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BackgroundPersonalised medicine (PM) has been fostered by technological and medical advances, but all stakeholders, including healthcare professionals, citizens and policy makers, should achieve adequate health literacy to promote PM implementation. The "Integrating China in the International Consortium for Personalised Medicine" (IC2PerMed) project, funded by the International Consortium for Personalised Medicine, focuses on this issue by highlighting the need to educate healthcare professionals and empower citizens. Within the aforementioned project, building on a mapping of European and Chinese policies in PM, experts in the field of PM participated in an online workshop and a following two-round Delphi survey, in order to identify the priority areas of intervention for healthcare professionals' education and curricula, engagement and empowerment of citizens and patients.ResultsNine experts completed the survey and reached a consensus on seventeen priorities: seven were related to health professionals' education and curricula, whereas ten on citizen and patients' awareness and empowerment.ConclusionThese priorities emphasized the importance of education and health literacy, multidisciplinary and international collaboration, public trust, and consideration of ethical, legal, and social issues. The present experience highlights the relevance of the involvement of stakeholders in informing decision-makers, developing appropriate national plans, strategies, and policies, and ensuring the adequate implementation of PM in health systems.

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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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.

Introduction: Several countries are either planning or implementing national strategies for the development and integration of Personalized Medicine (PM) into their healthcare systems. Personalized Medicine is an undisputed priority of the European Commission (EC), which has funded the project "Integrating China into the International Consortium for Personalized Medicine" (IC2PerMed), in order to ensure a common basis for Sino-European collaborations. By mapping the current PM landscape in the European Union (EU) and in China, IC2PerMed aims to provide key solutions toward a synergistic and coordinated approach in the field of PM. Methods: An extensive desk research was conducted, aimed at identifying documents on PM-related policies, programs, and action plans in the EU and in China, published up to November 2020. The search was conducted by exploring scientific and gray literature, and official institutional repositories. A descriptive summary condensed the information retrieved for both. Results: Since 2013, the year of publication of the first PM policy by the EC "Use of omics technologies in PM development," several documents have been published. PM is a key element of the policy agenda also in China, which in 2016 integrated PM into the 13th National Five-Year Plan, followed by the publication of several policies on technology infrastructure and big data. Both in the EU and China, especially in recent years, these policies addressed in detail the issues of big data, data interoperability and exchange, while defining the standards of information and communication infrastructures. Conclusions: In order to allow optimal collaboration, it is essential to understand similarities and differences between the respective policy strategies, with particular attention to data management and adopted infrastructures. The results of this project may enable the development of joint Sino-European research and innovation initiatives, promoting developments in the field of PM.

Background: To promote shared digital health best practices in a global context, as agreed within the Global Digital Health Partnership (GDHP), one of the most important topics to evaluate is the ability to detect what participating countries believe to be priorities suitable to improve their healthcare systems. No previously published scientific papers investigated these aspects as a cross-country comparison. Objective: The aim of this paper is to present results concerning the priorities identification section of the Evidence and Evaluation survey addressed to GDHP members in 2021, comparing countries’ initiatives and perspectives for the future of digital health based on internationally agreed developments. Methods: This survey followed a cross-sectional study approach. An online survey was addressed to the stakeholders of 29 major countries. Results: Ten out of 29 countries answered the survey. The mean global score of 3.54 out of 5, calculated on the whole data set, demonstrates how the global attention to a digital evolution in health is shared by most of the evaluated countries. Conclusion: The resulting insights on the differences between digital health priority identification among different GDHP countries serves as a starting point to coordinate further progress on digital health worldwide and foster evidence-based collaboration.

Background: Clinical trials are essential for bringing new drugs, technologies and procedures to the market and clinical practice. Considering the design and the four-phase development, only 10% of them complete the entire process, partly due to the increasing costs and complexity of clinical trials. This low completion rate has a huge negative impact in terms of population health, quality of care and health economics and sustainability. Automating some of the process' tasks with artificial intelligence (AI) tools could optimize some of the most burdensome ones, like patient selection, matching and enrollment; better patient selection could also reduce harmful treatment side effects. Although the pharmaceutical industry is embracing artificial AI tools, there is little evidence in the literature of their application in clinical trials. Methods: To address this issue, we performed a scoping review. Following the PRISMA-ScR guidelines, we performed a search on PubMed for articles on the implementation of AI in the development of clinical trials. Results: The search yielded 772 articles, of which 15 were included. The articles were published between 2019 and 2022 and the results were presented descriptively. About half of the studies addressed the topic of patient recruitment; 12 articles reported specific examples of AI applications; five studies presented a quantitative estimate of the effectiveness of these tools. Conclusion: All studies present encouraging results on the implementation of AI-based applications to the development of clinical trials. AI-based applications have a lot of potential, but more studies are needed to validate these tools and facilitate their adoption.

Vaccinations generate health, economic and social benefits in both vaccinated and unvaccinated populations. The aim of this study was to conduct a cost–benefit analysis to estimate the costs and benefits associated with the COVID-19 vaccination campaign for health workers in Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The analysis included 5152 healthcare workers who voluntarily received the Pfizer–BioNTech COVID-19 vaccine, divided into physicians, nurses and other health workers. Data about vaccine cost, administration and materials were derived from administrative databases of the FPG from 28 December 2020 to 31 March 2021. The costs associated with the COVID-19 vaccination campaign amounted to EUR 2,221,768, while the benefits equaled EUR 10,345,847. The benefit-to-cost ratio resulted in EUR 4.66, while the societal return on investment showed a ratio of EUR 3.66. The COVID-19 vaccination campaign for health workers in FPG has high social returns and it strengthens the need to inform and update decision-making about the economic and social benefits associated with a vaccination campaign. Health economic evaluations on vaccines should always be considered by decision-makers when considering the inclusion of a new vaccine into the national program.

Italy was the first country in the western world to be affected by the COVID-19 pandemic, arguably among the worst-affected ones, counting 12 million cases and 150 thousand deaths two years since the first case. Facing new challenges, Italy has enacted different strategies and policies to limit the spread of the SARS-CoV-2 virus and treat those affected by COVID-19. This narrative review provided an overview of factors, measures, and actions that shaped Italy’s first two years of the COVID-19 pandemic by investigating epidemiological data and using a mixed-method approach. This narrative review aimed to summarize the most relevant aspects and measures and analyze available data to provide policymakers and healthcare providers with the instruments to learn from this pandemic and improve their preparedness for future pandemic events. The first two years of the pandemic differ in that, during the first year, significant necessary changes to the way health systems were organized were implemented, increasing healthcare spending and adopting social and physical distancing measures that were stricter than the ones adopted in the second year. However, as the pandemic progressed, increased knowledge of the virus and related variants, as well as the introduction of highly effective vaccines, which were not equally available to the whole population, resulted in a stratification of COVID-19 infections and deaths based on factors such as age, vaccination status, and individual susceptibility to the virus.

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Objectives: Most countries initially deployed COVID-19 vaccines preferentially in elderly populations. We aimed to evaluate whether population-level vaccine effectiveness is heralded by an increase in the relative proportion of deaths among non-elderly populations that were less covered by vaccination programs. Eligible data: We collected data from 40 countries on age-stratified COVID-19 deaths during the vaccination period (1/14/2021-5/31/2021) and two control periods (entire pre-vaccination period and excluding the first wave). Main outcome measures: We meta-analyzed the proportion of deaths in different age groups in vaccination versus control periods in (1) countries with low vaccination rates; (2) countries with age-independent vaccination policies; and (3) countries with standard age-dependent vaccination policies. Results: Countries that prioritized vaccination among older people saw an increasing share of deaths among 0-69 year old people in the vaccination versus the two control periods (summary proportion ratio 1.32 [95 CI% 1.24-1.41] and 1.35 [95 CI% 1.26-1.44)]. No such change was seen on average in countries with age-independent vaccination policies (1.05 [95 CI% 0.78-1.41 and 0.97 [95 CI% 0.95-1.00], respectively) and limited vaccination (0.93 [95 CI% 0.85-1.01] and 0.95 [95 CI% 0.87-1.03], respectively). Proportion ratios were associated with the difference of vaccination rates in elderly versus non-elderly people. No significant changes occurred in the share of deaths in age 0-49 among all 0-69 deaths in the vaccination versus pre-vaccination periods. Conclusions: The substantial shift in the age distribution of COVID-19 deaths in countries that rapidly implemented vaccination predominantly among elderly provides evidence for the population level-effectiveness of COVID-19 vaccination and a favorable evolution of the pandemic towards endemicity with fewer elderly deaths. Keywords: COVID-19; Death; Population data; Vaccination.

Background: achieving Human Papilloma Virus (HPV) - related diseases control is an important challenge in public health. In Italy HPV vaccination uptake does not rise a sufficient level. The aim of this project is to identify strategies to promote HPV vaccination in Italy.Methods: an integrated approach consisting of a systematic review and a two-step panel consultation was used to identify strategies to increase vaccination uptake among adolescents, population target of the national vaccination program, and to promote vaccination in additional targets. Overall, ten experts in the fields of Gynecology, Public Health, General Practice and Pediatrics were involved along with Patients representatives. Recommendations were elaborated according to a set of criteria drawn from the Evidence to Decision (EtD) framework.Results: the systematic review led to the identification of three categories of strategies: reminds, education and multicomponent approaches respectively. A strong recommendation was formulated to use reminds tailored to vaccine recipients or their parents, and a moderate recommendation to use reminds directed to health professionals. A moderate recommendation was developed on the implementation of multicomponent interventions. A strong recommendation was yielded with respect to the promotion of HPV vaccination among women already treated for HPV-related diseases, fertile women not previously vaccinated and 25 year-old women undergoing cervical cancer screening. Lastly, a strong recommendation was formulated for catch-up initiatives targeted to women and men turning 18 years of age.Conclusion: this project led to the identification of several valuable strategies to improve HPV vaccination and strengthen HPV-related diseases control at national level.