Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project—a position paper

摘要

To discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model.