Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project-a position paper
| العنوان: | Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project-a position paper |
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| المؤلفون: | Ayca Kocar, Alireza Seperhi Shamloo, Georg Lindinger, Georg Schmidt, Hanno Tan, Marieke A. R. Bak, Dick Willems, Gerhard Hindricks, Nikolaos Dagres |
| المساهمون: | Ethics, Law & Medical humanities, General practice, Graduate School, ACS - Heart failure & arrhythmias, APH - Aging & Later Life, APH - Personalized Medicine, Cardiology, APH - Methodology, APH - Digital Health |
| المصدر: | Open Heart Open Heart, Vol 8, Iss 2 (2021) Open heart, 8(2):e001686. BMJ Publishing Group |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Research design, medicine.medical_specialty, medicine.medical_treatment, education, Decision Making, Myocardial Infarction, Harmonization, 030204 cardiovascular system & hematology, medical, 03 medical and health sciences, 0302 clinical medicine, Superiority Trial, Viewpoint, Artificial Intelligence, Health care, medicine, Diseases of the circulatory (Cardiovascular) system, Humans, Medical physics, 030212 general & internal medicine, outcome assessment, Clinical Trials as Topic, business.industry, Implantable cardioverter-defibrillator, research design, ethics, health care, 3. Good health, Test (assessment), Defibrillators, Implantable, Primary Prevention, Death, Sudden, Cardiac, Scale (social sciences), RC666-701, Position paper, Cardiology and Cardiovascular Medicine, Psychology, business, heart arrest |
| الوصف: | AimTo 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.MethodThe position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature.ResultsWe 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.ConclusionThe 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. |
| تدمد: | 2053-3624 2398-595X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f7d29cb24feffb18aeb60953bbcc924a https://pubmed.ncbi.nlm.nih.gov/34261778 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....f7d29cb24feffb18aeb60953bbcc924a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20533624 2398595X |
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