Genetic Testing (APOL1) Decisional Support for Potential Living Kidney Donors

项目摘要 载脂蛋白L-1或APOL 1基因的鉴定作为发展中国家的可能性增加的指标， 慢性肾脏疾病引发了一场关于潜在活体肾脏的即时基因检测的辩论 捐助者。虽然将基因检测纳入对潜在活体捐赠者的医学评估有利于患者， 确保知情、审慎的决策过程至关重要。拟议的研究已于 大量研究表明，传统的SDM流程和干预措施无法满足需求 少数民族人口。因为SDM需要知情的患者参与决策 过程中，需要新的方法，以确保全面，准确地了解风险，受益，影响和 替代方案我们建议采取参与性办法，为非洲国家开发决策支持工具， 美国潜在的捐赠者，因为他们认为基因检测是他们医疗评估的一部分。具体来说， 混合方法研究将进行开发和完善工具所需的形成性研究。多达6个焦点 小组访谈将探讨潜在捐助者对共同决策的偏好，并了解 在活体肾脏捐赠的背景下进行基因检测的风险、益处和影响（目标1）。这些发现 将为评估潜在捐助者决策偏好的简要定量调查的设计提供信息， 沟通方式，以及对基因检测、肾移植和生活的知识和态度 捐赠。该调查（N=500）将是第一个包括最佳-最差缩放方法来评估 潜在捐赠者对基因检测的风险和益处以及权衡的重视程度 捐助者愿意承担的风险和收益之间的关系（目标2）。将使用 Ottowa框架作为指导，以支持非裔美国患者及其家属做出关于 包括活体肾脏移植和基因检测。将进行其他修改 根据焦点小组访谈和已完成的调查结果。然后将对工具进行细化 在与标准化供应商的模拟咨询中迭代进行四轮测试， 由移植专家组成的德尔菲小组（Aim 3）。一个利益相关者委员会，由移植 专业人士和以前和潜在的活体捐赠者，将提供持续的反馈和指导， 研究阶段。在随后的R 01中，经过全面审查的新开发工具将在 使用随机对照设计的临床设置。如果成功，该工具将优化护理， 每年在美国评估数千名非洲裔美国人潜在的活体肾脏捐赠者。

PROJECT SUMMARY The identification of the Apolipoprotein L-1 or APOL1 gene as an indicator of increased likelihood of developing chronic kidney disease has sparked a debate about point-of-care genetic testing for potential living kidney donors. While integrating genetic testing into the medical evaluation of potential living donors benefits patients, ensuring an informed, deliberative decision making process is paramount. The proposed study is premised on a large body of research demonstrating that traditional SDM processes and interventions fail to meet the needs of ethnic minority populations. Because SDM requires an informed patient to engage in the decision making process, novel methods are needed to assure a full, accurate understanding of risks, benefits, implications and alternate options. We propose a participatory approach to developing a decisional support tool for African American potential donors as they consider genetic testing as part of their medical evaluation. Specifically, this mixed-method study will conduct the formative research needed to develop and refine the tool. Up to 6 focus group interviews will explore potential donors' preferences for shared decision making and understanding of the risks, benefits and implications of genetic testing in the context of live kidney donation (Aim 1). The findings will inform the design of a brief quantitative survey assessing potential donors' decision-making preferences, communication style, and knowledge of and attitudes toward genetic testing, kidney transplantation and living donation. The survey (N=500) will be the first to include the Best-Worst Scaling methodology to assess the level of importance potential donors place on the risks and benefits of genetic testing as well as trade offs between risks and benefits donors are willing to make (Aim 2). A draft of the tool will be created, using the Ottowa Framwork as guide, to support African American patients and their families making decisions about both living donor kidney transplants and genetic testing in this context. Additional modifications will be made based on the findings of the focus group interviews and completed surveys. The tool will then be refined iteratively over four rounds of testing in simulated consultations with standardized providers and four rounds with a Delphi panel of transplant professionals (Aim 3). A Stakeholder Committee, comprised of transplant professionals and previous and potential living donors, will provide ongoing feedback and guidance across all study phases. In a subsequent R01, the fully-vetted, newly developed tool will be implemented and tested in clinical settings using a randomized controlled design. If successful, the tool will optimize care for the thousands of African American potential living kidney donors evaluated in the United States annually.