Kidney Transplant Candidates’ Information Needs for Informed Decision-Making about Participating in a First-in-Human Pig Xenotransplant Clinical Trial
Saturday, September 21, 2024
10:15 AM – 11:15 AM CT
Location: Grand Ballroom B (First Floor)
Abstract: Purpose: First-in-human pig xenotransplant clinical trials may begin soon, raising ethical concerns about informed consent. We assessed patients’ information needs for decision-making about trial participation.
Methods: We conducted in-depth semi-structured telephone interviews with waitlisted kidney transplant patients at two transplant centers. Qualitative data were analyzed by thematic analysis.
Results: 28 patients participated (34% participation rate). Mean age was 49 years. Most patients were male (68%), White (54%) or Black (36%). Five themes emerged regarding information needs: (1) Risks of contracting and transmitting infection: Patients desired information about infectious diseases they could contract from the pig kidney, and the probability of contracting and transmitting those diseases to others. (2) Risks, benefits, and impact: Patients desired information about “success stories” of xenotransplant recipients; expected “life span” of the pig kidney; the impact of xenotransplant on their life expectancy; and impact of trial participation on quality of life compared to dialysis. (3) Xenotransplant research experience: Patients desired information on the number of trials completed, the number of pig kidney transplants performed to date, and the functional outcomes prior to their own participation. (4) Clinical trial logistics: Patients desired information about participants’ obligations for post-transplant monitoring (e.g., location, frequency, duration of testing and appointments); and a back-up plan if the xenotransplant failed. (5) The pig and its kidney: Patients desired information about the pig’s health, how it lived, died, and how the pig was genetically altered.
Conclusions: Findings suggest that kidney transplant candidates desire extensive information to provide informed consent for xenotransplant clinical trials.
Learning Objectives:
After participating in this conference, attendees should be able to:
1. At the end of this session, attendees will be able to describe information that patients need in order to make informed treatment decisions about participating in first-in-human xenotransplant trials.
2. At the end of this session, attendees will be able to describe what xenotransplant risks and benefits patients identified for their information needs.
Karen Maschke – The Hastings Center; Jessica Gacki-Smith – Northwestern University; Meg Matthews – Harvard University; Karen Traboulsi – Lehigh University; Dahlya Manning – Northwestern University; Michael Gusmano – Lehigh University
