Therapeutic Video Game on Trial
Today's episode covers the topic of Digital. Therapeutics given that earlier this month. The FDA approved its first ever prescription video game. And since this is journal, club, we go into one of the key clinical trials, underpinning this historic decision published recently in Lancet digital health by Scott Collins and colleagues, which evaluated this games ability to improve attention and kids with attention, deficit, hyperactivity, disorder, or adhd. Are Sister podcast. Sixteen minutes on the news also covered this topic debating the bigger picture. Questions of what is an isn't a digital therapeutic and where pricing and regulation comes in. You can find that episode at a Sixteen Zero Dot. com forward slash sixteen minutes. A sixteen. Biodiesel Team Partner Former MD entrepreneur. Justin Larkin joins me in this discussion where we cover the pros and cons of this video game compared to traditional pharmacological therapies. The game specifically targets the attention impairments in twelve year. Olds by having them help an Avatar navigate digital environment in the face of other distractions. We also discussed how the randomized controlled clinical trial or are. CT was designed the limitations of the study and the open questions to be addressed. Will you begin with what question this paper answers? Video game via digital therapeutic and I think this paper resoundingly answers that question of yes, a video game target, a specific mechanism of action can have advocacy to cross that threshold of being considered at their pubic, but then I think more importantly is. Can this specific video game have an impact on a child with Adhd? To the point where it could be considered a tool in the toolkit of physician, treating this patient and I would argue the resounding answer from this is certainly this is considered, both because it there's an obvious benefit, but also the risks associated with it proved to be pretty minimal. There's plenty more research to be done, but I think this does a great job at answering that in the subsequent FDA decision just went on to reinforce study further. My favorite part of the paper was getting to watch that supplemental file, showing the kids video game and see what the kid seems and being able to connect that to kind of the goals of the game. If you're to watch that video outside of. The context of knowing that this was coming from a digital therapeutic company or clinical trial. You probably wouldn't know that it was a digital therapeutic. You'd probably think it was any other game that our kids are playing these days, but I think the opportunity for digital therapeutics that creates an environment where a therapeutic can actually be enjoyable, can actually be entertaining, and the really cool thing about this program is that it learns it's able to know what the kids ability is, and then Taylor the game, and how hard it is based on how quickly they pick it up and it's always responding to that level of engagement as a kid learns to adopt those skills. If you think about nutritional therapeutic lake uphill. There's opportunity for real time iteration of the therapeutic. There's no ability to say hey. This person is responding great, so we're going to cut the sing off. This person isn't responding, so let's up titrate the dose. Where in the game there's this ability in real time to iterative on how the person's experiencing that there. Yeah. I've known kids with ADHD and some days. They have good days and some days. They have days where it's more difficult being able to have that happen. Real time seems really appropriate for this type of condition. I think it's a really great match. Between kind of underlying mechanism, underlying patient characteristics in the method of delivery of the therapeutic, so there's proof of concept evidence from previous studies. This therapeutic video game can help kids with Adhd, but this particular study really test that hypothesis with sophisticated and careful clinical trial design, so let's dig in now to some of the important details of the study, the built upon the pita studies by having truly randomized controlled trials. So this is where there's a control group women interventional group getting developed intervention, but then also importantly, all of the researchers involved were blinded to the intervention. Of Selves and the patients themselves are blinded to whether in the intervention group or not, so the control group also got a video game, and it was a word search game that it also learned was also rewarding, and also had a lot of the same kind of game design elements, but that video games doesn't target those same pathways that are issues. ADHD, an important is also used a method called the intention to treat meaning all of the people that were initially stratified into the two groups were included in a statistical analysis, regardless of whether they completed or not so really meeting at the top level criteria what it means to be a rigorous are ct for therapy. Yeah. This study is pre registered, and so the idea behind Predrag distraction. Is that you as a researcher? Lay Out exactly what you're going to do before you ever do the study how you're going to collect the data how you're going to analyze that data, and importantly you determined to be a significant outcome before you look at any of the data and that really help prevent that kind of post talk. We looked at the data. We see this as significant. Therefore, this is important. You're saying from the start. This is important and will only know if our study is successful if it meets this particular endpoint. To Study Island, importance of having got foresight in the design, but also another thing that was interesting in the study was the choice of outcome metrics traditionally adhd research. A lot of the outcomes have been focused on the number of different metrics and batteries of surveys, subjective measures to assess symptoms of adhd whereas this particular study use a measure called the Tova Api. That's Te'o via API, which is really focused on assessing objectively attention. They picked an outcome that really got out. Some of the core impairment comes along with Adhd and then a lot of circumstances is equated with some of the challenges. Kids have in the classroom and other settings.