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

为潜在活体肾脏捐赠者提供基因检测 (APOL1) 决策支持

• 批准号: 10494134
• 负责人: Heather Marie Gardiner
• 金额: $ 55.53万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10494134
• 关键词: Advocate; Affect; African; African American; African American population; African Trypanosomiasis; African ancestry; Alleles; Apolipoproteins; Attitude; Award; Belief; Benefits and Risks; Cancer Model; Caring; Chronic Kidney Failure; Clinical; Communication; Consultations; Decision Making; Development; End stage renal failure; Ensure; Evaluation; Face; Family; Family member; Feedback; Financial Hardship; Focal Segmental Glomerulosclerosis; Focus Groups; Genes; Gold; Graft Rejection; Group Interviews; HIV; Health; Hypertension; Individual; Intervention; Kidney; Kidney Diseases; Kidney Transplantation; Knowledge; Latinx; Living Donors; Medical; Methodology; Methods; Modification; Outcome; Parasitic infection; Patient Care; Patients; Persons; Phase; Process; Provider; Quality of life; Randomized Controlled Clinical Trials; Recommendation; Research; Risk; Safety; Series; Social Workers; Societies; Speed; Standardization; Surveys; Testing; Transplant Recipients; Transplantation; United States; Variant; Work; base; clinical decision-making; clinical practice; cost; cultural values; design; ethnic minority; ethnic minority population; genetic testing; genetic variant; improved; living kidney donor; minority patient; nephrogenesis; non-diabetic; novel; point of care; preference; programs; randomized controlled design; response; shared decision making; support tools; tool; willingness

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.

项目概要 载脂蛋白 L-1 或 APOL1 基因的鉴定作为罹患可能性增加的指标 慢性肾病引发了关于潜在活肾即时基因检测的争论 捐助者。在将基因检测纳入潜在活体捐赠者的医学评估中的同时使患者受益， 确保知情、审慎的决策过程至关重要。拟议研究的前提是 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。因为 SDM 需要知情的患者参与决策 过程中，需要新颖的方法来确保全面、准确地理解风险、收益、影响和 替代选项。我们提出一种参与式方法来为非洲开发决策支持工具 美国潜在的捐赠者将基因检测视为医疗评估的一部分。具体来说，这 混合方法研究将进行开发和完善该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助者对共同决策的偏好以及对 活体肾脏捐赠背景下基因检测的风险、益处和影响（目标 1）。研究结果 将为评估潜在捐助者的决策偏好的简短定量调查的设计提供信息， 沟通方式以及对基因检测、肾移植和生活的了解和态度 捐款。该调查（N=500）将首次采用最佳-最差衡量方法来评估 潜在捐助者对基因检测的风险和收益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）。将使用以下命令创建该工具的草稿 渥太华框架作为指导，支持非裔美国患者及其家人做出以下决定： 在这方面，包括活体肾移植和基因检测。将进行额外修改 基于焦点小组访谈和完成的调查的结果。然后该工具将被完善 在与标准化提供商的模拟咨询中迭代进行四轮测试以及四轮 与德尔福移植专家小组合作（目标 3）。利益相关者委员会，由移植组成 专业人士以及以前和潜在的活体捐赠者，将提供持续的反馈和指导 学习阶段。在随后的 R01 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环境。如果成功，该工具将优化对患者的护理 每年在美国对数千名非洲裔美国人的潜在活体肾脏捐赠者进行评估。