Rebecca Hays

Kidney Transplantation as Primary Therapy for End-Stage Renal Disease: A National Kidney Foundation/Kidney Disease Outcomes Quality Initiative (NKF/KDOQI™) Conference

BACKGROUND AND OBJECTIVES Kidney transplantation is the most desired and cost-effective modality of renal replacement therapy for patients with irreversible chronic kidney failure (end-stage renal disease, stage 5 chronic kidney disease). Despite emerging evidence that the best outcomes accrue to patients who receive a transplant early in the course of renal replacement therapy, only 2.5% of incident patients with end-stage renal disease undergo transplantation as their initial modality of treatment, a figure largely unchanged for at least a decade. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS The National Kidney Foundation convened a Kidney Disease Outcomes Quality Initiative (KDOQI) conference in Washington, DC, March 19 through 20, 2007, to examine the issue. Fifty-two participants representing transplant centers, dialysis providers, and payers were divided into three work groups to address the impact of early transplantation on the chronic kidney disease paradigm, educational needs of patients and professionals, and finances of renal replacement therapy. RESULTS Participants explored the benefits of early transplantation on costs and outcomes, identified current barriers (at multiple levels) that impede access to early transplantation, and recommended specific interventions to overcome those barriers. CONCLUSIONS With implementation of early education, referral to a transplant center coincident with creation of vascular access, timely transplant evaluation, and identification of potential living donors, early transplantation can be an option for substantially more patients with chronic kidney disease.

Consensus conference on best practices in live kidney donation: Recommendations to optimize education, access, and care

Live donor kidney transplantation is the best treatment option for most patients with late‐stage chronic kidney disease; however, the rate of living kidney donation has declined in the United States. A consensus conference was held June 5–6, 2014 to identify best practices and knowledge gaps pertaining to live donor kidney transplantation and living kidney donation. Transplant professionals, patients, and other key stakeholders discussed processes for educating transplant candidates and potential living donors about living kidney donation; efficiencies in the living donor evaluation process; disparities in living donation; and financial and systemic barriers to living donation. We summarize the consensus recommendations for best practices in these educational and clinical domains, future research priorities, and possible public policy initiatives to remove barriers to living kidney donation.

Living Donor Kidney Transplantation: Overcoming Disparities in Live Kidney Donation in the US—Recommendations from a Consensus Conference

Despite its superior outcomes relative to chronic dialysis and deceased donor kidney transplantation, live donor kidney transplantation (LDKT) is less likely to occur in minorities, older adults, and poor patients than in those who are white, younger, and have higher household income. In addition, there is considerable geographic variability in LDKT rates. Concomitantly, in recent years, the rate of living kidney donation (LKD) has stopped increasing and is declining, after decades of consistent growth. Particularly noteworthy is the decline in LKD among black, younger, male, and lower-income adults. The Live Donor Community of Practice within the American Society of Transplantation, with financial support from 10 other organizations, held a Consensus Conference on Best Practices in Live Kidney Donation in June 2014. The purpose of this meeting was to identify LKD best practices and knowledge gaps that might influence LDKT, with a focus on patient and donor education, evaluation efficiencies, disparities, and systemic barriers to LKD. In this article, we discuss trends in LDKT/LKD and emerging novel strategies for attenuating disparities, and we offer specific recommendations for future clinical practice, education, research, and policy from the Consensus Conference Workgroup focused on disparities.

Financial Neutrality for Living Organ Donors: Reasoning, Rationale, Definitions, and Implementation Strategies

In the United States, live organ donation can be a costly and burdensome undertaking for donors. While most donation‐related medical expenses are covered, many donors still face lost wages, travel expenses, incidentals, and potential for future insurability problems. Despite widespread consensus that live donors (LD) should not be responsible for the costs associated with donation, little has changed to alleviate financial burdens for LDs in the last decade. To achieve this goal, the transplant community must actively pursue strategies and policies to eliminate unreimbursed out‐of‐pocket costs to LDs. Costs should be more appropriately distributed across all stakeholders; this will also make live donation possible for people who, in the current system, cannot afford to proceed. We propose the goal of LD “financial neutrality,” offer an operational definition to include the coverage/reimbursement of all medical, travel, and lodging costs, along with lost wages, related to the act of donating an organ, and guidance for consideration of medical care coverage, and wage and other expense reimbursement. The intent of this report is to provide a foundation to inform discussion within the transplant community and to advance initiatives for policy and resource allocation.

Living Donor Kidney Transplantation: Facilitating Education about Live Kidney Donation—Recommendations from a Consensus Conference

The Best Practice in Live Kidney Donation Consensus Conference held in June of 2014 included the Best Practices in Living Donor Education Workgroup, whose charge was to identify best practice strategies in education of living donors, community outreach initiatives, commercial media, solicitation, and state registries. The workgroups goal was to identify critical content to include in living kidney donor education and best methods to deliver educational content. A detailed summary of considerations regarding educational content issues for potential living kidney donors is presented, including the consensus that was reached. Educational topics that may require updating on the basis of emerging studies on living kidney donor health outcomes are also presented. Enhancing the educational process is important for increasing living donor comprehension to optimize informed decision-making.

Living donor kidney transplantation: Improving education outside of transplant centers about live donor transplantation—recommendations from a consensus conference

Living donor kidney transplantation (LDKT) offers better quality of life and clinical outcomes, including patient survival, compared with remaining on dialysis or receiving a deceased donor kidney transplant. Although LDKT education within transplant centers for both potential recipients and living donors is very important, outreach and education to kidney patients in settings other than transplant centers and to the general public is also critical to increase access to this highly beneficial treatment. In June 2014, the American Society of Transplantations Live Donor Community of Practice, with the support of 10 additional sponsors, convened a consensus conference to determine best practices in LDKT, including a workgroup focused on developing a set of recommendations for optimizing outreach and LDKT education outside of transplant centers. Members of this workgroup performed a structured literature review, conducted teleconference meetings, and met in person at the 2-day conference. Their efforts resulted in consensus around the following recommendations. First, preemptive transplantation should be promoted through increased LDKT education by primary care physicians and community nephrologists. Second, dialysis providers should be trained to educate their own patients about LDKT and deceased donor kidney transplantation. Third, partnerships between community organizations, organ procurement organizations, religious organizations, and transplant centers should be fostered to support transplantation. Fourth, use of technology should be improved or expanded to better educate kidney patients and their support networks. Fifth, LDKT education and outreach should be improved for kidney patients in rural areas. Finally, a consensus-driven, evidence-based public message about LDKT should be developed. Discussion of the effect and potential for implementation around each recommendation is featured, particularly regarding reducing racial and socioeconomic disparities in access to LDKT. To accomplish these recommendations, the entire community of professionals and organizations serving kidney patients must work collaboratively toward ensuring accurate, comprehensive, and up-to-date LDKT education for all patients, thereby reducing barriers to LDKT access and increasing LDKT rates.

The Independent Living Donor Advocate: A Guidance Document From the American Society of Transplantation's Living Donor Community of Practice (AST LDCOP)

The independent living donor advocate (ILDA) serves a mandated and supportive role in the care of the living organ donor, yet qualifications and role requirements are not clearly defined. Guidance comes from Centers for Medicare and Medicaid Services (CMS) Conditions for Transplant Center Participation and interpretive guidelines, Organ Procurement and Transplantation Network (OPTN) Policy and CMS and OPTN site surveys, yet interpretation of regulations varies. Herein, the AST Living Donor Community of Practice (LDCOP) offers seven recommendations to clarify and optimize the ILDA role: (a) the ILDA must have a certain skill set rather than a specific profession, (b) the ILDA must be educated and demonstrate competence in core knowledge components, (c) the ILDAs primary role is to assess components of informed consent, (d) centers must develop a transparent system to define ILDA independence, (e) the ILDA should have a reporting structure outside the transplant center, (f) the ILDAs role should be integrated throughout the donor care continuum, (g) the ILDA role should include a narrow “veto power.” We address controversies in ILDA implementation, and offer pathways to maximize benefits and minimize limitations of approaches that may each meet regulatory requirements but confer different practice benefits. We propose a research agenda to explore the impact of the ILDA.

Living Donor Kidney Transplantation: Improving Efficiencies in Live Kidney Donor Evaluation–Recommendations from a Consensus Conference

The education, evaluation, and support of living donors before, during, and after donation have historically been considered the roles and responsibilities of transplant programs. Although intended to protect donors, ensure true informed consent, and prevent coercion, this structure often leaves referring nephrologists unclear about the donor process and uncertain regarding the ultimate outcome of potential donors for their patients. The aim of this article is to help the referring nephrologist understand the donor referral and evaluation process, help the referring nephrologist understand the responsibilities of the transplant program, and offer suggestions about how the referring nephrologist can help to improve efficiencies in the process of donor education and evaluation. A partnership between referring nephrologists and transplant programs is an important step in advancing living kidney donation. The referring nephrologists are the frontline providers and are in a unique position to offer education about living donation and improve efficiencies in the process. Understanding the donor referral and evaluation process, the responsibilities of the transplant program, and the potential role referring nephrologists can play in the process is critical to establishing such a partnership.

Informed Consent of Living Kidney Donors: Pitfalls and Best Practice

Informed consent is clearly considered the ethical bedrock fundamental to living organ donation, a procedure lacking medical benefits for its participants. Recent guidelines have focused on strengthening content components of living kidney donor informed consent, including Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) policies that prescribe key components, and integration of the Independent Living Donor Advocate (ILDA), as mandated by Centers for Medicare and Medicaid Services (CMS) and the OPTN/UNOS. The European Union member states’ Working Group on Living Donation provided recommendations for care standardization in the “Toolbox Living Kidney Donation,” including integration of an independent clinician advocate. However, even with these changes, studies suggest inconsistency in informed consent elements across transplant programs, and retrospective studies show that although the vast majority of living donors (LDs) reflect back positively on the experience of donation, some describe lacking complete knowledge of risks (or process) before donation. Processes to assure achievement of informed consent remain in the purview of individual transplant centers to implement and measure. Herein, methods to assess prospective LD intentionality, voluntariness, and understanding of risks/benefits are described, with promising techniques highlighted and recommendations for best practice outlined. Specific clinical challenges are addressed, including ambivalence, risk of secondary gain, and difficulty integrating understanding of risks. Finally, additional content elements are proposed to improve validity of informed consent in specific clinical circumstances.

A Case-Based Analysis of Whether Living Related Donors Listed for Transplant Share ESRD Causes with Their Recipients

BACKGROUND AND OBJECTIVES Two recent studies reported increased risk of ESRD after kidney donation. In both, the majority of ESRD was seen in those donating to a relative. Confounding this observation is that, in the absence of donation, relatives of those with ESRD are at increased risk for ESRD. Understanding the pathogenesis and risk factors for postdonation ESRD is critical for both donor selection and counseling. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We hypothesized that if familial relationship was an important consideration in pathogenesis, the donor and linked recipient would share ESRD etiology. We obtained information from the Organ Procurement and Transplantation Network (OPTN) on all living kidney donors subsequently waitlisted for a kidney transplant in the United States between January 1, 1996 and November 30, 2015, to determine (1) the donor-recipient relationship and (2) whether related donor-recipient pairs had similar causes of ESRD. RESULTS We found that a significant amount of information, potentially available at the time of listing, was not reported to the OPTN. Of 441 kidney donors listed for transplant, only 169 had information allowing determination of interval from donation to listing, and only 99 (22% of the total) had information on the donor-recipient relationship and ESRD etiology. Of the 99 donors, 87 were related to their recipient. Strikingly, of the 87, only a minority (23%) of donor-recipient pairs shared ESRD etiology. Excluding hypertension, only 8% shared etiology. CONCLUSIONS A better understanding of ESRD in donors requires complete and detailed data collection, as well as a method to capture all ESRD end points. This study highlights the absence of critical information that is urgently needed to provide a meaningful understanding of ESRD after kidney donation. We found that of living related donors listed for transplant, where both donor and recipient cause of ESRD is recorded, only a minority share ESRD etiology with their recipient.