Thank you. My apologies for not being able to attend the AOSSM in person this year. Family obligation, couldn't travel. But on behalf of the NATA, I want to extend our gratitude for allowing me to participate in this exchange lecture. My name is Steve Berlio. I'm director of the Michigan Concussion Center at the University of Michigan. I'm also co-PI on the CARE Consortium, which I'm going to talk a bit about today as it relates to concussion management. I'm going to do a quick share screen, and we will get started. Great. So before I get started into the presentation, I just want to disclose that funding for this project comes from the National Collegiate Athletic Association, Department of Defense. I also have some other funding that is unrelated to this project I'm going to talk about today. So the CARE Consortium started in 2014. It was largely launched to understand the acute natural history of concussion. It was a 30-site trial, and you can see the map here of the United States of the different locations that participated, including the Air Force Academy just down the street. And really what this structure allowed us to do, in addition to understanding the natural history of concussion, but was also allowed us to understand or evaluate different concussion management tools. So just a quick highlight of the methods. At each of the participating sites, every Varsity athlete was eligible to participate. We had roughly 90% participation across all of our schools. Every athlete that consented completed a baseline evaluation prior to their athletic season If they sustained an injury or suspected injury, they were evaluated again within six hours of the injury, 24 to 48 hours at the asymptomatic time point when they were cleared to return to play, and then six months post-injury, and then again at the beginning of the next season. One of the design features that we built into the study was to allow the sites to use the computer-based tests that they wanted to evaluate cognitive performance. So this included either the IMPACT, CNS Vital Signs, Cogstate, or ANAM, although the majority of our schools, about 80% or so, elected to use the IMPACT test. We also completed a neurostatus evaluation, the standardized assessment of concussion at each of the time points, along with the balance error scoring system, which is our postural control measure. So it is part of the reason that we built our research methods this way was to be compliant with domestic and international standards around concussion assessment. So I think most of us know that although there's some variance between these groups on what is actually recommended, the specifics of it, they largely all recommend a symptom evaluation, a postural control evaluation, and a cognitive evaluation. These are all obviously used to support the clinical exam, and then ultimately the gold standard for diagnosis falls with the clinician's impression and what they decide. We use the SCAT tool to kind of capture the symptoms, postural control, and cognitive evaluation, in addition to the computer test that I mentioned. So the first project or study I want to talk about is one that we looked at, the SCAT evaluation tools in addition to computer-based testing, within the first few days of concussion to try to understand if what was being used were the best tools being used, or whether there was a subset of tools or a specific implementation or sequence of tools that could get the best information. So what we see here, we chose three time points, one within the first hour of injury, which we deemed the sideline evaluation, one within the first 24 hours of injury, which we deemed the post-event evaluation, and then the third was this clinic evaluation, which was in the first three days of evaluation. And what came out across all three time points was that symptoms were the number one predictor of concussion, but across the board, the SCAT5 tool largely captured all of the relevant information a clinician would need to support that clinical exam. So that includes a symptom evaluation, the postural control evaluation on the firm surface, and then the neurostatus exam or the standardized assessment of concussion. It was also found in this study that the same-season baseline evaluation generated the best test results, so adding some weight to doing baseline testing, although I will say broadly when we look across the medical literature, it's a little bit up in the air whether or not baseline testing is necessary. The other thing that this analysis allowed us to do was to provide step-by-step progression that allows a clinician to stop at any point along the way where the data are very clear that the concussion has occurred, although I would still say that the clinical exam remains the gold standard in this evaluation process. So an example of this would be as if an athlete came off the field, they were complaining of significantly high headache and nausea and fatigue and blurriness and you just name a number of symptoms, there's really no reason at that point to go on to do a BESS or a neurostatus exam when it's painfully obvious that you can see what's already happened. I will say that we did use the impact test or load the impact test data into this model. It did not fall out as adding any additional information on top of what you could get out of the SCAT test, but that's not to say that computer-based testing in and of itself doesn't add additional information, perhaps at the return to play time point or for other individuals or specific cases where perhaps the clinician finds value in that. So turning our attention away from this kind of evaluation process, we are interested in what concussion recovery looks like. So in 2003, my colleague, Mike McRae, who was running the original NCA concussion study, published a paper in JAMA and reported that on average it took seven days for concussed athletes to return to asymptomatic status after injury. This was followed by the Berlin consensus document in 2016. There have been a number of consensus documents that led up to that one, where they reported that the average, sorry, normal clinical recovery, and that is symptom recovery, is largely around 10 to 14 days, and then anything extended beyond that is kind of deemed abnormal recovery. So what we were interested in is seeing as to whether or not our data set, the data set from the CARE Consortium, kind of adds up or kind of stacks up with these recommendations, or perhaps we need to rethink what concussion recovery actually looks like. So this first paper I want to talk about here, this is data that I led the analysis on, published in Sports Medicine a couple years ago. On the left-hand side, we see the median time to asymptomatic was around one week for all of our athletes. We had about 1,800 total athletes in the concussed group here. And then on the right-hand side, we see the medium time to return to play was around 13 days. And these numbers both fall in line with what we see both from the McRae study and the McCrory guidelines with that one-week, two-week recovery timeline. But what we noted as we were working through these data is when we think about medians, that's 50% of the individuals at that time point, which means that another 50% are extending beyond this kind of two-week window. So we started looking at what the week-by-week recoveries look like, and we see that it was about 50% are recovering or becoming asymptomatic within the first week, but it's only 16% are returning to play. 80% recovered asymptomatic, excuse me, within two weeks, about 56% within two weeks on return to play time. So this falls in line with the McCrory guidelines, but it's really not until we get to about four weeks post-injury that the substantial majority of individuals are being returned to their sport. And what we propose in the paper is to reframe how we were thinking about concussion recovery, and stating that normal concussion recovery may take up to one month. This is, certainly some people recover faster than one month, but stating it as this injury may take up to one month in the majority of individuals, take some burden, some social burden, some pressure off of the concussed athlete that may have symptoms that go into that third or fourth week, they're progressing exactly as you would expect, given the injury, premorbid factors, and other things. They just need a little bit more time to get through their injury. I would also say that in this data set, we did look at a number of modifying factors, whether it was concussion history, contact sport level, or males and females, and there were one to two days differences between kind of all of those factors, which would suggest we can manage these injuries roughly all the same. Tina Master then did a follow-up investigation using the same subset of individuals, about 1800, or excuse me, a little over a thousand male and female athletes, and she was interested in sex comparable sports, so removing athletes that participated in football, wrestling, or field hockey, where there was no opposite gender sport to participate in. And interestingly, what she found was there was no difference in return to play time in male and female comparable sports. So we're talking sports like basketball, soccer, baseball, softball, cross-country, things of that nature. So this is quite interesting, just given what has been put in the literature up to this point, suggesting that our female athletes are taking substantially longer to recover than our male athletes. This next paper, this was done by Spencer Liebel. He is a faculty member at the University of Utah. He completed this while he was a postdoc fellow here at the University of Michigan. It's currently in review, but Spencer was interested in looking at sport-by-sport recovery levels to see if sports could be grouped or clustered based on the recovery profile, sort of getting to this idea that maybe individuals that are less concussion-prone, faster recovery, maybe they go on to play at higher levels, or perhaps there are social-cultural factors within a given sport that may preclude or may accelerate recovery timelines or slow them down for that matter. And what he was able to show was that there was no between-sport differences, either in the time to asymptomatic or the total return to play time across all the sports that we had in our database. I'll just point out that football actually falls right in the middle of the recovery profiles. Seven days or so for time to asymptomatic and about 13 or 14 days for total return to play time in these two figures here on the right-hand side. And I'm pointing that out because I get a lot of comments or questions about football athletes returning within one week, being rushed back in, that sort of thing, but just highlighting that that doesn't seem to be the case here. The last study here I want to talk about is a value, excuse me, a study that's currently in review. So we noted that concussion recovery averages or the median time is right around 14 days to return to play, could take up to one month, but how individuals recover on the individual tests that are being administered and used to kind of inform that clinical decision is really poorly defined. So I just have the CONSORT diagram up here just to show that we had about 1800 or so concussed athletes that we had data on. On the left-hand side, what we see are the recovery profiles for the SCAT symptom severity, the BSI global score, the BESS total score, the SAC total score, and then the four sub-components of the impact test. It's all athletes kind of in the green on the left-hand side, and then we broke it down by male and female on the gray on the right-hand side there. The horizontal line that you see typically towards the bottom of each of these sub-figures, that's the baseline score, the average baseline score for each of the 1800 individuals, and then you kind of see the smooth curve that represents the return to baseline over time on each of the different measures. Overall, what we see is it takes about, the fastest recovering tool is the BESS bone score, that happens within about two days, and then the impact reaction time is actually the longest, taking out to about 24 or so days. We see very similar profiles in both men and women when we break those down, the BESS bone, the fastest at two days, and then the impact reaction time for men at 22 days, and then the impact visual memory score around 24 days for females. I would note that the variance around reaction time, the variance around this visual motor, excuse me, visual memory score, is quite large, so the clinical interpretation of that gets a little bit tough, but to kind of put this into maybe a little more user-friendly platform, if you will, I built this kind of rough calendar out, so we would have our injury day one, our athletes are pretty much not doing anything at that point, symptoms in some cases are still going up. Day two or so post-injury, we see this restoration on the BESS foam score. Day three, we see the BESS total score, the SACs, and some of the impact scores are coming back down to normal, back down to the baseline. Around day four, we see the BESS firm score returning to normal. BSI scores are starting to come back down around day four, day five, day six. You also see symptom resolution on average on day six for our athletes, and this fits in line nicely with some of the data I showed a couple slides ago. The last bit of our visual memory returning around day seven, and then at that point around day eight, nine, ten, eleven, twelve, we would start progressing our athlete through the return-to-play protocol, and then this fits in nicely. They may return to full sport around day twelve or day thirteen. Obviously, there's some variance around that, but that timeline sort of fits nicely with some of the return-to-play, average return-to-play times that we saw kind of in our larger data set a few slides ago. So overall, what does all of this mean? So Mike McRae published this paper a couple years ago. He was comparing football recovery rates from the original NCA concussion study in 99, 2000, 2001 to the CARE Consortium data set from more recently, trying to understand if there were differences or what the return-to-play protocol or return-to-play times look like, and what he found was in that original study, athletes were reporting symptoms for only two days, and then they were being held out for about another day, what he called the symptom-free waiting period or SFWP. So the total time out of sport back around the turn of the century was only three days. Fast forward 15 or so years, and we see that the time to asymptomatic has increased almost threefold. The time out of sport is up almost sixfold. So our median return-to-play time, at least in this data set that he was looking at, was a little over 12 days. What this means is clearly we are being much more conservative in how we're managing our concussions. Our athletes are better off. We know that they're not sustaining as many repeat concussions in the same season, and we obviously think that that's going to have better outcomes for their neurological health down the road. So I think we are certainly in a much better spot than where we were 15 years ago. Much more to be learned. Diagnostics are improving. Management is improving, but I feel confident in the direction that we're headed. So before I sign off, I just want to extend some gratitude to the more than 300 individuals that have worked on the CARE Consortium in either full or part-time capacity over the year. This is just a short list of those individuals. Some of you may be in the audience, but wanted to let you know that the project couldn't be done without them, as well as the great team here at the University of Michigan. My apologies again that I couldn't be there in person, but appreciate your time today. Thank you.

Steve Broglio

Michigan Concussion Center

CARE Consortium

concussion management

concussion research