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Advocacy Follow-Up OPTN

Guest Post-Living Kidney Donor Follow-up Public Comment

OPTN Proposal to Establish Minimum Requirements for Living Donor Follow-Up
December 23, 2011

Affected Policies/bylaws: 12.8.3.1 (Reporting Requirements); OPTN Bylaws, Appendix B, Attachment I, Section XIII (Transplant Programs) D (2) Kidney Transplant Programs that Perform Living Donor Kidney Transplants

The proposed minimum requirements are based on recommendations from the Joint Society Work Group (AST, ASTS, and NATCO) to the OPTN Living Donor Committee. Where were the American Society of Nephrology, American College of Surgeons, American College of Physicians, Society of Laparoendoscopic Surgeons, American Society of Anesthesiologists, the National Institutes of Health, and independent donor advocates? The policy is not just about ‘data’ but about the care and well-being of live kidney donors. It is dangerous to assume that the only experts are transplant industry insiders. Data collection and subsequent reporting of comprehensive, meaningful, and standardized quality indicators is the only way to define our risks both short and long-term. Quality indicators must be derived not only from the transplant literature but the more comprehensive medical literature including urology (nephron-sparing surgery, risks associated with pneumoperitoneum and unique to laparoendoscopic surgery), non-transplant nephrology (reduced renal mass and cardiovascular risks), anesthesia, and equal to the quality of such standards set by the American College of Surgeons Committee on Trauma. Approximately 150,000 live kidney donors have put themselves at risk in the United States (includes those who donated prior to 1988 and foreign nationals) with no registry or data to determine complication rates or adverse events for the healthy let alone the ‘marginal or medically complex expanded criteria’ live donor. We have lost any opportunity to capture comprehensive data on these donors. Live donors are a critical part of the transplant system yet there is little evidence that valued by the transplant community. Until we have comprehensive and reliable data, transplant surgeons cannot claim that live organ donation is ‘safe’ or “minimal risk.’ Without comprehensive and reliable data, we have no assurance that our programs are providing high quality care. But then, this proposal is only about the minimum requirements. Guess we have to start somewhere.

This proposal’s background information starts in 2006. Why not earlier? In 2000, the objective of the Live Donor Consensus Conference was to recommend practice guidelines for…all those concerned about the well-being of the live kidney donor. This conference endorsed a Live Organ Donor Registry that would collect demographic, clinical, and outcome information on all living donors. The rationale included concerns for donor well-being, limitations of current knowledge regarding long-term consequences of donation, the potential to evaluate the impact of changes in criteria for donor eligibility on the outcomes of donors, and the need within the transplant community to provide for quality assurance assessments.

A systemic review of the medical literature was conducted in 2000 (Merlin, et. al) to compare the safety and efficacy of laparoscopic live donor nephrectomy with the “gold standard” of open live donor nephrectomy. The authors concluded that the evidence-base for laparoscopic nephrectomy was inadequateM to make safety and efficacy recommendations. It will take “another decade or more to be confident of the risk following laparoscopic live donor nephrectomy.” In December of 2002, Art Caplan from The Univeristy of Pennsylvania decried that the lack of a national registry to monitor the health of living donors as “a scandal.”

Leventhal and colleagues (2004) wrote that the management of complications associated with laparoscopic nephrectomy is poorly described in the literature. There is a lack of regulation and uniformity in reporting of complications related to living donation as well as an absence of a national or international registry for tracking donor outcomes. The authors believe that unique complications related to live donor nephrectomy are underreported.

Gossman and colleagues (2005) published their experience on long-term outcomes of kidney donors. Surgeons and nephrologists have long argued that as long as the fate of all renal donors was unknown, the finding of normal renal function or blood pressure of those donors who were evaluated cannot serve as proof that unilateral nephrectomy is without adverse events. At an OPTN meeting Boston (October of 2005), we learned that OPTN living donor data was ‘woefully inadequate”; maybe 25% complete. More recent data analysis primarily by the OPTN Live Donor Data Task Force again concluded that OPTN data is “woefully inadequate” and therefore, meaningless. A decade later we are still debating what data elements should be collected with no accountability or enforcement of the mandatory data submission policy per the OPTN Final Rule. Thank you for this public disclosure of OPTN member noncompliance.

Perhaps now is the time to stop talking and start collecting meaningful data. No donor should be marked ‘lost to follow-up’ when health care facilities are required to document “next-of-kin” emergency contact information. Donors should have easy online access to the data that is submitted on their behalf and thus, verify its accuracy and completeness. It is our data, our outcome, our living donation story. Even better, now is the time for donors to self-report similar to the Boston Nurses study via online standardized survey tools. I am more than capable of submitting reliable and meaningful data with minimal cost to taxpayers.

Donna Luebke

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