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

项目总结 载脂蛋白L-1或载脂蛋白1基因作为增加发病可能性的指标的鉴定 慢性肾脏疾病引发了一场关于潜在活体肾脏的护理点基因测试的辩论 捐赠者。虽然将基因检测整合到对潜在活体捐赠者的医学评估中会让患者受益， 确保一个知情的、深思熟虑的决策过程至关重要。拟议的研究的前提是 大量研究表明，传统的SDM流程和干预措施无法满足需求 少数民族人口的比例。因为SDM需要知情的患者参与决策 过程中，需要新的方法来确保全面、准确地了解风险、收益、影响和 其他选项。我们建议采用参与式方法为非洲开发一个决策支持工具。 美国潜在捐赠者考虑将基因检测作为其医学评估的一部分。具体地说，这 混合方法研究将进行开发和改进工具所需的形成性研究。最多6个焦点 小组访谈将探讨潜在捐赠者对共同决策和对 活体肾脏捐赠背景下基因检测的风险、益处和影响(目标1)。调查结果 将指导设计一项简短的量化调查，评估潜在捐助者的决策偏好， 沟通方式、对基因检测、肾移植和生活的知识和态度 捐款。这项调查(N=500)将是第一次包括最佳-最差比例方法来评估 潜在捐赠者对基因检测的风险和好处以及权衡的重视程度 捐助者愿意承担的风险和受益之间的关系(目标2)。将创建工具的草稿，使用 奥托瓦框架作为指南，支持非裔美国患者及其家人做出关于 在此背景下，活体供体肾脏移植和基因测试。将进行其他修改 根据焦点小组访谈和完成的调查的结果。然后将对该工具进行改进 在与标准化提供商的模拟咨询中反复进行四轮测试和四轮测试 与德尔福的移植专家小组合作(AIM 3)。利益相关者委员会，由移植 专业人士以及以前和潜在的在世捐赠者将为所有人提供持续的反馈和指导 学习阶段。在随后的R01中，新开发的经过全面审查的工具将在 临床环境采用随机对照设计。如果成功，该工具将优化对 每年有数千名非洲裔美国人潜在的活体肾脏捐赠者在美国接受评估。

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.