Daniel Joyce: Hi, I'm Dan Joyce. I'm a urologic oncologist at Vanderbilt University, and I have the pleasure of being joined by Jackson Cabo, who is currently an endourology fellow at Mayo Clinic in Scottsdale, Arizona, and has published some recent work on financial toxicity in patients with stone disease. Jackson, thanks so much for being here. Great work. I can't wait to talk to you more about it.

Jackson Cabo: Really happy to be here. Thanks for the opportunity.

Daniel Joyce: And I know you have some slides prepared for us, do you want to start with those and then we'll chat after?

Jackson Cabo: Sounds good. Thanks again for the opportunity to present. I'll be presenting on our recent study; Treatment Deferral and Coping Mechanisms Associated With Nephrolithiasis-related Financial Toxicity, which we published in Urology. So for some brief background, stone disease is one of the most common urologic conditions with a prevalence of 11%, in recent studies, and is one of the most expensive accounting for over 1.4 billion healthcare dollars past year in the United States. The recurrent nature of stone disease certainly presents several potential triggers for disease-related financial toxicity in the way of missed work due to symptomatic stone events, need for repeat surgeries such as stenting followed by ureteroscopy as well as costs associated with preventative medications or measures. Furthermore, recent cross-sectional studies have suggested that about 20% of patients with stone disease report disease-related financial toxicity.

So when we talk about financial toxicity, it's really defined as essentially financial strain or burden associated with the cost of managing or treating a disease. And there are several components of this which include monetary expenses. And those include basically out-of-pocket spending, as well as indirect spending. So this can be costs associated with not just appointments or surgeries themselves, but also indirect spending in terms of costs associated with travel to make it to appointments. Financial toxicity also includes subjective metrics or components. And these include anxiety or concern about upcoming costs, uncertainty about ability to pay for future expenses. And then we also have objective components of financial toxicity. And these include coping behaviors, which may be a maladaptive behaviors as well. And these can include borrowing money in order to pay for healthcare-related costs, deferring recommended treatments or surgeries due to concern about the financial burdens associated with that. It also can include missed work or caregiver time off work in order to help manage or treat a disease.

So in addition to just reporting, say out-of-pocket spending, how else can we measure financial toxicity? So the COST-FACIT score is a validated instrument mostly described in the oncology space that characterizes the more subjective aspects of financial toxicity, such as concerns about future costs, the impact of financial burden on satisfaction, and the impact of financial burdens associated with the disease on quality of life or functioning. An important thing to keep in mind when interpreting these scores is that a higher score represents a lower financial toxicity or a lower financial burden, and a lower score actually represents higher financial strain. That brings us to our present study. In this study, we essentially sought to survey a large nationwide group of volunteers with kidney stone disease that are enrolled in the research match database, and we sought to characterize the impact of kidney stone-related financial toxicity on deferral of recommended surgical or medical therapy for stone disease in the past year.

In this study, we define financial toxicity using the COST-FACIT score with a COST-FACIT score under 21 used to identify patients with high financial toxicity due to their stone disease. Between our high and low financial toxicity groups, we compared coping mechanisms to deal with disease-related financial toxicity. And then also compared rates of deferral of recommended medical or surgical therapy for stone disease in the past year due to cost. Finally, we performed a multi-variable analysis to identify socioeconomic and disease-related factors that may be associated with treatment deferral. Moving to our results here, we found that 21.6% of patients in our cohort reported significant financial toxicity due to their stone disease. And those with financial toxicity were more likely to defer medical or surgical therapy in the past year. With 22.4% reporting deferring recommended surgical therapy in the past year due to cost. Interestingly, 19.4% of respondents reported borrowing money to pay for kidney stone treatment in the past year. And over half of the cohort with high financial toxicity reported cost was the greatest barrier to them not being able to follow nutritional recommendations for stone disease.

Here is our univariable and multivariable analysis looking at factors associated with deferral of recommended medical or surgical therapy in the past year. And as you can see on the left panel there, on the univariable analysis, higher income was protective against deferring recommended surgical or medical therapy in the past year. However, moving to the multivariable analysis, we see that association was lost and only three factors; younger age, greater disease burden as measured by ER visitation in the past year for stones, and higher financial toxicity, which is represented by lower COST-FACIT score were all independently associated with treatment deferral in the past year.

So said another way, higher cost score, so lower financial burden, was associated with lower odds of treatment deferral even after controlling for patient income. So moving to our take-home messages. In this nationwide study, nearly a quarter of stone formers reported significant disease-related financial toxicity, which is in line with other published works in this space. Of these individuals, one in four reported deferring recommended surgical procedures or medical therapy for their stone disease in the past year due to cost. And subjective financial toxicity as measured by the COST-FACIT score was a independent predictor of treatment deferral even after controlling for patient income. And importantly, high income alone was not predictive of lower rates of treatment deferral.

And so taking a step back, I think this points to a couple important points going forward. So certainly I think there's a need to make more cost-informed preventative and treatment recommendations for stone disease. Other published work has suggested that most stone formers do want their providers to make treatment recommendations with cost in mind. And finally, I think future work is also needed to better understand the temporal relationship between stone events and financial toxicity. This present work was a cross-sectional study, so it's really difficult to ascertain what particular events really trigger financial toxicity. Some work has been done certainly at the University of Pennsylvania and a couple other groups trying to characterize this, but that's something we certainly need to understand in order to address it better going forward. That's all I have. Thank you.

Daniel Joyce: Well, thanks so much, Jackson. That's really informative and important work in a disease space that I think we often overlook from a financial toxicity standpoint. A lot of the focus has been on cancer, and understandably so. Those are high-cost treatments that have huge implications if you don't comply with those treatments. It's interesting, you found some things that we see in the cancer space as well, younger patients, higher financial toxicity. However, that ability to get care wasn't so much due to their income. And so it raises the question of, well, is the financial toxicity that these patients in particular are feeling, the indirect costs, is it really not the out-of-pocket costs? It's more the burden of having to get this done, take time off from work, park, go to their visits and come to interact with the healthcare system. You mentioned price transparency and discussing that in some of the treatments as we prescribe things for our patients, but in this space, how can we really impact that requirement to come interact with us and the impact that has on these younger patients' lives?

Jackson Cabo: I think that's a great question. I think as you mentioned, indirect costs potentially being really significant in this disease state, I think one key factor we identified was certainly time off work was significantly greater in the high financial toxicity group. And I think that's something we probably underestimate. You can say, oh, well the cost of treatments are certainly not, of drugs, say are not nearly as high in the stone disease space as compared to the oncology space. But if you're having a young person who obviously is dependent on their job for their income and that's very important to them, missing a lot of time from work can be really, really impactful for these patients. Especially if we're saying, "Okay, well you come in, you get a stent, say you're down for a couple of days with that, and then you got to come back in a couple of weeks and then potentially miss a couple of days after a ureteroscopy."

And so I think the job-related impacts are probably really significant in this, especially in the younger population. In terms of how we address that, I do think it's difficult. I think certainly transparency in terms of what to expect upfront when you're counseling these patients upfront, say when you're deciding between intervention or trial of passage in terms of what you expect for time off work. Again, I do want to kind of give a shout-out to the University of Pennsylvania. Their group has done a great job in looking at work disruption related to different urologic procedures, so both ureteroscopy and PCNL, and looking at pain disruption and how that changes a couple of days after surgery.

So we do have a mounting body of evidence to say, "Hey, I expect you to potentially be down for this number of days and you have to understand if we're going to do this procedure, you may need to take this amount of time off work." Or, "On average, patients take this amount of time off work." So that it's at least more transparent as to what to expect in terms of missed time, which obviously has a large financial impact for these patients.

Daniel Joyce: I think it'd be really interesting to see too if leaving less stents makes a difference after you treat these stones, is there a role here for some Saturday stone surgery for people to make things easier for them? That's obviously something we resist as a medical community, but maybe could have a huge impact on patients. It's also interesting that a lot of these patients who experience high financial toxicity delayed their care, didn't get their stone treatment, and it's unknown how they did. So I guess my question is, is there some stone surgery, and to what extent, stone surgery is maybe not all that important and we could forgo? Is there a substantial number of stone patients that we could not treat and are we too aggressive with our surgical management of kidney stones?

Jackson Cabo: Yeah, that's a good question. Certainly when you talk about non-obstructing renal stones, obviously there's limited situations in which say our guidelines will say, "Oh, you should treat it." Someone who has a potential occupational hazard, they're a airline pilot or a truck driver or something like that where a renal colic event could be very, very serious to the safety of them and other people. But outside of that, when we're non-obstructing renal stones, you certainly, again, it's difficult to measure in our present study as it was self-reported data, and it would be difficult to measure, okay, what was the exact clinical situation in which you were recommended to have surgery? So certainly active surveillance for non-obstructing renal stones is certainly an option in many scenarios and as a way to potentially reduce cost burden. Of course, you would have to balance that with counseling the patient on, "Well, if you drop a stone down into the ureter and you develop obstruction, that's going to lead to time off work probably too."

And so I think as we get more and more data onto which stones can we surveil, which ones do we get to re-intervene on? Say there's residual fragments after a ureteroscopy, how do we decide whether we need to re-intervene or not? I think that's one where certainly it ultimately at least right now comes down to shared decision-making. And I think cost has to be part of that discussion as well in terms of, okay, is it safe to watch it? Do you understand how many days off work are you going to need if we do a ureteroscopy? And is a small, small chance that you develop a obstructive episode down the line worth it to you versus just going after it upfront?

Daniel Joyce: Yeah, it'd be really fascinating to see what happens to those patients who delay their care. So what's the impact on them downstream? Is it actually worse for them from a financial standpoint if they delay or did they save themselves some money? And then secondarily, what's it doing to our healthcare system also if these patients are delaying and delaying and delaying? And ending up in an ER, maybe in admission with sepsis, the cost associated with that from just a healthcare systems perspective would be really interesting to look at. What do we do? How do we fix this problem for those 20% of patients who really experience high financial toxicity? I mean, it's certainly important to characterize financial toxicity in these different spaces, but me personally, I just want to see more efforts to help make it better. So what can we do as clinicians and maybe what could we do as a healthcare system?

Jackson Cabo: So I think I want to touch on a couple of your points there. I think first of all, obviously in a very heterogeneous population of just stone formers in general, it's difficult to quantify, okay, what are the consequences of treatment deferral? Is it always a bad thing to defer treatment? And certainly in some patients with small non-obstructing stones, it's very reasonable to not intervene. But there is some data, certainly in patients with complex stone disease, say they have a staghorn stone, they're recommended for PCNL. There is good data, and a lot of this was from a group at UNC and others that has shown that deferral of treatment is associated with increased treatment complexity, so need for multiple procedures down the line to clear the stone burden, and higher cost of treatment overall to the healthcare system. But in the general stone-forming population, it's so heterogeneous, I don't think we have a good understanding of it right now.

In terms of how to address it, I think there are a couple of ways off the bat. I think firstly, when we're talking about preventative management of stone disease, there's a lot of good data that making multiple recommendations to a patient for preventing stones is not necessarily the way to go. If you tell them four or five things, there's good data now that that does not improve patient recall of the interventions, nor does it improve compliance of multiple interventions. And so potentially, you say you have a patient who has low urine volume on their 24-hour urine and they have a couple metabolic abnormalities, rather than saying, "Okay, well we're going to start this medication, we're going to do this, and then you also need to increase your fluid intake." Perhaps just say, "Hey, honestly, I think the biggest bang for our buck is just to increase fluid volume. There's no additional costs associated with that, and it's a simpler intervention."

So I think one is potentially simplifying our interventions for preventative management to stone disease and taking costs into account in that, because as highlighted in this study and others, cost is a significant reason that patients struggle to follow some nutritional interventions. If you're telling them, "Okay, you got to have fresh produce with all these meals." That may not be feasible for some patients, and it may be simpler to just say, "Hey, you know what? If you can drink a couple extra cups of water a day, that probably will make a greater impact for you." Than maybe saying, "Hey, you've got to do four or five different things to deal with it."

I think with regards to surgical intervention, I would say the way to start is just transparency about missed work because I think we don't always do a great job of that in saying, "Okay, hey, this offers the best chance to clear your whole stone burden." But I think counseling patients on, "Hey, the average amount of missed work from this procedure is this amount of time, and is that something... You have to understand that before we go forward with the surgery." And so I think transparency regarding missed work associated with the surgical intervention is a first step. But again, I think we do need to better understand how particular stone events and surgeries, how they impact financial toxicity directly because I think we still don't know that, at least regarding the temporal relationship between the two.

Daniel Joyce: Yeah, really great points. I think one of the nicest thing about your study is the nutritional component because we here at Vanderbilt are working on a bundled program for stone disease. That bundle program I think helps a lot with the out-of-pocket costs of healthcare, of what they pay us. However, it doesn't address anything regarding nutritional things that they have to pay for outside of the healthcare system. And so there is a cost component to this of just good nutrition that is stone helpful nutrition that can really be tough to address and probably is associated with a lot of socioeconomic factors that limit people to certain foods also.

From the stone side of things, I think as physicians and surgeons we're often not thinking about what's going to decrease time with us. In fact, I think it's pretty common that somebody would place a stent after a stone treatment and not leave a string and have them come back to clinic and have it removed, and just starting to reshape our thinking that's patient-centered; that really is about them. Not being risky and doing dangerous things, but if it's not risky to leave a string and have that person pulled out at home, that saves them a day, a day of interacting with healthcare. So I think that's really important. Jackson, this is fantastic work. I can't thank you enough for taking the time to sit and talk about it, and I look forward to hearing what you have next.

Jackson Cabo: Thank you again. Really appreciate the opportunity.