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Rheumatology Network sat down with Liana Fraenkel, MD, MPH, the lead investigator for the study: OPEX: Development of a novel overall patient experience measure to facilitate interpretation of comparison effectiveness studies. In partnership with CreakyJoints, Fraenkel is a rheumatologist at Berkshire Medical Center and Director of Patient Centered Population Health Research.
Rheumatology Network sat down with Liana Fraenkel, MD, MPH, the lead investigator for the study: OPEX: Development of a novel overall patient experience measure to facilitate interpretation of comparison effectiveness studies. In partnership with CreakyJoints, Fraenkel is a rheumatologist at Berkshire Medical Center and Director of Patient Centered Population Health Research. We discussed her interest in patient experience, the development of a hierarchy of adverse events using surveys, and how the results were used to draw conclusions that can enable patients and physicians to determine the levels of outcomes for a variety of treatment methods.
Rheumatology Network: Hi, Dr. Fraenkel, thank you for joining me today.
Liana Fraenkel, MD, MPH: Pleasure.
RN: As the lead investigator of the OPEX study, why are you interested in tracking patients overall experience on treatment?
LF: So, the objective really for this study came from talking with patients, frequently in rheumatoid arthritis. We now have a lot of choices on what we can prescribe for patients. And when we're trying to compare different medications options, the data we have from randomized trials separates benefits and risks. So, we can tell patients treatment A this many people responded compared to treatment B; we can say same thing in terms of the number of people who might have had a serious side effects on 1 treatment for the other. But overall, we can't really tell patients, you know, on treatment A, this is kind of what your life is like, this is what your quality of life is like on treatment A compared to treatment B, because there's no global measurement of how you kind of do, how you feel day to day. And those are the type of things that patients care most about. Most patients don't develop, thank goodness, serious side effects. They develop the less serious side effects that can really impact their quality of life. But there's no way to know how the people respond. How many of those people are also developing side effects, right? Do most people respond and have nothing? Or do most people respond well, in terms of their joint count, but also have some brain fog and have some queasiness, and just don't feel as well? So, that's what patients want to know, when we really just had absolutely no way of measuring that. So that's where this came from.
RN: Can you tell me a bit about trajectory mapping and the methodology used in this study?
LF: I cannot. But I can tell you a little bit about the methodology. So, the bottom line is this, the trajectory mapping is the genius of one of my collaborators, Dr. Broniatowski. And basically, he's a colleague of mine that I've met who really is brilliant and knows a lot about decision making from other fields. So, the trouble with this is that most of the ways that we measure how patients feel about things are measured, you know, on 1 particular thing, and it's difficult to figure out how to measure this global experience in terms of are there things that are similar. So do patients feel similarly about having some mild queasiness and a headache, or is 1 always worse than the other? And it was tough to figure out how to do this, I think that's why nobody's done it before. It took us a long time to figure out how to actually come up with a measure for this. So, David [Broniatowski] came up with this measure; he found somebody who previously described this in the past. And it required patience completing a fairly difficult survey. And what came out of it first was a hierarchy of side effects. So not only could we be basically tell which side effects are worse than others, some of them we know, right? We can assume that having a terrible side effect, God forbid, is way worse than having a rash that’s going to disappear in 3 days. But what we didn't know is that with of all the milder side effects, how do those rates rate against each other? And are any of them similar? Are there ones that patients consider equivalent? And we basically call those equivalent classes. And so, we ended up publishing in the paper, a hierarchy of side effects where you can see the ones that range from the mildest to the worst. And some of them are on the same road, meaning they're considered equivalent to patients. They have a similar impact on the quality of life. So, this is not a method that's commonly used. And it requires some effort to figure out how to do this. I think otherwise, it would have been done a long time ago.
RN: Were any of the results surprising to you?
LF: Yes. So, we assumed 1, there was 1 in particular that stood out, that's why I answered it so easily. We assumed that patients would feel very strongly towards having no side effects. That would have a magical place. So now no side effects would be ranked way above anything else, but we were wrong. And patients consider basically how they would be feeling both in terms of how much they benefit and any side effects they could be having. They lump together no side effects with mild side effects. And it taught us that basically patients expect to have some side effects on medications. They are willing to, that kind of is the norm. They don't expect no side effects. So, they were comfortable lumping all those together. And we went back to patients, to interview them after to ask about this finding, that's exactly what they said. So, they don't really buy in that nothing's ever going to have any side effects. They except a small risk of side effects. And they really didn't give any particular over emphasis to having something that would not cause any problems at all. They are very willing and very used to the acceptance of risk.
RN: What are some of the ways that you have found tracking experience helps both patients and physicians in treating rheumatic disease?
LF:In clinical practice, we do this all the time, right, because when we ask patients how they're doing in clinical practice, it involves both how well they're doing in terms of their pain, and their stiffness, and their fatigue, but also how they're doing in terms of their side effects. So, this is something we do in clinical practice all the time. The difference is, is that when you're facing a decision, and you want to be able to help a patient decide between, you know, I'm not doing so great now, should I consider taking this medication or this medication, that's where we run into trouble. There's just no way of being able to help somebody with that. So, this is a first stab at this. This needs to be, you know, validated and repeated in other patient populations. We did have a large number of people for a clinical study, but clearly, we could never represent all patients with rheumatoid arthritis. So, we really want to make sure that we recruit larger samples to make sure that this is how most people feel. That these are representative of other patient populations. But this might give people an actual way to compare A versus B. This percentage of people on medication A do great and have no side effects. This percentage do great but have some side effects. And you basically can map those out. And that way somebody could tell literally with a graph which one gives me the best opportunity to do well, but also to have the fewest side effects? Where we don't have a number represented at currently.
RN: Is there anything else that you'd like to add about your findings or anything like that before we wrap up?
LF: The other challenge that we should recognize is that not only is there variability in terms of how patients feel about side effects, but there's also variability in terms of when you recruit people. So, we also have to be cognizant that some patients who are filling out these questionnaires have had the side effects, some people haven't, and that might also cover how they feel. We've always assumed before that when people have had a side effect, they'll think that side effect is worse. But that's not true. That's also surprised me in the past, but in a previous study this one. We found that some people that have had a side effect in the past are actually are less worried about it, because they've coped with it already. They know what to expect. So, there's a lot of variability and how people feel about side effects, how they cope with them based on what their knowledge is, what they've experienced themselves, what they've heard from other people experiencing. So, although we want to be able to describe patient experiences, we have to respect that there will be variability and always consider that when we're counseling our patients.
RN: Well, thank you again for speaking with me today. I appreciate it.
Fraenkel L, Wei Z, Ramsey C, et al. OPEX: Development of a novel overall patient experience measure to facilitate interpretation of comparison effectiveness studies. PLoS One. 2021;16(1):e0245598. Published 2021 Jan 29. doi:10.1371/journal.pone.0245598