Melanie Cole, MS (Host): Welcome to Better Edge, a Northwestern Medicine podcast for physicians. I'm Melanie Cole, and we're highlighting today the development of a patient-reported outcome measure for ureteral stricture disease.

Joining me is Dr. Ziho Lee. He's the Chief of Trauma and Reconstructive Urology and an Assistant Professor of Urology at Northwestern Medicine. Dr. Lee, thank you so much for joining us today. As we get into this topic, how has the clinical understanding and management of urinary strictures and ureteral stricture disease evolved over the past decade? What are some of the key factors contributing to their development?

Dr. Ziho Lee: Ureteral stricture disease has really undergone quite a bit of innovation and advancement over the last decade. Historically and traditionally, a lot of ureteral stricture disease were reconstructed via an open approach. So, a lot of these patients either had large midline laparotomies or a flank incision to access the ureter. The ureter is kind of deep in the retroperitoneum and tracks deep into the pelvis. And so, sometimes it could be quite hard to access.

With the advancement of minimally invasive surgery and robotic surgery specifically, nowadays, the most common modality for approaching ureteral stricture disease is via the robotic fashion. So, a lot of these patients now can undergo a lot of minimally invasive surgery, which really allows for less postoperative pain, improved cosmesis, and earlier return to normal activities. And this has been quite outstanding. More recently, there have been a lot more emphasis on very difficult-to-manage ureteral stricture disease that maybe in the past were not managed surgically and were managed either with a chronic stent or a nephrostomy tube. And so, it's really an exciting time to be involved in this space.

Melanie Cole, MS: Dr. Lee, prior to the development of the patient-reported outcome measure for patients with ureteral stricture disease, how were outcomes traditionally measured in these patients?

Dr. Ziho Lee: In the literature, because a lot of these urinal stricture disease were not managed and not many people were doing high volume surgeries, there was a lot of heterogeneity within regards to the definition of success after the management of ureteral stricture disease. And so, anywhere from, you know, resolution of pain, the resolution of hydronephrosis on ultrasound or CT scan, or the absence of obstruction on a renal scan. And so, there was a lot of heterogeneity and there was no real consensus on what constituted success after these surgeries.

Even moreover, none of the prior definitions took into consideration any of the patient perspectives regarding what actually constitutes a surgical successful outcome. And that to me was problematic because, I think in this day and age, the medical care that we provide for our patients should really be individualized and customized to a specific patient. And if we're not taking into consideration patient perspectives and what they think about surgery, I don't think, we're doing as good of a job as we can.

Melanie Cole, MS: Tell us about quality of life for the patients before and after treatment modalities. What do these kinds of diseases do to the quality of life of patients that these patient-reported outcome measures were designed for?

Dr. Ziho Lee: A lot of our patients that I see in our clinic that are referred to me, the vast majority of them come with some type of drain, whether it's a stent, a plastic tube that's inserted within the body to help drain the urine from the kidney to the bladder, or even a nephrostomy tube, a drain that is directly inserted into the kidney that comes out of the patient's body. And with these drains come a lot of complications. So if you have a chronic drain, you're at higher risk for infection. These drains can be irritating, and you also need to get these drains routinely converted or exchanged. Because of that, it really is a detriment on a patient's quality of life.

Melanie Cole, MS: So, how was the PROM developed and validated?

Dr. Ziho Lee: When we set out to actually develop a patient-reported outcome measure for patients with ureteral stricture disease, we really wanted to develop an instrument using the scientific method. And because of that, we kind of partnered with our colleagues, more clinical data scientists, to really kind of come out and do this the right way. And so, the way that we did this was initially, we interviewed 14 patients to participate in what we call concept elicitation interviews where the patients come in and we ask a semi-structured series of questions regarding their kind of thoughts on the physical, mental, and social effects of ureteral stricture disease. And these interviews were really kind of more open-ended because we wanted to really get the patient experience without any of our biases.

So, we coded these interviews in order to quantify the different concepts that we're actually able to elicit. And we conducted these interviews until we were consistently generating less than 5% of unique codes. And this kind of allowed us to obtain concept saturation. And after this, we coded them and used them to quantify the different topics that we needed to focus on.

 After this step, what we did was we proceeded to the item generation approach. And so, what we did was based on these concept elicitation interviews, we developed novel items based on what the patient's valued. After developing our rough draft of our PROM, we obtained expert feedback from seven high-volume reconstructive surgeons. And so, what they did was they evaluated our PROM and provided feedback on their aspect. And based on their feedback, we made modifications and further refinements on the actual PROM itself.

And then, lastly, what we did was we then performed cognitive interviews. This was done to assess patient comprehension and the relevance of the PROM item. And in doing this, we took measures to further refine the PROM in order to have patients not only understand it better, but also have experts, making sure that nothing was missed. And when this process was all said and done, what we got was our finalized PROM. So, this consisted of 10 questions that really go through every aspect of the patient experience.

Melanie Cole, MS: Dr. Lee, this is so interesting to me. So how do you foresee these results of the research influencing clinical practice? Take us from bench to bedside here. How do you feel this will impact patient outcomes following surgery and the patient-reported outcome measures? How do you feel the patient satisfaction is going to be as well?

Dr. Ziho Lee: The reason that that's a great question is because we've seen in other areas of Medicine that when this process is undertaken, when physicians actually go out and really take the next step and really understand what the patient experience is like, what we've come to understand is that the patient's goals may not be exactly the same as the physician's goals. And this is kind of what we saw in our study as well. And so, when we went through our interviews, many of the patients, their primary goals were to get rid of the hardware, so, their stent or their nephrostomy tube, or relieve their symptoms. From a physician standpoint, our primary goal was to save kidney function. So, the kidney drains the urine into the bladder when the kidney is blocked from a ureteral stricture, that can cause irreversible renal function loss. And that to me was super interesting to see that discrepancy because there is a little bit of a disconnect. And for me, what this study has shown was we really need to focus on not just what the physician wants, right? We want to create a urinary system that drains appropriately to maximally preserve kidney function. Yes, that is very important to do. But what's also important is we really need to address our patient's concern. They're mostly concerned about the day to day. Are they feeling pain? Are they feeling nausea? are they having to live with a tube, whether that's inside or outside the body?

And for me, when after developing this patient-reported outcome measure, when I go talking with patients before surgery, I really bring these issues up. I like to ask my patients, "What is your goal? How can we do this procedure to help address your goals?" And what I've really come to see since rolling this patient-reported outcome measure out is it really empowers patients. It helps patients be in control of their medical care. And when I specifically address their concerns and say, "You know what, if we do surgery, I suspect that this pain will be gone. I suspect that we will be able to remove this drain and you likely will never need a stent or nephrostomy tube again." I think that just allows patients to feel as though they're more in control and be more satisfied in the type of care that they're receiving. And that to me has been pretty awesome to be a part of.

Melanie Cole, MS: Well, I'm thinking that's what makes you such an awesome physician and really a patient-centered approach the way you're speaking to them and counseling them and asking them what they want. So, taking what you just said, Dr. Lee, how can other physicians apply these findings in their daily practice? What would you like them to know about this?

Dr. Ziho Lee: I think, right now, validating our patient-reported outcome measure across multiple institutions across the United States, because our goal in doing this is really to standardize how we report successful outcomes after ureteral stricture reconstruction and by working with other colleagues across the country, to implement this in their practice. I think by having a standardized definition and being able to really take into consideration what do our patients want and what do our patients need, I think it really allows not just the patient, but also the physician to be really invested in a patient's care. What do they value and what should we also value?

Because I think at the end of the day, as a reconstructive surgeon, our goal really is to take care of patients and listen to them and see how to best approach these issues. Not just from a physician's standpoint, but from the standpoint of what's important to our patients. What can we do? How can surgery improve their lives? And I think by doing this and continuing our study and research in this space, working with other institutions and rolling it out on a national and an international level, we can really redefine the paradigm of how success is viewed after surgery when it comes to ureteral stricture reconstruction.

Melanie Cole, MS: Dr. Lee, as we wrap up, and this was such an interesting conversation and really such a great initiative for, really, that shared decision-making with patients. What other research are you working on to improve treatment and outcomes for this patient population?

Dr. Ziho Lee: Right now, when it comes to radiographic images, to assess for the presence of ureteral stricture after surgical reconstruction were really limited. And the reason for that is a lot of our patients that we do surgery on, they've had chronically obstructed systems. And so, they're going to have hydronephrosis. They may have hydronephrosis forever, even after surgery, even when they're not blocked. And I think, because of that, when we do radiographic studies after surgery in the form of ultrasound, CT scans, or even renal scans. Sometimes it's difficult to really assess whether or not there's actually an obstruction.

And, you know, historically, the best way to really assess for the presence of an obstruction is via what's called a Whitaker test, where by assessing the actual pressure within a kidney, we can see whether there is any outflow obstruction. But that test actually involves the presence of a nephrostomy tube or a tube that is inserted in a patient's back to really be able to assess intrarenal pressure.

What we're doing is we're working with our university researchers in the computational fluid dynamics space. And what we're doing is we're combining computational fluid dynamics and artificial intelligence to develop a new test to be able to measure pressure within a kidney via a radiographic study. And so, we're currently in the process of getting our pressure measurements and radiographic evaluations, but this is a very exciting field. And I feel very fortunate to be contributing to hopefully moving this field forward. And I feel very fortunate to be a part of all that.

Melanie Cole, MS: Well, thank you so much for joining us today, Dr. Lee, and sharing your incredible expertise and experiences in this field. So, thank you again, and to refer your patient or for more information, please visit our website at breakthroughsforphysicians.nm.or/urology to get connected with one of our providers. That concludes this episode of Better Edge, a Northwestern Medicine podcast for physicians. I'm Melanie Cole.