移植患者对参与首次在人类猪脏外移植临床试验的看法:混合方法研究
Elisa J Gordon1, Karen J Maschke2, Jessica Gacki-Smith3
1Department of Surgery, and Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Xenotransplantation
|February 6, 2025
概括
由于对安全性和功能的担忧,患者对猪异种移植试验的意愿很低. 了解这些患者的态度对于未来的异种移植研究中的道德知情同意至关重要.
科学领域:
- 移植研究 移植研究
- 医学伦理学医学伦理学
- 患者决策的参与
背景情况:
- 第一次在人类猪中进行异种移植试验即将到来.
- 关于患者参与和知情同意的伦理考虑至关重要.
研究的目的:
- 评估移植候选人对参加异种移植试验的态度.
- 了解异种移植试验招募的假设决策过程.
主要方法:
- 与28名患者进行了半结构化的电话采访.
- 在线调查由142名患者完成.
- 定性主题分析和定量描述性统计.
主要成果:
- 大多数参与者对感染传播和移植功能表示担忧.
- 在专注于猪安全性 (12.6%) 或功能 (16.9%) 的试验中报告了低意愿.
- 如果人类的可用性不太可能,健康状况下降,随着移植寿命的延长,愿意度就会增加.
结论:
- 移植计划必须解决患者对感染,移植功能和监测的担忧.
- 强有力的知情同意程序对于优化异种移植试验中人类受试者保护至关重要.
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