Better Data on Living Donor Risks Improves Consent

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A growing understanding of the health and psychosocial risks associated with being a living kidney donor is helping drive innovations that will improve the informed consent process, according to recent research.

Receiving a kidney donated by a living donor greatly improves the outcomes of patients with kidney failure. But it also creates risks for the 30,000 otherwise healthy donors around the world who donate kidneys each year. Ensuring that living donors give proper informed consent is essential. Now, a growing body of evidence on the risks associated with living kidney donation and emerging tools to help clinicians and patients assess them are helping to improve the process of informed consent.

“Our ability to walk donors through informed consent has exponentially improved,” said Robert S. Gaston, MD, director of the Comprehensive Transplantation Institute at the University of Alabama-Birmingham. “I think we will be able to plug [information] into a calculator really soon and give an absolute risk.” Gaston spoke at a Kidney Week 2016 symposium.

Modeling risk

Scientists have created models that can help clinicians assess the risks faced by an individual donor based on several demographic and health characteristics (Grams ME, et al. N Engl J Med 2016; 374:411–421). Living donors have about a 3.5- to 5.3-fold higher risk of kidney failure than comparable individuals in the US population, said Robert Foley, MD, associate professor of medicine in the division of renal diseases at the University of Minnesota. Fagan noted that the absolute risks of end stage renal disease (ESRD) are still low.

Among the factors that increase the risk of living donors developing ESRD are the development of post-donation diabetes or hypertension, which boost the risk of proteinuria fourfold and the risk of ESRD by more than twofold, respectively (Ibrahim HN, et al. J Am Soc Nephrol 2016; 27:2885–2893).

Even then, predonation factors can help identify individuals at greatest risk.

“What I’d really like to get to is a clinical model that would help donors,” Foley said. Ideally, he said such a tool would be very simple and use a spreadsheet program or graphs to explain individual risks and how they might be managed, for example, by keeping blood pressure within the normal range or making lifestyle choices to minimize the risk of diabetes posttransplant.

Pregnancy risks

Emerging data also suggest that women who have donated a kidney may have worse pregnancy outcomes.

Women who donate a kidney have an elevated risk of gestational hypertension compared with those who have never donated a kidney (OR 2.4; 95% confidence interval, 1.2 to 5.0; p=0.01) (Garg AX, et al. N Engl J Med 2015; 372:124–133).

Another study that compared donors’ pre- and postdonation pregnancies found a higher risk of preterm delivery, fetal loss, gestational diabetes, hypertension, proteinuria, and preeclampsia postdonation (Ibrahim HN, et al. Am J Transplant 2009; 9:825–834).

The absolute risks of these outcomes are low, and generally on par with or lower than the risk of this outcome in the general population because donors are healthier than the general population, said Mirna Boumitri, MD, an assistant professor of medicine in the division of renal diseases at the University of Minnesota. Still, “women should be counseled about postdonation risks to pregnancy,” Boumitri said.

Paying to donate

Living kidney donors may also face financial or psychosocial consequences of their decision to donate. But better and more consistent screening can help identify donors at risk.

Cheryl Jacobs, MSW, a clinical transplant social worker at the University of Minnesota Medical Center, said her institution has taken steps to ensure that donors are properly screened. They also use a donor advocate who is not involved in the donor’s medical care, which is now required by the Centers for Medicare & Medicaid Services.

“We really wanted to make sure we did things consistently,” she said.

Many donors report unchanged or even improved quality of life and other psychosocial function after donating a kidney (Clemens KK, et al. Am J Transplant 2006; 6:2965–2977). But a small number may face poor psychosocial outcomes, Jacobs noted.

A number of factors, including having good family or other support, viewing the donation process positively, having a higher level of education, and greater comfort with the decision to donate, all appear to protect against poor outcomes, Jacobs said. But other factors, including having poor mental health, limited support, a longer recovery, or financial hardships related to the donation, may lead to poorer outcomes.

Many donors report lost income, dependent care costs, as well as travel and health care costs related to their donation. One study found that 89% of donors suffered a financial loss during the first year after donation, with one-third reporting a loss of more than $2500 (Rodrigue JR, et al. Am J Transplant 2016; 16:869–876)

“Donors are paying to donate,” Jacobs said.

Donors may also have a harder time accessing health or life insurance, Jacobs said. Some programs have been created to help neutralize the costs to donors. For example, travel grants may be available for some donors. Additionally, the US Living Donor Protection Act, which would prevent insurers from punishing donors, was introduced recently.

“We owe it to donors to advocate where there are gaps,” Jacobs said.