Why Standardize the MBS Study? The MBSImP Approach

welcome to an introduction to the modified barium swallow impairment profile the purpose of this introduction is to orient you to the overall approach recognizing variation in terms of experience of the clinicians who are taking the training from very novice clinicians all the way through highly seasoned colleagues I'd like to start with a few salient points that underline the standardized modified barium swallow impairment profile an MBS is not a feeding assessment it's an assessment of swallowing physiology to allow a clinician to make good judgments and estimates about how patients will do using a simulated set of

liquid and food consistencies the MBS is not a pass/fail test it's way beyond aspiration and penetration if that's all that we're concerned about any technician could be trained to do such an exam the modified barium swallow study if done appropriately should provide visualization of oral pharyngeal laryngeal and esophageal components of bolus transport it should allow the clinician to identify and distinguish type and severity of impairment it identifies targets for treatment based on the nature of the impairment and response to interventions it requires a standardized protocol with flexibility as I'm going to discuss and standardized interpretation

so many of us have been doing modified very well as those for years and so we ask ourselves why do we need to change now because we know more now we know much more about the mechanism of swallowing that we did when this was first introduced by the eminent dr. Jerry Logan in my mentor and much of it's based on her science and the science of others going forward most importantly we should standardize in the best interest of our patients when a patient comes to us with a long history for example of multiple surgeries or

treatments or swallow studies they should know what to expect when they come in to a fluoro suite they should know what to expect in terms of the outcome of that examination if we do all do our own thing the results of one exam to another are non comparable standardization involves implementing and developing technical standards based on the consensus of different parties it should maximize compatibility interoperability safety reproducibility what I do and what you do regardless of our level of experience transparency so every clinician knows exactly what you did when you did your swallow study when

they're doing their swallow study and ultimately improving quality of the exam across clinics and clinical laboratories standardization should facilitate commoditization of customized processes that is getting things from the laboratory into your clinic translating our research to clinical practice we know that standardized practices impact very important aspects of a patient's health and well-being lack of standardized practice has been shown to for example in this slide result in variable lengths of stays for patients with similar DRGs and in this case nonspecific chest pain so this has nothing to do with swallowing but just to demonstrate how throughout

the scope of healthcare standardization has shown to impact the outcome of the patient a few other key points to remember is that evidence rather than our opinion that's the way I've always done it it works for me should guide clinical decision-making we need to look at a broader range of patient outcomes to better understand the true benefits and risks of healthcare intervention so for example the whole penetration aspiration thing that's very important airway protection is hugely important and it is a part of every swallow study done using the MBS iymp but it is one outcome

of a physiologic impairment so you just have to keep that in mind we're going way beyond that if we're going to advance patient care and research priorities should be guided in part by public health need one problem that we have in our field is the lack of agreement on coding on how we diagnose dysphagia etc and as a result the coding gives us inaccurate information about how wide the scope of dysphagia is in the United States and in the world if we had standardized measures to capture this page of both video fluoroscopic measures quality of

life measures and other health and clinical measures we would move the field forward toward better informing payers and regulators about the extent and pervasiveness of this impairing condition so according to a report called translating research into clinical practice that was published in and around 2007 and this was just in standardize about standardized practices in general not necessarily swallowing they said what you should attempt to standardize is your instrument your assessment instrument both in contents and in format we could say the same thing voice we could say the same thing about speech production as well as

swallowing and you select your instrument based on the question that you want to answer so the mvsim P doesn't make any statement about Modifieds or better than fees are better than manometry this is about one test if it's appropriate for your patient and that's the modified barium swallow study your data collection the protocol that you use when you're acquiring data your approach in your method we should attempt to standardize the way you analyze your data and interpret your data otherwise we're talking apples to oranges with one another across clinics reporting how we communicate in a

written and oral record the results of our study should be standardized so other care providers as well as our colleagues speech pathologists can understand what it is was the outcome of the exam the goal my primary goal when designing the first study to develop the MDS iymp of course then I didn't really know what it was going to be I was just trying to see if we could try within reason to develop a standardized approach was that it needed to be valid meaning it has to measure what it's supposed to measure both in its content

its construct and its validity related to things like quality of life and other health indices it needed to be reliable meaning if I can score it and you can't it means nothing if I can't get it out of the Martin Harris lab to the clinic then it's it really is of no value clinically so we had to come up with something my goal was to come up with something that was not only valuable for clinical researchers but very practical linked to clinical action for you the clinicians because I'm a clinician just like you and whatever

it was had to be the logic base not just symptom based like penetration aspiration so we published our first study and have published other related studies since this work takes a long time you need big datasets to do this so you don't see a new publication you know every six months every year because we're very careful about what we put through dissemination this all started by a good review systematic review of the literature back in 2004 presented to a panel of experts multidisciplinary experts who helped us with consensus on what things we should test during

a modified barium swallow and what a scale might look like that could achieve a metric that would help us interpret swallowing physiology so as a result of our consensus validation panel these were the components that the group determined there was evidence of their relevance to normal swallowing physiology so we included them in the proposed tool and we came up with a metric a rank order type scale from least meaning zero normal no impairment to the most impaired score we developed a standardized protocol because if we're going to develop standardized measures we have to be using

the same consistencies to assess physiology across clinics and labs and when we've known from multiple works in the literature by many authors the influence of bolus characteristics on swallowing physiology so we included those that have been tested in the past and had been recently standardized in in the Vera bar line now by Baco diagnostics and this is the protocol that we use now keep in mind that when we first did this study we were very strict on our protocol and the reason is because we weren't doing a study and we wanted to be very careful

we still maintain this protocol but understand that there is flexibility based on your clinical judgment you just always have to be you know weigh how much outside of the validity of the tool are you going to go in terms of scoring so this is the protocol so we do thin liquid two trials of thin liquid the first one we kind of discount and the reason is that as our experience has shown us that that first wall is typically not representative as many of you know especially seasoned clinicians patients do strange things on the first swallow

so we kind of discount that one we do a cup sip of thin liquid and we do a sequential swallow of course we don't go on if the patient has high impairment within a class of liquid we're not if they're grossly aspirating on 5 ml we're obviously not going to go on to a cup sip we give nectar 5 ml via teaspoon a cup set and sequential you notice we don't give multiple trials of each thing we we have to balance radiation safety and we feel that our data would support we're getting good samples of

impairment using this approach we use honey than honey 5 ml via teaspoon putting air bar pudding 5 ml via teaspoon solid bowl is half of a Lorna Doone cookie with three ml pudding on top we turn the patient in the anterior posterior viewing plane and we assess 5 ml nectar via teaspoon and 5 ml pudding via teaspoon what we did initially is trained a cohort of speech-language pathologist who had varied years of experience I think the in the beginning the least-experienced were three years and the most experienced were probably twenty plus we trained them in

how to use the scoring metric and we tested their reliability and what we found during our reliability testing is that the original scale wasn't perfect and it's never going to be perfect but the problem was that there were certain scores like between a1 and a2 that the visual eye could not discriminate a difference and so as a result we collapsed the - someone could say that you lose some fidelity in a scale and I guess you do but you also improve accuracy so the tool now when you look at each component is not balanced in

terms of the number of selections per component and that's because we only included what we got good reliability with we tested and scored the exam and 350 patients using our standardized protocol and then we subjected the data to confirmatory factor analysis and we tested construct an external validity I show you this slide because again this question always comes up and I know we get so concerned about penetration and aspiration and again it's very important but is only one component of an MBS you can look at our original data here that even though we had statistically

significant relationships between the PA scale scores in these 350 patients and our oral impairment and pharyngeal impairment you see the p-values here but if you look at this number here this is a correlation and if you square this you get the variation explained in oral impairment by the PA scale and it's about 5% the the variability explained inferential impairment by the PA scale is about 4% the point here is there are many dispatch ik patients who don't penetrate and aspirate who still need your services so penetration aspiration isn't what we treat we treat the physiologic

impairment so to summarize penetration aspiration is not a necessary or sufficient measure of impairment meaning you can have impairment without it and if that's all you report it's incomplete keep in mind we use the penetration aspiration scale on every single mvsim P exam so in conclusion the mvsim P tool has been developed and tested that captures oropharyngeal swallowing impairment it can be used reliably but reliability is dependent on training like training it's why we don't do train the trainer because everybody should get the same training in order to be reliable physiologic impairment fit a two-factor

model in our original analysis of oral and pharyngeal and you'll see that we call them domains rather than phases because they're not arbitrary you'll see that initiation of the fringe I'll swallow actually factored with the other components in the oral domain most likely because of the relationship of tongue movement to triggering a fringe will swallow and the esophageal clearance in the upright position we do look at it that's all we look at with the esophageal component it fell out of the analysis because we a lot of missing data as you can imagine there are patients

that you can't always turn or view the esophagus the other thing to remember is its standardization facilitates patient safety even though the degree of radiation exposure to our patients during an MDS is relatively minimal compared to other radiographic imaging we always have to be cognizant of the fact that any radiation exposure is signal we cannot keep a patient under fluoro and do every single consistency every single exercise it's not safe it's not necessary a study by Heather Bonilla a colleague of mine in our lab looked at the influence of the standardized protocol on radiation safety

and what we found in that study was that the average fluoroscopy time is a three minutes or less at an average of two point eight nine minutes we were always between two point eight and two point nine seven so we feel that this is very reasonable the radiation physicists tell us this it's extremely reasonable so we maintain that the protocol enhances patient safety and standardization facilitates translation as I mentioned before to clinical practice we know I articulated by the president of age RQ at the Asscher Leadership Conference a few years ago that variations and inequities

in clinical care exist and that results in difficulties translating any scientific advances things we find in the lab why don't they come to you you hear about all these fancy new approaches people are doing it you know professional meetings etc but why don't you ever get them in your clinic and there are reasons for that and there are reasons is because one reason is because of variation in equity and held it there translated and disseminated there are some barriers to translation and I think as CE s a seasoned clinician I can really relate to those

of you have been around a while you know first of all we have to be aware of new things that are coming out so well obviously we have to read the literature then we have to accept it based on the evidence and then the big thing is we have to adopt it and a lot of times people get through acceptance but they never adopt it and why don't they adopt it one is people say well always done it this way I've got this well-oiled machine why change and another is that knowledge of evidence remains separate

from and not integrated in decisions and actions and this came from a publication by Greene at all and the Journal of American Board of Family Practice that this is not just a problem with us in swallowing but in all areas of healthcare practice we we have to think through with an open mind about how we can do things potentially better now all this said there is a role for systematic variation in some standards meaning just because we're talking about a recommended standard for conducting the modified varium solo study does not mean we're being rigid that

you can never deviate from it you know I'm a clinician I know there are going to be times where I'm going to want to maybe if I think it's really going to give me added information something else to that particular patient or an additional swallow for example however in the modified barium swallow scoring guide please look at it you will see that all these compensations that we do within the context of the exam are not scored as part of the MBS InP score you can score them to show demonstrate how swallow physiology component improves with

the strategy but that that doesn't get put in your impairment score because we're trying to capture impairment in that room and score it so we can compare improvement from one session to another not just capturing compensation or at adaptation um so you do have to use your clinical judgment it's going to be based on your patient's performance the setting you're in and the cognitive communication status of your patient so in summary the standardized MBS iymp includes standardized method of training the protocol that you use the tool that you use in terms of the probes and

interpretation the vernacular and how you report your information in order to enhance reproducibility across clinics and laboratories you're going to enter into our web-based learning environment that's going to take you through our standardized training that we're constantly improving based on the feedback from our users our end users we take it very seriously we've updated videos we're now using high-definition images or Highline images from Highline recordings for example so we're always trying to make this a living breathing tool that will perfect and continue to perfect over time you're going to be introduced into the scoring method

that we have found enhances reliability between clinicians you're going to learn to you'll take a reliability test for example after plenty of practice and you're also going to be introduced to our reporting structure and you know a lot of clinicians stop here and I think they stop here after their training because they don't really understand all that our report can offer to them it allows us to enter patient medical history and most of this is all radio dial not free text it goes quickly what you'll learn once you practice is it takes about 10 minutes

to score the MDS iymp and it takes about 10 minutes to enter the report so it includes medical history mvsim P study scores and other related information that is important for HIPAA compliance for example it allows you to track the status of your patients Swallow physiology and outcome over time it allows you to evaluate the success of your management treatment and ideally optimizes your care through consistent practices as advocated and evidence-based medicine this is an example of what the report looks like again this was all Auto populated by point-and-click and this what you're looking up

here is sort of our signature logo if you will and what it does is it gives you the number of the component and the score the number of component this is component two and their value three and their value and it's explained here so it doesn't just spit out a number it tells your physician it tells your colleague what exactly their function was this is the the heart of the report which is the table of your scores and then we've added the ability to compare your most recent examination score to your previous or last report

so you can easily track change over time so do look at the reporting feature and now we're ready to get started