Carolina Castagna

Background: The spread of Personalized Medicine (PM) over the last decade defined a revolution in healthcare systems. PM is among the priorities of the European Commission’s research agenda, which funded the IC2PerMed international project aiming to integrate China into the International Consortium of PM (ICPerMed). In the context of this project, we mapped the existing policies related to PM in the European Union (EU) and at the EU Member States (EU-MS) level.Methods: PubMed, Google Scholar, Google, Microsoft and national and international institutions’ official repositories were searched in order to identify documents on PM-related policies, programmes and action plans at the EU and EU-MS level, published up to December 2020.Results: We identified 28 policies in the EU aimed at improving public health promoting and fostering PM implementation, through some actions including the standardization of good medical practice, use of big data and digital innovation, data sharing and cross-border interoperability, healthcare sustainability, disease prevention and patients’/citizens’ engagement. We identified 23 policies at EU-MS level which, notwithstanding national differences, have a common focus, such as patient-tailored treatment and targeted prevention, education of healthcare workers, research and innovation, big data harmonization and healthcare system sustainability.Conclusions: The definition of an integrated regulatory framework is essential to turn PM into an opportunity for citizens and patients with the involvement of all the stakeholders. This work can provide a valuable tool for decision-makers to define common approaches, priorities for research, development and increase international collaboration, which could overcome the fragmented European scenario and align the future direction on PM.

The COVID-19 pandemic called for a reorganisation of the methods for providing health services. The aim of this paper is to describe the organisational model implemented by one of Rome’s Local Health Units (LHU), ASL Roma 1, for the “at-home COVID-19 vaccination campaign” dedicated to a target population and to outline data related to vaccination coverage stratified by health districts. A cross-sectional study was designed to describe the strategies implemented by LHU to deliver at-home vaccination programmes. People eligible for the at-home vaccination programme included patients living in the area of the LHU, being assisted by the district home care centre or not transportable or individuals with social situations that make traveling difficult. Priority for vaccination was given to (I) age > 80 years, (II) ventilated patients with no age limit, (III) very seriously disabled people with no age limit. Patients’ data were acquired from regional and LHU databases. From 5 February until the 16 May, 6127 people got at least one dose of Pfizer-Biontech Comirnaty^® vaccine, while 5278 (86.14%) completed the necessary two doses. The highest number of vaccines was administered during the first week of April, reaching 1296 doses overall. The number of vaccines administered were similar across the districts. The average number of people vaccinated at home was 6 per 1000 inhabitants in the LHU. This model proved to be extremely complex but effective, reaching satisfying results in terms of vaccination coverage.

Health workers, especially those in patient-facing roles, had a significantly increased risk of COVID-19 infection, having serious outcomes, and risking spreading the virus to patients and staff. Vaccination campaign planning suggests allocating initial supplies of BNT162b2 vaccine to health workers given the importance of early protection to safeguard the continuity of care to patients. The aim of the study is to assess the effectiveness and safety of BNT162b2 vaccine among the health workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The retrospective cohort study was conducted among health staff working at the FPG. Vaccination data were collected from hospital records. The primary end points were vaccine effectiveness and safety. A total of 6649 health workers were included, of whom 5162 received injections. There were 14 cases of COVID-19 with onset at least 14 days after the second dose among vaccinated health workers and 45 cases among unvaccinated ones. BNT162b2 was 91.5% effective against COVID-19 (95% credible interval, 84.7% to 95.3%). The safety profile of BNT162b2 vaccine consisted of short-term, non-serious events. The promotion and boost of the COVID-19 vaccination campaign represents a key public health measure useful to curb the spread of the pandemic especially in vulnerable contexts, such as hospitals, where health workers carry out a paramount role for the entire community, and requires further protection with a possible booster dose in view of autumn-winter 2021.

Background: Breast Cancer (BC) is estimated to cause 2.3 million yearly new cases worldwide. Efforts towards standardized, quality assured and effective care have led to an increasing complexity and specialization of BC management. This systematic review's aim is to describe the state-of-the art of available literature investigating the enactment of personalised medicine and patient-centered care models in BC practice and build a framework towards personalised BC care within a patient-centered model. Methods: Databases were searched to retrieve articles reporting on BC management, evaluated in terms of patient-centered and personalised medicine approaches, assessing success factors or limits, in English, from the inception to December 2020. The investigated dimensions for patient-centered care models were audits, communication, informative systems and multidisciplinarity. Concerning Personalised Medicine, investigations were related to molecular boards, genetic testing and shared-clinical decision-making. Results: Out of 1885 records, 25 studies were included in the qualitative analysis. The main success factors are multi-professional collaborations with defined roles and responsibilities, training programs on genomic tools and adequate communication strategy (i.e universal genomic language) to involve patients in the decision-making process. Among detected barriers, delays in genetic testing use were linked to the lack of public reimbursement and of clarity in timing and appropriateness. Conclusions: Both these models are complementary and needed to ensure effective changes in the path of BC patient management. Our framework aims to the transformation of standardized application of evidence-based medicine into a dynamic and personalised care pathway. Key messages: The combination of the two care delivery approaches is scarcely investigated in literature. Our framework would allow to fill such gap and attributes a key role to sharing the decision-making process.

We conducted an umbrella review which synthetizes the findings of systematic reviews available in the literature that investigate the prognostic role of miRNAs as potential biomarkers in the field of tertiary prevention of head and neck Cancer (HNC). We selected systematic reviews in English related to HNC, with meta-analysis of observational studies that reported quantitative prognostic measures, hazard ratios (HRs), overall survival (OS) or disease-free survival (DFS). The methodological quality of the included reviews was assessed by using the AMSTAR-2 tool. The most reported miRNAs were the following: miRNA2, Let7 family and miR17, etc. Four out of six reviews particularly emphasized the link between miRNA21 expression and HNC patients. Recently the cumulative effects of sets of miRNAs have been increasingly studied and might be a stronger predictor of survival than single miRNA.