Development of a Robust Strategy for Living Kidney Donor Follow-up and Engagement

项目摘要：为活体捐赠者的后续行动和参与制定强有力的战略 美国有超过15万名活体肾脏捐赠者，而且新捐赠者的数量每年都在增加。 了解捐献的风险和后遗症是扩大活体供肾的实际要求 移植以及支持知情同意和尊重利他行为的伦理要求。这 需要收集捐赠者的细粒度后续数据，并与健康的非捐赠者进行比较。到目前为止， 国家在肾脏捐赠者后续行动和长期参与方面的努力都失败了。作为一个活的肾脏 捐赠者本人，我深切地意识到捐献后监测的严重和系统性的失误 无论是在捐助者一级还是在卫生系统一级。2013年，一项国家政策要求移植中心召开会议 实施了活体捐赠者随访标准，但事实证明，这项政策几乎不可能 移植中心，只有不到50%的人成功地满足了要求。 继续与移植中心接触不仅可以更好地科学地了解 捐献的含义，但也允许仔细监测捐赠者以确定早期生理变化 (如高血压)，并在这些成为主要不良后果之前进行干预。此外，一个适当的 健康的非捐献者队列从未被成功捕获和研究。为了改善正在进行的这种情况 失败，2017年，我们在10个肾移植中心启动了活体捐赠者集体(LDC)试点， 通过移植受者科学登记处(SRTR)进行集中。 为了努力以系统、科学的方式改进活体捐赠者的后续行动，可以传播到 在全国范围内，我们将迈出重要的第一步，评估10个试点如何移植 中心和SRTR实施了最不发达国家，并使用这些信息来规划这一重要的 努力吧。由于只有10个中心参与了试点，在美国273个移植中心中，至关重要的是 了解移植中心的各种特性对实施的障碍。指导原则 实施科学框架和混合方法方法，我们的目标是：(1)了解最不发达国家 在试点中心和SRTR之间实施，(2)进行形成性评估和评估移植 中心准备情况和参与全美最不发达国家的能力，以及(3)创建实施 完善和扩大最不发达国家的战略。 本研究将提供对实施挑战、成功和失败的全面了解 对活体捐献者进行跟踪的集中计划。这为美国所有的移植中心提供了基础 参与，解决历史上无法解决的和令人尴尬的卫生系统挑战，并且是必要的 准备未来的R01，以便在全国范围内制定和实施集中的活体捐赠者后续行动。

Project Summary: Developing a Robust Strategy for Living Donor Follow-up and Engagement There are more than 150,00 living kidney donors in the US, and the number of new donors is increasing yearly. Understanding the risks and sequelae of donation is a practical requirement for expanding live donor kidney transplantation and an ethical requirement for supporting informed consent and honoring an altruistic act. This requires the collection of granular follow-up data in donors, and a comparison to healthy non-donors. To date, national efforts at kidney donor follow-up and long-term engagement have failed. As a living kidney donor myself, I am intimately aware of the profound and systemic failures in post-donation surveillance from both the donor-level and the health system-level. In 2013 a national policy mandating transplant centers meet standards for living donor follow-up was implemented, yet this policy has proven nearly impossible for transplant centers, with fewer than 50% successful in meeting the mandate. Continued engagement with transplant centers not only allows a better scientific understanding of the implications of donation, but also allows careful surveillance of donors to identify early physiologic changes (such as hypertension) and intervene before these become major adverse outcomes. Furthermore, a proper healthy non-donor cohort has never been successfully captured and studied. To improve this ongoing failure, in 2017 we launched a pilot Living Donor Collective (LDC) at 10 kidney transplant centers, centralized though the Scientific Registry of Transplant Recipients (SRTR). In an effort to improve living donor follow-up in a systematic, scientific manner that can be disseminated to centers across the country, we will take the important first steps of evaluating how the 10 pilot transplant centers and the SRTR implemented the LDC and use this information to plan the next iteration of this important endeavor. Since only 10 centers participated in the pilot, out of 273 transplant centers in the US, it is critical to understand barriers to implementation across a wide spectrum of transplant center characteristics. Guided by an implementation science framework and a mixed methods approach, we aim: (1) to understand LDC implementation among pilot centers and SRTR, (2) conduct a formative evaluation and assess transplant center readiness and capacity for participation in the LDC across the US, and (3) create an implementation strategy to refine and expand the LDC. This study will provide a comprehensive understanding of implementation challenges, successes, and failures of a centralized program for living donor follow-up. This provides the foundation for all U.S. transplant centers to participate, solves a historically unsolvable and embarrassing health system challenge, and is necessary to prepare a future R01 to develop and implement centralized living donor follow-up nationally.