Tarantini Giuseppe, Fraccaro Chiara, Porzionato Andrea, Van Mieghem Nicolas, Treede Hendrik, Shammas Nicolas, Szerlip Molly, Thourani Vinod, Gerosa Gino, Marchese Alfredo, Speziale Giuseppe, Ludes Bertrand, Pollak Stephen, Vanezis Peter, Ferrara Santo Davide
Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy.
Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy.
Am J Cardiol. 2025 Apr 15;241:77-83. doi: 10.1016/j.amjcard.2025.01.015. Epub 2025 Jan 25.
Advances in personalized medicine and Systems Biology have introduced probabilistic models and error discovery to cardiovascular care, aiding disease prevention and procedural planning. However, clinical application faces cultural, technical, and methodological hurdles. Patient autonomy remains essential, with shared decision-making (SDM) gaining importance in managing complex cardiovascular treatment options. Effective SDM relies on collaboration between providers and patients, guided by P5 Medicine principles, which combine psycho-cognitive considerations with predictive, personalized, preventive, and participatory care. Here we propose a 3-step methodological proposal for implementing SDM and enhancing consent acquisition in cardiovascular care. The approach emphasizes personalized patient engagement and the need for clear, comprehensive consent processes. It identifies and addresses significant gaps in current practices, including the complexity of consent language, information dispersion, and the specific needs of vulnerable populations. Issues of Medical Responsibility and/or Liability may raise in the case of absence of consent acquisition or invalid consent due to insufficient/incorrect information. The International Guidelines on Medico-Legal Methods of Ascertainment and Evaluation Criteria are reported. In conclusion, the paper proposes practical solutions, including the use of artificial intelligence (AI) to enhance decision-making and patient counseling, and strategies to ensure that consent processes are both thorough and legally sound and respectful to the individual's autonomy.
个性化医疗和系统生物学的进展已将概率模型和误差发现引入心血管护理领域，有助于疾病预防和程序规划。然而，临床应用面临文化、技术和方法上的障碍。患者自主权仍然至关重要，共同决策（SDM）在管理复杂的心血管治疗方案中变得越来越重要。有效的共同决策依赖于提供者与患者之间的合作，以P5医学原则为指导，该原则将心理认知因素与预测性、个性化、预防性和参与性护理相结合。在此，我们提出了一个在心血管护理中实施共同决策和加强同意获取的三步方法建议。该方法强调个性化的患者参与以及清晰、全面的同意过程的必要性。它识别并解决了当前实践中的重大差距，包括同意语言的复杂性、信息分散以及弱势群体的特殊需求。在未获取同意或因信息不足/错误导致同意无效的情况下，可能会引发医疗责任和/或赔偿责任问题。报告了关于医学法律认定方法和评估标准的国际指南。总之，本文提出了切实可行的解决方案，包括使用人工智能（AI）来加强决策和患者咨询，以及确保同意过程既全面又合法合理且尊重个人自主权的策略。
