1. Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project-a position paper.
- Author
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Willems D, Bak M, Tan H, Lindinger G, Kocar A, Seperhi Shamloo A, Schmidt G, Hindricks G, and Dagres N
- Subjects
- Death, Sudden, Cardiac etiology, Humans, Artificial Intelligence, Clinical Trials as Topic ethics, Death, Sudden, Cardiac prevention & control, Decision Making, Defibrillators, Implantable, Myocardial Infarction complications, Primary Prevention ethics
- Abstract
Aim: 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., Method: The position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature., Results: We identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial. We underline the need for ethical-empirical studies about these issues, also among patients, as a parallel to the actual trials. The number of ethics committees involved is an organisational, but also an ethical challenge., Conclusion: The PROFID trials, and probably other studies of similar scale and complexity, raise questions that deserve dedicated parallel ethics and social science research, but do not constitute a generic obstacle. A harmonisation procedure, comparable to the Voluntary Harmonization Procedure (VHP) for medication trials, could be needed for this type of trials., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2021
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