Faculty Bibliography

In the setting of an overall decline in living organ donation and new questions about long-term safety, a better understanding of outcomes after living donation has become imperative. Adequate information on outcomes important to donors may take many years to ascertain and may be evident only by comparing large numbers of donors with suitable controls. Previous studies have been unable to fully answer critical questions, primarily due to lack of appropriate controls, inadequate sample size, and/or follow-up duration that is too short to allow detection of important risks attributable to donation. The Organ Procurement and Transplantation Network does not follow donors long term and has no prospective control group with which to compare postdonation outcomes. There is a need to establish a national living donor registry and to prospectively follow donors over their lifetimes. In addition, there is a need to better understand the reasons many potential donors who volunteer to donate do not donate and whether the reasons are justified. Therefore, the US Health Resources and Services Administration asked the Scientific Registry of Transplant Recipients to establish a national registry to address these important questions. Here, we discuss the efforts, challenges, and opportunities inherent in establishing the Living Donor Collective.

In 2013, the Organ Procurement and Transplantation Network (OPTN)/ United Network for Organ Sharing (UNOS) mandated that transplant centers collect data on living kidney donors (LKDs) at 6 months, 1 year, and 2 years postdonation, with policy-defined thresholds for the proportion of complete living donor follow-up (LDF) data submitted in a timely manner (60 days before or after the expected visit date). While mandated, it was unclear how centers across the country would perform in meeting thresholds, given potential donor and center-level challenges of LDF. To better understand the impact of this policy, we studied Scientific Registry of Transplant Recipients data for 31,615 LKDs between January 2010 and June 2015, comparing proportions of complete and timely LDF form submissions before and after policy implementation. We also used multilevel logistic regression to assess donor- and center-level characteristics associated with complete and timely LDF submissions. Complete and timely 2-year LDF increased from 33% prepolicy (January 2010 through January 2013) to 54% postpolicy (February 2013 through June 2015) (p < 0.001). In an adjusted model, the odds of 2-year LDF increased by 22% per year prepolicy (p < 0.001) and 23% per year postpolicy (p < 0.001). Despite these annual increases in LDF, only 43% (87/202) of centers met the OPTN/UNOS-required 6-month, 1-year, and 2-year LDF thresholds for LKDs who donated in 2013. These findings motivate further evaluation of LDF barriers and the optimal approaches to capturing outcomes after living donation.

As the organ shortage continues to grow, the creation of social media communities by transplant hospitals and the public is rapidly expanding to increase the number of living donors. Social media communities are arranged in myriad ways and without standardization, raising concerns about transplant candidates' and potential donors' autonomy and quality of care. Social media communities magnify and modify extant ethical issues in deceased and living donation related to privacy, confidentiality, professionalism, and informed consent, and increase the potential for undue influence and coercion for potential donors and transplant candidates. Currently, no national ethical guidelines have been developed in the United States regarding the use of social media to foster organ transplantation. We provide an ethical framework to guide transplant stakeholders in using social media for public and patient communication about transplantation and living donation, and offer recommendations for transplant clinical practice and future research.

From its infancy, live donor transplantation has operated within a framework of acceptable risk to donors. Such a framework presumes that risks of living donation are experienced by the donor while all benefits are realized by the recipient, creating an inequitable distribution that demands minimization of donor risk. We suggest that this risk-tolerance framework ignores tangible benefits to the donor. A previously proposed framework more fully considers potential benefits to the donor and argues that risks and benefits must be balanced. We expand on this approach, and posit that donors sharing a household with and/or caring for a potential transplant patient may realize tangible benefits that are absent in a more distantly related donation (e.g. cousin, nondirected). We term these donors, whose well-being is closely tied to their recipient, "interdependent donors." A flexible risk-benefit model that combines risk assessment with benefits to interdependent donors will contribute to donor evaluation and selection that more accurately reflects what is at stake for donors. In so doing, a risk-benefit framework may allow some donors to accept greater risk in donation decisions.

Studies have estimated the average risk of postdonation ESRD for living kidney donors in the United States, but personalized estimation on the basis of donor characteristics remains unavailable. We studied 133,824 living kidney donors from 1987 to 2015, as reported to the Organ Procurement and Transplantation Network, with ESRD ascertainment via Centers for Medicare and Medicaid Services linkage, using Cox regression with late entries. Black race (hazard ratio [HR], 2.96; 95% confidence interval [95% CI], 2.25 to 3.89; P<0.001) and male sex (HR, 1.88; 95% CI, 1.50 to 2.35; P<0.001) was associated with higher risk of ESRD in donors. Among nonblack donors, older age was associated with greater risk (HR per 10 years, 1.40; 95% CI, 1.23 to 1.59; P<0.001). Among black donors, older age was not significantly associated with risk (HR, 0.88; 95% CI, 0.72 to 1.09; P=0.3). Greater body mass index was associated with higher risk (HR per 5 kg/m², 1.61; 95% CI, 1.29 to 2.00; P<0.001). Donors who had a first-degree biological relationship to the recipient had increased risk (HR, 1.70; 95% CI, 1.24 to 2.34; P<0.01). C-statistic of the model was 0.71. Predicted 20-year risk of ESRD for the median donor was only 34 cases per 10,000 donors, but 1% of donors had predicted risk exceeding 256 cases per 10,000 donors. Risk estimation is critical for appropriate informed consent and varies substantially across living kidney donors. Greater permissiveness may be warranted in older black candidate donors; young black candidates should be evaluated carefully.

BACKGROUND:Annual visits with a primary care provider (PCP) are recommended for living kidney donors to monitor long-term health postdonation, yet adherence to this recommendation is unknown. METHODS:We surveyed 1170 living donors from our center from 1970 to 2012 to ascertain frequency of PCP visits pre- and postdonation. Interviews occurred median (IQR) 6.6 (3.8-11.0) years post-transplant. We used multivariate logistic regression to examine associations between donor characteristics and PCP visit frequency. RESULTS:, P=.001). CONCLUSIONS:The importance of annual PCP visits should be emphasized to all living donors, especially those with less education, men (particularly single men), and donors who did not see their PCP annually before donation.

About 6,000 individuals participate in the U.S. transplant system as a living organ donor each year. Organ donation (most commonly a kidney or part of liver) by living individuals is a unique procedure, where healthy patients undergo a major surgical operation without any direct functional benefit to themselves. In this article, the authors explore how the ideal of informed consent guides education and evaluation for living organ donation. The authors posit that informed consent for living organ donation is a process. Though the steps in this process are partially standardized through national health policy, they can be improved through institutional structures at the local, transplant center-level. Effective structures and practices aimed at supporting and promoting comprehensive informed consent provide more opportunities for candidates to ask questions about the risks and benefits of living donation and to opt out voluntarily Additionally, these practices could enable new ways of measuring knowledge and improving the consent process.