In January 2023, the US Organ Procurement & Transplantation Network (OPTN) required transplant centers to modify transplant list wait times for Black patients. JAMA Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, and L. Ebony Boulware, MD, MPH, Dinushika Mohottige, MD, MPH, and Tanjala S. Purnell, PhD, MPH, discuss why the OPTN mandate is a valuable model for reforming race-based practices.
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[Kirsten Bibbins-Domingo:] Hello and welcome to this JAMA author interview. I'm Dr. Kirsten Bibbins-Domingo, and I'm the editor-in-chief of JAMA, and the JAMA Network. On February 27th, 2023, JAMA published a viewpoint entitled 'Redressing the Harms of Race-Based Kidney Function Estimation'. This viewpoint examines the recent decision of the US Organ Procurement and Transplantation Network, or OPTN, to require transplant centers to modify the kidney transplant wait times for black patients who might have been adversely affected by the race-based approach to the estimation of glomerular filtration rate. I'm joined today by all three authors of this viewpoint. Dr. Dinushika Mohottige is a nephrologist and faculty member in the Icahn School of Medicine at Mount Sinai University in New York. Dr. Tanjala Purnell is an epidemiologist and faculty member in the Bloomberg School of Public Health at Johns Hopkins University in Maryland. And Dr. Ebony Boulware is a general internist, and the Dean of the Wake Forest University's School of Medicine in North Carolina. Welcome, and thank you so much to all three of you for joining us today.
[Tanjala S. Purnell:] Thank you.
[Dinushika Mohottige:] Thank you.
[L. Ebony Boulware:] Thank you so much for having us.
[Kirsten Bibbins-Domingo:] I want to first begin by setting the stage for this big decision. This weaves together two important pieces which relate to the disparities that we see in kidney disease, and particularly in kidney disease transplant, and then what we've been doing for years, which is using race in our estimation of how the kidney is functioning. And so I want to set the stage because those two are important to understand about what this decision actually means. Dr. Purnell, maybe you can start by giving us a sense of what are the disparities we're talking about, and specifically as they relate to kidney transplant Wait times?
[Tanjala S. Purnell:] Absolutely. It's an honor to be here, and to talk about this very important topic, in particular the stark disparities in the burden of kidney failure, and in access to what we know to be the optimal treatment for many patients living with kidney failure, which is a transplantation. And so really when we think about where these disparities really lie, first we have to begin thinking about who's at risk of developing kidney failure, and unfortunately we know that people who identify as black Americans are much more likely than those who identify as white Americans to be diagnosed with kidney failure. Once diagnosed, we know that, unfortunately, despite the much larger burden of the disease, black Americans are also, and just black people in general who are being treated here in the United States, and labeled as such in our national registries, we know that they're less likely to see a nephrologist before having to begin permanent treatment for kidney failure. So usually prior to chronic dialysis treatment. We also know that in terms of thinking about well, who ultimately goes on to receive a transplant, often one of the biggest barriers is a referral to a transplant center in a timely manner. And that necessarily also would require a conversation often about transplant, as a treatment option and an assessment of whether or not this is what is in the best interest of this patient, and whether or not the patient might be potentially suitable. Once that happens, we then know that there's yet another disparity in terms of the people who start on day one, and actually try to get through the evaluation process for a transplant. And so, I remember years ago, wondering why there was such a high dropoff rate in terms of why so many people who start on day one never make it through that process. And one of the things that I learned is that it really is a process that often takes weeks or even months to complete. And, unfortunately, there are disparities in terms of who ultimately makes it through to the end to ultimately be wait listed, or to receive a transplant from a living donor. And then, finally, well actually it's not finally, second to last in terms of who gets the transplant, their disparities, and then ultimately what happens post-transplant for both patients and living donors. We see this at every single stage of the process.
[Kirsten Bibbins-Domingo:] So you're describing a very long process where at each stage there can be delays in recognition, in diagnosis, in getting onto a list. You described a long process, that's the long process to even getting onto the list. Is that correct?
[Tanjala S. Purnell:] Absolutely. And what we've really found is that getting onto the list is really the big hurdle. That's the mountain really, in a lot of ways. And often when we think about, well, why are we continuing to experience these disparities and what can we do about it often from a policy standpoint, et cetera, we often immediately go to, well, for the people who are already on the waiting list. But there are very few times when we've actually tried to tackle from a policy and systemic level, what happens and what can we do, to really try to redress some of the inequities in terms of who gets on that waiting list in the first place, because that's where many of the barriers lie.
[Kirsten Bibbins-Domingo:] So let's focus now to this process of getting onto the wait list, because that's a big point. We know that. So you've described a big problem, many parts in this process where there are disparities, but we're focused now on getting onto the list, right. And here's where the other part of the story is, what things get you onto that list. And Dr. Mohottige, you're a nephrologist, you tell us about this other story that has been developing, which really has to do with how we understand a patient's kidney function and what we have historically used to understand a patient's kidney function.
[Dinushika Mohottige:] Thank you. Yes. So I think one of the most monumental shifts in medicine has actually been the kidney community, and the general medical community's deliberation around the use of race-based kidney function estimating equations. And the reason this is so important is because estimated glomerular filtration is one of the key mechanisms that is used to not only surveil for kidney disease, but to determine the severity of kidney disease. However, historic race inclusive or race-based kidney function estimations previously incorporated a black race coefficient, which increased the estimated kidney function of black individuals by anywhere between 16 to 21%. Clearly this had significant implications across several domains, including delaying potential referral for transplant consideration, and more specifically in delaying transplant wait listing and the accrual of time on the wait list. And I think the key point here is, in terms of wait list time for individuals who are not on dialysis, that estimated glomerular filtration value had to be less than or equal to 20 mills per minute to start accruing that time. So this new policy decision is really pivotal, and it started with the foundation of the American Society of Nephrology and National Kidney Foundation Task Force unified recommendation that the race free equations that were developed, specifically CKD-EPI 2021, creatinine based equations that do not include the black race coefficient, be implemented throughout all laboratories. And I think the second kind of foundational piece of what happened in terms of the OPTN policy was their decision on July 27th 2022, to essentially mandate that all transplant centers use that race neutral EGFR equation to estimate candidate's kidney function.
[Kirsten Bibbins-Domingo:] That is fantastic. I want to make sure that we get up to speed. The race coefficient that I know all clinicians will know was a part of the estimating equation that was used very widely, that it essentially would make a patient I was treating, their kidney function would appear better than it actually was with this particular coefficient in it, and it would incorrectly do this, right? We're not talking about oh, that it would incorrectly do this. And this was recognized that the way we conducted the studies, that there were a lot of assumptions built in that resulted in sort of biased estimations, that in fact were biased and disadvantaged then black patients, in terms of the pivotal indication to say, well you've reached that point that we're ready to list you for transplant. Is that a fair summary?
[Dinushika Mohottige:] Exactly right. So this idea that race somehow conferred some difference in muscle mass or some difference in creatinine and therefore that should be used as a coefficient to sort of adjust the estimating equation was found to be problematic, and therefore adjusted. It not only was based in sort of bias, but also again did create harms across these various outcomes in terms of surveillance, in terms of referral, in terms of accumulating wait time, because it overestimated kidney for a very specific population.
[Kirsten Bibbins-Domingo:] Fantastic. And this was a big deal within the kidney community to actually say that there was a lot of science that got us to this point, that science is biased and is not the correct way, and in fact resulted in harms for black patients, and that these estimating equations that no longer have a race coefficient is the way to go. So we have a set of disparities, we have an important contributor that those of us in science and medicine have contributed to, that leads to a bias in this decision that adversely affects a particular group of patients, and that underlies this decision. So tell us then a little bit more about what exactly was decided by this group and the governing body I guess, for the way transplants are procured and then ultimately allocated. [Dinushika Mohottige:] Sure, sure. So again, the first step in the OPTN decision was really again the mandating of transplant centers using the race neutral EGFR equation to estimate kidney function function. So that was July 2022. But then the OPTN Minority Affairs Committee and the Kidney Transplantation Committee specifically proposed this pathway to modify the wait time for black kidney candidates who had been disadvantaged by the prior use of race inclusive calculations. So this was really fundamental. I think it highlights two concepts. First is this transparency and truth telling. So it named the harm of the equation that was incurred specifically by black and African-American individuals, due to that race-based equation. It then secondly mandated that essentially transplant centers will go back and identify individuals who are black or African American, who were impacted by those race based calculations, and then identify the amount of wait time that they could have gotten back, again, if that race free neutral race free or race neutral calculation had been used instead. So it's sort of a multi step policy. And, again, I think one important piece to highlight is, that every single transplant center is being required to notify all kidney candidates that are registered at that center about this policy. And then as well, they are being required to basically communicate whether they are eligible for this wait list time modification based on documentation. So it's requiring quite a bit of review. It is requiring very transparent communication and then it is requiring submission of that back listed time back to OPTN.
[Kirsten Bibbins-Domingo:] Wow, okay. We've now adopted this new equation that doesn't have this race coefficient in it that's required now of all centers. There's an active notification part that accompanies this, and all centers have to do it. And then there is the sort of trying to address the inequity by actually giving back time, that if we had used the right equation initially, to give them back that lost time. And does that for me then as a primary care doctor, do I see that as my patient moving up on a transplant list?
[Dinushika Mohottige:] Yes, absolutely. And I really appreciate the way you made that point, because I think this is something that everybody should know about, not just Nephrologists, not just transplant centers, but primary care physicians as well. This is an important opportunity to empower patients with that information that this is something that is happening, and they might be impacted. Perhaps they had an EGFR that was calculated with the race based equation that a primary care physician collected, and that's not exactly in the transplant center records. So this is an important opportunity, even for primary care physicians perhaps, to have that conversation to identify that record and to empower a patient with that recorded race-based estimation to say, hey, you can go back to the transplant center, provide this data, and now we can get this wait list time back potentially.
[Kirsten Bibbins-Domingo:] Oh, wonderful. Dr. Boulware, I want to bring you into this conversation. You are a longtime researcher of kidney disease, and documenting many ways in which these disparities exist, interventions to overcome. Help us put in context this particular decision done in this way.
[L. Ebony Boulware:] Well, first, I just want to back up and say that I think this entire picture that's been painted demonstrates the harms of race-based medicine. Putting a coefficient in an equation to estimate kidney function not only harmed individuals, black individuals, explicitly and exclusively their capabilities to receive appropriate preventive treatments, because the prevention guidelines are hinge on the estimated marital filtration rate. But also the rates at which folks, again, as Dr. Purnell said, would get referred to Nephrologists, receive treatments based on their kidney function, and even their waiting time or for their transplant eligibility and then further their waiting time. So not only is it just the harm of having your kidney function being misappropriated or misestimated, also all the downstream effects of this. So the one thing actually leads to a cascade of harms to black individuals.
[Kirsten Bibbins-Domingo:] Yeah, thanks for making that point. I don't mean to interrupt you, but thanks for making that point, because I think we focused on the listing for transplant, but that the harm associated with the race-based estimating equation pertains to all of the steps that Dr. Purnell outlined so nicely at the beginning.
[L. Ebony Boulware:] Exactly. And then in the case of the transplantation, I think there was an estimate of about 1.7 years on average that wait list time was affected, which is significant for an individual to have to wait more than a year longer potentially to get a transplant. So that's a significant harm. I think the thing that really stands out to me about this policy decision is that, as far as I'm aware, this is one of the first times that there have been efforts to actually redress the harms of race-based medicine. So we've had a lot of discussion throughout medicine of the need to really examine our race-based medicine practices. And there are many opportunities to examine that, not only in kidney function, but also with pulmonary function estimation, looking at deliveries after C-section, looking at cancer risk estimators, where race-based medicine is currently being practiced. So there's those many opportunities. But once we even begin to identify these and expose them, we need to do something to address the harms. And so this is one of the first times to really redress the harm done to people who are living today, who have experienced this harm, and to really try to restore what they've lost if that can be done at least in some effort. So this process of first identifying the problem as Dr. Mohottige said, then exposing it and making it transparent and visible to the people who were harmed, and then offering a solution or some sort of way of redressing that, is one of the first times, and I think it provides a model for all of American medicine on how to deal with this problem.
[Kirsten Bibbins-Domingo:] I am always concerned when our conversations about health equity focus rightly on the multiple contributors to the inequities we see, but miss the opportunity to see the specific ways in which the way we conduct medicine, the way we conduct our science have contributed. And this is such a nice example of both a very real way where something that we've used in medicine for so long was clearly a contributor, and that the way to redress it is clearly built into these sets of decisions. So I think it's really an important piece.
[L. Ebony Boulware:] And just to build a little bit about that, and we talk a lot about historically marginalized and particularly black individuals mistrust of the healthcare system, and this is an example of why this is often well justified mistrust, because people put their lives in our hands and they expect to be treated equitably, and yet there are practices that we have that result in inequity. I think what's great about this, though, is that the process of restorative justice where we expose it, we claim this, and then we come up, we get input from those who are harmed, and then we develop solutions that they're aware of. And in part of developing, which was a case with this policy, is one way that we might begin to gain the trust of the public again, in particular these historically marginalized individuals who have good reason for a number of different in our history of medicine. And I think as you mentioned, really how we as a medical and scientific profession take that on as our responsibility to redress that harm. One other thing I just want to mention is that with this policy, as I think Dr. Mohottige was mentioning, was that every single transplant center will have to go back and tell the individuals on the list that this has occurred. But what's interesting is that every transplant center maintains their list in their own ways, and so they'll be coming up with their own strategies to how to do this. And so it'll be very important as this process unfolds, to learn what are the best practices about how to inform people about this and ensure they know or that their primary care physicians know, whoever needs to know, that their weightless time should be adjusted or has changed. I think that's an opportunity for us to learn further as this unfolds.
[Kirsten Bibbins-Domingo:] So will there be ways that this is monitored then over time to see how it's happening, to ensure that all the centers do it in a reasonable way?
[L. Ebony Boulware:] I haven't seen that explicitly mentioned in the policy yet, so we're looking for that kind of a monitoring. It would be very important to do. If the policy has teeth, it will have to be monitored and there's have to be some accountability for it.
[Kirsten Bibbins-Domingo:] And any sense how this policy has been received up to now?
[Dinushika Mohottige:] I think one of the important things that OPTN did was, as it does with new policies, provide a period of time for open input. And so this was a really important opportunity for our kidney care organizations to come together with some unified proposal. And I know Dr. Purnell and I both sit on the National Kidney Foundation Transplant Advisory Committee, which put together a comment on this proposal, and how important it is as a restorative sort of policy and practice. There was a lot of input from impacted community members and as Dr. Boulware just pointed out as well, I think that's the key source of sort of truth and that should be driving these policy changes. I think that made this fundamental. It's not what ivory tower researchers and other folks think is what people who are living with kidney disease, black people living with kidney disease in the United States have had to experience and endure, their voices being heard and how this harm can be rectified. And that taking into account of that critical voice as the focus of the effort, I think that is so essential. And frankly, even if there are challenges perhaps in terms of the implementation, administrative and otherwise, I think the fact that those voices were centered in this process is what makes it so spectacular, and such an important example for policy makers, for organizations and institutions.
[Kirsten Bibbins-Domingo:] The equitable processes itself, a part of the act of redressing this wrong that's done. So the disparities we have in the US are so great, and there are still very clear examples where things that we have done historically continue to do in medical clinical practice, contribute to those disparities. Are we optimistic that this momentum and the way in which the kidney community and those who research do this have shifted, are we optimistic that this will be a model for other aspects of medicine that have this challenge?
[L. Ebony Boulware:] I might say I'm cautiously optimistic. I think this is a great example of how this can unfold, but it was not without significant effort on the part of many throughout the country and internationally to really draw attention to this, and really push on this, and for advocacy organizations to continue to think about how do we address this, how do we recognize the downstream harms? So this has to be a continuous effort. It has to be an ongoing dialogue, that in an ongoing process to really examine our practices throughout medicine over time. I'm optimistic that if we're able to keep that going, that we can see some change.
[Tanjala S. Purnell:] I'm also really encouraged by the fact that this is one of the few times that we've actually had a mandate that backs up health equity advocates, in a way that really prioritizes the changes that we've been sort of saying, this needs to happen, or if we change this or if we fix this, this is the potential impact. I am thinking back to even when the task force made the recommendations to use race neutral calculators, and the first thing that many members of the committee that I chaired as part of the American Society of Transplant Surgeons said was, we are in full support. We're taking this back to our institutions. Before that task force recommendation came out, there was pushback at the individual level. The recommendation came out, and that at least gave them something to say, well, this is endorsed by our major professional societies. But then even beyond that, the next big challenge was, well, how is it going to be implemented at our institution? We are still, despite us being sort of the experts from the transplant world, our institution still defaults to whatever happens in the nephrology world, or in the primary care world. And so now with this policy saying, hey, all centers have to do this, that has a very different connotation and I think that it gives us a leverage that honestly, I haven't seen in this field or perhaps even, I can't remember any recent other examples sort of in the health equity space where we've seen actually being backed up by policy, by mandates, and so I'm hopeful that maybe this could be one example so that we can get more concrete help in the future for other things that we've been recommending.
[Kirsten Bibbins-Domingo:] I think you've said it so nicely, it's very hard to move practices that are sort of entrenched in organized medicine, and even despite the efforts of many people doing this on a one-to-one basis, that it really does take the big organizations then and the policies that still drive how we generally take care of patients to really make that type of shift. The implementation is still going to be a challenge, but it still has to start with something like this. Dr. Mohottige, I'm going to give you the last word. You're the first author of this viewpoint. What is it that you want clinicians or patients to take away from this historic decision?
[Dinushika Mohottige:] There is often so much nihilism, I think, around what can be done to mitigate inequities that are so deep, that are so structured, and for me, this decision offers some hope that through collaboration, through genuine engagement with patients, with multi-sector stakeholders, and through rigorous science, that we can collaborate and really translate evidence and engagement into equity and enhancing policy. That to me, gives me hope for the future.
[Kirsten Bibbins-Domingo:] Wonderful. Wonderful. So well said. Thank you, the three of you for joining me today for this important conversation. Thank you for writing this viewpoint that is published in the February 27th issue of JAMA, and thank you for all of the work that you're doing in this important area. Thank you.
[Dinushika Mohottige:] Thank you so much for having us.
[Kirsten Bibbins-Domingo:] JAMA and the JAMA Network will continue to publish and report on kidney transplant wait times for black patients, and on other issues important for advancing health equity. Sign up for our emails on jamanetwork.org to stay up to date.
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