What does it take to consent to islet cell xenotransplantation? Insights from an interview study with type 1 diabetes patients and review of the literature

Publikation: Beitrag in FachzeitschriftÜbersichtsartikel (Review)BeigetragenBegutachtung

Beitragende

  • Johannes Kögel - , Ludwig-Maximilians-Universität München (LMU) (Autor:in)
  • Sandra Thiersch - , Ludwig-Maximilians-Universität München (LMU) (Autor:in)
  • Barbara Ludwig - , Medizinische Klinik und Poliklinik III (Autor:in)
  • Jochen Seissler - , Ludwig-Maximilians-Universität München (LMU) (Autor:in)
  • Georg Marckmann - , Ludwig-Maximilians-Universität München (LMU) (Autor:in)

Abstract

Background: The transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus (T1DM). Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed consent process for xenotransplantation. Methods: We conducted qualitative interviews with seven T1DM patients to assess their information needs prior to xenotransplantation. Before the interview, the participants received a model informed consent form for a clinical trial with porcine islet cells transplantation. The interviews were transcribed and analysed using qualitative content analysis. Results: In the interviews, we identified several requirements that are crucial for patients with T1DM in order to consider xenotransplantation as a potential treatment option: therapy-related requirements, professional care and supervision, successful behaviour and attitude management, improving quality of life, and managing control/self-determination challenges. Regarding the informed consent form, several of the participants’ questions remained open and should be addressed in more detail. The interviewees stressed the importance of personal consultations. Conclusions: To become a sustainable therapeutic option, patients especially expected an improved diabetes control and a reduction of diabetes-related burdens. Health-related aspects prove to be pivotal for diabetic patients when considering porcine islet cell transplantation. The use of pigs as source for organ retrievals was not considered as problematic.

Details

OriginalspracheEnglisch
Aufsatznummer37
FachzeitschriftBMC medical ethics
Jahrgang22
Ausgabenummer1
PublikationsstatusVeröffentlicht - 1 Apr. 2021
Peer-Review-StatusJa

Externe IDs

PubMed 33794874

Schlagworte

Ziele für nachhaltige Entwicklung

Schlagwörter

  • Diabetes, Informed consent, Patient evaluation, Porcine islet cells, Qualitative interviews, Xenotransplantation