Informed consent and artificial intelligence applied to RCT and Covid-19

Artificial intelligence (AI) tools allow to extract knowledge from big data and are increasingly used for research purposes applied to -omics, diagnostic images, complex patterns of diseases and system medicine, drug development, robotics, and other topics. The management of big data, largely made of individual clinical data, poses specific ethical challenges that must be addressed in research studies and that should be reflected in the informed consent process. Explaining the mechanisms used by AI algorithms in supporting clinical decision making may be particularly difficult because of the opacity of its process. Moreover, depending on the quality of data feeding their algorithms, AI applications may result in errors. As the General Data Protection Regulation (GDPR) includes the possibility that a patient withdraws his/her informed consent from a study, it may be challenging to update AI algorithms accordingly. On the other hand, AI tools may help support the recruitment and retention of participants in clinical trials matching eligibility criteria with individual data collected for clinical purposes in electronic health records, and improve data collection and analytics. The possibility to stream data from wearable devices offers the possibility to generate large data volumes relevant to Patient Reported Outcomes feeding AI predictive algorithms. The Covid-19 pandemic has promoted the application of digital tools and of AI in clinical trials in order to limit personal contacts. The pressure exerted by the pandemic will possibly speed up the adoption of AI solutions for clinical trials and will highlight their potential ethical implications. © 2021

Knowledge and Perception of COVID-19 Pandemic during the First Wave (Feb-May 2020): A Cross-Sectional Study among Italian Healthcare Workers

Italy was the first country in Europe to face the coronavirus pandemic. The aim of the study was to analyze healthcare workers' (HCWs) level of information, practice, and risk perception towards COVID-19. We set up a cross-sectional study through SurveyMonkey^R and distributed the link through Facebook and Whatsapp closed groups. The research instrument was a 31 items questionnaire distributed using Facebook and Whatsapp. It was conducted in Italy from February to May 2020. The study participants were general practitioners, pediatricians and other health professionals. A total of 958 participants were included: 320 (33.4%) general practitioners, 248 (25.9%) pediatricians and 390 (40.7%) other health professionals. The highest response rate was from Northern Italy (48.1%), followed by Central Italy (29.9%) and Southern Italy (22.0%). Less than a half (46%) of respondents felt they had a good level of information of COVID-19 case definition and of national prevention guidelines. Respondents reported to have changed their clinical practice;particularly, they increased the use of masks (87.1%, p < 0.001), disinfection and sanitization of doctors' offices (75.8%, p < 0.001), the use of protective glasses (71.2%, p < 0.001), alcoholic hand solution (71.2%, p < 0.001), and hand washing (31.8%, p = 0.028). HCWs are at high risk of infection;less than a half of them felt adequately prepared to face COVID-19 pandemic, so they need extensive information and awareness of the disease to take adequate precautionary measures, and they are crucial to disseminate good practices.