Blaise M. Delfino, M.S. - HIS:
You're tuned into the Hearing Matters podcast, the show that discusses hearing technology, best practices and a global epidemic, hearing loss. Before we kick this episode off, a special thank you to our partners, Redux - Faster. Dryer. Smarter. Verified. Sycle - built for the entire hearing care practice, OtoSet - the modern ear cleaning device, Fader Plugs, the world's first custom adjustable ear plug.
Welcome back to another episode of the Hearing Matters podcast. I'm your founder and host, Blaise Delfino. And as a friendly reminder, this podcast is separate from my work at Starkey. On this episode of the Hearing Matters podcast, our co-host, Dr. Douglas Beck interviews Dr. Ted McRackan of the Medical University of South Carolina or MUSC. As a hearing care professional, I cannot applaud Dr. Ted McRackan and his team at MUSC enough for the incredible research that they're conducting at MUSC. So without further ado, enjoy the conversation between Dr. Beck and Dr. McRackan.
Dr. Douglas L. Beck:
Good morning. This is Dr. Douglas Beck and you're listening to the Hearing Matters podcast. Today, we'll be speaking with Dr. Ted McRackan, a neurotologist, and we'll be speaking in particular about the Cochlear Implant Quality of Life scale and how it came to be.
Ted, welcome to the program. Glad to have you.
Dr. Ted McRackan:
Yeah, thanks so much, Douglas, for having me. Appreciate it.
Dr. Douglas L. Beck:
Absolutely. Can we spend a moment, I know you're a neurotologist for those who are unaware and there are many who are not familiar with the term, so you start with medical school, then you do your general residency in otolaryngology-head and neck surgery, then you do an additional one or two-year fellowship in otology and neurotology and that makes you a neurotologist, did I get that right?
Dr. Ted McRackan:
That's exactly right. Yeah. All the neurotology fellowships are two years now, so.
Dr. Douglas L. Beck:
I'm familiar with that, which is terrifically good for the patients, not so good for the career, but it's a brilliant move. When neurotology started, 'cause I am that old, it was a one-year fellowship, well, most of the guys that I knew, and for a lot of people, it was kind of on-the-job training back in the early days. So having a formal program is much, much better because you become much more well-rounded. And neurotology, of course, is where you focus on the diseases of the inner ear, the middle ear and the facial nerve and skull base.
Dr. Ted McRackan:
Correct. Yeah, that's exactly right. So kind of everything for all ages, from the youngest of the young to the elderly, and hearing, balance, skull based tumors, all sorts of great stuff that we get to help patients with.
Dr. Douglas L. Beck:
And do you specialize in one particular area of neurotology or, it's a terrible term, but are you a general practitioner in neurotology?
Dr. Ted McRackan:
Yeah, I do it all. I think my directorship hats kind of sit as a skull-based director at MUSC, Medical University of South Carolina, and also the medical director of the Cochlear Implant Program. So those are my two director hats I wear, but I see the full breadth of neurotology.
Dr. Douglas L. Beck:
That's fantastic. And tell me a little bit, where did you go to medical school, where did you do your residency, where did you do your fellowship?
Dr. Ted McRackan:
Yeah, so I'm originally from Virginia, but ended up in Charleston, South Carolina for college and then stayed here for medical school at the Medical University of South Carolina, actually. And then went to Vanderbilt University Medical Center for residency, then went out further west to The House Ear Clinic for fellowship, which you're familiar with.
Dr. Douglas L. Beck:
Very much so.
Dr. Ted McRackan:
And then afterwards, I returned back to MUSC in Charleston.
Dr. Douglas L. Beck:
Fantastic. And how long have you been there now?
Dr. Ted McRackan:
Yeah, this is coming almost my ninth year. It happens fast. Yeah.
Dr. Douglas L. Beck:
Wow, that's fantastic. Yeah, I was at House back in the very early '80s and I had the honor of working with Dr. William F. House many times, and Dr. Derald Brackmann, Dr. Luxford, Dr. [inaudible 00:04:08], de la Cruz, Ralph Nelson, all those guys and what a joy. There was so much knowledge.
Dr. Ted McRackan:
Yeah, I feel like I want to interview you about that. That's far more interesting than what I'm doing.
Dr. Douglas L. Beck:
No, it's all good, it's all good. Anyway, so listen, let's talk about the development of the Cochlear Implant Quality of Life Item Bank. Why did that need to be developed and what is that?
Dr. Ted McRackan:
Yeah, so the cochlear Implant Quality of Life instrument sets. So first of all, they're a set of instruments that are available and freely available on our research website to download for use, and they actually measure patient's abilities, self-reported functional abilities using six different domains. So it's communication, entertainment, environment, emotional, listening effort and social abilities. And so these are the patient's self-reported abilities in real world setting. So it's where the rubber meets the road, it's how those patients feel like they're doing moving outside of the audio booth and how they're functioning in the real world. So there's a set of instruments where one is a expectation instrument. So before a patient gets a cochlear implant, we can actually measure a patient of how they think they're going to do with their cochlear implant, how it [inaudible 00:05:24]-
Dr. Douglas L. Beck:
Sure.
Dr. Ted McRackan:
... And we have data and it correlates directly with our workhorse, which is the Cochlear Implant Quality of Life-35 instruments, which is the functional outcome measure. But it correlates directly with that. And we have data from over 700 cochlear implant users from across the United States. So we have the normative data of how experienced cochlear implant users perform. So patients who are a year or more out, how they perform on the Cochlear Implant Quality of Life-35 instruments. So patients before their implant, we can actually look now at their expectations of how they think they're going to perform and see whether or not that's realistic or not.
Dr. Douglas L. Beck:
And this is so important because when we started with cochlear implants, a lot of folks don't know that cochlear implants have been around 65 years. The first ones were done in 1959-1960. Bill House in Los Angeles did two or three of them in 1960-1961, and it was FDA approved in '86 for adults and in '90 for children. So we've been doing cochlear implants for a long time, and the counseling challenge is formidable because people want to get a cochlear implant and hear normally, and that's not a reasonable expectation. What happens with cochlear implants is that they start after they've been programmed by the audiologist. Some people sound great right off the bat, they tune up and they do great, but that's rare. Generally speaking, in my experience, people will start with a cochlear implant and things sound kind of funny. They sound like maybe Mickey Mouse or Donald Duck and over the course of 30, 60, 90 days, things start to normalize. You go in, you get things reprogrammed, and it gets better and better and better over time, generally speaking. Is that your experience?
Dr. Ted McRackan:
Yeah, no, that's exactly right. And that's part of the research we're doing is trying to provide the information that patients need to make that decision, to make that hearing journey easier for them.
Dr. Douglas L. Beck:
Yeah, and it's interesting also that when we started doing cochlear implants on a large scale back in the '80s in Los Angeles, every patient would come in and get a psychological evaluation. I believe it was the Wechsler Index by Dr. Wechsler and his colleagues, and they would get a full psychological profile of cochlear implants pre-implantation. And the reason for that was primarily to make sure that the expectations were aligned with the outcomes.
Dr. Ted McRackan:
Yes. That's a major part of our research program now, is looking at that expectation and seeing whether or not patients meet or do not meet that expectation, how that overall leads to their satisfaction or regret or happiness about proceeding with a cochlear implant. Well, the other major part of the counseling process is understanding what the patient's baseline abilities are-
Dr. Douglas L. Beck:
Yeah.
Dr. Ted McRackan:
... And whether or not they should proceed with a cochlear implant. And that's the other part of the Cochlear Implant-35 Profile instrument we have is we get baseline data, so we can see where these patients are now-
Dr. Douglas L. Beck:
Right.
Dr. Ted McRackan:
... And see again where that normative data show most cochlear implant users perform. We're trying to work on things to predict how patients will do with a cochlear implant, which we all know is essentially impossible. And despite 30-40 years of research that has gone into it, we're still not great at it, but we can actually just give them the information the patients need to make their decision. That's kind of the current model, is that shared decision-making model that a medicine is moving towards or should be in. It's not up to me whether the patient should get a cochlear implant or not, it's a discussion. It's a discussion of me providing information that the patients need in order to make that decision. And so that's just another tool we have available now is the CIQOL instruments.
Dr. Douglas L. Beck:
And when you think about outcomes with cochlear implants or stapes surgery or tympanoplasty with mastoidectomy, skull based surgery, there's no promises, there's no guarantees. We learn everything we can. We apply that individually to each patient as an N of 1 and we make intelligent outcomes predictions, but those are only predictions and there are no guarantees.
And I think we have to be very clear, and I think you are, that each patient is individual and the fact that the vast majority of patients can probably use a phone six months after cochlear implantation, that doesn't mean everybody's going to. And the ability to predict and to individualize that prediction, we haven't really been very good at that. We used to gather not only psychological profiles, but back in the early days, this is probably before you were born, we had something called the MAC battery, which was the Minimal Auditory Capabilities battery, which was, I want to say, Elmer Owens and Dorcas Kessler, I think put that together. That was from UCSF 40 years ago. And then you would really have an extensive audiologic baseline, not just air, bone and speech stuff, but truly a whole entire palette of audiologic information from which to make your predictions.
But that's really been minimized in the last few years. I know of individual audiologists who've told me that some of their cochlear implant patients didn't even get a good hearing aid evaluation. In other words, they might've been evaluated with a severe or profound hearing loss, but their hearing aids weren't working properly or the hearing aids were 15 years old or the hearing aids were not the latest technology or something as simple as an earmold that didn't work properly or was a dome, which is totally inappropriate for that patient most of the time. And so the audiologic information given to the neurotologist to discuss with the patient may not be as good as it needs to be. And these are all backstop issues. When I refer a patient to you, you're presuming I have done a complete comprehensive audiometric evaluation. That's where your discussion starts.
Dr. Ted McRackan:
Yeah, no, no, absolutely. We see that all the time clinically, having to reprogram hearing aids on the fly when they come in for their evaluation. We wish everything was perfect when they came in here, but that's certainly not the case. But getting back to what you were saying-
Dr. Douglas L. Beck:
Yes, sure.
Dr. Ted McRackan:
... Of what those expectations were though, we also developed this cochlear implant quality of life functional staging system. So-
Dr. Douglas L. Beck:
Sure, let's talk about that.
Dr. Ted McRackan:
... We have with speech recognition scores, [inaudible 00:11:27] percentage scores or any patient reported outcome measure on a 0 to 100 scale, there's no inherent meaning of what those numbers mean.
Dr. Douglas L. Beck:
Yeah.
Dr. Ted McRackan:
So a score of 40 or expected to perform at a 60, there's no real meaning there. And what we do with the functional staging system is actually use some fancy psychometric analyses to basically determine how many unique stages there are, functional stages, per domain. So it varies from three to five depending on the different domains. For example, the communication domain has five. And then you actually determine what those cut scores are between the five ability levels for cochlear implant users. And then you can actually, since we use this something called item response theory, it's very predictive of how patients respond based on, for every score from 0 to 100, we can predict accurately how someone responded to every item on the instrument.
Dr. Douglas L. Beck:
On your website, you do have a spot where you can enter the raw scores and it tells you what the actual interpreted score should be on that.
Dr. Ted McRackan:
Exactly, yeah. And it tells you what the state should be in. And what's nice about that is then you could actually create clinical vignettes based on that score and you can say, "Well, look, you think you're going to score in stage five the highest level, and this is what stage five means." But you have to understand, 20% of patients score on stage four and this is what stage four means, this is 40% score in stage three. So you can actually go through each of the stages and rather than just saying, "Well, that's a really high score," or "You're probably not going to perform there, set your expectations lower," you can actually say, "Well, here's what to expect." Now, like you said, we're not guaranteeing you this is how you're going to perform, but these are the situations where you might still struggle, you might still need lip-reading, you might still need other things, just to give a patient really a better idea of a year out after their cochlear implant what's the most likely outcome they might see.
Dr. Douglas L. Beck:
And this tool, just by way of background, I was looking at some of the research on this, and one of the early publications that you were involved with was 2019 and at that point, you had seven domains, which was reduced to six because the seventh one just wasn't clinically efficacious, let's say. But you started with an online questionnaire that went out to 500 adult cochlear implant patients and this was over 20 cochlear implant centers, and that came up with 101 questions for the CIQOL, and that was reduced further and reduced further and reduced further until, I guess, you got the bank of 81 items over six domains. Does that sound right?
Dr. Ted McRackan:
Right. Yeah, exactly. That's exactly right. So the modern way of developing these instruments is that what I mentioned, the item response theory. And really, it's just a much more rigorous way of identifying, one, are the domains that you think you're measuring actually unidimensional constructs? Are they measuring only one thing, are they not really interacting with the other domains? And then are the items that are included in that domain, are they actually measuring the ability levels of your patient group of interest?
Dr. Douglas L. Beck:
Yeah, so this gives you tremendous predictive power. It could be right, it could be wrong, but it's mostly pretty much on target, I'm going to guess.
Dr. Ted McRackan:
Well, I'm not sure predictive, but it lets us really know, hone in on what the individual patient's ability levels are. The analogy that's always used is like a math test. If you have a math test that's really easy, and you might have some really smart kids who all got a 100% on it. You can't differentiate the ability levels of those kids who've got a 100%.
Dr. Douglas L. Beck:
Sure. Ceiling effect there.
Dr. Ted McRackan:
Exactly major ceiling effect, but what item response theory does is it really breaks down at every ability level, make sure you have items that differentiate-
Dr. Douglas L. Beck:
Right.
Dr. Ted McRackan:
[inaudible 00:15:07] it gets with patients at that ability level and measures the full ability spectrum. So that's what, if you look on the staging system paper that we came out with, it's got these beautiful graphs of what the ability levels are-
Dr. Douglas L. Beck:
Right.
Dr. Ted McRackan:
... For each respondent. And that allows us to do that. We know where each item has its optimal measurement characteristics. So we can-
Dr. Douglas L. Beck:
And that paper that you just mentioned is the Laryngoscope paper, 2022?
Dr. Ted McRackan:
Right, right.
Dr. Douglas L. Beck:
So that one for people looking for the title development and implementation of the cochlear implant quality of life functional staging system, Laryngoscope, November 2022.
In that paper, you talk about the CIQOL-35. So it's 35 essential questions, right? How long does that take to administer?
Dr. Ted McRackan:
It's about four and a half minutes.
Dr. Douglas L. Beck:
Oh, my goodness.
Dr. Ted McRackan:
Yeah, it really does not take that much time. We actually have developed and are beta testing an app in a web-based format where clinics can subscribe and actually use this to give it, to administer to patients before they even come into clinic.
Dr. Douglas L. Beck:
Sure, great.
Dr. Ted McRackan:
Also, they can just click through it and it also automatically interprets the scores and provides feedback for the patients, especially regarding counseling and for the clinicians where they can actually look at the scores and it helps with the interpretation of the score and it skips a lot of the steps that I do in my head on a daily basis to help interpret the score and how to use it clinically, but also helps monitor patients over time.
Dr. Douglas L. Beck:
In the paper, I think you said that goes out to 6 or 12 months post-op?
Dr. Ted McRackan:
Yeah, yeah. So our plan is it's going to be adaptive for every clinic if they want to give it 1, 3, 6, 12 months, which is what we plan on doing.
Dr. Douglas L. Beck:
Right.
Dr. Ted McRackan:
It monitors patients over time. It identifies patients who aren't improving. There's interpreting what's an improvement and not an improvement. It's not as easy as people used to think it was. There's changes based on where you are on the scale. And so rather than having clinicians with these tables at their desks of determining where they were, where are now, whether it's improvement, so we've baked that into the app in the web-based format. So it will flag patients if they haven't improved from baseline or if they've gotten worse or better. It lets clinicians know of, all right, this is a patient...
And we have early data now that shows that if a patient by one month or three months doesn't demonstrate an improvement that's clinically significant, that patient has a very low likelihood of demonstrating improvement. So that might be a patient where you need to actually change what you're doing, change programming, add more auditory training, encourage more hours of usage for that patient. So we're trying to make it really so... The goal all along was to create something that wasn't just, okay, another patient-reported outcome measure, but something that can actually be used in realtime to help patients make decisions.
Dr. Douglas L. Beck:
What about patients... Because when we talk about a typical cochlear implant candidate, we're talking about typically severe or profound sensorineural hearing loss, usually very low word recognition scores. And even though that sounds like a peculiar patient, those are typical cochlear implant patients, but then within the cochlear implant candidates, you have some people who have cochleas that might have different Mondini deformations, and would this scaling, would this be appropriate for all cochlear implant candidates or is this just the ones with patent cochleas?
Dr. Ted McRackan:
Yeah, it is a great question. For all of our stuff that was done internally, we had a really nice control over the patients, but when we went through all the other centers, and we actually ended up with 30 centers throughout the country being involved in the research in the end, but sometimes you're going to lose a little bit of that, but we measured, we made sure there were postlingually deafened adults. We did not include any prelingually deafened adults, but individual cochlear abnormalities. It is just hard. We did direct-to-patient research, and so it was hard for patients to report that. So it didn't end up being included in the analysis and the etiologies of deafness weren't... It's so hard for, we often don't know. So you end up with 60+ percentage of patients with unknown positive deafness.
Dr. Douglas L. Beck:
Yeah, of course, of course.
Dr. Ted McRackan:
So we think it's validated in all postlingually deafened adults, and no matter what kind of how much residual hearing was present before the surgery, so we had people using hybrid or electroacoustic stimulation modalities who were included in the study, so the full range of pre-CI hearing. But for those kind of more specific questions, I'm really uncertain.
Dr. Douglas L. Beck:
Yeah. Well, and this is always a problem with large studies, right? Because when you look at large epidemiologic studies, they're based on a large population of people and there's variation. That's why we always need to know the standard deviation and the sensitivity and confidence intervals, things like that. For the typical candidate for cochlear implant, this makes good sense and I'm totally on board, but we have to use it with caution then if we're talking about a Mondini's type III or somebody who's got an ossified cochlea, it may or may not apply as well.
Dr. Ted McRackan:
Yeah, no, that's very true.
Dr. Douglas L. Beck:
Okay. And tell me about when you're seeing patients and you know that this patient is a particular cochlear implant patient, whichever of the three you and the patient may have selected, because there's Med-el, there's Cochlear, and there's Advanced Bionics, so whichever one of those they're going to get, does this staging allow you to interpret one outcome better than the others? Does it relate more to Cochlear or more to Advanced, more to Med-el, or are they all-
Dr. Ted McRackan:
Yeah, we had all the manufacturers included in the study, so we had a nice proportion for each.
Dr. Douglas L. Beck:
So where's the study going? What's the next step?
Dr. Ted McRackan:
Yeah, so the next step is really, we focused a lot more recently on that counseling aspect and how we can better advise patients about whether or not they want to proceed with a cochlear implant. That's a major, major hurdle. As it used to be, Douglas, you know, in the early stages of cochlear implantation, patients were profoundly deaf, they had no hearing, no word recognition, the decision of proceeding with the cochlear implant, other than the safety concerns that were there early on, for many years wasn't that hard of a decision. There really weren't a lot of options available. Obviously, there's cultural issues that play a role, but the average postlingually deafened adult, really it made sense if you had no word recognition, you were going to get better, likely. But the question of how much better was the question, but now it's expanded, right?
Dr. Douglas L. Beck:
Oh, sure.
Dr. Ted McRackan:
Ballgame now, and these decisions, we always joke 'cause we die for a vanilla cochlear implant candidate to walk in the door. Everybody we see now, there's very specific hearing patterns and asymmetries and whether or not the benefits of, the decision-making process has gotten so much harder over time and this is where we really see the value of the CIQOL instruments because data from us and others have consistently demonstrated that word recognition scores, our standard metric for outcomes, don't correlate with patient's self-reported functional abilities.
Dr. Douglas L. Beck:
Absolutely.
Dr. Ted McRackan:
So we really want to move towards something that really, really resonates with what patients really care. And that's why we included patients in the early stages of developing the actual instrument. We did focus groups and they were included 'cause we wanted to include what mattered to the patient. So now the real question is the development of these instruments is the boring part, it's now applying them. It's now applying them and seeing what we can do with them and how we can not at all replace speech recognition testing, but supplement and use this information to help patients along the decision-making process.
Dr. Douglas L. Beck:
Not to go down memory lane too far, but when you talk about previous profound loss cochlear implant candidates, I can tell you that back in the early '80s, if your thresholds were less than 110 dB, you were probably not getting a cochlear implant and we would look at people 105, 110, 115, 120 DB HL thresholds. Those were the early candidates before the FDA approved it. And even after the FDA approved it, which I'm pretty sure was '86, it had to be a profound loss. So you're exactly right. Now, we can go down to a moderate loss depending on multiple factors per FDA. And of course, there are some times when people go beyond those suggested guidelines.
It's a joy to talk to you. I think this is very exciting and I think this is a necessary development because of all the reasons we've discussed. Oftentimes, patients do have unrealistic expectations. Oftentimes, you and I, as professionals who are involved with cochlear implants, we can't really tell exactly where that patient is when they say they're having difficulty or it's not doing what they had expected or it doesn't sound like it used to. These are really hard things to quantify and the more tools you have that are research-based and outcomes-based, the better it is for the patient and the clinicians.
Dr. Ted McRackan:
Yeah, what's really interesting is the expectations piece. We just had a paper recently come out where we basically demonstrated that the larger the gap between the patient's expectation and how they actually performed, the less satisfied they were with their decision to proceed-
Dr. Douglas L. Beck:
Oh, sure.
Dr. Ted McRackan:
... The more decisional regret is the research term that's used and basically as that gap grew, the more dissatisfied they were. And so that's what really puts the emphasis on why it's so important to get that counseling piece right to make sure patients have realistic expectations. And people always say, "Well, are you going to tell people not to get a cochlear implant?" And that's not the conversation we have. It's setting expectations and asking that patient, "Do you now want to proceed with a cochlear implant or not?" 'Cause if you think you're going to get here, and that's why you want to be able to understand everybody in the most crowded bar in Charleston at midnight, it is probably unrealistic expectation. Now, some get there-
Dr. Douglas L. Beck:
Yeah, they do.
Dr. Ted McRackan:
... And it's awesome. Work hard, use your implant for many, many hours a day, do all the auditory training you can to try to get there, it is an awesome goal to have, but it may not be that realistic and then just some inherent limitations with the device and with your neural health in general that may be playing a role and limit that stuff.
Dr. Douglas L. Beck:
No, and I think that's a good point. I think that's a fair comparison. I would use buyer's remorse as the same sort of a situation, but I think if you go in with your eyes open and you have realistic expectations and you've asked those questions and somebody has a dataset that addresses those concerns based on well-done statistical analysis of the outcomes, everybody's in better shape. And I think that this is an empowering thing for patients because they have a much stronger concept of what they're about to embark on and what the more likely outcome is going to be for them as an individual.
Dr. Ted McRackan:
Yeah.
Dr. Douglas L. Beck:
Yeah. All right. Well, Ted, I want to thank you so much. I know that I was able to get online very easily and look at your website online, and I think the easiest way to do that is if somebody just Googles CIQOL, right? Wouldn't it...
Dr. Ted McRackan:
Yeah, it's education.musc.edu/CIQOL. All of our instruments are free to download. You just have to fill out a quick form. And a lot of our manuscripts are available on the website to take a look at as well.
Dr. Douglas L. Beck:
Fantastic. And I really enjoyed learning on the website and I thought it was particularly easy to use. I really liked it. Thank you so much.
Dr. Ted McRackan:
We have a manual, we have a CIQOL manual that we developed as well that takes you through everything step-by-step.
Dr. Douglas L. Beck:
I forgot about that, but that's about 25 or 30 pages. I was looking through it yesterday and it was just intuitive. It's set up exactly as you would like it to be set up and you can find what you need easily and you can download it as PDF or you can print the 25 or 30 pages, but very useful, absolutely.
Dr. Ted McRackan:
All right, thank you so much, Doug, for having me. I appreciate it.
Dr. Douglas L. Beck:
Thank you. Great. Appreciate your time, Ted, and I wish you all the best.
Dr. Ted McRackan:
Thank you.