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

Journal: Open heart
Published Date: Jul 1, 2021

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.

Authors

  • Dick Willems
    Ethics, Law, and Humanities, Amsterdam Public Health, Amsterdam UMC Locatie Meibergdreef, Amsterdam, The Netherlands d.l.willems@amsterdamumc.nl.
  • Marieke Bak
    Ethics, Law, and Humanities, Amsterdam Public Health, Amsterdam UMC Locatie Meibergdreef, Amsterdam, The Netherlands.
  • Hanno Tan
    Department of Cardiology, Heart Center, Academic Medical Center, Amsterdam, The Netherlands.
  • Georg Lindinger
    Institute for Health Care Management and Health Sciences, University of Bayreuth, Bayreuth, Bayern, Germany.
  • Ayca Koçar
    Institute of Management for Medicine and Health Sciences, University of Bayreuth, Prieserstr. 2, Bayreuth, 95444, Germany.
  • Alireza Seperhi Shamloo
    Leipzig Heart Institute GmbH, Leipzig, Sachsen, Germany.
  • Georg Schmidt
    Medizinische Klinik und Poliklinik, Technische Universität München, München, Bayern, Germany.
  • Gerhard Hindricks
    Department of Electrophysiology, Heart Center Leipzig at University of Leipzig, Strümpellstr. 39, 04289 Leipzig, Germany.
  • Nikolaos Dagres
    German Heart Center of the Charité-University Medicine Berlin, Augustenburger Pl. 1, Berlin, 13353, Germany.

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