ArticleXenotransplantation
Patients' Information Needs for Informed Consent to Participate in First-in-Human Pig Kidney Xenotransplant Clinical Trials: A Mixed Methods Study.
Article in Xenotransplantation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Ethical and Linguistic Quality of Participant Information Sheets and Their Association with Recruitment Outcomes : An Empirical Bioethics Study of Clinical Trials.Journal of bioethical inquiry · 2026Article
- Global Consultation for Clinical Xenotransplantation: International Xenotransplantation Association Consensus and Communiqué Update.XenotransplantationReview
- Xenotransplantation Literature Update: January-June 2025.XenotransplantationReview
- Views of Living Donor Liver Transplant Recipients About Xenotransplantation in Türkiye: A Qualitative Study.XenotransplantationArticle
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
backgroundTransplant 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.
methodsWe 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.
resultsTwenty-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.).
conclusionWe 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.
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Registered trials
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