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.

To reduce vaccine-preventable diseases in workers, workplace vaccination campaigns can be implemented on-site. The aim of this systematic review was to evaluate adherence to workplace vaccination campaigns. Three databases, PubMed, ISI Web of Science, and Scopus, were screened systematically for articles in English or Italian addressing participation in an on-site vaccination program by employees. The following data was extracted: authors, year, country, type of vaccine, type of workplace, sample size, vaccination rate. Data on the prevalence of flu vaccination were calculated and pooled using a random-effects model. Thirteen articles were included in the review, ten in the meta-analysis. Most studies were conducted in the USA (30.7%) and most vaccination campaigns were against influenza (69.2%), with a pooled estimate of 42% (95% CI: 0.25–0.60%); participation rate was highly variable, ranging from 88.9% for an influenza vaccination campaign to 5.7% for a Lyme disease vaccination campaign. Offering free on-site vaccination can be a successful tool to ensure adherence to vaccination campaigns and administration of all required doses according to the vaccine administration scheme. The occupational physician can play a key role in implementing workplace campaigns for employee mandatory vaccinations.

Importance: Repeated transfusions in preterm neonates with anemia of prematurity replace fetal hemoglobin (HbF) with adult Hb (HbA), which has a low oxygen affinity. The reduction of HbF is associated with a higher incidence of retinopathy of prematurity (ROP).Objective: To assess whether HbF and HbA are differently associated with cerebral tissue oxygenation in preterm neonates.Design, Setting, and Participants: This cohort study was a single-center, pilot study on cerebral oxygenation kinetics in preterm neonates with a gestational age between 24.0 weeks and 27.9 weeks who were admitted to the neonatal intensive care unit of Policlinico Universitario A. Gemelli IRCCS from December 27, 2021, to May 15, 2023. This study was ancillary to the ongoing, double-blind, multicenter Umbilical or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN) randomized clinical trial. The BORN trial outcome was ROP severity in neonates randomized to receive standard packed red blood cell (PRBC) transfusions obtained from RBCs of adult donors (A-RBCs) or from cord blood (CB-RBCs). According to standard procedures at the institute’s neonatal intensive care unit, patients concurrently received continuous cerebral near-infrared spectroscopy (NIRS) monitoring. This cohort study was not prespecified in the trial protocol.Exposure: Transfusion with A-RBCs or CB-RBCs.Main Outcomes and Measures: The main outcome was the kinetics of cerebral regional oxygen saturation (crSO₂) and cerebral fraction of tissue oxygen extraction (cFTOE) associated with A-RBC or CB-RBC transfusions. Cerebral NIRS monitoring was performed by neonatologists and nurses, who were blinded to the PRBC type. The NIRS monitoring was conducted starting with the blood product order, during transfusion, and for the subsequent 24 hours after transfusion completion. The mean treatment effects of A-RBCs or CB-RBCs were quantified using a linear mixed model for repeated measures.Results: Of 23 randomized neonates, 17 (11 male [64.7%]; median gestational age at birth, 25.6 weeks [IQR, 25.3-26.1 weeks]) with a median birth weight of 840 g (IQR, 580-900 g) were included in the study; NIRS was evaluated for 42 transfusion episodes, of which 22 were A-RBCs and 20 were CB-RBCs. Globally considering all posttransfusion time points, the overall crSO₂ covariate-adjusted mean after CB-RBC transfusions was 5.27% lower (95% CI, 1.20%-9.34%; P = .01) than that after A-RBC transfusions, while the cFTOE after CB-RBC transfusions was 6.18% higher (95% CI, 1.66%-10.69%; P = .009) than that after A-RBCs.Conclusions and Relevance: The findings of this cohort study suggest that A-RBC transfusions may be associated with more oxygen delivery to cerebral tissues of preterm neonates than transfusions from CB-RBCs. This finding may explain the previously observed association between low HbF and high ROP risk. It also suggests that use of CB to meet the RBC transfusion needs of neonates with a gestational age of less than 28 weeks may protect cerebral tissues from overexposure to oxygen.

The COVID-19 vaccination has proven to be the most effective prevention measure, reducing deaths and hospitalizations and allowing, in combination with non-pharmacological interventions, the pandemic to be tackled. Although most of the adverse reactions to vaccination present mild symptoms and serious effects are very rare, they can be the cause of legal action against the healthcare workers (HCWs) who administered it. To highlight differences in the medical liability systems, we performed a search for the three most populous countries in each continent on vaccine injury compensation programs, new laws or policies to protect HCWs administering vaccinations introduced during the COVID-19 pandemic, and policies on mandatory vaccinations, on literature databases and institutional sites. We found that in seven countries the medical liability system is based on Common Law, while in eleven it is mainly based on Civil Law. Considering the application of specific laws to protect HCWs who vaccinate during the pandemic, only the USA and Canada provided immunity from liability. Among the countries we analyzed, fourteen have adopted compensation funds. From an international perspective, our results highlight that in eleven (61.1%) countries medical liability is mainly based on Civil Law, whilst in seven (38.9%) it is based on Common Law.

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.