Emergency Seizure Care, PediDOSE and Exception from Informed Consent – PediaCast 509
- PediDOSE seeks to improve the emergency management of seizures in children. Several communities across America are participating with an exception from informed consent. Tune in to learn what this means!
- Emergency Seizure Care
- PediDOSE Research Project
- Exception from Informed Consent
- Pediatric Emergency Care Applied Research Network
- PediDOSE Study Site
- Seizure Action Plan! – PediaCast 372
- Seizures & Epilepsy – PediaCast CME 048
- Infantile Spasms – PediaCast 507
- The Many Complications of Sickle Cell Disease – PediaCast CME 071
Announcer 1: This is PediaCast.
Announcer 2: Welcome to PediaCast, a pediatric podcast for parents. And now, direct from the campus of Nationwide Children's, here is your host, Dr. Mike.
Dr. Mike Patrick: Hello, everyone, and welcome once again to PediaCast. It is a pediatric podcast for moms and dads. This is Dr. Mike coming to you from the campus of Nationwide Children's Hospital. We are in Columbus, Ohio.
It's Episode 509 for January 20th, 2022. We're calling this one "Emergency Seizure Care, PediDOSE and Exception from Informed Consent". I want to welcome all of you to the program.
I know it's a mouthful but we're going to break all of those terms down for you and let you know how they're related to one another. That's coming up soon.
But first, I want to welcome all of you to a new year of PediaCast episodes. We actually kicked the year off last week over on the CME podcast, with an episode on sickle cell disease. And although that podcast is geared for pediatricians and other pediatric providers, meaning it contains lots more technical terms and medical jargon, we go a little bit deeper into the content.
Despite that, I feel like many of you would find that show interesting because I think pretty much everybody out there has heard the terms sickle cell anemia or sickle cell disease. But unless that condition impacts your family or you take care of kids or adults with sickle cell disease, you probably really don't know too much about it.
All right, you may be asking, "Why should I care if it doesn't impact my family?" Well, sickle cell disease impacts lots of your fellow Americans, especially African-Americans, Latino Americans and Middle Eastern Americans. And as we're all trying to understand one another in America, which is a very important thing to do, it is useful to recognize the challenges that other people face.
It builds awareness. It leads to understanding. It fosters empathy. And so, if you're interested in learning about something that impacts a significant number of people around the world and you can tolerate some technical terms and medical jargon, then I would encourage you to check out PediaCast CME, Episode 71. And I'll put a link to it in the show notes for this episode, 509, over at pediacast.org, so you can find it easily.
Of course, you can also go wherever you listen to podcast and search for PediaCast CME. And that one will pop up as the most recent episode.
All right, so how are we kicking off the new year on this podcast? Well, as the title mentioned, we're going to talk about emergency seizure care, a research project called PediDOSE, and the concept of informed consent and what it means to have an exception from informed consent.
And just to give you a heads up, the bulk of our conversation is going to center around the research project. Because it's a really interesting one and a fine example of how we can improve the practice of medicine in a fairly easy and practical way.
Of course, we will cover seizures and the emergency treatment of seizures, albeit briefly because we have covered seizures and their management many times on this program.
And I'll leave links in the show notes to some of those past programs about seizures themselves in depth. We'll touch on them. But if you want to know a lot more about seizures in detail, you'll be able to find those episodes easily over in the show notes.
Then, we're going to turn our attention to PediDOSE which is the research project that is taking place in several communities across America, perhaps in your community. And it's an interesting one because it starts with the EMS system, Emergency Medical Services system.
So let's say your child has a seizure. Maybe they've never had a seizure before. And you call 911. So EMS arrives. They begin treating your child and whisk him or her off to the emergency department. That is a daily occurrence across America.
Well, in communities participating in the study, some of the EMS agencies will be using a conventional protocol for treatment and others will be using a standardized protocol. And we'll get into the nitty gritty of what each of those mean in a little bit.
But you don't really have a choice what your child gets. It depends on who responds to the emergency. And while informed consent is an important part of any research project, people should participate voluntarily and know all the benefits and risks of participating and then making informed decision, while that is ideal, sometimes there are exceptions.
So we'll explore exactly what that means and how it looks. And to help us do that, we'll be joined by two really terrific guests. Dr. Manish Shah is a pediatric emergency medicine at Texas Children's Hospital. And Dr. Joseph Sullivan is pediatric neurologist at UCSF Benioff Children's Hospital.
Before we get to them, I do want to remind you, you can find PediaCast in all sorts of places. We're in the Apple and Google Podcast apps, iHeartRadio, Spotify, SoundCloud, Amazon Music, and most other podcast apps for iOS and Android.
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And then, finally, I want to remind you, the information presented in every episode of our podcast is for general educational purposes only. We do not diagnose medical conditions or formulate treatment plans for specific individuals. If you have a concern about your child's health, be sure to call your healthcare provider.
So let's take a quick break. We'll get our guests connected to the studio and then we will be back to talk about emergency seizure care, PediDOSE and exception from informed consent. It's all coming up right after this.
Dr. Mike Patrick: Dr. Joseph Sullivan is a pediatric neurologist at UCSF Benioff Children's Hospitals and a professor of Neurology at the University of California San Francisco. Dr. Manish Shah is a Pediatric Emergency Medicine physician at Texas Children's Hospital and a professor of pediatrics at Baylor College of Medicine.
They're here to talk about a new research project related to the emergency care of seizures. It's a study called PediDOSE. And we'll also talk about informed consent and exception from informed consent and how these concepts relate to medical research .
So lots to cover, but first, let's a give a warm PediaCast welcome to our guests, Dr. Joseph Sullivan, Dr. Manish Shah. Thank you both for stopping by today.
Dr. Manish Shah: Thank you for having us.
Dr. Joseph Sullivan: Yes, thank you.
Dr. Mike Patrick: Yeah, really appreciate you coming and spending some time with us. Let's start with you, Dr. Sullivan. Just sort of remind us what a seizure is, just so we have a baseline understanding of exactly what we're talking about.
Dr. Joseph Sullivan: Sure. There are many different definitions of seizures and this is still debated at epilepsy meetings to this day. But a brief definition would be an abnormal and synchronized burst of abnormal electrical activity in a population of neurons in the brain that evolves over time. Meaning it has clear beginning and a middle and an end.
And depending on where that population of neurons is located in the brain, that will determine what the patient or child actually experiences or what an observer actually witnesses.
Dr. Mike Patrick: So if it's really one limited part of the brain, you might just have one arm or one leg that's stiff and shaking. But if it's the entire area of the brain that controls all the muscles, then you're going to have that whole-body stiffening and shaking, right?
Dr. Joseph Sullivan: That's exactly correct. Exactly.
Dr. Mike Patrick: What about sensory? So sensory parts of the brain, can you have a seizure where you smell things or hear things?
Dr. Joseph Sullivan: Yeah, you can have a seizure in any part of the brain that can allow you to experience pretty much anything. That could be a sensory seizure. Sometimes, there are seizures that occur in the memory portions of the brain that cause a deja vu type effect.
The opposite though, there are actually areas of the brain that don't necessarily have a specific function. And so the patient may actually not experience anything.
And we only know that when we actually have electrodes on the brain and see these abnormal electrical activity that evolves over time. And I could be sitting there at the bedside having a conversation with a child and not have any idea that a seizure is actually occurring. And again, that's because it's not interfering with any of those critical brain or bodily functions.
Dr. Mike Patrick: Well, that's really interesting. So then, the next question becomes what causes that? What causes neurons in the brain just to automatically start firing on their own?
Dr. Joseph Sullivan: So there are so many different causes for seizures, especially in children. And they range from genetic causes to causes related to brain injury. Whether that be brain injury that maybe occurred during the birthing process, brain injury that occurred later as a result of a stroke or something like traumatic brain injury.
There are even seizures that can happen very commonly in children that result just because of a high fever. And so there's a whole myriad of different causes. And that's our job, when someone does have a seizure, to try and figure what that underlying cause is, so that we can address any potentially treatable conditions.
Dr. Mike Patrick: Yeah, absolutely. We are really going to be focusing on the emergency care of seizures and the PediDOSE study. But I just want listeners to know, if you're interested in going sort of deeper and learning more about seizures themselves, we have done some previous episodes on PediaCast with those. And I'm going to put links in the show notes.
One of them is called Seizure Action Plan, which is kind of like for folks who have asthma, you may have an asthma action plan. Like if you have an attack, this is what you're going to do. And the kids with seizures can also have a seizure action plan. So we talked about those.
We also have one for the providers out there. It's a CME episode called Seizures and Epilepsy and we'll put a link to that one. You can earn Category 1 CME credit listening to that particular episode. And then, we did one just recently on infantile spasms. That was PediaCast Episode 507. So all of these things will be over in the show notes at pediacast.org for this episode, 509.
So then, Dr. Sullivan, what should parents and family do when the seizure is witnessed. So you're there in that moment. Your child may be stiff and shaking. What do you do?
Dr. Joseph Sullivan: Yeah, this is obviously a very frightening moment for a parent or family member, if this occurs for the first time. And even in someone with an established epilepsy diagnosis where seizures have occurred multiple times, it never gets easy to watch your child having a seizure.
So the first thing is remain calm, if at all possible. Don't panic. The first thing we want to also do is make sure that the child is safe. They may be unaware of their surroundings. Like you said, Mike, they may be shaking on the ground. So we want to make sure that they're not around anything where they're going to have a secondary injury, such as a hard coffee table, if they're standing at the top of the stairs.
We want to just gently lower them to the ground and make sure that their body is away from anything that could cause secondary injury.
Secondly, you want to try and support their head, especially if they're shaking. We don't want their head to be hitting off a hard surface.
We don't want to put anything in the child's mouth. This is sort of an old wives' tale that's been perpetuated forward that someone can swallow their tongue. Certainly, unfortunately, some patients do bite their tongue. And that can be quite painful.
But during the seizure, we really don't want you to be putting fingers, spoon, popsicle stick, nothing like that in the mouth because that can actually cause injury to you, as a person who's putting them in their mouth. And also cause injury to the child because they're forcefully going to bite down on whatever object that may be.
Then we simply want to try and observe everything that's happening. Because in most instances, a seizure will ultimately stop. And the observations that a bystander has in terms of what's going on with the seizure and during the seizure is very important for us as clinicians, as we try to figure out what type of seizure it is, what may have been the underlying cause.
Sometimes, if there's another family member that's around, even videotaping it can be incredibly valuable. And you also want to time the seizure to the best of your extent. Because if you're going to be calling emergency medical services, which we're going to get into later in this podcast, it's going to be important for those providers to know how long the seizure has been ongoing.
And then, lastly, I think if the seizure does stop, when the seizure has stopped, if you can roll the patient usually on to their left side, they're often still going to be unresponsive. There may be a lot of saliva or drool and we just want to make sure that that saliva and drool has the ability to sort of drain out of the mouth with gravity. And so putting them on the left side can be very helpful.
Dr. Mike Patrick: Yeah, that is a really great recap of exactly what you need to do when a seizure is occurring. Let's say you do get to that point where it's been five minutes and it's still not stopping. And at that point, you're thinking about calling 911 and summoning emergency medical care.
The whole point of the PediDOSE study is really to see can we do something better in the way that it is conventionally done?
So why don't we start, Dr. Shah, with you. And just kind give us an idea. You're an EMS responding to a house where there's a child that's having a seizure. So how was that conventionally, what does that look like right now? We're going to try to improve on that. But what does it look right now in time?
Dr. Manish Shah: Sure. So whenever Emergency Medical Services arrive on a scene, they need to make sure that the scene is safe. And they quickly assess the child to make sure that they are breathing okay and that their airway is open and that they have a circulating pulse. But once they've dealt with those immediate things, they're making transitions to focusing on the seizure itself.
And so, specifically, paramedics which have the highest level of training in EMS, they are clinicians that currently can treat seizures with a medicine called the benzodiazepines. So there are several types of benzodiazepines that ambulances carry but the most common kind is the medicine called midazolam. And these medications can be given in several ways, as a nasal spray, a muscular injection, through an intravenous line, through a needle inserted in a rump then or even rectally.
But giving it as a nasal spray or a muscular injection are really the preferred routes based on prior research. And since medication dosing for children is typically based on their weight, most paramedics use a special measuring tape that provides an estimated weight based on their length. Once they figure out this weight, then paramedics typically calculate a dose in milligrams which then get converted to a dose in milliliters.
Mike, when paramedics have told us in our prior research when we interviewed them about this process, they've told us that doing multiple calculations is a process prone to errors. When a child is actively having a seizure and they must also address from parents, who are concerned about the child's wellbeing, questions that they may have.
And so, paramedics have even suggested to us that it would be easier to follow their protocols if there were no calculations and the protocols were more consistent about how and when to treat the seizures.
Dr. Mike Patrick: So when you think about this, from the paramedic's standpoint, as it's sort of practiced right now, you're going to have to figure out the patient's weight, you're going to have to determine how you're going to give this medicine, which for many of them, they start an IV. That's kind of the old training, the, "Hey, we need to vascular access."
And so they're going to take time to start an IV. And then, you have to think, well, what's the dose of the medicine I'm going to give, which may be different if it's given intranasally versus if it's given in IV. So you have to remember which dose is the right dose depending on which route you're going with.
And then the bottle of midazolam may have different concentrations too, right?
Dr. Manish Shah: Absolutely.
Dr. Mike Patrick: There's 5 mg/mL. There's 1 mg/mL. So there's all of these different steps. And the end result of that is it can be and often is a delayed administration of the medicine, incorrect dosing if you did one calculation a little bit wrong.
So I think what you found is that a lot of these kids when they get to the emergency department are actually still seizing, right?
Dr. Manish Shah: That's right. About one out of three children that are seizing in front of the paramedic are still seizing when they arrive at the emergency department. That's why I think we can do better because we have evidence to guide what works better than other things.
Dr. Mike Patrick: So that's the description of the conventional dosing, sort of how it's mostly done these days. So now, give us an overview of the PediDOSE study and what the standardized dosing protocol looks like.
Dr. Manish Shah: Sure. So the PediDOSE study stands for Pediatric Dose Optimization for Seizures in Emergency Medical Services. So the objective of PediDOSE is to determine how the use of a standardized pediatric seizure protocol when compared to using the conventional or current EMS protocols affect several outcomes.
So that standardized protocol has three essential components. One is it prioritizes giving midazolam immediately after ensuring the scene safety and patient stability, while placing a lower priority on other interventions such as checking a blood glucose level or placing an intravenous line.
It also emphasizes giving midazolam only by the nasal or the intramuscular routes.
And then, the third main feature of the standardized protocol is that it advises the use of one to four age-based doses that don't require any calculations. And I think about these four doses like small, medium, large or extra-large depending on the child's age.
Dr. Mike Patrick: So when we're thinking about this, you're just going to determine what age the child is. And if you know the age, you can have a little chart that says if they're between 6 and 16 months, you're going to give this much. If they're 17 months to 5 years, you're going to give this dose. Six to 11 years and then 12 and older is kind of the adult dose.
Dr. Manish Shah: Exactly.
Dr. Mike Patrick: One of the concerns I think that paramedics would have is could these doses be too large? And so we know if you do have too big of a dose of these medicines, it can not only stop the seizure but it may also stop your brain from telling you to breathe. And so you can have a respiratory failure if these doses are too high. So is that then kind of a secondary thing that you're measuring to see if that happens or not?
Dr. Manish Shah: Absolutely. So currently, with current care, one out of six kids needs help breathing during their seizure or after their seizure has stopped, either during that EMS care or in those first 30 minutes after arrival to the emergency department.
So you're absolutely right, that if you get too much of a benzodiazepine like midazolam, you could stop breathing. But prior research has shown that only happens if you get more than two doses and you get too much of a dose.
What we know from the doses that are currently used is that most kids get underdosed. And what we know from the standardized doses that we plan to use at PediDOSE is that these doses are safe doses that have been used in pediatric emergency medicine and pediatric dentistry without any significant adverse events.
Dr. Mike Patrick: You really must have spent some time figuring out these dosage ranges for the various ages. You really had to think about what's the average weight of a particular age group. And then, to make sure that you're not going more than I think it's 30% over the recommended dose of the .2 mg/kg per dose. So you really had to do some fancy calculations to figure out those dosing groups, right?
Dr. Manish Shah: Yes, our team thought very carefully about the doses. And we used standardized growth charts for children to calculate what would be the optimal cutoff to transition from one age-based dose to another age-based dose. And so we feel that the doses that we have choses and the age cutoffs we have chosen are really optimal based on standardized growth charts for children.
Dr. Mike Patrick: Okay. So really the question that you're trying to answer is will standardized dosing, so putting kids into one of those four groups based on their age and giving them one of those four doses and doing it always either intranasally or intramuscularly, will that compared to the conventional dosing, the way that we've always done it, decrease seizure frequency upon arrival to the emergency department without increasing the incidence of respiratory failure within 30 minutes of arrival? Is that a fair summation of what you're trying to answer here?
Dr. Manish Shah: That's exactly right, Mike. Yeah, I think you've summarized that quite well.
Dr. Mike Patrick: So give us a little information about how this project then unfolds. So how exactly is it that you're going to show that this is a better way to do it?
Dr. Manish Shah: Sure. The study involves 6-month-old to 13-year-old patients who are seizing in front of the paramedic and the EMS agencies in the 20 different cities that have agreed to participate in the study. And the study involves something called exception from informed consent under federal guidelines because all of these children meet those criteria and to have a study like this done.
We're going to leave out the children who have an allergy to benzodiazepines like midazolam, those who are known or present to be pregnant, and those who are the severe growth restriction is determined by the paramedic.
But over four-year period, those participating agencies in all 20 cities will be randomly assigned to switch from their current pediatric seizure protocol to using the standardized protocol that we're studying. And so every four months, two cities will switch and we'll compare the outcomes in patients treated under the standardized protocol with the current protocol.
And then, we will collect information from all of the patients that are enrolled from the EMS agencies and the paramedics. We'll only collect hospital-based data from those who are being transported specifically to hospitals affiliated with the research study.
And in those hospitals, we are going to use a portable electroencephalogram or EEG, which is basically a headband that will be applied to the child after arrival to the hospital to determine whether or not they're actively having a seizure or if they're just drowsy after the seizure, which is a very common thing.
Dr. Mike Patrick: So just to kind of sum that up, we have 20 different cities across the United States. And by the way, for those of you in Central Ohio, Columbus is one of those 20 cities. And so, the whole agencies either going to do it the old way or they're going to do it the new way, one of the two.
And so when you summon EMS, you don't really have any control whether your child is going to get the old way or the new way because that's just the way that that particular EMS agency is doing at that particular time, right?
Dr. Manish Shah: Right. And for your Ohio listeners, it's specifically only the Cincinnati Fire Department and the Columbus Fire Department that are participating EMS agencies in Ohio. And each of the other 18 cities has specific EMS agencies. Sometimes it's just one agency and sometimes it might be more than one in a given area.
Dr. Mike Patrick: Okay. But you don't really have any control which of the protocols, whether the old way or the new way, that your particular EMS system is going to provide care for your child.
Dr. Manish Shah: That's right, because if you think about it from a practical point of view, if a paramedic has to in the moment just figure out, "Am I supposed to treat them the new way or the old way in the moment?" that can get confusing as well. When a medical director for an EMS agency switches their protocol, that is the new protocol that all of their EMS clinicians must operate under.
And so, it really makes sense when doing an EMS-based study to compare what's currently done to switching a protocol to something new to what you're studying, and so how that affect everyone.
Dr. Mike Patrick: Yeah, and I suspect you have a program when that switch happens. When they go from doing it the old way to doing it the new way, you probably have resources for them. You know, dosing cards and educational process and all that kind of thing, right?
Dr. Manish Shah: Right. And so to do a study like this really takes collaboration with the EMS agencies and the people who lead those agencies, their educators, the physicians who provide medical oversight. And so that's why we will give each of these EMS agencies a six-month advance notice before they have to make that switch. So that they have the time to prepare everything they need on their ambulances as you refer to. And also, to provide the education to their paramedics, that they know about the study and they know that the switch is coming.
Dr. Mike Patrick: So really, as we think about medical research, most of the time, you're going to have informed consent. And we're going to then talk about how this is an exception from informed consent.
Dr. Sullivan, what exactly is informed consent and why is that an important concept?
Dr. Joseph Sullivan: Mike, you just mentioned, this is a research study. And so a research study is trying to answer a question that has not yet been answered. So there's uncertainty as to whether or not the hypothesis or the theory is going to be correct or not.
And because we don't know this, we want everyone who is potentially going to be involved in clinical research to understand the potential risks and benefits of participating. And so, it's very, very important, and this is for any level of research, whether it be minimal risk, moderate risk, or major risk for there to be a detailed discussion with, in this case, the parent or legally authorized representative of the patient as to what is going to be involved being a participant in the PediDOSE study.
Dr. Mike Patrick: So very important that anyone involved in research as a subject, whether you're a child who can understand what's going on, certainly, you're a parent of a child who may be enrolled in the study, it's going to be important to understand the risk and benefits of participating in that study, having a clear idea. And then giving your consent which is an informed consent, you understand the risks and benefits.
But in this particular case, because parents don't really have a choice of which protocol the EMS agency is going to be using, you have to have an exception to that normal informed consent process.
So give us a little of your thoughts, Dr. Shah, on how that came about, like how do you go about designing this study in a way that's still respectful to parents and their desire to have some sort of informed consent.
Dr. Manish Shah: Absolutely. So as Dr. Sullivan summarized, getting consent is an important ethical principle when we do research with people. But it also creates a dilemma when it's not realistic to try to explain the risk and benefits of a study in the midst of a life-threatening emergency like a seizure.
And because it's essential to be able to improve emergency care through research, the Food and Drug Administration or the FDA has specific regulations about what studies qualify to be done with what is called an exception from informed consent process and how to do it.
So the FDA has reviewed the PediDOSE study and they have agreed that PediDOSE meets the qualifications to be conducted in this manner because it meets several criteria. So one is seizures are a life-threatening condition that must be immediately treated.
The second thing is current treatment, as I mentioned earlier, is not satisfactory since many kids are underdosed and still arrive seizing.
And then, the third thing is collecting data on these patients is necessary to determine the safety and effectiveness of the new protocol.
The next criteria is obtaining informed consent prior to being treated by the paramedic is not feasible because the child nor their parent or guardian are really in the state to provide consent in the moment because the parent or guardian is stressed when they're seeing their child have a seizure. And the child is having a seizure, so they can't even be informed about the study in that moment.
Also, there isn't a reasonable way to identify these patients because that half of the children for whom an ambulance is called for seizure are having their first-time seizure ever. Because this new standardized protocol has the prospect of a benefit to the child, it qualifies for this exception. And it also qualifies to the exception because it wouldn't be possible to do the study without it.
So because it meets all of these criteria, the FDA has agreed that PediDOSE qualifies to be a study that qualifies for exception from informed consent. And so all of the eligible patients will be enrolled. If a parent or guardian decides not to have their child's data collected after that point of enrolment and they make that known to the research staff affiliated with the study, then no further data would be collected from that point onwards.
Dr. Mike Patrick: So there's nothing hidden here. I mean, you're going to treat the kid with what is the standard of care for that particular EMS agency at that particular time. And then, once they get to the emergency department at some point, someone is going to approach them to get their informed consent at that point, correct?
Dr. Manish Shah: That's correct. If the research coordinator is there when the patient and the parent are there, at the earliest feasible opportunity, they will have that conversation and the children who are going to the affiliated emergency departments.
Sometimes, parents may have heard about the study in advance through a podcast like this or through some other means. And so, if they tell the paramedic, I heard about the study, I want to talk to somebody while they're on the ambulance, then the paramedic will give them the phone number for that research staff member and they can have that conversation while they're en route to the hospital.
And then sometimes, if the research coordinator wasn't able to make contact in that moment in the emergency department, then the research coordinator will do their best to follow up with them by either calling them or sending them a letter and if a phone call is unsuccessful.
Dr. Mike Patrick: So this whole process to obtain this exception from informed consent, you mentioned you applied to the FDA. And then they review everything and then basically give you their stamp of approval, and then you're set to go? Is that right?
Dr. Manish Shah: Well, not quite. It has to also undergo an approval by an ethics review board, which is known as an institutional review board. And so, for our study, that's based at the University of Utah. And all of the sites, the 20 sites that are participating in the study, they also have a local review that occurs as well. And they rely on that University of Utah Ethical Review Board review of the study.
And so, we have to undergo a process before we even start patient enrolment. That's called community consultation where we let people know about the study. And then we have to report those findings to that ethical review board before we even start enrolment. And that ethical review board sometimes might make recommendations based on the feedback that the community has provided about things that we might need to change before we actually start enrolment.
Dr. Mike Patrick: So this sort of thing is not undertaken lightly by any stretch and there still a lot of oversight and accountability that's involved here through the FDA, but then also through the ethics board in Utah. And then each of the sites that are participating in the study, any institutional review board is going to have to go through all of them as well.
So there's really many many eyes on this, to make sure it's being done in a way that is fair to patients and families, right?
Dr. Manish Shah: Absolutely. And the study also has a data safety monitoring board where during the process of enrolment and, periodically, this data safety monitoring board will also review the data to ensure that we are conducting the study in a safe manner. And if there are any safety concerns, then they would erase those, and that could lead to stopping the study early if that were to occur.
Dr. Mike Patrick: So it's going to be important for folks, especially if we're really trying to get the word out about this, to understand exactly which communities are participating in this project. And we already mentioned here in Ohio, Columbus and Cincinnati.
Dr. Sullivan, where else can folks expect to perhaps have a child enrolled in the study?
Dr. Joseph Sullivan: Yes, as Manish had mentioned, there are 20 sites all across the United States that are participating in the study. I'm at the University of California San Francisco. And so, one of our institutions in Oakland is going to be participating. And it's largely, correct me if I'm wrong, Manish, it's county based because that's how a lot of the EMS agencies are set up. So that this can be ruled out in a systematic sort of way in that individual county.
Dr. Manish Shah: Yeah, in some communities, it's county-based. I think the three sites in California, that's the case. In other communities, at some of the other 20 sites, it just might be a city, a municipality.
Dr. Joseph Sullivan: Yeah, maybe Manish, you might have more at the tip of your tongue in terms of the different cities across the country that are involved. I don't want to misspeak on someone that may or may not be included.
Dr. Manish Shah: Sure, absolutely. I can say that there's 20 sites that span the entire United States. So we have some on the West Coast, some on the East Coast, some in the Midwest, and some in the south. And so I would say, every major regional area of the United States is represented through those 20 sites.
Dr. Mike Patrick: So parents can always ask, if you're curious, if your child is having a seizure and you've listened to this podcast, and you're wondering if your cities, EMS folks are going to know, correct?
Dr. Manish Shah: That's correct. Somebody who's listened to the podcast, if they want to see these specific sites, they can also read about it in further detail on the study website as well.
Dr. Mike Patrick: Yeah, and we'll put a link to that in the show notes over at pediacast.org so folks can find that pretty easily. You've mentioned community consultations a couple of times. What exactly is that?
Dr. Manish Shah: Sure. So officially, community consultation is a process that a study team goes through for an exception from informed consent study to gather feedback from the community about the study prior to patient enrolment. So that they can consider that feedback and make any relevant changes before beginning enrolment.
So that can be done through surveys, through focus groups, through town hall meetings to actively receive feedback. It can also be done by informing the public about the study through other means, like newspaper articles, radio interviews, podcast like this one, social media posts and posting information on websites.
So doing community consultation is important to ensure that the community is aware of the study and has the opportunity to voice any major concerns that they had. And as I mentioned before, all of the findings from that community consultation process need to be summarized and then reviewed by that ethical review board before any patient enrolment can begin.
Dr. Mike Patrick: So what kind of timeline do you think that you're looking at in terms of beginning the study and then how long the study will take before you have some result to share with folks.
Dr. Manish Shah: Sure, so that National Institute of Neurological Disorders and Stroke, which is part of the NIH has funded this study for five years. The study started in August 2021 so just about six months ago. But we're currently in that period of study planning and some of the sites had started their community consultation period.
And so, once that period is done and we have that final ethical review board approval, then we will enroll patients over a four-year period. That study enrolment is anticipated to begin in late May of 2022. And since it takes time to analyze data and prepare for when we expect to have results to report to the public and the scientific community probably in 2027.
Dr. Mike Patrick: Great. And maybe we'll have you back here to talk about the results.
Dr. Manish Shah: Yes, that would be great.
Dr. Mike Patrick: That would be awesome.
One other thing that I wanted to point out is this kind of study and lots of other studies as we advance the field of pediatric emergency medicine is coordinated through a group called the Pediatric Emergency Care Applied Research Network, also known as PECARN to those of us in the world of emergency medicine. Tell us a little bit more about that group.
Dr. Manish Shah: Sure. So PediDOSE is being conducted through the Pediatric Emergency Care Applied Research Network or PECARN. And so in order for PediDOSE to be conducted in PECARN, it had to go through even a vetting process through the network to get approval for the study and had to incorporate feedback that many clinical researchers within that network provided over a several year period.
So PECARN is the only federally funded research network for pediatric emergency care. And it's funded by the Health Resources and Services Administration's Emergency Medical Services for Children Program. PECARN's primarily based at university-affiliated hospitals across the country. And they've been doing pediatric research on hospital-based pediatric emergency for over 20 years. For almost 10 years, however, they've also been doing EMS-focused research to generate evidence to improve care along the entire emergency care continuum.
Dr. Mike Patrick: Great. And we will put a link in the show notes to PECARN's website if you'd like to learn more about what they do and some of the ways that they've really advanced the practice of pediatric emergency medicine, as you said, over the last 20 years. So that will be available in the show notes.
We'll also have a link to the PediDOSE information page at Texas Children's Hospital so folks can find that easily. And then we'll have information for you again on all the specific sites that are participating and then also ways that you may be able to contact researchers if you're interested in participating in the study. Maybe your child had a seizure.
Is that something that can be done? So let's say a family has a child that had a seizure, was taken care of by EMS and taken to a hospital. Even after the fact, could someone call to see about getting their child enrolled? Or is it really just at the point of initial contact with EMS?
Dr. Manish Shah: Yes, it's actually just at the point of contact with EMS. So if their child is between six months and 13 years old, during our four-year enrolment window and their child is actively seizing in front of the paramedic in an EMS agency that is participating in the study, then their child is automatically enrolled.
However, if they don't want their child to have ongoing data collection, then they can make that known to the research staff, either en route to the hospital or in the emergency department, or even after the fact, if any further data collection is being collected. But we don't collect any data once the child gets discharged from the hospital.
But I will say that if a parent or guardian wants to express their views about the study, one thing I would ask, because as part of that community consultation process, if you live in one of those 20 areas, is to go to the website. And there's a link on the website to fill out a survey. And if you answer the questions to that survey, then that will provide some important feedback our study team, as we consider if we need to make any revisions.
And in addition, there is the opportunity there. Where if you would like to participate in a more in-depth interview about the study itself and doing exception from informed consent research, then there's an opportunity to participate in one-hour interview. And you can just provide your contact information if you would like at the end of that survey.
Dr. Mike Patrick: Great. We really appreciate both of you stopping by and talking about seizures and the emergency care of seizures and PediDOSE study. Really a fascinating information.
And again, all those links in the show notes, if you want to hear more about seizure themselves, we have some links to past PediaCast episodes that we talked about previously, and including infantile spasms seizure action plans. And then, we have that CME podcast on seizures and epilepsy really focused on providers at that point.
All right, well, once again, Dr. Manish Shah with Texas Children's Hospital, and Dr. Joseph Sullivan with UCSF Benioff Children's Hospital, thank you both again for stopping by today.
Dr. Manish Shah: Thank you.
Dr. Joseph Sullivan: Appreciate it.
Dr. Mike Patrick: We are back with just enough time to say thanks once again to all of you for taking time out of your day and making PediaCast a part of it. Really do appreciate that.
Also, thanks to our guests this week, Dr. Manish Shah from Texas Children's Hospital and Dr. Joseph Sullivan from UCSF Benioff Children's Hospital.
So you probably noticed that during the course of that interview that none of us were prepared with the list of cities that is involved in the PediDOSE study. But I have those for you right now, because if you're listening, you deserve to know where exactly this research project is taking place.
So as we did mention in the interview, Columbus and Cincinnati here in Ohio are two of the 20 communities. The rest of them pan out like this. Hanover, Michigan; Atlanta, Georgia; Buffalo, New York; Charlotte, North Carolina; Dallas, Texas; Denver, Colorado; Houston, Texas; Indianapolis, Indiana; Los Angeles, California; Milwaukee, Wisconsin; Pittsburgh, Pennsylvania; Portland, Oregon; Sacramento, California; Salt Lake City, Utah; San Francisco, California; Seattle, Washington; Tucson, Arizona; and Washington DC.
So that's the list. Just pause and rewind 30 seconds and play it again, if you didn't quite catch all of them and you want to see if your city is involved in this research program or not.
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Thanks again for stopping by. And until next time, this is Dr. Mike saying stay safe, stay healthy and stay involved with your kids. So, long, everybody.
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