Featuring Caroline Fife, MD, and Marissa Carter, PhD

Welcome to Speaking of Wounds, a podcast by the Wound Care Learning Network. I'm Dr. Jennifer Spector, the Assistant Editorial Director for WoundSource, and we're happy to have you listening today.

Just as a reminder, this podcast is intended as an informational tool for medical professionals and is not intended to diagnose or treat any medical conditions, nor does it guarantee payment or reimbursement for any services rendered. I'll let our guests introduce themselves shortly, but we're so excited to have both of them with us today to speak on their expertise surrounding research perspectives on quality of life in wound care. The Wound Care Learning Network had the privilege of meeting with them during the Symposium on Advanced Wound Care Spring session in Orlando, Florida, and we're so excited to present this episode to you today.

I'm Dr. Caroline Fife. I'm the Clinical Editor of Today's Wound Clinic and a long-time wound care practitioner.

I'm Dr. Marissa Carter. I'm a health economic specialist and a clinical trial design specialist and a biostatistician, and I also and work for the WCCC.

So one of the things that I've been wanting to talk about is the research that we did looking at the numerous medical problems that patients with chronic wounds and ulcers have. And this came out of a project that I did in which I was trying to get a quality measure approved by CMS, briefly, managed to do that, to look at the quality of life of patients with chronic wounds and ulcers. And so we used the Wound QOL and gave it on a tablet to hundreds of patients and discovered that there was no relationship between their quality of life score and whether their wound healed. And so I contacted you to say, I think I have an idea about why this is not working.

And my concept was that it was because the patients had so many other problems. And then you took it from there, as you often do, a very elegant analysis of what the real barrier to measuring quality of life in relation to wound care is. So what we did, and Caroline's idea was a good one, and that is, we're asking the question, why are patients so sick? So let's establish the fact, how are patients sick? How do we measure it? And so we looked at two different ways.

The first thing was comorbidities. We did a massive look at all the comorbidities that each patient has. We divved them all up, categorized them, and so forth. Then we used a very novel different way of looking at patients' quality of life in terms of their comorbidities using what we call utility, where that's the scale of 0 to 1, where 0 is dead and 1 is perfect health. And we looked at each patient. We did some serious mathematical transformations. And we discovered something very interesting. And that is, when we looked at each patient's score, we found their utility numbers were pretty low. And why are they low? Because they have such awful things that are wrong with them. A lot of them have -- They're paralyzed.  They're in heart failure. They're immobile, they (have) anxiety. They're depressed. They have serious chronic heart failure and lots of other diseases. So their middle of the road score tells us that quality of life really is bad.

It's very low in the absence of a wound. And we finally, we validated our mathematical approach to this quality of life establishment using very specific EQ5D5L stories and data from several different countries. And lo and behold, our measurement approach and the numbers that came from those 12, 13 studies, are almost the same.

So one of the things that's hard for me is, you know, I'm a simple girl. I looked at these several hundred patients, the comorbid conditions they had, and I said, wow, they look really sick. And then you put numbers to that.

And the concept of utility score does not mean anything to me as a clinician. I confess that it's not a concept that seems important or logical to the average practicing clinician, although maybe I'm bringing the marks down of the average clinician because I struggle so much with it. So I'm going to rephrase in simple language what I think you said, which is that if you look at the severity of underlying conditions and just understand how much those affect a person's life and life expectancy, The underlying medical conditions that most people with chronic wounds had were worse than the wound itself.

And as a result, the incremental suffering caused by the wound turned out to be less important than we originally thought. The icing on the cake was, we see in so many studies that wound quality of life, whatever the instrument, doesn't change with healing. Healing a wound in the great scheme of things for most of our very sick patients is a small thing. It doesn't move the needle and that was a long-held suspicion I'd had and it was a hypothesis and in a sense we have started to prove that as true. 

I think maybe that's overstating. Every patient wants to be healed and when we ask patients what they want of their wound care, they will say, to be healed. But the fact is, many of the quality of life instruments ask questions like, how does this impact you walking upstairs? Well, (they say) I could never walk upstairs. How does this impact your ability to be mobile? Well, (they say) I'm not mobile. How does this impact your ability to go on vacation and enjoy your free time? Well, (they say) I can't do that either. So It becomes challenging to measure a piece of quality of life that's impacted, which means we're not asking the right questions.

So we may need to ask them questions about their out-of-pocket expenses or social embarrassment or the time factor in changing a dressing, but the big picture things in quality of life are so impacted by their breathlessness and their immobility and their other challenges that - the wound is less of a contributor. - So the answer to why are our patients so sick? It's because they have such a breadth of such very serious problems in their life. - Which is why they have a wound that doesn't heal.

Right, it's a circular thing in a sense. It's not always about their wounds. It's about the context of understanding the patients, how sick they are, and the wound is really just a small compartment in that entire problem.

So I think that's another thing. Clinicians will often say, oh, but my wound center is special because our patients are so sick, you just don't understand. And the answer I feel is, yes, they're all sick. All of our patients are like this. You're not special, but it is true. And this is a big problem from a survival standpoint in terms of running a clinic.

When the hospital administration wants you to get a patient in and out of a room in 15 or 20 minutes. And the patients are immobile, they need three people to assist them. That's not the problem of the wound.

That's just the fact that they're very frail, very compromised people. So I think we're going to have to have a new reality check on what it's like to care for these patients because it's not at all a simple thing. Yes, absolutely.

And it extends into so many areas. We run randomized controlled trials whose populations look nothing like these people we've been talking about. So how can you generalize some of those trials to the people we're talking about? And I think the result is that the FDA and CMS and other payers have no idea what a real patient looks like because they see these clinical trials of superficial singular wounds and the average patient has more than one wound, which by the way is the other reason that I forgot to mention why the quality of life factor sort of failed is that it never occurred to me when a patient has multiple wounds to tell them oh keep in your mind which wound it is that you're thinking about when you're answering these quality of life questions because that's a ridiculous idea isn't it like it's all of them and yet we do clinical trials where we look at just their left leg wound not their right leg wound or the third wound on their left leg not all of them.

So I'm very concerned as a clinician about the fact that we continue to do research at the level of the wound and not at the level of the patient who has multiple problems. But that's another barrier for quality of life working because there's not a one-to-one. And when we're all done, if the wound had healed, one wound healed, the other one didn't.

What do we do with the quality of life then? It's almost like when you're working in control trial land and you think of just one wound, so this idea sticks in your head, "Oh, the patient only has one wound." One to one. Well, in our real-world patients, they have lots of wounds. Yes.

So, in a sense, you need to get out of that protective umbrella of control trial land and get into the real world and understand there's a vast difference, guys. We're going to have to have a different tool. I think there might be ways to measure the things that matter to the patient, and I think that was my mistake going into it is thinking it's somehow a tool designed generally for wounds.

I think maybe that's the process going through with the wound cue is trying to figure out, okay, let's ask the patient what matters to them. And just to finish the concept about the CMS quality measure that could be reported under MIPS, CMS then rejected that measure because they said simply measuring quality of life is not a quality activity. What they expected was for us to be able to demonstrate a specific percentage, a measurable improvement in quality of life in relation to our treatment.

And clearly the QOL failed as a tool. I'm not trying to dismiss that, but conceptually for all the reasons we've said it failed. So if we're gonna be able to use quality of life as a surrogate endpoint, we'll have to first find out what aspect of quality of life is the thing that we should look at.

And to keep in mind that from the standpoint of CMS or reimbursement, simply asking people about quality of life is not something that the payers care about. They want to be able to measure in what way it's better, which is a completely different perspective than we had. So I'm always frustrated when a manufacturer or someone wants to know if their device, their treatment, their whatever has changed quality of life and I keep thinking you need to stand far enough back that I can't swing at you because it's expensive to measure, it's time consuming, there's no reimbursement for it and we have yet to find a way to do it in a way that is consistently related to outcome, so I want people to stop asking me about quality of life until these problems have been solved, and I haven't seen a lot of investment in trying to do that.

I mean, as a final wrap-up, I would say trying to figure out the quality of life in patients is not as simple as it seems. We have spent 30 years in utility work trying to discover, how do you measure that there are gazillion ways to do this and we're still arguing which way is right. So you can tell you the nature and the depth of the problem is going to be an on-topic research for the next 20-30 years.

And all patients with chronic wounds are very sick. We'd like to thank doctors Fife and Carter for taking the time to speak with us today at SAWC Spring. That wraps up the discussion for today but for more information on today's topic, we invite our listeners to explore all the resources available through the Wound Care Learning Network and at Woundsource.com.

Thank you again for joining us today on this episode of Speaking for Wounds and enjoy the rest of your day.