A Quality Systems Perspective on Sensitization and Kidney Allocation System Changes

Laurel Damashek is the Executive Director of the International Society of Glomerular Disease and a member of the NephCure Board of Directors. She is on the organizing committee of the Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis Project, which is cosponsored by the International Society of Glomerular Disease, NephCure, the Kidney Health Initiative, and the National Kidney Foundation.

Reading “Calibration of Priority Points for Sensitization Status of Kidney Transplant Candidates in the United States” was intriguing from several angles.¹ I am a kidney transplant recipient myself because of FSGS. In fact, I was delighted to realize my case falls within the period of the Scientific Registry of Transplant Recipients dataset analyzed in this study! Professionally, my role is devoted to supporting scientific understanding and improved clinical outcomes of glomerular disease. In addition, much of my previous career was engaged in designing and improving risk management and quality systems.

First, I appreciate the tremendous effort of the Organ Procurement and Transplantation Network workgroup that originally devised and implemented changes to the kidney allocation system in 2014 with the goal of decreasing inequities in transplant access for highly sensitized candidates and also applaud Schold et al. for conducting their thought-provoking analysis. It is almost a cliché that changes to complex systems may result in surprising results and unintended consequences (cue butterfly wing flapping). Crucially, this study closes the loop between the intention that the kidney allocation system changes were engineered to support and their results in practice, demonstrating that the revised algorithms may have overshot the goal with the result of unfairly privileging highly sensitized individuals.

This highlights the critical importance of building feedback mechanisms into risky elements within a system, especially when the system itself is being changed. One of the basic tenets of quality systems is “do it/check it”: In other words, confirming that each effort within a complex process achieved its goal. While I am excited about the insights from this study, it prompts me to ask whether such quality control and surveillance could be conducted on a regular basis after protocol changes—perhaps biennially instead of a decade, as was done here.

As the kidney community (myself included!) works on other projects intended to improve aspects of complex systems, this makes me think that we should plan from the outset to measure actual versus intended effects, even after project completion. We should also remain open to acknowledging unintended consequences and devising mitigations, with an approach of continuous improvement. I hope that the novel techniques mentioned (for instance, ABO-adjusted calculated panel reactive antibody and genetic metrics) will be one effective strategy for refining the allocation system by identifying and matching particular subsets of highly sensitized candidates.

I was also struck by the large-scale portrait of transplant candidates dealing with high levels of sensitization. The authors observe that young, previously transplanted, Black, and/or female individuals are particularly affected. I would be fascinated to see further research into the underlying factors among the previously transplanted cohort, including age of onset of disease, cause of graft failure, recurrence of primary disease, and so on. Because many glomerular diseases, such as FSGS, minimal change disease, IgA nephropathy, and complement-associated conditions, can recur after transplant, unfortunately I have talked with many people who have received a transplant only to see disease continuance or recurrence lead to loss of kidney function once again. It is a tragedy for everyone when this happens: the recipient and their loved ones, the donor and donor family, and the medical team. Dealing with the additional hurdle of sensitization from the previous transplant adds insult to injury.

I am hopeful, however, that the recent research advances and impressive number of clinical trials in progress for disease-specific therapies will enable many more people to live with functioning native kidneys for longer and perhaps avoid reaching ESKD altogether. The Scientific Registry of Transplant Recipients dataset in this study reiterates the story that even the most advantaged transplant candidates are waiting years on average in the terrible twilight zone of kidney failure and dialysis before receiving a transplant (which of course comes with its own host of risks and limitations). Cross-stakeholder efforts, such as the work by the Kidney Health Initiative to establish surrogate end points in IgA nephropathy or the Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis Project to achieve a similar goal for FSGS, are promising upstream approaches that ultimately benefit these patients.

To borrow a metaphor from the maritime world, if the kidneys are a ship, at this point in history, we are a little better off than the Titanic: We have passable life vests available in the form of dialysis and seaworthy lifeboats of transplantation for some of the passengers. My hope is that while we continue to significantly improve each of these technologies and the systems surrounding them, we are also moving toward an era of keeping many more ships afloat.

Disclosures

Disclosure forms, as provided by each author, are available with the online version of the article at http://links.lww.com/CJN/B882.

Funding

None.

Author Contributions

Writing – original draft: Laurel Damashek.