confronted with cancer, and this is carried out at an affordable cost.

How to Integrate Personalized Medicine into Prevention? Recommendations from the Personalized Prevention of Chronic Diseases (PRECeDI) Consortium.

Medical practitioners are increasingly adopting a personalized medicine (PM) approach involving individually tailored patient care. The Personalized Prevention of Chronic Diseases (PRECeDI) consortium project, funded within the Marie Sklodowska Curie Action (MSCA) Research and Innovation Staff Exchange (RISE) scheme, had fostered collaboration on PM research and training with special emphasis on the prevention of chronic diseases. From 2014 to 2018, the PRECeDI consortium trained 50 staff members on personalized prevention of chronic diseases through training and research. The acquisition of skills from researchers came from dedicated secondments from academic and nonacademic institutions aimed at training on several research topics related to personalized prevention of cancer and cardiovascular and neurodegenerative diseases. In detail, 5 research domains were addressed: (1) identification and validation of biomarkers for the primary prevention of cardiovascular diseases, secondary prevention of Alzheimer disease, and tertiary prevention of head and neck cancer; (2) economic evaluation of genomic applications; (3) ethical-legal and policy issues surrounding PM; (4) sociotechnical analysis of the pros and cons of informing healthy individuals on their genome; and (5) identification of organizational models for the provision of predictive genetic testing. Based on the results of the research carried out by the PRECeDI consortium, in November 2018, a set of recommendations for policy makers, scientists, and industry has been issued, with the main goal to foster the integration of PM approaches in the field of chronic disease prevention.

Highly-integrated programs for the prevention of obesity and overweight in children and adolescents: results from a systematic review and meta-analysis.

BACKGROUND: Since overweight and obesity has become epidemic in children and adolescents, the aim of this study was to determine the role of highly-integrated programs in preventing and reducing prevalence of children and adolescent obesity and overweight, even evaluating if this approach has properly been effective in communities with different determinants as in the Pacific Area. METHODS: According to PRISMA guidelines, a systematic review of literature was conducted and a meta-analysis was performed to compare obese/overweight prevalence between the intervention and the control group. RESULTS: We identified 23 studies describing 14 programs. For 11 out of 14 programs, obese/overweight prevalence changing from baseline were definable and meta-analysis of them showed a significant change of obese/overweight prevalence (-0.03; 95% CI = -0.04 to -0.01; P < 0.0001). Secondary outcomes as dietary (such as vegetable intake, carbonated beverages, fruit juice, drinks, healthful food consumption), physical activity and TV-time-spent was analyzed in many of the studies to define community readiness and behavioral changes. Macro-interventions, based on what was observed in our systematic review have a high potential to reach the entire population. CONCLUSION: Adoption of coordinated cross-sectoral, multi-component and multi-stakeholder initiatives to oppose obesity remains a challenge, but it is also desirable as one of the possible solutions to this major public health issue.

Developing a new clinical governance framework for chronic diseases in primary care: an umbrella review.

OBJECTIVES: Our goal is to conceptualise a clinical governance framework for the effective management of chronic diseases in the primary care setting, which will facilitate a reorganisation of healthcare services that systematically improves their performance. SETTING: Primary care. PARTICIPANTS: Chronic Care Model by Wagner et aland Clinical Governance statement by Scally et alwere taken for reference. Each was reviewed, including their various components. We then conceptualised a new framework, merging the relevant aspects of both. INTERVENTIONS: We conducted an umbrella review of all systematic reviews published by the Cochrane Effective Practice and Organisation of Care Group to identify organisational interventions in primary care with demonstrated evidence of efficacy. RESULTS: All primary healthcare systems should be patient-centred. Interventions for patients and their families should focus on their values; on clinical, professional and institutional integration and finally on accountability to patients, peers and society at large. These interventions should be shaped by an approach to their clinical management that achieves the best clinical governance, which includes quality assurance, risk management, technology assessment, management of patient satisfaction and patient empowerment and engagement. This approach demands the implementation of a system of organisational, functional and professional management based on a population health needs assessment, resource management, evidence-based and patient-oriented research, professional education, team building and information and communication technologies that support the delivery system. All primary care should be embedded in and founded on an active partnership with the society it serves. CONCLUSIONS: A framework for clinical governance will promote an integrated effort to bring together all related activities, melding environmental, administrative, support and clinical elements to ensure a coordinated and integrated approach that sustains the provision of better care for chronic conditions in primary care setting.

Effectiveness of nutritional interventions addressed to elderly persons: umbrella systematic review with meta-analysis.

Background: The number of Europeans aged over 65 will double between 2010 and 2060, reaching 30% of the European population. Nutrition is emerging as a key element of healthy life since both obesity and malnutrition are established risk factors for morbidity and disability. The aim of this umbrella review (UR) is to summarize the findings of all current systematic reviews (SRs) and meta-analyzes (MAs) on the effectiveness of nutritional intervention designed to promote healthy aging in older individuals. Methods: Eligible articles published in English or Italian between January 2000 and May 2016 were identified in six databases. Only studies that analyzed nutritional interventions in the population of 65 years and over, or papers specifically targeting older adults were deemed eligible. Results: Twenty-eight papers, out of which twenty-five SRs and three MAs, met the inclusion criteria and were included in this umbrella SR. Supplementation with vitamin D and other kind of products was highly effective in preventing falls and fractures. Furthermore, several interventions, ranging from the prescription of supplements to environmental and organizational programs, resulted in an improvement in energy and protein intake, as well as positive weight outcomes. Positive findings were also found for the elderly at risk of malnutrition and for older patients with dementia. Conclusions: The findings of this UR indicate that the use of a wide range of supplements and environmental and organizational intervention improve a number of anthropometric, nutritional and functional indices in the elderly.

Fertilizing a Patient Engagement Ecosystem to Innovate Healthcare: Toward the First Italian Consensus Conference on Patient Engagement.

Currently we observe a gap between theory and practices of patient engagement. If both scholars and health practitioners do agree on the urgency to realize patient engagement, no shared guidelines exist so far to orient clinical practice. Despite a supportive policy context, progress to achieve greater patient engagement is patchy and slow and often concentrated at the level of policy regulation without dialoguing with practitioners from the clinical field as well as patients and families. Though individual clinicians, care teams and health organizations may be interested and deeply committed to engage patients and family members in the medical course, they may lack clarity about how to achieve this goal. This contributes to a wide "system" inertia-really difficult to be overcome-and put at risk any form of innovation in this filed. As a result, patient engagement risk today to be a buzz words, rather than a real guidance for practice. To make the field clearer, we promoted an Italian Consensus Conference on Patient Engagement (ICCPE) in order to set the ground for drafting recommendations for the provision of effective patient engagement interventions. The ICCPE will conclude in June 2017. This document reports on the preliminary phases of this process. In the paper, we advise the importance of "fertilizing a patient engagement ecosystem": an oversimplifying approach to patient engagement promotion appears the result of a common illusion. Patient "disengagement" is a symptom that needs a more holistic and complex approach to solve its underlined causes. Preliminary principles to promote a patient engagement ecosystem are provided in the paper.

Alliance Against Cancer, the network of Italian cancer centers bridging research and care.

Alliance Against Cancer (ACC) was established in Rome in 2002 as a consortium of six Italian comprehensive cancer centers (Founders). The aims of ACC were to promote a network among Italian oncologic institutions in order to develop specific, advanced projects in clinical and translational research. During the following years, many additional full and associate members joined ACC, that presently includes the National Institute of Health, 17 research-oriented hospitals, scientific and patient organizations. Furthermore, in the last three years ACC underwent a reorganization process that redesigned the structure, governance and major activities. The present goal of ACC is to achieve high standards of care across Italy, to implement and harmonize principles of modern personalized and precision medicine, by developing cost effective processes and to provide tailored information to cancer patients. We herein summarize some of the major initiatives that ACC is currently developing to reach its goal, including tumor genetic screening programs, establishment of clinical trial programs for cancer patients treated in Italian cancer centers, facilitate their access to innovative drugs under development, improve quality through an European accreditation process (European Organization of Cancer Institutes), and develop international partnerships. In conclusion, ACC is a growing organization, trying to respond to the need of networking in Italy and may contribute significantly to improve the way we face cancer in Europe.

Health systems, quality of health care, and translational cancer research: the role of the Istituto Superiore Sanità - Rome.

Faced with the challenge of ensuring high-quality and cost-effective health systems in the context of persistent financial crisis, a global strategy for cancer prevention and treatment represents a priority for public health bodies and governments. The key goals for the initiative are to define standards of cancer prevention and care while leveraging the continuous progress of biomedical research in the interest of public health. In Italy, the establishment of a network of Comprehensive Cancer Centres (CCC) named the Alliance Against Cancer (ACC) is an important initiative taken by the Ministry of Health to foster common strategies for enhancing the quality of oncology research and care at the national level. The Istituto Superiore di Sanità (ISS) has played an important role in supporting ACC activities through a special national program called ISS for ACC, launched by the Italian Ministry of Health in 2006. A similar role has been pursued in subsequent initiatives, including ISS support for a project aimed at providing international accreditation of the CCC of the ACC, funded by the Italian Ministry of Health. The results of this initiative, reported in the current issue of Tumori, are especially significant since specific indicators of quality for research and cancer care have been successfully defined for all the participating institutes. As the leading technical and scientific body of the Italian National Health Service, the ISS will continue to play a proactive role in supporting national networks and strategic national and international initiatives aimed at promoting public health.

Health of the Elderlies and Healthy Ageing: Challenge for Europe.

Population ageing is a major challenge for European Union (EU) society and economy, particularly for Italy, which is the oldest country in Europe. According to the World Health Organization, two-thirds of European citizens who have reached the retirement age suffer from at least two chronic conditions, with a strong pressure on healthcare systems. Moreover, EU countries already spend, on average, more than a quarter of their gross domestic product on social protection, above all pensions, health and long term care. The current financial crisis is putting a strain on this system. In this context, it becomes increasingly necessary to promote a healthy and independent ageing, by improving outcomes for patients and society while ensuring health systems sustainability. To this purpose a proactive approach to chronic diseases prevention (primary, secondary and tertiary) as well as an integrated healthcare approach and also patients' empowerment are required so as to make daily life more age-friendly. It is also necessary to share health and social best practices, adopt policies really effective against elderly social exclusion and strengthen older people participation in society. A joint effort of all key stakeholders is needed to create a society in which older people can play an active role.

Building successful collaborations between Public Health and Primary Health Care.

Public Health (PH) and Primary Health Care (PHC) need to be better integrated, at different levels of the healthcare system, in order to improve health and social outcomes. The aim of this study was to review international models and approaches supporting the integration of PH and PHC and to classify these according to their main focus. A literature search was performed using the main scientific databases, to identify national and international journal publications regarding models to support integration between PH and PHC. The final set of the documents provided a broad coverage of the topic. Four models of integration were identified: general integration, chronic disease prevention, targeted prevention or care delivery and infection control. Models differed in their levels of implementation, stages of development and focus. This review, by classifying the main characteristics and results of the experiences retrieved, indicates a relatively scarce use of integration models in the global health care landscape, with the exception of Canada. In fact, Canada has been a leader in developing models of integrated health systems that combine tailored approaches to influence personal health behaviour and community-oriented approaches to influence the health of the population. The review also revealed a general lack of experience in evaluating the sustainability of integration between PH and PHC, not only in terms of cost-effectiveness, but also in terms of better health and work conditions and self-perceived quality of care in the population. Collaboration between PH and PHC seems to be an important strategy for achieving principles of equity and access in health care and for ensuring a more equal distribution of health care services.

The financial crisis in Italy: implications for the healthcare sector.

The global economic and financial crisis is having and impact on the Italian healthcare system which is undergoing a devolution process from the central government to regions and where about one third of the regional governments (mainly in the central and southern part of the country) are facing large financial deficits. The paper briefly describes the current macro scenario and the main responses taken to face the crisis and highlights the downside risks of introducing "linear" cuts in the allocation of resources. While justified by the risk of a national debt default, present fiscal policies might increase inequalities in access to care, deteriorate overall health indicators and population wellbeing, and sharpen existing difference in the quality of care between regions. Preliminary evidence shows that the crisis is affecting the quality of nutrition and the incidence of psychiatric disorders. During this difficult financial situation Italy is also facing the risk of a major reduction in investments for preventive medicine, Evidence Based Medicine infrastructures, health information systems and physical capital renewal. This cost-cutting strategy may have negative long term consequences Also, important achievement in terms of limiting waiting lists, improving continuity of care and patients' centeredness, and promoting integration between social and health care may be negatively affected by unprecedented resources' cuts. It is essential that in such a period of public funding constraints health authorities monitor incidence of diseases and access to care of the most vulnerable groups and specifically target interventions to those who may be disproportionally hit by the crisis.