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病发病率高于一般人群; 这种过度风险的大部分（但不是全部）归因于ApoL 1基因的变异。ApoL 1长期肾脏 建立了移植结局（APOLLO）网络，以解决ApoL 1检测在以下方面的作用（如果有的话）： 肾移植APOLLO网络将招募约700 LD和1600 DD， 同时跟踪LD和接受者的结果。所有参与者都可以选择接受ApoL 1测试 报名结束后的成绩。APOLLO网络有可能增加对肾脏的了解 黑人之间的健康差距，并改善移植结果。然而，ApoL 1的引入 测试有可能使黑人器官捐献者蒙受耻辱，减少黑人LD的数量，并加剧不平等。它 也提出了一系列关于临床实践的伦理问题：谁来测试，如何使用测试结果， 谁来分享成果。 我们提出了一个为期3年的辅助R 01项目，该项目不仅与APOLLO网络有关，而且与未来的 涉及针对黑人患者的基因检测的项目。我们的团队成员在阿波罗号上服役 指导委员会和社区咨询理事会，并让不同的利益攸关方参与制定 研究目标和研究问题（RQ）： 目标1.回答RQ 1：哪些因素影响参与者对竞争性ApoL 1检测临床评价 ApoL 1测试结果的实践和参与？ a.对APOLLO参与者进行基于网络的调查，评估竞争性ApoL 1的可接受性 临床实践。 B.确定预测APOLLO参与者对不同ApoL 1临床政策的态度的因素， 参与者是否可以访问他们的ApoL 1测试结果。 目标2.回答RQ 2：ApoL 1检测结果返回后，参与者有哪些体验？ a.对600名参与者进行调查，这些参与者访问他们的ApoL 1测试结果，以评估对 信息，对测试的满意或遗憾，以及使用这些信息的意图。 B.进行定性访谈，探讨参与者决定是否接受ApoL 1治疗的原因 测试结果，并检查这些决定对参与者和家庭成员的影响。 目标3.回答RQ 3：是否可以使用德尔菲小组程序， ApoL 1检测临床实践的不同利益相关者群体？ a.我们将使用一个德尔菲小组过程，代表所有DD家庭成员，DD接受者，LD，LD 接受者和移植人员。