Identifying and exploring solutions to the ethical challenges of ApoL1 testing of donors with recent African ancestry through mixed methods research with stakeholders

通过与利益相关者的混合方法研究，确定并探索针对具有非洲血统的捐赠者的 ApoL1 测试的伦理挑战的解决方案

• 批准号: 10112755
• 负责人: James M Dubois
• 金额: $ 37.81万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10112755
• 关键词: APOL1 gene; Address; African; Allografting; Attitude; Clinical; Communities; Comprehension; Consensus; Decision Making; Demographic Survey; Eligibility Determination; End stage renal failure; Enrollment; Ensure; Ethical Issues; Ethics; Evaluation; Face; Family member; Fostering; Future; General Population; Genomic medicine; Genotype; Healthcare Systems; Human Resources; Incidence; Individual; Interview; Kidney; Kidney Diseases; Kidney Transplantation; Living Donors; Measures; Modeling; Online Systems; Organ Donor; Organ Transplant Research; Organ Transplantation; Outcome; Participant; Policies; Predictive Factor; Process; RQ2; Regrets; Research; Research Methodology; Risk; Role; Series; Stigmatization; Surveys; Test Result; Testing; Transplant Surgeon; Transplantation; Trust; United States; Variant; Work; biobank; black patient; clinical practice; cognitive interview; data sharing; experience; genetic counselor; genetic testing; health disparity; health literacy; high risk; improved; instrument; member; minority healthcare; organ allocation; precision medicine; recruit; research study; risk variant; satisfaction; social; transplant centers; trustworthiness

PROJECT SUMMARY Blacks in the United States have a higher incidence of end-stage kidney disease than the general population; much, but not all, of this excess risk is attributed to variants in the ApoL1 gene. The ApoL1 Long-term Kidney Transplantation Outcomes (APOLLO) Network was established to address the role, if any, of ApoL1 testing in kidney transplantation. The APOLLO Network will enroll and genotype approximately 700 LD and 1600 DD while tracking outcomes for LD and recipients. All participants will have the option to receive their ApoL1 test results after enrollment ends. The APOLLO Network has the potential to increase understanding of kidney health disparities among Blacks and improve transplantation outcomes. However, the introduction of ApoL1 testing risks stigmatizing Black organ donors, reducing the number of Black LD, and worsening disparities. It also raises a series of ethical questions about clinical practices: who to test, how to use test results, and with whom to share results. We propose a 3-year ancillary R01 project that will be relevant not only to the APOLLO Network, but to future projects involving genetic testing that targets Black patients. Our team members serve on the APOLLO steering committee and community advisory council and have engaged diverse stakeholders in developing the following aims and research questions (RQ): Aim 1. Answer RQ1: Which factors influence participants' evaluation of competing ApoL1 testing clinical practices and engagement with ApoL1 test results? a. Administer a web-based survey to APOLLO participants that assesses the acceptability of competing ApoL1 clinical practices. b. Determine factors that predict APOLLO participants' attitudes toward diverse ApoL1 clinical policies, and whether participants access their ApoL1 test results. Aim 2. Answer RQ2: What are participant experiences with the return of ApoL1 testing results? a. Administer a survey to 600 participants who access their ApoL1 test results to assess comprehension of information, satisfaction or regret with testing, and intentions to use this information. b. Conduct qualitative interviews to explore the reasons behind participants' decision whether to receive ApoL1 test results, and examine the impact of these decisions on participants and family members. Aim 3. Answer RQ3: Is it feasible to use a Delphi panel process to obtain an informed consensus among diverse stakeholder groups on ApoL1 testing clinical practices? a. We will use a Delphi panel process with representation from all DD family members, DD recipients, LD, LD recipients, and transplant personnel.

项目摘要 美国黑人的终末期肾脏疾病的发生率要高于一般人群。 这种过多风险的很多但不是全部归因于Apol1基因中的变体。 APOL1长期肾脏 建立了移植结果（Apollo）网络，以解决APOL1测试的角色（如果有） 肾脏移植。阿波罗网络将注册和基因型约700 ld和1600 DD 同时跟踪LD和收件人的结果。所有参与者都可以选择接受其APOL1测试 入学后的结果结束。阿波罗网络有可能增加对肾脏的理解 黑人的健康差异并改善移植结果。但是，引入apol1 测试风险会使黑色器官捐献者污名，减少黑色LD的数量，并使差异恶化。它 还提出了一系列有关临床实践的道德问题：谁测试，如何使用测试结果以及 谁分享结果。 我们提出了一个为期3年的辅助R01项目，不仅与阿波罗网络相关，而且与未来有关 涉及针对黑人患者的基因测试的项目。我们的团队成员在阿波罗任职 指导委员会和社区咨询委员会，并聘请了多样化的利益相关者开发 以下目的和研究问题（RQ）： 目标1。答案RQ1：哪些因素会影响参与者对竞争APOL1测试临床的评估 实践和参与APOL1测试结果？ 一个。对Apollo参与者进行基于网络的调查，以评估竞争Apol1的可接受性 临床实践。 b。确定预测阿波罗参与者对各种apol1临床政策的态度的因素，以及 参与者是否访问其APOL1测试结果。 AIM 2。答案RQ2：APOL1测试结果的返回结果是什么？ 一个。对600名访问其APOL1测试结果的参与者进行调查，以评估对 测试的信息，满意或遗憾，以及使用此信息的意图。 b。进行定性访谈，以探讨参与者决定是否接收APOL1的原因 测试结果，并检查这些决策对参与者和家人的影响。 AIM 3。答案RQ3：使用Delphi面板流程获得知情的共识是否可行 APOL1测试临床实践的不同利益相关者群体？ 一个。我们将使用DD Family，DD收件人LD，LD的Delphi面板过程 接收者和移植人员。