Personalized Medicine is an evolving and often missinterpreted concept and no agreement of personalization exist. We examined the PM discourse towards foucauldian archeological and genealogical analysis to understand the meaning of “personalization” in medicine. In the archaeological analysis, the historical evolution is characterized by the coexistence of two epistemologies: the holistic vision and the omic sciences. The genealogical analysis shows how these epistemologies may affect the meaning of “person” and, consequently, the ontology of patients. Additionally, substitutions/confusions of the term PM (...) are related to continuously evolving medical knowledge and new technologies; different etymological roots of “personalization” and “person”; and cultural differences. In conclusion, if the definition of “personalization” in medicine is not clear, patients might get wrong expectations about what is achievable for their health. Therefore, epistemological trends should not be separated as they drive same goals: providing accurate diagnosis and treatments based on large data to predict disease progression. (shrink)

Objective: To assess the psychological distress of healthcare providers working in the field of obstetrics during the coronavirus disease 2019 pandemic and to identify factors associated with psychological distress at the individual, interpersonal, and organizational level.Design: Cross-sectional survey study.Setting: Four University hospitals in Italy.Participants: HCPs working in obstetrics, including gynecologists, residents in gynecology and obstetrics, and midwives.Methods: The 104-item survey Impatto PSIcologico COVID-19 in Ostetricia was created by a multidisciplinary expert panel and administered to HCPs in obstetrics in May 2020 (...) via a web-based platform.Main Outcome Measures: Psychological distress assessed by the General Health Questionnaire-12 included in the IPSICO survey.Results: The response rate to the IPSICO survey was 88.2%, and that for GHQ-12 was 84.4%. Just over half of the GHQ-12 respondents reported a clinically significant level of psychological distress. Psychological distress was associated with either individual, interpersonal, and organizational factors in dealing with the pandemic.Conclusions: Results confirm the need for monitoring and assessing the psychological distress for HCPs in obstetrics. Interventions at the individual, interpersonal, and organizational level may relieve the psychological distress during the COVID-19 pandemic and foster resilience skills in facing emotional distress. (shrink)

The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because these findings may be beneficial to (...) patients and their families. Communicating individual BRCA results was not anticipated during clinical trial design. Consequently, options were not available for patients to indicate their preference for receiving their individual results when they signed pharmacogenetic informed consent. Differences in local requirements, clinical practice, and opinion regarding the ethical aspects of how to convey genetic results to patients are all potential barriers to returning individual BRCA results to patients. Communicating the aggregate BRCA result from this study provided clinical investigators with a mechanism to disseminate the overall study finding to patients while taking individual circumstances, local guidelines and clinical practice into account. This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results. This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees. (shrink)