So, at the last meeting, we gave you some homework, and at the end of every session, we gave you a little bit what to do. So what I asked you to do was to iron out your hypotheses, so whatever you developed, and we'll talk about, for those that weren't here, just to iron out your hypothesis with further literature searches, smooth out your introduction, make three specific aims or think about your specific aims, and work out the preliminary data and methods, and we'll probably end up doing that at the next session. Now, did anyone change their hypothesis? The stuff you were doing, remember we talked about, anybody change? Is it the same hypothesis? Everybody's about the same? No change. Okay, good. So, when we talk about specific aims, you need three aims, basically three things. You need three aims that build on each other, and then you need short paragraphs under each aim about how you are going to do that aim. So it's like aiming a gun. How am I going to do that? And then those will expand into your material methods. You don't want your aims to be material methods. You want one quick sentence, and then move forward with that. So, examples. So specific aims, if you're doing a retrospective study, the population you're going to study, where are they? Where's that population? How do you have them? How do you get access with them? That'd be one. And then number two, how are you going to study them? How are you going to collect that data? Is it going to be in an Excel sheet, or is it going to be in, I would recommend everybody think about using REDCap. We'll talk about that at another meeting, but it's the UH, almost essentially UH Excel sheet, and using those as that. How are you going to collect the data, and then how are you going to analyze them? So that's three very nice specific aims, and that could be done with any retrospective or prospective study. We're going to get some time here, so what we're going to do, just like we did before, we're going to read through your hypothesis, we're going to read through your introduction, and we're going to read through your specific aims, but I want to go around now, and I'm going to check through to help you with your specific aims, and see where we can do, and then we'll go from there. All right? So let's go into these little groups. Tell me what you guys got. So, we were thinking, when we started looking for more articles and support, that we needed to tweak the hypothesis. Good, okay. Going back a little bit to make it make more sense, because there's a lot of data that already was supporting, or already making the conclusion that we were trying to do with our hypothesis. Gotcha. Right, right. And you wrote your introduction. We did. And the patient population that I was looking at was trying to work with the Laboratory Center of Medicine. That's good, that's number one. Yeah. And to develop a survey. Yeah. So that's number two. Okay. So that's number three. Okay. So that's number four. Okay. So that's number five. Okay. So that's number six. Can you sort of write down like what their duration of exercise, how often do they exercise and what kind of intensity? Yeah, so you would say this is number one, to develop a tool to analyze the patient population. And this tool would include, you know, six questions, five questions, how many questions, that would further understand the relationship between those two variables that you just said, the immune system and exercise. Specific aims, number one is, you know, collect a population of patients coming out of this practice or this area. That's number one. And then number two is to utilize or develop a tool of so many questions to compare the two variables, which are the amount of exercise and the amount of infections or effects on immune system. Number three is to analyze the data to using statisticians. And then at the end of that paragraph, you will say, using these three specific aims, we aim to prove or disprove our hypothesis. And you repeat your hypothesis. So basically my aim would be to collect patients, there would be adult patients in a UH primary care practice within Nashville County, collect all initial vitamin D levels and corresponding patient BMI, and then analyze the results with the statisticians. This is your primary, and you want to make this one, two, three. I need like three lines underneath each one of these, telling me like, you know, where are these people at and that kind of thing. And then this you won't need. And I want you to go to PubMed, and I want you to type in there. I want you to look and see, do a preliminary look to see if there's any other literature. If there is other literature, and I want you to look at that and see if you can schmooze this into a different hypothesis, if need be. Does that make sense? Okay, so we've got, we did that. I think we're pretty close to what we want. So what I'm going to do is, like we did yesterday, you're going to pick your champion. Someone's going to read them out for you. Priya, I would like you to come up. If you could, I would like you to start with your hypothesis, then your introduction, and then your specific aims. And come on right up here. We hypothesize that combination therapy upon discharge from a United States community-based hospital would demonstrate similar admission rates to tertiary care centers outside of the United States. And by combination therapy, which is not included here, which it should have been, we're studying corticosteroids in patients who were admitted for acute asthma exacerbation. When they're discharged, what therapeutic regimen are they going home on, whether it's PO steroids or inhaled steroids, which either both of those or one of those is affecting the readmission rates within 30 days. So it's a retrospective study we're doing here. So that was our hypothesis in terms of rate reduction. Acute asthma exacerbations requiring hospitalization remain prevalent in the United States. Readmissions pose an additional unnecessary burden on the health care system. Multiple attempts at using different therapeutic modalities upon discharge have been targeted at reducing readmission rates in tertiary care centers outside of the United States. Systemic and inhaled corticosteroids are used routinely in the management of acute moderate to severe asthma. It has been well documented that either oral corticosteroids or inhaled corticosteroids administered upon discharge reduce hospital readmission rates. However, the role of ICS used in combination with OCS post-discharge remains unclear in tertiary care centers and has not been studied in community-based hospital populations in the United States. We aim to show that ICS, in addition to a short course of OCS upon discharge, will yield similar 30-day readmission rates for asthma relapse in a community-based hospital population in the United States when compared to tertiary care centers outside of the United States. So just a little bit of background. The guidelines that we follow in patients for acute asthma exacerbations are based on research studies that have been done in Europe, actually, believe it or not. So most of these studies, large population studies on big tertiary care centers have never really done in the United States, and especially not in a community-based hospital such as ours. So that's one of the reasons we picked this and one of the reasons why we are emphasizing on the community-based hospital setting in the United States in our paper. So specific aims. Aim number one, we will identify an eligible study population within the university hospitals, regional hospitals, by using specific diagnosis-related group codes within our electronic medical record over a period of 10 years. This study population will be refined as described in our material methods. Number two, we will collect and organize non-identifiable data on each patient discharged and or readmitted within the 30 days of discharge with the primary diagnosis-related group codes specific to asthma exacerbation from university hospitals. All data will be compiled and stored on UH RedCap. Specific aim number three, we will analyze the collected data using the Lake Area College of Osteopathic Medicine blinded statistician. We will compare our data using parallel statistical analysis from studies previously performed on populations at tertiary care centers outside of the United States. Thank you. Can you believe she just put that together in the last 30 minutes? She's a ringer. What I did was before, while I was putting together this Scholar 7, I had sort of an alpha test. I had a group of internal medicine residents that we put together this process. We were meeting every Monday, and this is how this came out. You're doing exactly what we did for them, and they have an IRB submission already. It didn't take very long. Four weeks. But you notice some of the key statements there. Some of the things you can add in each paragraph is that if there's a data code or there's a diagnostic code, you can put it in there and how things are collected through the RedCap, and then it's the same thing for every study, whether it's retrospective or prospective. You see how this is flowing. So you have your hypothesis, you have your little bit of an introduction, feeding them a little bit, and then you're going to put your specific aims, so if it's any more than two sentences after one statement in your specific aims, it goes in your material methods. So we just want to be very brief, be very impactful. This is how I'm going to do it, and then you're going to lead them to your hypothesis again at the end of those, and then the next level we're going to try to do is your preliminary data. So this is the next. This is the proof for the next. So, Mike, at that table, if you could help them work specific aims, and then the rest of us are going to do our preliminary data. So the preliminary data could be your own, could be someone else's data, and then make sure they know what you told them. Sequentially and logically discuss the data until it reaches your hypothesis and make the argument from the literature. So you've already done this. We've already talked about this in the sense that you've done a mini literature search for your hypothesis and where it fits in the literature. So there's a hole in the literature. There's an end to this that you need to now write why this logically makes sense using more words. What I typically do is I take your introduction, and we talked about your three-sentence introduction, correct? Each sentence now becomes a paragraph. You see what I'm saying? So if your first sentence of your introduction is saying that not a lot of data in, let's say, stress fractures, or most of the data about stress fractures are on a large population of athletes in both upper, so you give them more data on that. And then number two is that second sentence is that a lot of people have done a lot of work, and we're going to tell them a little bit more about it. And your third is why you're leading them to look at your hypothesis. I want you to take those three sentences, and you need to use literature. You need to use what you have and what you brought, and using literature to make those three paragraphs. So if that first sentence should be, like in yours, the first sentence should be, you know, stress fractures are reported frequently in athletics throughout the United States. You know, so-and-so at all showed this and this and this and this. But there's been a last sentence in that paragraph should be, not many people have looked at the variation among the sports with stress fracture. The next paragraph, track and field has reported a lot of stress fractures, a reference, and then go on. And at the very end, no one's compared stress fractures, and that's your first sentence to the last paragraph. No one's seen that, and then this is why we're doing it. Do you see what I'm saying? So right now, what I'd like you to do is take that introduction, the three-sentence introduction. I want you to expand that into three paragraphs. You should have literature, and using those literature that you referenced. I think we got something schmoozing out here, so if we can start it up. I'm going to have you want to come up and read the preliminary data. Asthma is a serious health and economic concern in the United States, affecting 1 in 12 adults and costing an estimated $53 billion a year. In 2013, there were 439,000 asthma-related hospitalizations and 1.8 million asthma-related ED visits. The estimated average cost of a single asthma-related hospitalization in 2013 was $24,000. Optimizing treatment on discharge is imperative, given 12% to 16% of patients treated in hospital for an asthma exacerbation relapse within two to four weeks of discharge from tertiary care centers outside of the United States. The 2015 Global Initiative for Asthma, GINA for short, guidelines recommend daily oral corticosteroids equivalent to 50 milligrams of prednisone for five to seven days without tapering, as well as regular ongoing ICS therapy. Although the only published systemic review suggested there was insufficient data to support the use of combination therapy upon discharge, this included only ED studies that were conducted in tertiary centers outside of the United States. There is a lack of data comparing community-based readmission rates in the United States to the previously described data from the tertiary care centers outside of the United States. We hypothesize that combination therapy, as in OCS and ICS, upon discharge from a United States community-based hospital will demonstrate similar readmission rates to tertiary care centers outside of the United States. We aim to prove or disprove our hypotheses using the following specific aims. Thank you. So you notice that, you know, what I taught you today was you take those three sentences, make three paragraphs, and then have three sentences within each paragraph. You can expand that. So as you go home today and as we review this, try looking through the literature. Get a little bit more in depth. Pull it apart a little bit. Make sure it's leading you somewhere. Don't put something in there just to put it there. Make sure it's leading you somewhere. Each paragraph leads you down that avenue, right? So your real homework is to take what you've gotten here, put it on one document. I need one Word document, on one Word document, not with a bunch of other stuff on it, just as we did through, and then I want you to write the materials and methods. Why that's important is because when we get to the later stages of Scholar 7, we're going to be cutting and pasting what you've done onto your IRB application, and then that's what's going in. So right now, your job in the next two weeks, we'll send out the stuff. Expand it. Make it a little bit longer. We don't want this any more than a couple pages long, but expand everything. And then I want you to take your specific aims, and then I need three paragraphs on your specific aims, and that will be your material methods. You'll have the title, Material Methods, and then your first specific aims, the first sentence from your specific aims, bolded and underlying, number one, and this is how I'm going to do it. You're going to expand on how you're going to do it. And in that section, it might be how am I going to find where are these patients going to be at, and then number two, how am I going to collect the data? Well, I'm going to collect the data using this diagnostic code, specifically this diagnostic code, and I'm going to run it through there, and I'm going to put it all collecting this type of data, and you're going to do male, female, all the demographic studies. You're going to pull that together, and then you're going to pull together the other outcomes and other things you need to know and store in REDCap. And then lastly, number three, I'm going to analyze it, because I already spoke to the statistician. Here's the name of the statistician, and this is where we're headed with that. We're going to submit it. We already told us that we're going to need 5,000 patients to look at to make this study any worthwhile or whatever. So that's sort of your goal. And once we get to material methods, we're only going to need one last paragraph, and that's a conclusion. Then we're done. And then your last six and sevens cut and paste, and then review, and then we may do number seven individually with individual groups with a couple mentors to make sure that the final product is where it should go. What I also like to know at the next meeting is I need to know where you're going to submit this to. And so OMED, Cleveland Academy, OOS, Ohio Osteopathic Symposium, or something in your field. So it might be an orthopedic journal, it might be a podiatry journal, it might be a PMNR, but a meeting. What meeting are we going to send an abstract to and give you enough time? So it might take one to two months to get this IRB through, and then you're going to collect data, and you can collect preliminary data. You can collect enough data to create an abstract to send to the meeting. It doesn't mean you have to have your study done. You can have enough to get the stuff to the abstract. And once you have the abstract, they may tell you you want to do a poster, and then you've got a poster. Right there, you're scholarly. You have taken this to the point where you're all going to be proud of it. And then you're going to take that, and then after you present a poster, maybe even do an oral presentation, you're going to write that up as a manuscript, and we'll talk about that later as we have smaller sessions to really walk you through that. Okay. Okay, that's your homework. Got it? All right, thank you.

research proposals

hypotheses

data analysis

literature review

statistical planning