Living Kidney Donor Outcomes
Title: Kidney Donor Outcomes Cohort (KDOC) Study
Funding: NIDDK (R01DK085185)
Study Website: http://www.kdocstudy.com/
One of the long-term goals of our research program is to characterize the surgical, medical, functional, psychological, and financial outcomes of living kidney donation. The objective of this study is to establish a multisite prospective cohort of living kidney donors, their recipients, and a healthy comparison group. This cohort will be used to assess donor outcomes and their predictors over a 2-year period initially, with the intention of continuing to assess these outcomes in subsequent years. This study will extend our considerable preliminary work by simultaneously examining outcomes that are of importance to donors, recipients, healthcare providers, and policymakers. The rationale for the research is that, once these outcomes and their predictors are known, we can further develop and refine educational strategies and informed consent processes for both living donors and their intended recipients, as well as provide systematic data to inform policy discussions and clinical care practices. To accomplish our objective, we are pursuing three specific aims:
- Prospectively assess primary and secondary outcomes of living kidney donation.
Primary outcomes of interest include surgical, medical, functional, and psychological outcomes. Our primary hypothesis is that, while living donors may experience short-term functional limitations, they are not at any increased risk of medical morbidity, functional impairment, or psychological complications at the final study endpoint (2 yrs). Secondary outcomes include donation costs (direct, indirect), satisfaction, decision stability, and miscellaneous consequences (e.g., problems getting and/or maintaining health or life insurance). Our secondary hypothesis is that living donors incur moderate non-reimbursed costs, but report very high levels of satisfaction and decision stability over time.
- Identify the donor, recipient, and center variables that are most strongly associated with living donor outcomes at the 2-year follow-up assessment.
On the basis of previous literature, we will examine variables hypothesized or shown to be predictive of key donor outcomes, including sociodemographic characteristics, donor-recipient relationship type, obesity, smoking history, isolated medical complexities, mental health history, donation knowledge, dispositional optimism, and recipient characteristics (e.g., graft function, QOL). In addition, an important question in transplantation is the impact of provider/facility-level characteristics on outcomes and potentially whether these differences exacerbate disparities in outcomes in certain patient populations. In this aim, we will also evaluate whether the primary outcomes vary significantly between the six centers based on several characteristics, including LDKT volume, ratio of LDKT to deceased donor transplants, pre-emptive LDKT volume, donor travel distance, and number of competing transplant centers within 100 miles, among other characteristics of the donor populations. Specific hypotheses, based on extant literature and clinical experience, will be developed and tested as part of this aim. One advantage of a cohort study is the ability to collect substantial amounts of data across multiple outcomes and to examine key relationships among these variables as new research findings emerge. While we can identify and anticipate some hypotheses to be addressed (e.g., donors with isolated medical complexities will be at increased risk for negative medical outcomes at the 2-year assessment, relative to those without such medical complexities.), others will be informed by new findings that have not yet been reported in the literature. Therefore, we have not established a priori hypotheses as part of this specific aim.
- Identify disparities in donor outcomes and factors that are associated with such disparities.
There are several potential disparities in living donor outcomes that have not yet been systematically examined. First, certain minorities have higher incidence of health conditions that can lead to kidney disease (e.g., hypertension, obesity, diabetes). The expansion of living donor eligibility criteria to include donors with well-controlled hypertension, obesity, or metabolic syndrome may place African Americans or Hispanic Americans at higher risk for long-term negative outcomes following donor nephrectomy, which may account in part for lower rates of living donation among minorities. Unfortunately, much of what we know about living donor outcomes is based on White donors. Second, women historically represent the majority of living donors and we know little about gender disparities in donor outcomes. Third, there is some evidence that older living donors may be at higher risk of poorer outcomes, but this also warrants further examination. Finally, the relative impact of donation on those of lower socioeconomic status is largely unknown. It is possible that those with higher indirect donation expenses and/or without health insurance may have disparate outcomes relative to those with more financial resources and health insurance. We propose to evaluate whether disparities exist along these parameters and, if so, the factors associated with them.
Rodrigue JR, Schold JD, Mandelbrot DA, Taber DJ, Phan V, Baliga P. Concern for lost income following donation deters some patients from talking to potential living donors. Prog Transplant. In press.
Rodrigue JR, Fleishman A. Health insurance trends in United States living kidney donors (2004-2015). Am J Transplant. In Press.
Hays R, Rodrigue JR, Cohen D, Danovitch G, Matas A, Schold J, LaPointe Rudow D. Financial neutrality for living organ donors: Reasoning, rationale, definitions and implementation strategies. Am J Transplant. 2016; 16:1973-81.
Tushla L, Rodrigue JR, LaPointe Rudow D, Hays R. Live donor kidney transplantation consensus conference: reducing financial barriers to live donation. J Nephrol Soc Work. 2016; 40:21-7.
Rodrigue JR, Schold JD, Morrissey J, Whiting J, Vella J, Kayler L, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA. Direct and indirect costs following living kidney donation: Findings from the KDOC study. Am J Transplant. 2016; 16:869-76.
LaPointe Rudow D*, Hays R*, Baliga P, Cohen DJ, Cooper M, Danovitch GM, Dew MA, Gordon EJ, Mandelbrot DA, McGuire S, Milton J, Moore DR, Morgieivich M, Schold JD, Segev DL, Serur D, Steiner RW, Tan JC, Waterman AD, Zavala E, Rodrigue JR*. Consensus Conference on Best Practices in Live Kidney Donation: Recommendations to optimize education, access, and care. Am J Transplant. 2015; 15:914-22. (* co-senior authors)
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Rodrigue JR, Lapointe Rudow D, Hays R. Living donor kidney transplantation: Best practices in live kidney donation – recommendations from a consensus conference. Clin J Am Soc Nephrol. 2015; 10:1656-7.
Tan JC, Gordon EJ, Dew MA, LaPointe Rudow D, Steiner RW, Woodle S, Hays R, Rodrigue JR, Segev DL. Living donor kidney transplantation: Facilitating education about live kidney donation – Recommendations from a consensus conference. Clin J Am Soc Nephrol. 2015; 10:1670-7.
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Rodrigue JR, Fleishman A, Vishnevsky T, Whiting J, Vella J, Garrison K, Moore D, Kayler L, Baliga P, Chavin K, Karp S, Mandelbrot DA. Development and validation of a questionnaire to assess fear of kidney failure following living donation. Transpl Int. 2014; 27:570-5.
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Schold JD, Goldfarb DA, Buccini LD, Rodrigue JR, Mandelbrot DA, Heaphy ELG, Fatica R, Poggio ED. Comorbidity burden and perioperative complications for living kidney donors in the United States. Clin J Am Soc Nephrol. 2013; 8:1773-82.
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Rodrigue JR, Schutzer ME, Paek M, Morrissey P. Altruistic kidney donation to a stranger: Psychosocial and functional outcomes at two U.S. centers. Transplantation. 2011; 91:772-8.