EPISODE 36

[INTRODUCTION]

[00:00:00] ANNOUNCER: Do you enjoy listening to On The Ear, but wish you could earn ASHA CEUs for it? Start today! SpeechTherapyPD.com has over 175 hours of audio courses on-demand, with an average of 19 new audio courses released each month. Here's the best part, each episode earns you ASHA Continuing Ed Credits. Oh, no wait. This is the best part. As a listener of On The Ear, you can receive $20 off in annual subscription when you use code EAR21. Just head to SpeechTherapyPD.com to sign up and use code EAR21, E-A-R-2-1 for $20 off your annual subscription.

[00:00:48] DS: You're listening to On The Ear, an audiology podcast sponsored by SpeechTherapyPD.com. I'm your host, Dr. Dakota Sharp, Au.D, CCC-A, audiologist, clinical professor and lifelong learner.

While I primarily work with pediatric cochlear implants and hearing aids, I am absolutely intrigued by the many areas of audiology and communication in general. This podcast aims to explore the science of hearing, balance and communication with a variety of experts in hopes of equipping you to better serve your patients, colleagues and students. Let's go! We are live and On The Ear, brought to you by SpeechTherapyPD.com.

[INTERVIEW]

[00:01:35] DS: In the world of cochlear implants appropriate expectations for recipients are critically important. Research suggests that other than audio logic factors, clinicians see realistic patient expectations as one of the most important factors in deciding whether to move forward with a cochlear implant. How do we accurately assess patient expectations? Today's guest has crafted a tool to assist us in the process and ultimately improve our assessment of patient outcomes. Dr. Teddy McRackan, M.D is the director of the Skull Base Center and Medical Director of the Cochlear Implant Program in the Department of Otolaryngology and Head and Neck Surgery at the Medical University of South Carolina. 

Dr. McRackan was born in Virginia and moved to Charleston to attend the College of Charleston. He received his medical degree from the Medical University of South Carolina and completed his residency at Vanderbilt University in Nashville, Tennessee. Afterward, he moved to LA for a fellowship in otology-neurotology and skull base surgery at the House Ear Clinic. 

Dr. McRackanÕs clinical practice is focused on comprehensive management of ear, hearing, balance, and skull-based disorders in adults and children. Dr. McRackan has published a comprehensive neurotology textbook and has written over 100 peer-reviewed articles and book chapters. His research interests focus on the development and application of novel measures to evaluate outcomes and individuals with hearing loss and cochlear implants in order to improve patient results. His work is so critical for a lot of you listeners out there who are audiologists and speech-language pathologists and we're so grateful to have Dr. McRackan here.

[DISCLOSURE]

[00:02:57] DS: Just a couple of quick financial disclosures, I'm the host here On The Ear and receive compensation from SpeechTherapyPD.com. Dr. McRackan received compensation for his contributions to this presentation. 

[INTERVIEW]

[00:03:06] DS: We're so grateful to have you here, Dr. McRackan. Teddy, can I call you, Teddy?

[00:03:12] TM: Yes, absolutely, Dakota.

[00:03:13] DS: Awesome.

[00:03:13] TM: Yeah. Thanks for having me.

[00:03:14] DS: Of course, of course. Now, I was telling you beforehand, this is our first time having an ENT on the podcast. A critical aspect of audiological care in the ENT is definitely a big part of what we do as audiologists. I'm just so grateful you agreed to join me for this.
[00:03:29] TM:  No, no, it's a real honor. 

[00:03:31] DS: Awesome. Well, first of all, I'm really curious that we're both from Virginia, which is cool. We've briefly talked about this in the past. I'm curious what brought you into the world of cochlear implants, specifically, and why you decided to go down that route of being an Otolaryngologist?

[00:03:44] TM: Yeah. So in medicine, one of the big decision trees is whether you go into a surgical subspecialty, or a surgical specialty surgery, or medicine, the two big decision points. Then I was clear, I wanted to do something more procedural, more surgical, and really, my interactions with the neurotology team at MUSC many years ago, were really foundational in my pursuing ENT, in general. Then as I moved throughout ENT just became more and more drawn to ear anatomy or ear physiology, ear surgeries, and the impact that those surgeries had on individuals' lives. 

I mean, there's nothing cooler than a cochlear implant, right? You have someone who has extremely poor hearing, not getting a lot of benefit from a hearing aid. You give them a cochlear implant, and we'll probably talk more about this at the end, but on average, people have an incredible response and it's a life-changing device, right? It's one of the only neural prostheses we have like this available for patients. It's just, I mean to have a surgery you do, you turn it on, youÕre doing electrical stimulation and you're having a direct impact on a patient's everyday life with something that's essentially while they're awake, and while they have it on. It continuously stimulated the auditory nerve is just a fascinating thing. So that was what brought me into it. 

[00:05:03] DS: That's really, really cool. It's interesting to hear that specifically cochlear implants and how they work is something that really fascinates you. I know Otolaryngology is such a big umbrella. There's so many different ways to practice that both, I guess, in medicine and in surgery. It's really cool that you were drawn specifically to the idea. I mean, I know you do a lot of things other than cochlear implants. I definitely know that's a big part of your practice. I'm curious, was there an early experience or anything like that, that really made you more interested in cochlear implants and hearing loss specifically, under that bigger umbrella of otology-neurotology?

[00:05:36] TM: Yeah. I think from an early part of my career it was pretty obvious to me how, what an incredible impact hearing loss has on an individualÕs life and how comprehensive that impact is. Not just from obviously a communication standpoint, but the more broader implications of that hearing loss, the social isolation, emotional distress, the impact on relationships. I mean, to me, it was just such a broad impact on these individualsÕ lives that was, and then I'm like look at now we have something that is available, right, that is commonly implanted, that can really help that. 

I think hearing aids, I think hearing aids are extremely important. They're exciting in their own right. I mean they're doing a bit of lifting, but the amount of lifting that cochlear implantation has to do is just so great. That surgical element to it, it's just beautiful anatomy, as well. It's an elegant procedure and it hit on all cylinders for me. Yeah.

[00:06:50] DS: Absolutely. It sounds like from the beginning you've been interested in that bigger picture of hearing loss as it relates to someone's daily life and their quality of life, specifically. I guess that interest in quality of life, specifically, something you were intrigued by early on, or did that come later with more exposure to cochlear implant patients?

[00:07:08] TM: Yeah. I think it came probably later with more exposure. Just sitting down and talking with patients it's amazing, the end of the stories they tell of when you're early on your cochlear implant, potential candidates talking to them about their everyday experiences. It's very eye-opening. I mean, I think the measurement of that quality of life and the impact of the implant on individualsÕ overall quality of life and their real-world functional abilities. The fascination for me I've always been a numbers nerd, but for me, in a measurement kind of nerd. For me, the idea that we had, outcome measure, speech recognition ability that just did not strongly correlate with peoplesÕ  real world experiences was very eye-opening to me. 

I saw that it's just an incredible gap and how we practice cochlear implant care. For those who don't know, in research by us and others have basically demonstrated that it's somewhere between four to 16% of patients' self-reported, real-world communication ability can be described by speech recognition ability. That's words, sentences, sentences and background noise. So there's just not a strong correlation between how a patient does in an audio booth even with background noise and those individualsÕ real-world experiences. So for me, that was the really the ignition for my research piece was that discrepancy that I was seeing there.

[00:08:46] DS: I'm curious. Do you feel that correlation, does it go both ways? I feel like, personally what I've seen in clinic, it certainly can, right? You might have somebody who's a star performer speech reception wise, but then isn't super happy with their experience, maybe it didn't live up to their expectations, but on the polar opposite I could have somebody who gets their cochlear implant has barely any speech perception abilities at all, but they're just so overjoyed at their sound awareness that they get from their device that they're very happy with their device was really poor. I guess that correlation that you're talking about is the data showing us in both directions that can be a poor predictor?

[00:09:18] TM: Yeah, absolutely. What I'll say is, maybe not, because I think we often conflate going to these terms of quality of life and patient-reported outcome measures and functional abilities, all as one. I think we're talking about different things. I think we really don't see a pitch to score extremely low on speech recognition ability, for our Cochlear Implant Quality of Life instrument. We don't see them scoring particularly high on the communication domain, right? I mean, you may see other things in environmental domain, but there's got to be a baseline speech recognition ability to get over the hurdle. 

Now, when you do have some degree or some decent speech Ð we can argue about what that is, probably, well that speech recognition ability is, then you see a huge vast difference in how that's applied in the real world. Now, what I'll say is, one of my favorite patients we had as part of our focus groups, was a sweet lady who, she had meningitis that had bottomward, from completely normal hearing to bilateral complete hearing loss, profound, profound. She performed with her cochlear implants she had 0% word recognition, right? 

Every test and bile, you look at that and say, ÒWell, that was a failure, what did we really gain?Ó But she was over the moon excited about a cochlear implant because it took her into the real world. She could hear sound. So before a cochlear implant, she stayed in her apartment all the time. She didn't feel comfortable going out and walking her dog, which was the most important things in her life, was getting out and walking. Then she had a cochlear implant, and she could sit, she could hear traffic, she could hear people on the street. So she felt comfortable. She started going back out into the world and interacting with people once again. I mean, I think, we kind of talking about degrees of success with cochlear implantation, but that's an obvious one where hugely impactful in her life. Again, as speech recognition scores go, you can say, well, there's no improvement. 

[00:11:16] DS: Yeah. I think that's a perfect example of that discrepancy. That's an interesting point for people who might not be in the cochlear implant space as clinicians who might see someone come in who's no response 0% or has a hearing history where you would say, ÒWell, I mean, technically on paper, your cochlear implant candidate, but what would you really get out of this thing?Ó You know what I mean? They don't know stories with patients with similar experiences to this, right? I think that's a really helpful reminder. I'm wondering where there specific clinical cases that made you want to explore this quality of life like the subcategories, further, what kicked off this research project?

[00:11:53] TM: Yeah, I mean, the kicking off was reading the literature, showing this discrepancy, right, between what we're holding up as the holy grail of our outcome measure and the fact that it didn't really agree with patients real-world experiences. Then they were those the different domains within our instruments came from is we did a series of three focus groups with cochlear implant users. Patients were the ones who actually developed all of the items that are included in the instrument, develop what the domains were. We categorize things. They did all sorts of fancy psychometric testing to confirm that those domains were valid. 

I tell researching this all the time is that, when it comes to the research and the development of these instruments, I really undervalued on the onset of the focus groups. I was like, all we know what's going to be in these instruments, there's all these different problems out there, people have asked all these different questions. It was actually completely foundational to everything that's come since then. I mean the responses we got from them and just for people who aren't aware of the different domains for the instrument or communication, entertainment, emotional, environmental, listening effort, and social, right? So many things like listening effort, things like environmental sound, awareness, those are things that we don't really measure, and really don't talk about at all. 

A lot of these other areas, right, as from emotional, social, these are things we generally talk about patients, to talk to patients about, but it's not that we really have the capacity to prove it to really measure on a routine basis, but all of those came from those focus groups and those patients. WeÕre the first instrument to actually do that in the cochlear implant world is actually to have those conversations with patients and let them be the sources for what's included in the instruments, which I think did provide a lot of power. It's really gotten us to the functional staging system. All the things that I think are pretty exciting that we're doing now, I mean, none of them would have been possible without having the instrument VA meaningful outcome measure and by meaningful meaning, meaningful from a patient's perspective.

[00:14:01] DS: Yeah. That makes sense. That's really interesting that that's where the idea of, I guess, maybe not the idea, but the questions on the questionnaire originated from is from actual input from cochlear implant recipients. I think that is an amazing place to start. Going from there, what were some of the next steps? I mean, I can't even imagine the steps that go into creating a questionnaire that then can be utilized for like, I don't know that you'd call it objective data purposes, but for reasons that you can use more scientifically and in a research sense, who else was on the team that helped develop this to help make this a tool that's utilized by more clinicians than maybe just your own center?

[00:14:35] TM: Yeah. This is a true team science research collaboration. Myself, Judy Dubno, who finds needs no introduction for many of you, but one of the great minds in hearing research, Craig Velozo, who is the director of occupational therapy at MUSC. He's a Psychometrician.

[00:14:53] DS: Oh, cool. 

[00:14:53] TM: I don't even remember how we crossed paths, but we were looking for it, basically exactly him, we came across for one of Ð I think was one of these research searches on campus to find collaborators. Then his postdoc, Brittany Hand, who is a occupational therapist, and a Ph.D, who's also a Psychometrician and a methodologist. She's now at the Ohio State University. We've maintained a collaboration with her. So the process starts with developing your items from the focus groups, and the items by these, I mean like the question stems that are included in the instrument. Then we vet them with the separate group of cochlear implant users to make sure they understand what they mean, they can repeat back to us what we think they mean. At that point, you have this huge item pool of questions to be included in the final instruments. 

Then it goes, extensive psychometric testing, so factor analyses, item response theory. The psychometric analyses, again, were very foundational kind of the work that came later, but what that basically does is it makes sure that the items that you're including in your instruments cover the ability range of your population, and make sure that you align individual ability levels with the difficulty of the individual items. So you basically get a big menu of items for every domain, and you confirm that all the domains are unidimensional and only measuring one construct. Then with at the end of the day, what you get is basically menu of items, and you know which items are best at measuring patients who have a really high ability level, and you have an understanding of which items are better at testing patients at the lowest ability level, and then everything in between. 

Then what you do is, you start with 101 items, and then you pare it down and select items that cover the ability spectrum or really good at differentiating patient ability levels and that took our 35-item instrument. It's you get this wonderful menu then select the best items that patients came up with. Then they get you to your 35, CIQOL-35 Profile which measures patient outcomes in the six domains that I mentioned before. Then we also developed a 10-item global instrument, which is more of a global assessment. It doesn't provide any domain-specific information.

Then the next step is you have to validate it so that we put it against the NCIQ, Nijmegen Cochlear Implant Questionnaire, and it gets the HUI3, the Health Utility Index Mark 3. We compare the psychometric properties. Without going into too much of it, it outperformed both of those and did reliability testing. That's what gets you your final instrument. That's four of years of my life and five minutes in there.

[00:17:32] DS: You guys are reaching ahead for that now, where it's basically ready to be distributed, is this something people can access and utilize?

[00:17:39] TM: Yeah. It's free to download. You have to fill out a user agreement that you're not going to do certain things with it. But yeah, if you go education.musc.edu\ciqol if you just search, I think, CIQOL. My Google, at least it brings me there to the website where you can download it for free under the scoring manual, and there's automated scoring versions of it available.

[00:18:03] DS: Would you mind giving me a couple of examples of things that would be in like each of those six domains? 

[00:18:07] TM: Yeah. For example, in the communication domain, some of these are fairly obvious, but again, the wording of these items matters from a measurement standpoint, so some items that were similarly worded were thrown out because some versions performed better on a consistent basis. But, yeah, from the easiest items in the communication domain would be, I'm able to have a conversation in a quiet place without asking the other person to repeat themselves. Getting a little bit more difficult would be I can hear and understand without looking at the person speaking. Then the most difficult item in that domain would be, I can follow the conversation in a group of five people in a crowded restaurant when I cannot see everyone. 

[00:18:45] DS: Got it. Is it using like Likert scale? 

[00:18:48] TM: Yeah. It goes, yeah, never, rarely, sometimes, often, and always.

[00:18:52] DS: Got it. 

[00:18:53] TM: Then go through the emotional domain. My hearing loss makes me feel inadequate. I become frustrated when I cannot follow a conversation. Then going to the entertainment domain. I'm able to enjoy music, music sounds clear and natural to me. Environmental domain, everyday sounds, birds chirping, rain, car horns, etc. are clear to me. I'm able to hear cars approaching and traffic, that moving on to the listening effort. I can easily have a conversation in a noisy place, restaurant, party, store that I have to concentrate when having a conversation with strangers in a noisy place, again, for the listening effort. The social domain. I have the confidence to socialize. I avoid social situations due to my hearing loss. I feel left out when I'm with a group of people due to my hearing loss. 

The item response theory psychometrics, the nicest thing about it is that you actually know how all of these individual items perform with different users. If someone's a high user, is reporting always able to endorse a certain activity, we know how each item interacts with that individual. What we ended up creating, and we have our cochlear implant quality life functional stating systems coming out. It's been accepted to become out in the very near future and the laryngoscope. It was my trial, logical side-to-side of thesis. I'm glad it's behind me, but Ð wonderful graphs.

[00:20:17] DS: Congrats.

[00:20:18] TM: Yeah. Thanks. These wonderful graphs where it actually shows hierarchical ability level for each of these items, and then you can look at the different response patterns. If someone scores, let's say, 50 on the communication domain, I mean that it really doesn't have any real inherent meaning, right? You know that zero is the worst, 100 is the best. So it's somewhere in the middle, but you don't really know what functional abilities are associated with that. So the cochlear implant quantify functional staging system, what it's done is actually looked at the response pattern. It's a very reliable response pattern for these items for individuals. You can actually say, look, a score of 50 is associated with these responses. 

Someone who has a score of 50 is able to do XY and Z is not able to do this, this, and this. So for each domain, so the communication domain has five stages in it. It goes through from one being the lowest ability level to five to the highest ability level. Then we have all other domains actually have three stages. That's just from a measurement standpoint, that's all that patients were distributed into. But it gives us a new way of discussing outcomes with patients of clinicians knowing what individual patientsÕ abilities are by looking at a score. We can actually start to direct therapy based on the staging system, because we know what the barriers are for individuals to say from go to stage two, to stage three. Those are very different than someone trying to go from stage three to stage four. 

It gets back to the rehabilitation model of treating patients at the area where they're having the most difficult and this is very common in physical therapy, occupational therapy. This is what they do on a routine basis, but it's been lost with cochlear implant care and hearing care in general, but this is actually an evidence-base where we can get back to it. Also, it's a way of discussing outcomes with patients and potential patient outcomes. As part of all of this psychometric testing we've done, validity testing, we have data on 705 cochlear implant users from across the United States. We have a 30, Cochlear Implant Center Consortium, which helps recruit patients for all these studies, because all these psychometric analysis took a ton of patients to be able to build these models. 

We had all these data on 705 patients, a cochlear implant user, and these are all people with at least 12 months experience with a cochlear implant, your routine cochlear implant patient, not SSD, not Single Sided Deafness, not some big asymmetric hearing loss, but your traditional cochlear implant, bilateral hearing loss patient. We can then talk about real-world outcomes. We know the percentage breakdown, right? We know from the 705 patients, we have essentially developed normative data, right, for a cochlear implant userÕs functional ability. Instead of focusing on things like, well, the average person gets 60% word recognition, and not really knowing what that means, in real-world setting. We can actually use examples. We've developed clinical vignettes that go with all of the different stages, where you can really talk to patients about their outcomes, using these real-world examples.

[00:23:18] DS: This is awesome. I'm so grateful that you just shared that breakdown. I'm really excited about that tool. I mean, it sounds amazing. I liked that as you were wrapping up that thought you were talking more about the clinical implementation for that. I'm curious Ð this is a two part question here. One, I guess I'm a little bit surprised that as the surgeon, you are interested in taking on a roll and the questionnaire side of things, right? I always think of that as the audiologist has to deliver the questionnaires, we do the speech recognition testing before that's common among ENTs to be more interested. I mean, no, I'm sure you guys are interested in the bigger picture and how the cochlear implant is impacting their life, but specifically in gathering that objective, or its objective and subjective data from the patient?

[00:24:04] TM: Yeah. I know. They make fun of me at our program, but I'm a secret audiologist. This goes along with all of that. That was my secret dream was probably to be an audiologist that I just ended up being a surgeon. But no, I mean, I think there's more and more people interested in this, right? Because we don't want to do a surgery on somebody who is not going to get much benefit and it's taking something to the operating rooms a serious responsibility, right? There's a lot of weight on your shoulders. There's complications. Things can happen. 

I mean, we certainly we want to make sure that patients have a clear one clear understanding of the potential outcomes that dovetails a little bit of expectations. Also that they know what they're getting into and then they know the potential benefit and that this patient is most likely going to get a benefit. That's what some of our upcoming research is discussing of predictive models for using the status dating system and our instrument to see, can we use it to help with the cochlear implant evaluation process.

[00:25:00] DS: Got it. The way that it's currently being utilized, do you see it as more of a tool that we would use in the candidacy stages to get a sense of their expectations? It sounds the questions are more geared towards current situation. I guess it could be utilized pre-implant and post-implant. You can monitor their progress with all of these different domains. I'm curious how you see it currently being utilized. It sounds like in the future it can be more of a comparison to other metrics, as well.

[00:25:30] TM: Yeah. I mean a major problem in research in general, right? It's the implementation, right? You develop all these things, but how do you actually implement them clinically so it actually impact an individual patient who's sitting in front of you. It's a major hurdle and implementation science is an area of interest of mine and many other people out there. It's the next step of how do we create evidence and then implement that evidence. Currently at our center, we're using it in a comprehensive fashion. We are using it on the cochlear implant evaluation side to starting to use it more and more, I should say. I'm using it on a very regular basis because I can calculate all these things just by looking at response patterns. 

[00:26:19] DS: Sure.

[00:26:20] TM: On the instruments, but yeah, so it mean, so I think from a pre-implantation standpoint, the wording of the instrument is such that someone can complete it, whether or not they have a cochlear implant. We really worked on the wording to say, if you do not have a cochlear implant, please answer how you answer with your hearing aids or without or if you don't use hearing aids without your hearing. We massage the wording. It took about 18 versions of it to get it, but we were happy with patients understood what we were actually saying. 

Yeah, so we can get patients' pre-operative ability, right, for all six domains. We have normative data for 705 cochlear implant users. We have the staging breakdown. We have the score breakdown. So we actually can look at patients, how they score on the CIQOL-35 Profile, and then say, look, while your speech recognition, let's say maybe pretty good, you're not functioning that well, right? Or the opposite, you could say, look, you're doing really well, with your hearing aids right now, from a functional standpoint. Gosh, we'd be lucky to get this score with our cochlear implant.

[00:27:30] DS: Got it.

[00:27:30] TM: Then we're working on more predictive models for that, and we have a lot of technology coming out that's going to be coming out of our center in the near future to help other centers ease, implement this with more ease and develop app and web-based. It's very easy to use for any cochlear implants center to adopt it, and not have to calculate the scores by hand and things like that. There's a lot of them coming up, but we can use those to have those conversations with patients. Again, using real-world examples and not say, ÒWell you have you have AZ bio plus 10 of 20 and the average score is this, which is it's hard for patients to really understand it and we've done some cognitive interviews with patients. 

It's not their favorite thing is discussing these things that, I mean, some patients like it, the word recognition, because they think of it a math test, like well, I got 20%, right then and I got 7% right now. I can fathom what that means, but I mean, they don't know that that doesn't really correlate with their real-world abilities. So the patients, we've talked to, they love the staging system and discussing outcomes in that manner. Then the other side, it's the XO, so using it, it's what is your baseline functional ability, but then we've now developed in psychometrically validated the CIQOL Expectation Instrument.

We did that by actually converting every item in the 35 item profile to an expectation based question or saying like, I will be able to. Yes, but changing just the wording slightly to get an idea, because you talked earlier about the work that Sandy Prentice was the senior author on it, from a CI audiologist standpoint, realistic expectations is the most important thing beyond audiometric testing, that makes an audiologist recommend cochlear implantation for a patient, but the reality is we don't have a way to really measure what we previously didn't have a way to measure what patients expectations were, right? We have these generalized conversations. 

Then if they told us what their expectations were, we didn't have a way to say whether or not that was realistic or not, right? I mean, we all use our personal experience, variability from audiologist to audiologist, of physician to physician of what realistic expectations are. This instrument by, so we converted every items, that means that every item correlates and corresponds with the CIQOL-35 Profile Instrument. When patients Ð

[00:30:05] DS: That is so cool. I didnÕt realize this, expectations cool.

[00:30:09] TM: Yeah. So basically, you can look at it. We can actually using our normative data for 705 cochlear implant users, we can actually say, ÒLook, you are way off.Ó Right? ÒYou are in the fifth percentile of, I think, how you perform.Ó Right? Or you're way under X now. You should expect a lot more from your cochlear implant. 

[00:30:29] DS: Sure. Yeah.

[00:30:30] TM: The important thing is we're not saying, we're not predicting anything for these patients, but we're just providing patients the data or saying, look, 80% of patients score at this point or higher, right? We have these, we republished these, and we have a new manual, it's going to be coming out very shortly, where it actually Ð it has distribution curves, so you can take a patient, go on to it, look at their score, and say, look, I know this, you think, youÕre not going do, but gosh only 20% of people perform at that level or higher. So you can actually use the expectation instrument to one measure their level of where their expectations are, and then maybe modify it as needed based on our previously published normative data.

[00:31:12] DS: That is really cool. That's a really exciting tool for us to use. I mean, you're so right, that we have these very general conversations with our clinical expertise and our gut feelings about how we feel someone is feeling about their cochlear implant. I mean, this isn't even a metric, I haven't really thought about how much more objective it could be, and how helpful that is as a counseling tool. You're exactly right, these questionnaires, they're almost always a jumping-off point for more conversation. I just think having this as a jumping-off point for conversations about expectations, or conversations about outcomes, and how things are moving along, and then using that to target certain skills and rehabilitation is just such a needed tool. I'm really, really excited about that. It's really cool.

[00:31:59] TM: Yeah, I mean, and again, once again you can use the staging system with it and seeing, say, ÒLook at patients in stage one their chances of moving on. We're publishing more data on the stage progression and the predictive ability of early of pre-CI functional stage on how predictive that might be able to be. We have some exciting stuff. Again, just going away from the pre-CI, clinical visits, moving over to monitoring patients postoperative, it's a great way to monitor when patients have plateaued when their performance has plateaued, or they have not demonstrated early benefit. 

We have some, once again, some more data coming out that shows the really huge, how hugely important early benefit is for these patients. If they haven't benefited by a certain time period, then gosh, it does, it's a pretty grim outlook for these people. It can be used for a wide array of sorry, I messed my words up. It could be used for a wide variety of applications that are the cochlear implant world and the post period as well, so yeah Ð

[00:33:17] DS: Did I lose you? Your voice faded out and now I'm not hearing it at all.

[00:33:24] TM: Oh, my gosh.

[00:33:25] DS: Oh, there you are.

[00:33:25] TM: Okay, I can hear you now. I think I lost my signal. Yeah, what was the last thing you heard? 

[00:33:29] DS: No, it and it ended perfectly on a thought. 

[00:33:32] TM: Okay.

[00:33:32] DS: I have something I want to put there. Yes, I completely agree. I think - I don't see adults really anymore in the cochlear implant space. What I did before, something that I felt like I had to deal with, not all the time, but pretty often was an older adult patient who's four years in with their cochlear implant and they're like, ÒThis thing, it never helped me. I don't even know why I did this. This isn't really providing me much benefit at all.Ó Then I can go back to a year ago and my visit now, it's like, they're very excited about all of their progress. They're doing really well. I'm like I've got to go back into my visit and like, ÒLook, here, you were so happy a year ago. What are you talking about?Ó I think having a number even or more so than that those specific subcategories. 

[00:34:24] TM: Yeah. We were hoping to get very, very granular with this with the technologies we're working on with our folks at MUSC is to go, you go item by item, right? Every question in our instrument, you should be able to go back in time and say, ÒLook, I know you're not saying I get much benefit, but remember, before your implant for item five, on communication, this is where you were and this is where you are today.Ó Right? You went from never been able to do this to sometimes. That's not, maybe not a home run, but I think there's a lot of reinforcement, but also discounting is a term that's commonly used in this world where people discount their prior benefits. I think we see a lot of discounting in cochlear implant patients over time.

[00:35:11] DS: Absolutely. I think also when people are making the decision whether to move forward with a bilateral cochlear implant, having that a comparison can be a really good motivator and reminder of where they were people forget how much they were struggling pre-implant all the time. I see that all the time like, ÒYou're doing so much better. Now, you just don't remember.Ó You're so right. Pointing back to the previous measurements is going to be a great tool to help people remember those differences and all of the progress that they've made. That's really, really cool. 

[00:35:39] TM: Yeah. It may not convince them, but at least, you know, better than we have some data. Yeah.

[00:35:46] DS: Awesome. Maybe switching gears here just a little bit, thinking more about the cochlear implant team and how that functions for you, even when it comes to utilizing a tool like this. Where do you see, well which members of the team would be responsible for asking the questions for the questionnaire, assessing the responses, keeping track of those numbers, and then maintaining those conversations. I get as a team, we're hopefully all on the same page, here's the progress this patient is demonstrating. Here's how they feel about their progress. I'm curious how that takes place for your team specifically?

[00:36:26] TM: Yeah. I know. It's a struggle, even for the teams that develop these things. I mean, it really is. I think ideally, right, you have a patient who's comfortable with technology, you can send them the instrument before their visit, they can complete it at home, or while they're waiting in the waiting area, and it's scored, and it's available for the clinicians from the time that that patient's there. The issue is when you and that's an ideal world, right? One, not all of our patients are comfortable with technology. Two, they may not follow our instructions of completing them. That would be the ideal situation. That can be done. You can have that automated through red cap and other ways. 

Again, this is an area we're focusing on of the implementation side of these instruments for long term. I mean having your front desk people, have them say, look, anybody, well, we do say anybody who has the word cochlear implant attached to their visit, or seeing these providers, who only see cochlear implant patients, just give everybody these instruments, just have them, we give them a stack, we make sure it's filled to the top that's never empty, and can always give them the instruments. 

Now, the problem there is that it's just hard to score on the spot. I mean, maybe you have to know what you're doing. Some items are reverse scored, so you have to keep that in mind. I mean, we have automated versions of it, but they're PDFs, and those are electronic. So if you have iPads available. It's a way you can actually very quickly, you can pull these PDFs on iPads and you have patients just touch along and they'll automatically score it for you. But being completely honest, it is a struggle. It is a constant battle. 

Before surgery, we try to get everybody a packet ahead of time that they filled out, they bring in that's filled out for a while. We actually were requiring patients to complete the packet and return it to us before we were scheduling for evaluations. We've gone away from that we thought it's a barrier that was probably unnecessary, but it is, it's a constant battle to get good data.

[00:38:44] DS: Sure, sure. I mean, it's nice, because the questionnaire doesn't sound too overwhelming. It does sound like, I mentioned before these are good jumping-off points for other conversations. The questions are so specific that I feel like people can have specific stories that come to mind when that same situation has come up for them. Did you mention before, a global, a 10-item global?

[00:39:07] TM: Yeah. I mean Ð yeah, we were conflicted in our research team about the development of the global. I knew people would want it, but at the same time, we put so much work in developing to ensuring that these individual domains were Unidimensional Constructs, and we can do all this work, so it seemed silly, and it's not psychometrically valid, most of the time. So just, okay, now total all the scores, and that's the global score. What we actually did was another step. We took the 35 items. We did a whole another set of factor analysis and psychometric analysis, and we create a 10-item global from those 35 items. Those was like something in between there where we weren't just giving in and going against all of our strong psychometric work we did to create these domains, but it was also something that was available, it was, it is psychometrically valid. 

I think it's nice to use if 10 items, it's quick, but it's not, there's no domain-specific data there, right? I think what we're going to find the more we look into using these instruments is, we're going to have some people who might be doing amazingly well, from a communication standpoint, but they're struggling from a social and emotional standpoint, right? They haven't seen that same progression and that's probably means we need to provide more comprehensive care to these patients, right? Maybe our psychology, psychiatry colleagues need to get involved. These patients will be then identified because when you think about somebody who has been socially isolated for a long period of time due to hearing loss. Then, okay, they have hearing now, and then itÕs like, ÒAll right, now just go back into the real world.Ó That may not be the case for everybody. I mean, they might have that ability, but they may not be applying that ability as much as they should. So I think that's the strength of the profile. 

There's also the staging system only works for the profile. There's no global staging system. I think there's a lot of Ð I always recommend using the profile, it's only 35 items. If you compare it to the NCIQ, which has been commonly used that's 60 items. The SSQ is it's also quite long. I think, it's 49 items. If my memory serves me correct. That doesn't really give you any information besides going to speech quality, Spatial sound. So it doesn't really give you any of those other domains that are important to cochlear implant users. I say, well, yes, 35 items. We estimate it, it takes about five to six minutes to complete for patients that I always recommend doing that.

[00:41:52] DS: Yeah. I think it's great, you guys offer the goal option. I agree, I think the staging system is such a cool and unique tool for maintaining and monitoring progress and keeping setting, oral rehabilitation goals through that. I think that's really cool. I'm curious, have y'all done any, I mean, I don't even know how Ð this is maybe actually a dumb question, but I don't even know, are you connecting it all, the data we've used for so long to monitor these outcomes has been speech recognition testing, right? Are any of these stages related to certain speech recognition scores or easy bio and noise scores? Is that even a metric that y'all care about? Or do y'all see this more as the quality of life specific purpose?

[00:42:37] TM: Yeah, I know. I mean, someone [inaudible 00:42:41] said, I don't care about speech recognition scores, and it's not true. I think they're very valuable. They are measuring what we are trying to improve, right? At the core level, but that's just the starting block. The analogy I like to use is, there's really strong evidence that architecture students, so students who get AÕs in architecture school, are less successful than the people that get BÕs in architecture school. That is because the people who are AÕs are by the book, they know everything they know, but the people who are getting the BÕs are probably, they think are more creative and they're better and actually applying the principles of architecture in novel ways, right? So they actually become better architects. 

I think that it's just a good example, to think about the speech recognition score, where it's like, ÒYeah, you know that F student in architecture school is not going to be a great art architect.Ó Right? You know what I mean? The first thing is 0% word recognition is not going to be a great cochlear implant performer, right? Not going to be your all-star. It's that how you apply that speech recognition ability in the real world that matters, right? If no one lives in an audio booth. That's just the first step, right? So getting good speech recognition is cool. I wish all my patients right had the highest speech recognition score, but that's just gives you a pass to then use it in the real world. It's just the first step and it's consistent with the WHOs, ICF model for hearing loss and it's very consistent with all of that.

What's really incredible is we have some data coming out. If you look at Ð if you model outpatients based on their preoperative staging, where they start off, pick and show different paths from the CIQOL, but then if you take the people who were differentiated based or stratified based on their preoperative, CIQOL stage, and then you look at those same patients speech recognition scores, they're like exactly the same on average. While you have these people who have ended up, start off on various different functional abilities, and end up with very different functional abilities, when you look at their actual speech recognition scores pre-op, the post-op, it's almost you can't tell, which is stage one, two, three and four. It's really interesting to look at. I think it's important that obviously, we want everyone to have the highest speech recognition score possible, but it's just part of the picture when it comes to the cochlear implant outcome.

[00:45:18] DS: That makes sense. It's still something we'll utilize as another measurement, but I completely get it. It's what I expected you to answer, right? I was like, I think it's a dumb question, because I myself don't really see how it connects here, but cool, cool. That's awesome. I love that as a tool. I'm really excited. Now keep in mind, I only work with pediatric cochlear implants. I'm curious, are you guys trying to figure out a way to model this for parents to answer about kids or maybe educators? 

[00:45:44] TM: Yeah. There's a [inaudible 00:45:45] in Miami, doing some really wonderful work with developing new problems for different age groups and children. I mean, adult, I have the easy job, because they can all respond, right, or most of them can respond to you and fill out there questionnaire. I mean, kids, it's just it's a completely different animal. 

[00:46:04] DS: Absolutely.

[00:46:05] TM: She's did excellent job of breaking it down by different age groups and when parents respond when the actual patients respond. I think there's a lot of excellent work being done, and needs to be done in that area, because I mean, I think the idea of expectations is incredibly important when it comes to the parents making the early life decisions for their kids.

[00:46:28] DS: That makes sense. Well, hey, maybe one day in the future, I'd love to see that tool to utilize.

[00:46:33] TM: Exactly. Yeah, maybe I'll say Ð I'd love to collaborate with somebody on that one. I don't think I have the energy to start from scratch again. I'd be happy to if anyone out there wants to collaborate, I'm happy to provide some advice.

[00:46:45] DS: You're just now hitting that finish line. I don't know, but you want to start in the center for another race. 

[00:46:49] TM: Exactly. 

[00:46:51] DS: Cool. Okay, jumping back then again to the cochlear implant team. I do think or I'll leave it up to you. We could talk a little bit about the cochlear implant team, or we could talk Ð I remember another presentation I've seen from you before, you talked a little bit more specifically about hearing aid-related speech recognition outcomes for people and how they might not line up with what we expect from someone's unaided performance to their aid performance. I know that's Ð is that an area of research you are still interested in in digging into?

[00:47:21] TM: Yeah. I am. Again, this is one of those areas. I don't know what it says about me, but I find it fascinating to know when these things are said in public or what I was taught as a resident that are just absolutely not true. I'm a contrarian. I remember in residency of looking at audiogram, and looking at speech recognition testing, and saying, ÒYeah, this person they have a NU6 score of 70%. They'll do fine with their hearing aid.Ó Or 80, or, ÒOh, wow. Look at that. They're 40. They're going to do terrible with the hearing aid.Ó The question was, whether there's any evidence for that, that's what we started to look at with some of that work we were doing. Basically, what we found is that there's extremely low correlation between patients. 

I think terminology is important here. I call it earphone, your phone is headphone inserts, that's what we do on a routine, what you all do on routine basis for clinical audiogram and clinical speech recognition testing. Then unaided, I consider sound field testing without anything in the [inaudible00:48:27] at a consistent level, 60dB. Then 80 is what the hearing is. But what we found was from the earphone condition to the aided extremely, extremely low levels of correlation, right. Meanwhile, we have patients all the time out in the community who get fit with hearing aids, and they never actually perform any speech recognition testing with the hearing aids on, audiologists don't on a routine basis, until the bottoming out and they have to be a candidate for a cochlear implant, right? 

I mean, that's the only time that aided word recognition is really done is when someone's undergoing cochlear implant evaluation. So thereÕs a really very low levels of correlation there. Now, Terry Swollen, and we published a paper on that sense that says, yeah if you have to look at a receiver operator curve, there's a level you hit right. Terry 60/60 criteria 60% on earphone and 60% pure tone average, that someone is most likely going to be a cochlear implant candidate, or should always be seen for cochlear evaluation, but there's a lot of gray area in between there, right? 

[00:49:31] DS: It is, yeah.

[00:49:32] TM: We've had patients who surprised us 76% on their NU-6 earphone scores. We then tested them with their hearing aids in place and they just bought them out.

[00:49:42] DS: Yeah. Just to clarify this is with appropriately programmed hearing aids. These are like to target, this is the best case scenario.

[00:49:50] TM: Yeah, absolutely, absolutely. Then for one of the study's patients, if they weren't for the target, they got fit the target and went home for two weeks with their hearing aids. Then came back and then this is the result. So I mean, it's pretty eye-opening, but it's something we on a routine basis, we say, and I still heard residents say it all the time. From a surgical standpoint our academy guidelines for acoustic neuroma hearing outcomes, and uses earphone word reckon. We're very guilty, as well. But, no. I mean, I think we've looked at this in our cochlear implant evaluation population and the hearing aid population as well from some clinical trials and it's pretty striking. 

It's tough, there's a few physicians and people who really want to push cochlear implantation, who've tried to get me on board with, and I'm happy to help with trying to change audiologistsÕ practice. I mean, that's not my spot, right? I don't think any audiologist wants a surgeon coming in and telling them how to do their job. I do think it makes sense to routinely perform aided word recognition testing. While I've talked all about this, the quality of life and proms and just as an aside, patients self-reported communication abilities also don't correlate with their aided speech recognition with your hearing aids. We've published on that as well, but as an aside, it seems that if you're doing it for cochlear implant, you should do it for all of your hearing outcomes, right? 

If the patient has a hearing aid in place, I know there's limitations to needing a booth and time and everything like that, but if maybe just the patients who are struggling with a hearing aids and not loving them, just doing a 25 word list and Nu-6 CNC, just to get an idea of how they're performing, I think a lot of audiologists would be very surprised at what they find. 

[00:51:40] DS: Yeah. The first time I heard you present on this research that was when I was shocked that I had in my mind. This guy is an audiologist surgeon, what surgeon is interested in hearing aid, speech recognition? It just blew my mind in the first place, but even more mind-blowing than that was the results that you all found. I can't imagine that the majority of listeners are specifically cochlear implant audiologists because it's such a niche within a niche, right? I do think a lot of them out there are doing a lot of hearing aid work. I think it's such a helpful reminder. 

Again, I don't Ð sure you don't have to be the one to force anyone, but this is really compelling data, right? I think, other than questionnaires, there isn't a ton of outcome data for hearing aids that we collect, right? We don't really do too much aided testing with hearing aids, because it's not a really good metric of anything, but this speech reception testing could be a really helpful metric to help understand, are we actually helping them with these devices or not? If not, is a cochlear implant a better option?

[00:52:40] TM: Right. Or there's lots of new technologies for middle ear implants and implant. I mean thereÕs other things out there, or just saying, look, something's wrong with the programming of this hearing aid? Or maybe you need the next model up hearing aid, right? I mean, I think there's a lot of decision trees, but unless you have the data to make the decision, you don't know, you're just going to have an unhappy hearing aid patient, right? 

[00:53:03] DS: Exactly.

[00:53:04] TM: He's not really that happy with the performance, maybe that's all you get, and that's where it stands. I think having just the more data can be really helpful.

[00:53:11] DS: Yeah, that's awesome. I'm really grateful that you're doing that work, too, because that is such a common misconception is. Well, this was your performance before your hearing aids. You're going to do about this well, probably even better with your hearing aids. That's just certainly not something we can say as objectively, true. The data just doesn't support that. 

Okay, so we're coming up about the end of our time, but I did want to ask you one other question when it comes to Cochlear Implant Quality of Life. Let's break it down with a final example. You've got someone who comes in. They're an adult in their 60s with a gradual hearing loss. It's got a sloping configuration, we'll say moderately severe to profound and they come to you and they say, ÒDr. McRackan, should I get this cochlear implant? Is this going to help me?Ó What does that conversation look like to you as the surgeon? I know what it looks for me as the audiologist when a patient asked me that, but I'm curious when they come to you, how do you approach those kinds of conversations?

[00:54:09] TM: Probably assuming they meet like a speech recognition Ð

[00:54:12] DS: Yeah. They're a candidate, right? They're definitely a candidate. Maybe they're not the most 0%, you definitely need this candidate, but they're a candidate. Let's say they're a 40 percenter.

[00:54:22] TM: By the way, these conversations are going to get more difficult, right, as the criteria have expanded for cochlear implantation.

[00:54:29] DS: Absolutely.

[00:54:30] TM: It should be a lot and far, far more nuanced with noise testing and people in that gray area, as CMS expands. But these conversations are not going to get easier, over time. Well, I think, having a clearer understanding of what they expect to get out of it. What environments they currently interacting, right? Are they are they someone who just sits at home and doesn't really interact much? What do they want? Do they want to get out more? So really, what are they expecting from the cochlear implant? Again, using the data fron the CIQOL and then looking at the conversation of what they want to get out of it. ItÕs not about performance, expectation, but what they hope to gain from their life. 

Then I obviously am biased, but again, using their baseline CIQOL scores to guide the conversation, right? To look at it and say, look, gosh if someone's performing really poorly, and noise and even with just a few listening partners you say, ÒLook, most people get to that level with a cochlear implant, right?Ó You can get percentages, [inaudible 00:55:33]. But if they're saying, ÒLook, I'm doing okay, I'm struggling in very large, crowded environments, and I can't see everybody talking.Ó Well, I think we have to be realistic about the limitations of cochlear implantation. We have to be honest with people, they look, very few people develop that capacity, right? I mean, that those are your really, your all-stars, and you might be one of them, but here's the breakdown of the numbers and the percentage. 

I think we're really spoiled Dakota, where we are in cochlear implantation, right now. You and I trained in areas where cochlear implants basically always existed, right? I mean, we weren't part of that. I say we were the second or third generation of cochlear implant clinicians where the first people we're just trying to get any sound awareness, right? Second generation, we're just trying to get that bump to build just a little bit more. Now we can be snobs and talk about the limitations of cochlear implants. I think we're really spoiled to be to have these more nuanced conversations, but I'm hoping we're getting to a point in developing the data needed to have these nuanced conversations and as the criteria expand we can put real guardrails on to what the potential outcomes for cochlear implant users are. Yeah, not a straightforward answer. 

[00:56:54] DS: No, no, no, that's great. I loved it because that's exactly how I see this tool that you all developed, being utilized is for those conversations, and not just saying, ÒWell based on my opinion, and how long you've had your hearing loss for, have you Ð it's like I can, of course, still have those conversations, but now I have a metric where I can say, ÒWell, look, you're probably going to be in about this category. We would expect you to make this much progress.Ó There's just so much more helpful to have a tool that can support those conversations and give someone a more objective look at what their potential list. I just think that's awesome. I'm so excited for this tool. Would you mind as we wrap up here if people have any questions for you how they can get in touch and where they can get access, too? Is it safe to call it the CIQOL? 

[00:57:37] TM: Yeah. CIQOL. Yeah. We tossed around a lot of different names, but yeah, CIQOL is what we ended up on.  My email address is just my last name spelled correctly, it's M-C-R-A-C-K-A-N@musc.edu. A lot of people put E N on the end or MCC, It's M-C-R-A-C-K-A-N. Our research team, you can also reach us there's, ciqualityoflife@musc.edu. The website is just https:\\education.musc.edu\ciqol and that will bring to our website. It has more information about the instruments that has uses of it. Soon weÕll have a nice, really pretty manual, a user manual, but now all of the instruments, scoring manuals are all on there. We have German, Arabic, and French, also available on there Ð We have other nine other languages are probably underway. 

[00:58:37] DS: ItÕs awesome.

[00:58:39] TM: ItÕs really exciting. Yeah, international, but weÕre being pretty stricted, but the cross-cultural adaptation process around, just letting people just translate it and just go ahead and use it. We're having them follow some guidelines that have been set up. So yeah, it's wonderful to see collaborators from across the world. We're very spoiled also in the United States that we have speech material because a lot of these languages don't have validated speech material to test patients. They're really rely on, very excited about having a well-validated proms.

[00:59:06] DS: Awesome. Well, Teddy, it has truly been an honor for you to be on here. When you guys inevitably develop the next tools or if there's ever another research topic or if you just want to come on and talk about more the surgeons perspective on the cochlear implant process. I'd love to talk to you about your thought process through a surgery at some point. I think that'd be so cool to hear more about. I'd love to get you back on, but thank you again for joining me. It's been an awesome conversation.

[00:59:29] TM: Yeah, absolutely. Thanks, Dakota.

[END OF INTERVIEW]

[00:59:32] DS: That's all for today. Thank you so much for listening, subscribing, and rating. This podcast is part of an audio course offered for continuing education, through SpeechTherapyPD. Check out the website if you'd to learn more about the CEU opportunities available for this episode, as well as archived episodes. Just head to SpeechTherapyPD.com/ear. ThatÕs SpeechTherapyPD.com/ear.

[END]

OTE 36		Transcript

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