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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

Objectives: The objective of the present policy analysis was to understand how a disinvestment approach to the process of health technology assessment (HTA), applied to the field of medical devices, might help Italian policymakers to properly spend the resources in healthcare. Methods: Previous international and national experiences in disinvestment for medical devices were reviewed. Precious insights for the rational expenditure of the resources were derived by assessing the evidence available. Results: The disinvestment of ineffective or inappropriate technologies or interventions with an inadequate value-for-money ratio has become a growing priority for National Health Systems. Different international disinvestment experiences of medical devices were identified and described through a rapid review. Although most of them have a strong theoretical framework, their practical application remains difficult. In Italy, there are no examples of large and complex HTA-based disinvestment practices, but their importance is becoming increasingly acknowledged, especially given the need to prioritize the funds provided by Recovery and Resilience Plan. Conclusions: Anchoring decisions on health technologies without reassessing the current technological landscape through a robust HTA model might expose to the risk of not ensuring the best employment of the resources available. Thus, it is necessary to develop a strong HTA ecosystem in Italy through adequate consultation with stakeholders to enable a data-driven and evidence-based prioritization of resources toward choices characterized by high value for both patients and society as a whole.

Background and objectiveThe capacity to promote and disseminate the best evidence-based practices in terms of digital health innovations and technologies represents an important goal for countries and governments. To support the digital health maturity across countries the Global Digital Health Partnership (GDHP) was established in 2019. The mission of the GDHP is to facilitate global collaboration and knowledge-sharing in the design of digital health services, through the administration of surveys and white papers. ObjectiveThe scope of this study is to critically analyze and discuss results from the Evidence and Evaluation GDHP Work Stream's survey, understand how governments and countries intend to address main obstacles to the digital health implementation, identify their strategies for a communication of effective digital health services, and promote the sharing of international based best practices on digital health. MethodsThis survey followed a cross-sectional study approach. A multiple-choice questionnaire was designed to gather data. Choices were extracted from research publications retrieved through a rapid review. ResultsOut of 29 countries receiving the survey, 10 returned it. On a scale from 1 to 5, eHealth systems/platforms (mean = 3.56) were indicated as the most important tool for centralized infrastructure to collect information on digital health, while primary care (mean = 4.0) represented the most voted item for healthcare services to collect information on digital health. Seven Countries out of 10 identified lack of organization, skepticism of clinicians, and accessibility of the population as a barriers to adopt digital health implementation, resulting to be the most voted items. Finally, the most endorsed priorities in digital health for Countries were the adoption of data-driven approaches (6 Countries), and telehealth (5 Countries). ConclusionThis survey highlighted the main tools and obstacles for countries to promote the implementation of

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Le infezioni correlate all’assistenza (ICA) e la resistenza agli antibiotici (Antimicrobial Resistance, AMR) rappresentano una vera e propria emergenza sanitaria, con un impatto rilevante in termini clinici, sociali ed economici [1]. L’utilizzo eccessivo e inappropriato di farmaci antimicrobici è uno dei principali fattori di insorgenza della resistenza agli antibiotici nei patogeni umani, a causa di mutazioni o scambi genetici che ne facilitano la sopravvivenza. Gli effetti della resistenza, ovvero l’incapacità di un antibiotico, somministrato alle dosi terapeutiche, di ridurre la sopravvivenza o inibire la replicazione di un batterio patogeno, comportano gravi rischi di salute pubblica a livello globale, con aumento di mortalità per infezioni e ingenti costi sanitari e sociali. L’antibioticoresistenza è un fenomeno multifattoriale e multisettoriale, contro il quale interventi singoli e sporadici mostrano un impatto limitato [1, 2]. Una delle più importanti conseguenze derivanti da tale fenomeno è rappresentata dalle ICA che, assenti al momento del ricovero, si manifestano in un individuo durante la degenza in ospedale o in un qualsiasi contesto assistenziale, con una sempre più crescente selezione di ceppi di patogeni Multi-Drug Resistant (MDR). A livello europeo, ogni anno, le ICA colpiscono circa 4 milioni di pazienti e sono causa di oltre 37.000 decessi, di cui solo 10.000 in Italia. I costi per la gestione di queste infezioni, inoltre, superano il miliardo di €/anno, con un impatto economico notevole anche in termini di prolungamento dei tempi di degenza e maggior impiego di antibiotici. I dati provenienti dagli ospedali italiani mostrano un’incidenza di ICA del 5 ± 10%, con un tasso di mortalità fino al 20 ± 30% [1-6]. L’Organizzazione per la Cooperazione e lo Sviluppo Economico (OCSE) ha inoltre stimato che, tra il 2015 e il 2050, circa 2.4 milioni di persone potrebbero morire in Europa, Nord America e Australia a causa di infezioni da superbatteri

This analysis of the Italian health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. Italy has a regionalized National Health Service (SSN) that provides universal coverage largely free of charge at the point of delivery, though certain services and goods require a co-payment. Life expectancy in Italy is historically among the highest in the EU. However, regional differences in health indicators are marked, as well as in per capita spending, distribution of health professionals and in the quality of health services. Overall, Italy's health spending per capita is lower than the EU average and is among the lowest in western European countries. Private spending has increased in recent years, although this trend was halted in 2020 during the coronavirus disease 2019 (COVID-19) pandemic. A key focus of health policies in recent decades was to promote a shift away from unnecessary inpatient care, with a considerable reduction of acute hospital beds and stagnating overall growth in health personnel. However, this was not counterbalanced by a sufficient strengthening of community services in order to cope with the ageing population's needs and related chronic conditions burden. This had important repercussions during the COVID-19 emergency, as the health system felt the impact of previous reductions in hospital beds and capacity and underinvestment in community-based care. Reorganizing hospital and community care will require a strong alignment between central and regional authorities. The COVID-19 crisis also highlighted several issues pre-dating the pandemic that need to be addressed to improve the sustainability and resilience of the SSN. The main outstanding challenges for the health system are linked to addressing historic underinvestment in the health workforce, modernizing outdated infrastructure and equipment, and enhancing information infrastructure. Italy's Nat

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Background: Digital health interventions have significant potential to improve safety, efficacy, and quality of care, reducing waste in healthcare costs. Despite these premises, the evidence regarding cost and effectiveness of digital tools in health is scarce and limited. Objectives: The aim of this systematic review is to summarize the evidence on the cost-effectiveness of digital health interventions and to assess whether the studies meet the established quality criteria. Methods: We queried PubMed, Scopus and Web of Science databases for articles in English published from January 1, 2016 to December 31, 2020 that performed economic evaluations of digital health technologies. The methodological rigorousness of studies was assessed with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2009 checklist. Results: Search identified 1,476 results, 552 of which were selected for abstract and 35 were included in this review. The studies were heterogeneous by country (mostly conducted in upper and upper-middle income countries), type of eHealth intervention, method of implementation, and reporting perspectives. The qualitative analysis identified the economic and effectiveness evaluation of six different types of interventions: (1) seventeen studies on new video-monitoring service systems; (2) five studies on text messaging interventions; (3) five studies on web platforms and digital health portals; (4) two studies on telephone support; (5) three studies on new mobile phone-based systems and applications; and (6) three studies on digital technologies and innovations. Conclusion: Findings on cost-effectiveness of digital interventions showed a growing body of evidence and suggested a generally favorable effect in terms of costs and health outcomes. However, due to the heterogeneity across study methods, the comparison between interve

The recent progress of genomics research is providing unprecedented insight into human genetic variance, susceptibility to disease and risk stratification. Current trends predict that a massive amount of genomic data will be produced in the upcoming years which, when coupled with the fast-paced development of the field, will create new social, ethical, and legal challenges. In the complex legislative environment of the European Union, genomic data sharing policies will have to weigh the benefits of scientific discovery against the ethical risks posed by the act of sharing sensitive data. In this complex, interconnected environment, blockchain provides a unique and novel solution to accountability, traceability, and transparency issues regarding genomic data sharing. Implementing a distributed ledger technology-based database could empower both patients and citizens to responsibly use genomic data pertaining to them because it allows for a higher degree of control over the recipients of their data and their uses. The blockchain technology will engage both data owners and policymakers to address the multiple issues of genomic data sharing and allow us to redefine the way we look at genomics.

The May 2022 proposal from the European commission for a 'European health data space' envisages advantages for health from exploiting the growing mass of health data in Europe. However, key stakeholders have identified aspects that demand clarification to ensure success. Data will need to be freed from traditional silos to flow more easily and to cross artificial borders. Wide engagement will be necessary among healthcare professionals, researchers, and the patients and citizens that stand to gain the most but whose trust must be won if they are to allow use or transfer of their data. This paper aims to alert the wider scientific community to the impact the ongoing discussions among lawmakers will have. Based on the literature and the consensus findings of an expert multistakeholder panel organised by the European Alliance for Personalised Medicine (EAPM) in June 2022, it highlights the key issues at the intersection of science and policy, and the potential implications for health research for years, perhaps decades, to come.

At the onset of the SARS-CoV-2 pandemic, individual and social measures were strengthened through restrictive non-pharmaceutical interventions, labelled with the term "lockdown". In Italy, there were two lockdowns (9 March 2020-3 May 2020 and 3 November 2020-27 March 2021). As part of preventive measures, healthcare workers and the administrative staff population of Policlinico A. Gemelli underwent nasopharyngeal swab tests from 1 March 2020 to 9 February 2022, a long time interval that includes the two aforementioned lockdowns. The population included 8958 people from 1 March 2020 to 31 December 2020; 8981 people from 1 January 2021 to 31 December 2021; and 8981 people from 1 January 2022 to 9 February 2022. We then analysed pseudo-anonymized data, using a retrospective observational approach to evaluate the impact of the lockdown on the incidence of SARS-CoV-2 infections within the population. Given the 14 day contagious period, the swab positivity rate (SPR) among the staff decreased significantly at the end of the first lockdown, every day prior to 18 May 2020, by 0.093 (p < 0.0001, CI = (-0.138--0.047)). After the fourteenth day post the end of the first lockdown (18 May 2020), the SPR increased daily at a rate of 0.024 (p < 0.0001, 95% CI = (0.013-0.034)). In addition, the SPR appeared to increase significantly every day prior to 17 November 2020 by 0.024 (p < 0.0001, CI = (0.013-0.034)). After the fourteenth day post the start of the second lockdown (17 November 2020), the SPR decreased daily at a rate of 0.039 (p < 0.0001, 95% CI = (-0.050--0.027)). These data demonstrate that, in our Institution, the lockdowns helped to both protect healthcare workers and maintain adequate standards of care for COVID and non-COVID patients for the duration of the state of emergency in Italy.

We assessed challenges that the COVID-19 pandemic presented for mental health systems and the responses to these challenges in 14 countries in Europe and North America. Experts from each country filled out a structured questionnaire with closed- and open-ended questions between January and June 2021. We conducted thematic analysis to investigate the qualitative responses to open-ended questions, and we summarized the responses to closed-ended survey items on changes in telemental health policies and regulations. Findings revealed that many countries grappled with the rising demand for mental health services against a backdrop of mental health provider shortages and challenges responding to workforce stress and burnout. All countries in our sample implemented new policies or initiatives to strengthen mental health service delivery - with more than two-thirds investing to bolster their specialized mental health care sector. There was a universal shift to telehealth to deliver a larger portion of mental health services in all 14 countries, which was facilitated by changes in national regulations and policies; 11 of the 14 participating countries relaxed regulations and 10 of 14 countries made changes to reimbursement policies to facilitate telemental health care. These findings provide a first step to assess the long-term challenges and re-organizational effect of the COVID-19 pandemic on mental health systems in Europe and North America.

We assessed challenges that the COVID-19 pandemic presented for mental health systems and the responses to these challenges in 14 countries in Europe and North America. Experts from each country filled out a structured Healthcare systems questionnaire with closed- and open-ended questions between January and June 2021. We conducted thematic Health policy analysis to investigate the qualitative responses to open-ended questions, and we summarized the responses closed-ended survey items on changes in telemental health policies and regulations. Findings revealed that many countries grappled with the rising demand for mental health services against a backdrop of mental health provider shortages and challenges responding to workforce stress and burnout. All but one country in our sample implemented new policies or initiatives to strengthen mental health service delivery – with more than two-thirds investing to bolster their specialized mental health care sector. There was a universal shift to telehealth to deliver a larger portion of mental health services in all 14 countries, which was facilitated by changes in national regula- tions and policies; 11 of the 14 participating countries relaxed regulations and 10 of 14 countries made changes to reimbursement policies to facilitate telemental health care. These findings provide a first step to assess the long-term challenges and re-organizational effect of the COVID-19 pandemic on mental health systems in Europe and North America., We assessed challenges that the COVID-19 pandemic presented for mental health systems and the responses to these challenges in 14 countries in Europe and North America. Experts from each country filled out a structured questionnaire with closed- and open-ended questions between January and June 2021. We conducted thematic analysis to investigate the qualitative responses to open-ended questions, and we summarized the responses to closed-ended survey items on changes in telemental health policies and regulations. Findings revealed that many countries grappled with the rising demand for mental health services against a backdrop of mental health provider shortages and challenges responding to workforce stress and burnout. All but one country in our sample implemented new policies or initiatives to strengthen mental health service delivery – with more than two-thirds investing to bolster their specialized mental health care sector. There was a universal shift to telehealth to deliver a larger portion of mental health services in all 14 countries, which was facilitated by changes in national regulations and policies; 11 of the 14 participating countries relaxed regulations and 10 of 14 countries made changes to reimbursement policies to facilitate telemental health care. These findings provide a first step to assess the long-term challenges and re-organizational effect of the COVID-19 pandemic on mental health systems in Europe and North America. Keywords Mental healthhealthcare systemshealth policyhealthcare reformtelehealth

Background: The literature supporting telehealth management is growing accelerated by the COVID-pandemic. We hypothesize that there are risks of adverse events associated with telehealth interventions. Methods: A review of PubMed (including MEDLINE), Embase, ISI (Web of Science), VHL/GHL, Scopus, Science Direct, and PsycINFO was conducted for all adverse events associated with telehealth from January 1, 1960 to March 1, 2021. This systematic review and meta-analyses were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: Of 5,144 citations 78 published studies met criteria for quality evaluation and underwent full text abstraction including the qualitative synthesis. Of the 78 included studies 8 were included in the quantitative synthesis resulting in 2 meta-analyses. The results of the meta-analysis suggest that monitoring patients using telehealth techniques is associated with 40% lower mortality risks among patients suffering from heart failure, compared to those who received traditional care. The results of the random-effects meta-analysis showed the pooled relative risk of mortality to be 0.60, indicating that patients that underwent telemonitoring had a lower mortality risk compared with the patients that underwent usual care. Among patients with heart implants, patients who received telemonitoring had a 35% lower mortality risk compared to patients receiving traditional care. Conclusions: While RCTs of telehealth interventions demonstrate enhanced patient outcomes in a number of studies and pave the way to evidence-based practice, the heterogeneity of the research questions suggest an important need for more complementary studies with consistent outcome assessments.

The COVID-19 pandemic has put a lot of pressure on all the world's health systems and public health leaders who have often found themselves unprepared to handle an emergency of this magnitude. This study aims to bring together published evidence on the qualities required to leaders to deal with a public health issue like the COVID-19 pandemic. This scoping literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A search of relevant articles was performed in the PubMed, Scopus and Web of Science databases. A total of 2499 records were screened, and 45 articles were included, from which 93 characteristics of effective leadership were extrapolated and grouped into 6 clusters. The qualities most frequently reported in the articles were human traits and emotional intelligence (46.7%) and communication skills such as transparency and reliability (48.9%). Responsiveness and preparedness (40%), management skills (33.3%) and team working (35.6%) are considered by a significant percentage of the articles as necessary for the construction of rapid and effective measures in response to the emergency. A considerable proportion of articles also highlighted the need for leaders capable of making evidence-based decisions and driving innovation (31.1%). Although identifying leaders who possess all the skills described in this study appears complex, determining the key characteristics of effective public health leadership in a crisis, such as the COVID-19 pandemic, is useful not only in selecting future leaders but also in implementing training and education programmes for the public health workforce.

Objective: To improve the safety and quality of patient care in hospitals by shaping clinical pathways throughout the patient journey. Study Setting: A risk model designed for healthcare organizations in the context of the challenges arising from comorbidity and other treatment-related complexities. Study Design: The core of the model is the patient and his intra-hospital journey, which is analyzed using a data-driven approach. The structure of a predictive model to support organizational and clinical decision-making activities is explained. Data relating to each step of the intra-hospital journey (from hospital admission to discharge) are extracted from clinical records. Principal Findings: The proposed approach is feasible and can be used effectively to improve safety and quality. It enables the evaluation of clinical risks at each step of the patient journey. Conclusion: Based on data from real cases, the model can record and calculate, over time, variables and behaviors that affect the safety and quality of healthcare organizations. This provides a greater understanding of healthcare processes and their complexity which can, in turn, advance research relating to clinical pathways and improve strategies adopted by organizations.