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. 2025 Jan-Feb;32(1):e70016.
doi: 10.1111/xen.70016.

Patients' Information Needs for Informed Consent to Participate in First-in-Human Pig Kidney Xenotransplant Clinical Trials: A Mixed Methods Study

Elisa J Gordon  1 , Michael K Gusmano  2 , Jessica Gacki-Smith  3 , Hannah L Brooks  4 , Margaret M Matthews  5 , Dahlya Manning  6 , Joseph Leventhal  7 , Karen J Maschke  8
Affiliations

Patients' Information Needs for Informed Consent to Participate in First-in-Human Pig Kidney Xenotransplant Clinical Trials: A Mixed Methods Study

Elisa J Gordon et al. Xenotransplantation. 2025 Jan-Feb.

Abstract

Background: Transplant programs preparing to initiate first-in-human pig kidney xenotransplant clinical trials must be especially careful when obtaining participants' informed consent. Little is known about the kind of information patients want for making an informed decision about trial participation.

Methods: We conducted semi-structured telephone interviews with waitlisted kidney transplant patients about information needs regarding participating in a first-in-human pig kidney xenotransplant trial, which guided development of a prototype consent form. Subsequent usability testing interviews sought patient feedback on the consent form. We analyzed qualitative data by thematic analysis and quantitative data by descriptive statistics.

Results: Twenty-eight patients participated in semi-structured interviews; 16 patients participated in usability testing interviews. Most interview participants were male (68%, 56%), White (54%, 56%), or Black (36%, 31%), respectively. Interview participants identified five types of information needs: (1) the potential for infection contraction and transmission; (2) risks, benefits, and impact of xenotransplant trials; (3) xenotransplant clinical trial and recipient experience; (4) clinical trial logistics; and (5) the pig and its kidney. Usability testing participants suggested adding details to the prototype. Participants' preparedness to make a decision about participating in a xenotransplant trial increased after reviewing the prototype (12.5% vs. 31.3%, n.s.).

Conclusion: We identified multiple unique types of information patients desired to make informed decisions about pig kidney xenotransplant trial participation. Transplant programs initiating xenotransplant trials should be prepared to address patients' information needs to optimize informed decision-making for trial participation. The prototype consent form may support a patient-centered approach to informed consent.

Keywords: clinical trial participation; comprehension; disclosure; ethics; information disclosure; kidney patients; patient‐centered; patient‐provider communication; qualitative; recruitment; research ethics; xenotransplantation.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

References

    1. Montgomery R. A., Griesemer A. D., Segev D. L., and Sommer P., “The Decedent Model: A New Paradigm for De‐Risking High Stakes Clinical Trials Like Xenotransplantation,” American Journal of Transplantation 24, no. 4 (2024): 526–532, 10.1016/j.ajt.2024.01.035. - DOI - PubMed
    1. Lovelace B. Jr and Martin P., “In a First, Surgeons Successfully Transplant a Pig Kidney Into a Man,” NBC News, March 21, 2024, https://www.nbcnews.com/health/health‐news/first‐pig‐kidney‐transplant‐h....
    1. Molteni M. and Boodman E., “Gene‐Edited Pig Kidney Transplanted Into a Living Patient for the First Time,” STAT, March 21, 2024, https://www.statnews.com/2024/03/21/first‐xenotransplantation‐crispr‐gen....
    1. Mallapaty S. and Kozlov M., “First Pig Kidney Transplant in a Person: What It Means for the Future,” Nature 628, no. 8006 (2024): 13–14, https://www.nature.com/articles/d41586‐024‐00879‐y. - PubMed
    1. Eisenson D., Hisadome Y., Santillan M., et al., “Consistent Survival in Consecutive Cases of Life‐Supporting Porcine Kidney Xenotransplantation Using 10GE Source Pigs,” Nature Communications 15, no. 1 (2024): 3361, 10.1038/s41467-024-47679-6. - DOI - PMC - PubMed

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