Explore the groundbreaking realm of orthopedic research with a twist of humor as Dr. Michael Koren and Dr. Garry Kitay take you through the intricacies of clinical trials and medical innovations. Uncover how studies potentially revolutionize athlete recovery and understand the impact of performance-enhancing drugs in controlled environments. This episode isn't just a discussion; it's a journey through the transformative potential of rigorous research in sports medicine, where the anecdotal gives way to the empirical.
Raise your glasses as we blend the scientific with the sippable in the "ortho sipping scotch study." Drawing inspiration from the Lady Tasting Tea Experiment, a cornerstone of modern medical statistics, we humorously test our abilities to discern the order of scotch and ice, paralleling the meticulous nature of clinical trial design. Our conversation with Dr. Kitay isn't just about advancements in orthopedics; it's a toast to the fusion of history, science, and a dram of good spirits. Join us for an episode where each pour is paired with a dose of insight into the world of medical research.
Check out the full series: ✅Part 1: Innovation and Ingenuity in Medicine - Released January 31, 2024 ✅Part 2: Pioneering Orthopedics and the Complex Ethics of Treating Athletes - Release February 7, 2024 ✅Part 3: Laughter and Libations in the Lab Orthopedic Advances and Scotch Studies -Release February 14, 2024
Explore the groundbreaking realm of orthopedic research with a twist of humor as Dr. Michael Koren and Dr. Garry Kitay take you through the intricacies of clinical trials and medical innovations. Uncover how studies potentially revolutionize athlete recovery and understand the impact of performance-enhancing drugs in controlled environments. This episode isn't just a discussion; it's a journey through the transformative potential of rigorous research in sports medicine, where the anecdotal gives way to the empirical.
Raise your glasses as we blend the scientific with the sippable in the "ortho sipping scotch study." Drawing inspiration from the Lady Tasting Tea Experiment, a cornerstone of modern medical statistics, we humorously test our abilities to discern the order of scotch and ice, paralleling the meticulous nature of clinical trial design. Our conversation with Dr. Kitay isn't just about advancements in orthopedics; it's a toast to the fusion of history, science, and a dram of good spirits. Join us for an episode where each pour is paired with a dose of insight into the world of medical research.
Check out the full series: ✅Part 1: Innovation and Ingenuity in Medicine - Released January 31, 2024 ✅Part 2: Pioneering Orthopedics and the Complex Ethics of Treating Athletes - Release February 7, 2024 ✅Part 3: Laughter and Libations in the Lab Orthopedic Advances and Scotch Studies -Release February 14, 2024
Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased evidence, proven facts powered by ENCORE Research Group and hosted by cardiologist and top medical researcher, Dr. Michael Koren.
Dr. Michael Koren:
Hello, I'm Dr. Michael Koren.
Dr. Garry Kitay:
And I'm Dr. Garry Kitay.
Dr. Michael Koren:
And Gary and I have been having a fascinating discussion about orthopedics and research and some of the things that you do day to day in terms of innovating in the OR treating professional athletes. And then we ended our last discussion about running clinical trials and how we thought that things like using quote "performance enhancing drugs could be best done in a research setting. We certainly don't advocate it in a non-research setting, but if you do it in a research setting, maybe we would discover things that would actually help people. We can learn how to have people can heal faster from injuries, for example, and do it within studies rather than more anecdotally. And that got into a discussion about a very famous experiment called the Lady Tasting Tea Experiment, and I married that concept with a conversation that you and I had. So when I invited you to the podcast, you mentioned that you were familiar with the fact that in certain podcasts the host will treat the guest to some really good scotch. You mentioned that, so it got me thinking OK, well, there's no reason why we can't enjoy scotch during our podcast and also got me thinking about this experiment. So just to remind our listeners about it is that this famous experiment was conducted under the authority of somebody named Ronald Fisher, who is a very familiar name to people like me in clinical research, but probably not familiar to most people.
Dr. Michael Koren:
But Ronald Fisher was the person responsible for modern medical statistics and he created sort of the theoretical underpinnings of what we do today in statistics, most notably creation of a null hypothesis and then either accepting or rejecting null hypothesis based on the data and all the medical studies that we do use this concept. And the concept started from an experiment called the Lady Tasting Tea Experiment, and this was from somebody that was working at the university with him, who claimed that when preparing tea for your afternoon tea which was common in Britain she can tell if they put the milk in first or put the tea in first, and there's a lot of skepticism about that. How can you tell, once it's mixed up, that she claimed that she could. So Ronald Fisher.
Dr. Michael Koren:
Dr. Fisher created this experiment where in four examples, he put the milk in first and then added the tea, and the other four examples, he put the tea in first and then added the milk, and he then created the statistics to determine whether or not she in fact had this ability, and he determined through statistics that in order for her to truly have this ability, we'd have to reject the null hypothesis that she couldn't do it based on getting it right four out of four times. In fact, in her case, she got it right eight out of eight times. But in order for her to reject the null hypothesis, she had to get it right four out of four times, which she did. And so this was the beginnings of modern statistics, where you have a p-value and based on that p-value, you either reject or accept the null hypothesis. So with that in mind, we're going to do the ortho sipping scotch study, and you claim that you can tell if we put the ice cube in first and then scotch or put the Scotch in first and then add the ice cube.
Dr. Michael Koren:
Did I?
Dr. Garry Kitay:
Did I claim that?
Dr. Michael Koren:
I think you did, of course we were drunk at the time, but I think that's what I heard, and so our producer was kind enough to provide the investigational product for this study. That's a very fine Scotch.
Dr. Garry Kitay:
Oh yeah, it might take me a while to test this. Yes, and there you go. And then we have several trials. We have a local brand, the St. Augustine Distillery.
Dr. Michael Koren:
They have, no, they've paid no promotional fee for this. This is just happened to be in somebody's cabinet. And then a good old Johnny Walker black label. Again no promotional fees for these.
Dr. Michael Koren:
We'll get to that eventually, but we're not for this particular podcast. So any of that. So those are the possible products. So we have this done in the way a clinical trial would be set up where somebody has been kind enough to create a little card that talks about all the samples, and then all those samples will correspond to a log that only one person knows. I'm blinded to it, you're blinded to it, we don't know. Yes, I'm just making the observations, yes, and recording them, writing them down. Actually I'm asking somebody to write them down for me, because that's what I usually do and then you're the one that's going to be the test subject to decide.
Dr. Garry Kitay:
Okay, so I'm the test, so not the guinea pig. No, we don't use that term.
Dr. Michael Koren:
The guinea pigs have objected to it, actually. All right, so you can pick any sample. This is so, by the way, there's a term here called randomization, so this was randomly decided. I don't know how this was decided in terms of the ice cube first or the Scotch first, and it can be any given order, but we're going to give you the opportunity to test any sample and then you tell us if you think it was the ice cube or the Scotch that was placed into the cup first.
Dr. Garry Kitay:
Okay, well, I am the grateful test subject. Okay, here we go. U nsure still, I think I need a second tasting.
Dr. Michael Koren:
Okay, please take your time.
Dr. Garry Kitay:
And undoubtedly it was the Scotch first.
Dr. Michael Koren:
Scotch first. Sample #1, Scotch first. Okay, no clues? No, I said that.
Dr. Garry Kitay:
I said it because the ice was still well formed there, so I thought I didn't have that much time to melt.
Dr. Michael Koren:
Well, you can see that we need some work on our technique here, because the producer has already given up the blind by making a face at us. So the blind has been broken, so we're going to have to do this whole thing and start from scratch, but the point of this, of course, is just give the audience a sense for how medical statistics were developed in the first place with an experiment similar to this. The other thing is that medical research has progressed.
Dr. Garry Kitay:
And you're saying research can be fun.
Dr. Michael Koren:
Yes, absolutely can be fun. 100% can be fun, and things that you may not have thought about testing can in fact be tested. So that's the other part of it, but I will also say that we, you know, we're also. One of the very important rules about research is that you have to be self-critical. So in every publication you always have to list the limitations, because the thought is is that you, as the expert, know more about the weaknesses of a study than anybody else, so we have an ethical obligation to disclose the weaknesses of a study. So in this case there are a few very overt weaknesses, unfortunately.
Dr. Michael Koren:
Number one I forgot to get informed consent from you, so we'll not be able to publish these results. That's number one, right? Number two is that we only have six cups here, and we know from the Fisherian experiment that you need at least eight cups to do a legitimate experiment, and that's something called a power calculation. You have to know how many samples or how many patients or how many things you're going to look at in order to get the results, to get a reasonable result. And if you do a study that's underpowered, like this study, it's actually unethical. So unfortunately, it doesn't cut it from that standpoint. And then, of course, our blinding investigator needs to wear a mask or something so that she doesn't laugh when we get it wrong, right?
Dr. Garry Kitay:
Right, all those errors, and I'm still not unhappy with the study.
Dr. Michael Koren:
Okay, well there you go. So, so, fortunately. So unfortunately, we won't be able to publish the results, but I think we illustrated some important principles for the audience. So this is was kind of a whimsical idea, but you and I've actually worked on something that was really important, that made a difference. So I don't know if you want to tell people about the beginnings of the Kineticure work that we did together, probably about 15 years ago, that resulted in a very successful clinical trial, yep.
Dr. Garry Kitay:
In orthopedics, one of the more common conditions that we encounter and treat is arthritis. This is, I do, upper extremity procedures, but of course we are able to do research, you know, and that has to do anywhere in the body or physiology. That applies to anything that we can understand, and this was a knee problem, and we were approached with a potential treatment for knee arthritis that was noninvasive. It involved placing a vibratory device on the knee that included heat application and included what's called continuous passive motion, motion to the knee and vibration, wasn't it?
Dr. Michael Koren:
Yeah, the three modalities.
Dr. Garry Kitay:
I didn't mention that I thought I had. So and we were able to be involved and construct a study to compare people with the true device versus people with a sham device and recorded results that included pain scales, also included range of motion and was able to validate the efficacy of this for that term where the device was studied, which was four week periods.
Dr. Michael Koren:
Yeah, it was a beautiful study, very impressive. I'll give you some credit. The sponsor study came to you because initially they went to some very high profile medical centers who were not really able to enroll in the study. And they came to you and then you and I had a little conversation and we made a few suggestions to change the protocol and within about nine months I think, we had about 70 patients in the study and we're able to prove that combining heat, vibration and motion was better than any individual modality and this was a huge commercial success for the company. They were able then in turn to sell that product to somebody else for hefty amounts. So again, we didn't get that money, just to be clear. We were the independent testers.
Dr. Michael Koren:
But it just shows you that the implications of good research can be very valuable for a lot of sponsors and that it can occur in a private practice setting. Absolutely, and in fact, we enhanced the private practice setting and we wrote the article that was ultimately published in a very good orthopedic journal, as I recall, or as a rheumatology journal. But yeah, so that was a really fun time. We did a lot of good, we helped a lot of patients and the sponsor was very pleased with the results.
Dr. Garry Kitay:
I agree. It's my recollection. I don't think it's as fun as this study in front of us, but I think it was very successful.
Dr. Michael Koren:
Well, of course, now our challenge is we're going to have to go out to one of these sponsors and see if they want to fund this study, n ow. They know the possibilities.
Dr. Garry Kitay:
Right, and you said at least eight. We need to have at least eight testers, maybe more.
Dr. Michael Koren:
Well, Gary, this has been a delight. It's been a pleasure. Thank you for sharing your wisdom, your experience, and thank you for the audience for listening to another episode of MedEvidence.
Dr. Garry Kitay:
It's my pleasure, privilege and looking forward to coming back.
Narrator:
Thanks for joining the MedEvidence podcast. To learn more, head over to MedEvidence. com or subscribe to our podcast on your favorite podcast platform.