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To cover for you today is um the department research overview um talking about finding or developing research questions, some of the faculty mentors or the divisions in our department that where you might find your faculty mentors uh the facilities in our department as well as uh project plan forms. So, not necessarily maybe in this order, but they'll all be here. So this is the research division for the Department of Orthopedics. I serve as the director of research. And then we have four basic scientists who also do various types of research in um gene therapy, um bone cancer cell tissue bases, tissue repair and then um 3D printing for drug screening with respect to clinical research. It takes a whole host of people and we actually need more. Um we have a research administrator who helps with all the grant funding, um grant submissions. She does not write the grants but does the budgets for them. We have an engineer who runs our gait lab and our um comparative orthopedics and biomechanics lab, which I will explain to you in a little bit uh surgical skills lab manager, which is um I will also explain further and then we have uh research coordinators or clinical research coordinators at various levels for each of the different divisions, with the exception of trauma, which currently has a, a doctoral student um assisting with their research lines. So I mentioned that I would men talk a little bit more about some of our laboratories. Um We have a gene therapy laboratory and it, it obviously by name um provides uh an excessive amount of research related to musculoskeletal disorders. Um and Doctor Zani, who is the primary researcher in that lab was actually the recipient of the 2004 Niclas Andre um award for um and the Kappa Delta Award in 2005, which are actually two of the most prestigious honors you can ever receive in orthopedic research. Some of the research that they're doing in the lab um obviously has to do with gene therapy, but specifically with osteoarthritis, um chondro-osteodystrophy type of soft tissue and connected um skeletal tissue uh problems. Um They also look at skeletal developmental conditions and they study um different patho pathogenesis in the treatment of arthro fibrosis, something similar to like frozen shoulder syndrome. We also have the in King Ons Spot Research Center and that's over in the hospital and it contains one of the most complete collections of musculoskeletal pathology information that you could ever find in the entire United States just to give you an example of what, where this came from or how did this area get developed. Um Doctor Kot um provided funding in honor of his mentor who was Doctor William Anakin. Doctor Anna King actually was the founder of our Department of orthopedics at the University of Florida. Doctor ing specialized in orthopedic oncology. And he included in this lab area over 9000 cases during his study of musculoskeletal pathology um that pro still to this day provides information for orthopedic oncologists and people doing research in that area. It is one of the largest um sitting or well functioning um data banks that is available in the United States today. Another lab that we have is the Human dynamics lab. Um and this lab is um has 3d motion capture system and instrumented treadmill. Um And all of that allows us to do um a musculoskeletal motion evaluation and it's run by a biomedical engineer, but it's also used by many departments such as the biomedical engineering department, Mechanical and aerospace engineering, physical medicine and rehabilitation. And then some students from applied physiology and kinesiology. Another use for the lab is that we um sometimes develop customized motion analysis service for patients um particularly in the areas of volleyball, baseball, softball, golf, tennis, and archery. Uh We work a lot with the UF volleyball team and recently also the UF Soli softball team. And now we are beginning a new phase where we are developing protocols for pediatric patients with abnormal gaits um such as idiopathic toe walkers, CP Children um and other Children with various scoliosis and other deform musculoskeletal deformities. Other uses of the lab are for education where we train undergraduate and graduate students and as well as medical students in how to use the equipment and use it for research purposes. And actually we have rented it out to outside companies for motion testing, particularly when they're developing new devices. Another lab that we have that started in 2008 is the Comparative Orthopedics and Biomechanics Laboratory. Um It's a joint venture between our department in the College of Medicine and the College of Veterinary Medicine, specifically the small Animal Science Clinical Sciences Department. Um And this is a fun lab because I get to work in this lab sometimes with uh carrying out orthopedic research that we do both on human specimens and small animal specimens. Um One of the veterinarians over in the small animal sciences is world renowned in the area of fracture repair and fact fracture healing for dogs. And so you can imagine that we can use some of his knowledge um uh to transfer over into our um area with the humans. If you look on the top, uh right of your s of the slide, you'll see a robot arm and it's moving, believe it or not a human cervical spine as we were testing the amount of motion available for the spinal cord within the cervical spine. Um when it's moved the mission of the Comparative orthopedics and biomechanics lab is to assist the Colleges of Medicine and Vetri veterinarian medicine. Obviously to advance medical practice. Um researchers work together. Um We do all different types of testing. Um And we also work on testing prosthesis as well as um other types of reparative um methods. So, in a surgical technique and when it's new, it might be tested in our lab to see how well that technique works. Uh We will certainly have shortly have a study going in on in that lab where we're looking at a uh new fracture repair technique for the femur. Um We have the psychomotor and surgical skills lab as I mentioned before. Um it is both an education and research lab. I teach a course during summer a for doctoral students. Um It's an advanced musculoskeletal anatomy class. Um And it, it's quite fun. They use specimens to learn and, and improve their knowledge base that they already have on human anatomy. Um But the primary purpose besides education is um its use in on campus by other departments to educate both medical students and residents as well as graduate students. Um So you can see the list of departments that have used and continue to use our lab for education of their residents and fellows. The other group of people that use the lab are um faculty within our department, developing and designing um implants as well as externally, companies come in and rent the lab to be able to teach surgeons new surgical techniques or introduce them to new implants that they might be using. And then finally, we often use the lab ourselves to prepare specimens that we're going to take over to the comparative orthopedics and biomechanics lab for testing. So I'm gonna switch gears now that I've kind of given you an overview of the people in the research division and the labs we have and talk a little bit about where would a med student get a research question from? Well, many times you can go and ask our faculty and they have lots of research questions. I refrained from providing you with a super long list of research questions because those questions change from day to day. And by the time I pro make a slide with them on, some of our residents may have selected those questions for their specific projects. So the anatomy of a good research question just comes from curiosity in most cases. Let me give you an example. Years ago in the department, I was sitting in a lecture by one of our faculty and they were discussing fracture repair. Uh And they were talking about using a specific type of plate to put on the bone to repair the fracture. And each x-ray that I looked at as they were discussing this had a different number or different amount of screws put through all the different holes. Sometimes they skipped some of the holes on the plate, sometimes they put screws in every single hole. So after the lecture was over, I went and asked my colleague what, you know, what helped them determine which hole to put a screw in to stabilize the fracture. The answer was I do whatever I think's best because that's how I was taught. And I said, well, isn't there some systematic method that we do this? And me being a researcher would think there should be a systematic method. And he looked at me, he said, no, he goes, go ask some others. And I did ask some of our other faculty members in our department. And to my surprise, nobody had an answer. So we actually just because of that simple little question, did an entire research project trying to look at if the number of screws you put in a to stabilize a plate. And um how well is it, how good does it work in just the initial construct for healing cause? Obviously, we did this on this study on specimens and not in live humans. Um Interestingly though you would have thought by the time I was asking that question that somebody, since they've been using fracture plates for um severe fractures for quite some time, you'd think somebody would have come up with the idea of questioning the number of screws. So in a good thorough search of the literature, only pulled up two articles on that one that was done and tested on actually um wood and another one that was done screwing the plate into a metal pole. And I'm not sure why they would use a metal pole cause that even is further from um similar to human bone uh from what the wood would be from human bone. So we embarked upon that question and um found out different times where the screws would back out if it, if not enough screws were placed in there, oh backwards. So curiosity is a good way to start some other things about your research question is that you want to make sure that you write it down and you know exactly what your question is because when you start doing research in the department of orthopedics, I'm probably one of the people you'll run into. And I'm going to ask you, what is your question? Because your question will help us help you in designing your study. It'll help us help you in doing data analysis. And then in the end, when we hope you're writing an abstract for presentation or preparing a manuscript for publication, that research question is written really well, will help you do that. So you have to keep in mind you have to add, think about everything. And you remember way back when you were little and you were learning about who, what, when, where, why and how we add also. So what and what if the, so what and the what if uh help us identify possible gaps in the research that's already been done or the information that we already know. The what if is, you know, what if we had done it this way? Would it, would it be better for the patient? That's usually what the type of, what if? Question the. So what is one of my favorite questions? Because I'm always telling our residents, our fellows and other people that if you can't answer the. So what question, why are you even doing the research? So you need to be able to answer that question. So how do you develop your question? I often recommend um students that work with me research wise, the doctoral students I work with to try the finer principle. First thing is it feasible is uh um is money required? How many patients do you need? How much equipment do you need, is the equipment available and how much guidance do you need to make the study take place? Um Money is usually a hard one to come by unless you write lots of grants. Um patients, we have lots of them here at the University of Florida and our department sees many, many, many every single day. The key question there is though, is the type of patient you wanna study available in our department? And truthfully probably yes, but it depends on again the question that you're asking specifically in orthopedic oncology. Some of the patients that we see are coming from a very long distance and their type of cancer is very rare. So if you wanted to do a study on that type of cancer in those patients, you would have to be here for quite a long time. So you, you probably wanna look at a different patient population. Interesting is um related to you. Do you find the question that you're trying to answer? Interesting? If not, I can assure you that it's gonna be one of the longest processes you've ever participated in. Because if you don't like what you're studying, you're not going to like what the project and you're not going to get it done many of our residents when they've started a project that they've really not like they don't finish it. The project should be novel. Now that doesn't mean that we're going to be solving anything super human and super great novel means that it takes what was previously done in other investigations and extends it beyond what they've done. You will probably still collect some of the data that the previous researchers collected and that's to help kind of set the ground so that you know that your data is similar to theirs. But then you have some novel aspects or some different data points that you also can are collecting. Um You want to make sure that you're collecting that si similar data so that you can either conf confirm or potentially refute previous results. Um It needs to be ethical there are certain things that sometimes outside researchers come and say, well, we'd like to do this with your orthopedic patients and I have to sit there and explain to them. We're not gonna do that because it's not ethical. Um, uh, y you know, so some things, um, people who are not normally get exposed to orthopedic trauma patients or orthopedic patients that, um, even doing elective surgery in orthopedics, they don't understand that some studies that you think need to happen probably can't happen. For example, randomized controlled trials. Everybody says those are the most important and the best type of study to do a lot of times in the medical world, randomized controlled trials are not ethical. And then finally, it needs to be relevant. This is my, so what question um is it relevant to clinical practice? Does it improve the basic science knowledge to continue building on sometimes in gene therapy? If you look at what they're doing, you're scratching your head saying. So what? But if you realize that that's the next step towards some end goal, then it all makes sense. So relevance is uh um also critically important, I think in some cases because when you get to the end of the study, if it's relevant and it makes sense to you, and it was interesting to you. It's more fun. Another method to look at how to develop your question is the po principle which many of you I'm sure have heard of and that's simply looking at the patient or the problem or what population you're gonna use. Um What intervention are you going to do? Uh What comparison? So you're gonna compare something hopefully before the intervention and then after the intervention and what outcomes are you gonna use to um collect your data to make that comparison. So an example that I can give you is um one from actually our own department that we've did a, a um Multicenter study with. Um, and so in this case, RP was trauma patients with open fractures and we did all patients 18 years and older. Um I um was essential essentially in, within the, the intervention was with the preparation procedures for surgery. We were comparing chlorhexidine essentially to provodine. So, uh some of the patients, well, I let me back up for 22 month window. We would um, prep every patient in the or would be prepped with chlorhexidine the next two months, they would be prepped with provo iodine. The exceptions to that are there are some people allergic to these various types of things. And so therefore they, you don't use something that we, you already know they would be allergic to. And then, oh, the outcome measure that the main outcome measure that we were looking at was infection. Um There were other measures that we looked at, but the primary measure was infection. Another method that I don't use that frequently. I use the first two more so than this one, but I'll present it because some other people have heard about it is the prepare method which is looking at a problem. In other words, an injury or disease, a patient or population is your second p action. That's your intervention alternative, that's your placebo. And again, sometimes in medical research, doing a, using a placebo is not um ethical so you can't use it. Um And then result is your patient outcome measures and evidence that relates to the level of evidence of the data, you collect it. So if you randomized your study, your level of evidence is probably gonna be much higher than if you do a study. That is simply an observation study. But don't get me wrong observation studies are still very valuable in the medical world. So here's some examples of just getting started on the research question. If you're looking at therapy, what you wanna often you oftentimes see people comparing is one intervention effective compared to another intervention or a new intervention has been developed. And they wanna know, are they similar? Because the newer intervention is actually cheaper diagnostic testing is the accuracy of a test or a device. I'm working with two medical students right now where we're developing a survey to see if physicians themselves know what are the best diagnostic test to use for various different types of orthopedic injuries, prognosis? Of of course, is your likely outcome where the progression. Um Sometimes we look at um because some diseases continue to progress. So we look at the survival for the condition or we use what we call Kaplan Meyer curves. In in statistics to look at the survival of the patients etiology is the cause of the condition. We oftentimes look at risk factors or other factors that might cause the condition. And then prevention would be those types of questions. You would ask yourself that what are things that we could intervene with? Or in other words, what would be the intervention that would cause or hopefully reduce the risk of disease? So, if you want to do research in orthopedics, the other thing I thought I probably should present to you is that we have a thing called a project proposal form. Because if you've never worked with the University of Florida's Institutional re Review board, you have no idea just uh exactly how much time and effort it takes to get your IRB approval done. But uh in our department, we've developed this form where the the uh project proposal form is filled up by faculty residents, fellows, whoever in our departments wanting to do research um or research with our patients. Because this helps the clinical research coordinator submit the grant proposal and helps us make sure that you've actually done your homework before starting your study. So there's lots of questions you answer. Yes or no. And if you don't know how to what the right answer should be. You typically would just ask the clinical research coordinator that's gonna help you. In other words, whatever division you're in um the protocol that you develop with your faculty mentor needs to be reviewed by them and signed off by them and then it's reviewed by me and signed off by me before this study starts. Hmm Look at this. We use the PICO form in having you tell us what you plan to do. So we actually have you write a very short abstract. Um We have you provide a good background and significance. It can exceed slightly more than one page if you need to, but you need to demonstrate that you have references and you've reviewed up to date references because we frequently had people say, well, I wanna do research on this and then when I hop on to my computer and good old um Google scholar or I hop into the library and look up some PUBMED references, I find out that the study that person wants to do has many publications already. So then you have to be very careful and define how your study is different from those many others that I just found. The next section is your specific games and your research hypotheses. Um Sometimes we're fine if uh if you write a research question because then we can help you change it into the research hypotheses. But keep in mind a simple hypothesis. If you're comparing two things is to just say there's no significant difference between the two. So then you would be using just a basic null hypothesis. Then your research plan needs to be written out very carefully because we wanna know what's your population, what is inclusion and, and exclusion criteria, particularly because you'll probably be dealing with patients or if not you're dealing with patients, medical records and we need to know exactly what you wanna include or not include other things that you would be expected to provide is intervention. What are you doing to your subjects? Maybe you're not doing anything per se if you're doing too, um if you're doing a retrospective chart review, but you're looking at subjects from two different categories. So that would be kind of your intervention, so to speak. And you're comparing those two different groups. Then what variables specifically are you collecting a word to the wise? Sometimes less is more. I have found that when I teach uh my graduate students, my doctoral students and the residents to make their research question very specific and have very specific variables that they're gonna collect. Um that the, the outcome of the study is much cleaner and much better. The more variables you add in the harder it is A to get all those variables collected. Um and B to decide really, really what is the research question and what variables are most important for, for the person helping you with your stats. Maybe it's my even me helping you. Um what are the variables that need to be thrown into that analysis? And then time, the other thing is what is your time window? Keep in mind that collecting data um or developing a survey? All of that takes a lot more time than you realize. Surveys have to be completely developed before they go um to the IRB. All data points need to be defined before, before any paperwork can be submitted to the IRB. Of course, the institutional review board is gonna wanna know what are some potential discomforts or risks to the patients. Um In retrospective studies, you're not contacting the patients. So there's not a lot of discomfort or risk. The only risk would be if somebody was uh who got access to the data, who was not supposed to have access to the data and could identify who the patients were. Um Of course, we oftentimes ask, what are the IRB will ask, what are the possible benefits again, in a retrospective study, probably not direct benefits to the patients right there. However, even in prospective studies, there might not be definite benefits to the patients. We are consenting into the study. But the important thing is can you state um that there might not be any benefits to the patients in the study but future uh or, but this study may impact future care of future patients and that's kind of what they're looking for. Conflict of interest usually doesn't have much to do with the medical students unless somehow you've already invented something and you're wanting to do research on the thing you've invented and you're already making lots of money on it. Conflict of interest is something that we have to look at um based upon your mentors, some whom have um implants and other things that they've developed that are being used across the United States and throughout the world. And then of course, the last oops come back here. The last section is the references that remember um in your background and significance, you are going to provide some references. Um So keep in mind that the project proposal form is not the IRB form. The IRB has lots and lots of pages that we fill out electronically and we have um certain sections where we know the wording that needs to be put in there that if you don't use that exact wording, it will probably get pushed back. Um So again, keep in mind that somebody's got to help you put this into the IRB and that will be um the clinical research coordinate coordinator in almost every case within our department. So the bottom line is to get help with this. Your study often running is you need to be thorough and make sure your inclusion exclusion criteria and variables are very, very well done that really impacts getting things through the IRB review, your study plan with whomever your faculty mentor is and turn the form into the clinical research coordinator um of the division that you're working in. Um and they will help you get your IRB approval taken care of. So speaking of divisions that you might wanna work in. Here's the divisions in our department. Foot and ankle has several surgeons, spine has one surgeon, adult reconstruction at the moment has one surgeon, but we're in the process of hiring more. Um sports medicine has quite a few physicians, trauma orthopedic trauma. We have uh four surgeons, um orthopedic pediatrics. We have four surgeons hand in upper extremity. I'm going to lose count. But I believe we have four, but we have three that are no, we have five, but we have three that are very active in um research orthopedic oncology. We have three and the research division, there are five faculty members and then, then again, that whole host of other um people who are research um trained. So there's a lot of faculty within our department. Um It's fair game for you to reach out to them and ask them if you if they have a research project or if they're willing to take on a student to, to do a research project. Um All I ask is that um you c see me when you contact them because sometimes they're just like me, their emails get overloaded and they don't see it. Um And I can help um you get in be in better contact with different people. Um, many times you might wanna just call and ask if you can have a meeting with me and I do zoom meetings with students to see what they're most interested in. And then see if I can attach you to a, um, orthopedic physician in our department to help you collect your data. Some other things, um, with respect to working with people within our department to help you do. Your research is one plan ahead, the more you are planning ahead and the better you plan ahead, the more likely you're going to be successful. Please understand that every clinical research coordinator in our department has approximately 25 or more studies that they're working with right now. Our department has 170 IRB approved studies. That's right. I cannot keep track of them all myself. We have Excel spreadsheets that help us keep track of our studies. Um And so that's a lot. Um several of our clinical research coordinators have conducted and published their own research. Some of them have served as faculty members at other institutions. So that means they too have a doctorate. So keep in mind when you're talking to the Cr CS in our department, all of them are very well educated have publications after their own name and they're not just someone telling you you can or can't do something, they're someone very educated in research. Um So the other area that they are very educated in other than just orthopedics and research is all of the regulatory processes for research. Um We have to take more um training that, uh that than you could imagine. Uh if you wanna do research in our department, you probably have to take three online courses that take you about all total, less than an hour for all three courses combined. Um, but we are constantly having to upgrade and do additional training um for our to, you know, supervise research and keep running research in the department. Above all, I wanna say, don't guess, always ask first because in our department, we function in a team culture type work area or work environment. So with that, keep in mind that showing appreciation to the faculty, the people who are helping you with your research goes a long way. But also keep in mind the research that you do, the better it's done, the better it provides our open stores and opportunities for career growth for yourself. Um And that's essentially our end goal for any of the um medical students residents or fellows who do research with us is to improve their opportunities for career growth and for, you know, moving up the ladder in orthopedics. So that's what I have.