Research Week 1 Part 1.docx

Hey class of 2022, happy new year and what a year it's going to be. This is your year. This is the year that you graduate. This is what you work for. You can get into clinical practice very soon with your registered respiratory therapist credential and really make your mark on the world. I'm Dr. Gut...

Hey class of 2022, happy new year and what a year it's going to be. This is your year. This is the year that you graduate. This is what you work for. You can get into clinical practice very soon with your registered respiratory therapist credential and really make your mark on the world. I'm Dr. Gutierrez and I teach the clinical research experience, which begins every January, lasts for four weeks. It's a didactic experience and then you go for scheduled two day sessions at the VA hospital with me as your clinical mentor to learn how to do research at the bedside. What we've done this year is to introduce four modules that have been extensively revised and one of the new features is that we do a module overview like this one. This is module one. It's intro to respiratory therapy research. And I'd just like to kind of go over a few of the highlights that we'll talk about in this module. All right. Well, here we are. We have module one contents. Let's briefly go through that so you'll know what's coming up in this module. I know that in other classes, sometimes when we talk about all the knowledge that you have to accumulate over a certain period of time, they'll say something like, well, we're just scratching the very tip of the iceberg. Well, in this particular course, we're not even going to do that. We're actually going to focus on one snowflake that is sitting on top of the research iceberg. And the reason for that is because there's a whole lot to know about research, but we have to start somewhere. And so this clinical research experience is intended to give you just that, a start. You will also be looking in just a few minutes at the syllabus, and I encourage you to print out a hard copy of the syllabus and to study it carefully so you'll know what to do and when. And we are going to hit the highlights on that in just a few minutes. And there's also a skills rubric that I'm going to be going over with you in just a moment. If you see something listed in your file for module one and it's preceded by the word read, that means that I would like for you to read that and read it for understanding. On the other hand, if it says suggested reading, that's something that you can quickly scan, familiarize yourself with it a little bit so that you can have a reasonable idea of what we're talking about. If it says read, that's something that you should definitely sink your teeth into, so to speak, and really try to understand what they're talking about because you're going to see those concepts again and again. We're going to be introducing the concept of respiratory therapy clinical research, and this is just like any other research, but of course with a respiratory therapy bend to it. How is research regulated? There are regulatory agencies that dictate what you can and cannot do. We're going to look over that. How do you formulate a research question? Or sometimes it's called a research problem. Those are equivalent. Whether you're talking about a research question or a research problem, we're talking about the exact same thing. I actually prefer a research question because since it is a question, it kind of presupposes that there's an answer to that question. And so that's a really good way of starting to think about something that you intend to do research on. We'll also look at basic research. This is bench research. It does require having a control group and an experimental group. We will also talk briefly about evidence-based medicine, and some of you may have learned this as evidence-based practice. Again, those two terms are equivalent. So whether we say evidence-based medicine or evidence-based practice, we're talking about the exact same thing. We'll interest you to know that we will also be looking at selected respiratory therapy research methods. And I say selected because again, we're not going to be able to look at every conceivable type of research that is done in respiratory therapy. But I would like to introduce you to just a few of the more common ones and the ones that you'll be very likely to need once you're in clinical practice. We're also going to be doing a three-week long project where you will use a research article by Ari and her group. This is a research paper that you'll be able to get a copy of. I have that actually listed in your Module 1 file. So if you want to make a hard copy of that and retain it for your edification, please feel free to do that. Write notes on it, whatever you wish to do. We want to look at this research paper over the course of three weeks. And each week there will be answers, we call them tweak answers, and those answers you will please place in the discussion section of Canvas for this course, RET 2533C. [ Silence ] [ Silence ] [ Silence ] Well, if you haven't noticed it already, everything is structured in numerical order in each of the modules. So it's easy to know what to do first, what to do second, and so forth and so on. You'll notice that there are some readings that are assigned prior to specific units. The reason for this is because the reading enables you to begin to think about some of the concepts that we will be discussing in the actual units that follow. For example, in this particular unit, we're asking you to read Article 1.1 before going on to Unit 1.2. So this is Unit 1.2, Introduction to Respiratory Therapy Research, and let's specifically focus on degrees and departments. Alright, our objectives are going to be to first of all explain why the BS degree in the respiratory therapy profession is needed at this time. We'll also discuss the scope of practice for the Emerging Advanced Respiratory Therapy Practitioner. And when you think about this practitioner, think about the ARMP, Advanced Registered Nurse Practitioner, as being synonymous with this type of credential. Or the Physician's Associate degree. Both of those degrees, or I should say both of those credentials, are credentials that require a Master's degree. So we're going to see that the ARTP will also require a Master's degree. We'll discuss the role of research in academic departments, like our very own department at Hillsboro Community College, the RIT department. And also in clinical departments, like the departments that you're doing your clinical rotations in this semester. We'll list some skills, not all the skills, but many skills that students and practitioners alike should be learning right now. They should have a handle on these right now in order to prepare to take their rightful, professional positions in healthcare in the immediate future. [silence] Well, times are changing and healthcare is becoming more chronic and more clinically complex. I think everyone agrees. And not just do we understand that from casual visual inspection of our units and our floor care areas, but the research literature bears that out. So because of the chronicity and because of the fact that we have a much more clinically complex environment, the American Association for Respiratory Care and the profession as a whole have decided that it's really time to increase the entry level degree to the Bachelor of Science degree. So by 2030, RRTs will need to have a bachelor's degree in order to be able to practice in this new, much more advanced environment. What we're hoping will happen is that RRTs will be able to use their newfound knowledge and research to critique clinical practice and to thereby help develop new diagnostics, new therapies, and new protocols that are not just safer, but more efficacious and more effective. What's the difference between efficacious and effective? Well, efficacious refers to something that is effective at the local level in a small group of patients. When something works at a local level for a small group of patients, we refer to that as being an efficacious undertaking or an efficacious intervention. On the other hand, if it's pretty much the case that regardless as to where you are all over the globe, whatever it is that we are instituting, it could be a therapeutic, it could be some type of diagnostic, it could be some kind of surgical procedure, if it's pretty much going to be effective wherever we are, in whatever country we happen to be in, then we refer to it as being effective. So if you think back to what's happening with the COVID-19 situation and the emergence of the vaccination programs that we now have in place, you know that they very often speak about something being efficacious, the vaccine being efficacious. And that's because they obviously started out with small groups of patients just to see if the vaccinations are safe and if in fact they are helping individuals not to get infected. And then as more individuals get the vaccine all over the globe, we can start switching the terminology from something that is efficacious to something that is effective. And of course we want it to be effective for everyone all over the globe. The evidence that we have now shows that health care providers with bachelor's degrees have higher level thinking skills. They also provide better quality care and safer care. And that overall we are seeing reductions in morbidity and mortality because of more advanced degrees out on the floors. And this is information that has been promulgated by our colleagues in nursing, but we're seeing the same type of result in other health care professions as well. At the end of the day, our T departments want individuals that have a baccalaureate degree. So the writing is on the wall. The baccalaureate degree for registered respiratory therapists is a must and will become so by 2030. Here's the AARC's position paper on how they came to the decision that the A.R.T.P. is now needed. The A.R.T.P. of course being the Advanced Respiratory Therapy Practitioner. This is a step that has been in the making for a long period of time and it is intended to help the situation that we now find ourselves in in this country where we have a burgeoning population, but without the health care resources that we need to be able to provide for that population. The Ohio State University is the very first university in the country now offering a Master of Respiratory Therapy program for individuals who want to become Advanced Respiratory Therapy Practitioners. Again, you should think of this credential, the A.R.T.P. as being very similar to what the A.R.N.P. has and what the Physician's Associate has. For A.R.N.P.'s as well as for Physician's Assistants, their degree is in fact a Master's degree level. So they are individuals that are graduating from programs that are graduate programs as opposed to undergraduate programs. And I think what we're seeing now is a trend, a slow trend by all health care professions in this direction. Why now? Why at this time A.R.T.P.'s? Well, the Center for Disease Control has found that if you look at the leading causes of death in the future, those causes of death are going to be to a very significant extent heart and lung disorders. It's now being projected that by 2030 there will be at least 12,000 fewer cardiologists and pulmonologists that are needed to care for individuals that have heart and lung problems. That's a tremendous shortage. And so bold solutions are required. The A.R.R.C. has gone out and said, you know, we have several bold solutions that we would like to propose, but at the top of that list is the A.R.T.P. Now, please don't misunderstand. The A.R.T.P. is not intended to replace the registered respiratory therapist. Instead, the A.R.T.P. is to be a practitioner that's going to be able to lead and to strengthen the respiratory therapy team. This individual will have an advanced prescription privileges, which, of course, registered respiratory therapists do not have. That's why we have protocols, because protocols, of course, are evidence based initiatives that, yes, provide us with a modicum of decision making, but not advanced prescription privileges as A.R.T.P.'s would have. In addition to this, A.R.T.P.'s would have advanced training in respiratory therapy and also research applications. And that last part is a very big reason why we're seeing the introduction of A.R.T.P.'s now. It's the fact that research, the ability to do scientific research in the clinical environment now is so fundamentally important. It has always been important, but it has taken on new importance because of the chronic clinically complex nature of the medical environment that we now inhabit. Because of this, the A.R.T.P.'s scope of practice will be beyond that of the original registered respiratory therapists. And so we see the A.R.T.P. as coming into an environment where they will be able to help us tremendously. Well, in order to work in this new environment, what qualities will A.R.T.'s need in order to be able to do the research that everyone is talking about? Well, there are some very simple things that can be done. For one, A.R.T.'s can be on the lookout for equipment or procedures or ideas that really need to be improved in some way. I'm sure that even though you've been in clinical practice for a short period of time, you've perhaps wondered or you've been curious about things and whether it's not easier, more efficient, more effective, safer to do the kinds of things that you do in another way. Well, that's the beginning of what is required in order to be able to do a researcher, curiosity. Importantly also, A.R.T.'s should be able to review and rank scientific literature. And by that I mean looking at the scientific literature and being able to determine if it's strong literature, is it weak literature? And we'll have a lot to say about that in the next few units. It's important to be able to also bring out that information during rounds. For example, if you're doing ICU rounds, we would like for you to be able to reference the literature that you have read. Sometimes questions come up and the team there at the bedside is not sure of something. In many cases, if the registered respiratory therapist or the A.R.T.P. have read scientific information in a journal somewhere and they can bring that information to the forefront of the discussion, that informs the practice of everyone that makes up those rounds. Also, thinking about how you might design a research plan to answer a clinical question, just thinking about it. That doesn't mean that you're actually going to put that into operation necessarily, but just thinking about it. This is step one. It's conceiving what's possible. Thinking about how your team, a team that you might lead, might conduct a study, might collect data, might go on to perform statistical analyses and tests, maybe even presenting the findings at some departmental meeting like your department there at the hospital or perhaps a state meeting or maybe a nearby college like HCC. And perhaps even the AARC Congress that meets annually. Think about publishing your findings as well. Key to all of this is the ability to identify someone in your immediate area that perhaps has done research and that can be a nurse, a doctor, another registered respiratory therapist. It can be a health care professional. It can be a statistician, someone who has done research and simply ask them for assistance. Ask them to maybe serve as a resource person to you if you should have questions, maybe pointing out books, journals that might be able to help you to understand dimensions of research. In reality, the fact that you're taking this coursework, even though it's just three weeks of coursework and then immersion in the clinical research practicum at the VA, you've taken your first step toward doing exactly that, toward being able to understand research and what research really entails. What about academic departments and clinical departments? Well, RT schools and clinical departments should definitely be preparing their students and their staff so that they can understand published articles when they read articles, for example, in respiratory care or systematic reviews and meta-analyses. And we will see what those are. Perhaps you've already used systematic reviews and meta-analyses. I know that you've heard of clinical practice guidelines because the ARC has numerous CPGs. The institution of continuous quality care improvement or CQI initiatives to determine the efficacy of something or the safety of something. These are often duties that befall a registered respiratory therapist who works in a department and it's important to be able to understand how continuous quality improvement works. Students and staff should receive in-services and research methodology so they can assist in putting together clinical practice protocols and in participating in quality assurance programs and in doing clinical research projects. Why do all of this? Well, it all comes back to what we've already said and that is that our RT researchers are the ones that tend to provide the best care. And the same is true for nurses that are researchers. They tend to provide the best care. And the same thing is true of doctors who do research. They tend to provide the best care. So there is a very strong correlation between those two concepts and that's something that we're going to continually talk about as we go through the units. Alright, this is unit 1.2.5, Regulating RT Clinical Research. In this unit, what we're going to do is we're going to talk a little bit about what it means to actually do regulated research. And at the core of everything is the desire to be ethical. As professionals, we want to make sure that we treat our patients ethically all the time. So we will define regulated clinical research, again with a focus on respiratory therapy research. We want to go over just a very small part of a history of dubious clinical research. I think it's important to do that because that sets the stage for why we have the regulations that we have today. These dubious clinical research behaviors led to the development of regulatory policies and procedures that we're going to talk very briefly about. We're also going to describe the IRB approval process, IRB being the Institutional Review Board. We'll explain the role of IRB oversight during research. And we will also discuss the PI's responsibility with regard to the IRB. What is a PI? A PI is a principal investigator. A principal investigator is the individual who is tasked with leading a research team. Can RRTs be PI's? Stay tuned and we'll find out. First of all, let's define what we mean by regulated clinical research. Research that requires approval from an IRB or other agencies is by definition regulated. And this regulation comes about because of the need to protect patients and to be able to bring patients into research projects in an ethical way, in a safe way, and in a way that is effective and efficient. Now selected hospitals in Tampa Bay use an IRB. And as a matter of fact, many of them use the IRB at the University of South Florida. Many of the hospitals have their own IRBs. The IRB at the University of South Florida is very popular, but it also is a cost, which means that if you're doing research and you need to have an IRB review your research, it is going to charge a fee because these are professionals that are using their professional time and they're coming together for the purpose of reviewing proposed research to make sure that it's going to be safe for patients and that patients won't have a negative outcome as a result of the research. The research may also need to be approved by other non IRB entities. For example, there are research and development committees in hospitals. The VA, for example, has an R&D committee that also reviews research. There are ethics committees. There's the Food and Drug Administration where you're using medications, experimental medications with patients. The reasons for all of these things is that researchers have not always treated their participants, their subjects, humanely. Now we do prefer the word participant rather than subjects, although in the older literature you're going to see that subjects is used a lot, and as a matter of fact is still used in some cases. People have been subjected to research without their informed consent. And even though I'd like to tell you that that doesn't happen today, there are still cases where that sometimes does happen. So we have to be on guard. And anyone who does research has a vested interest in making sure that not only do they do ethical research, but that their colleagues also do ethical research. Many individuals have endured harsh treatments. Some have even had fatal outcomes as a result of research conducted that has not been first reviewed by a body like an IRB. Researchers have in some instances even faked data and have submitted false research reports. Obviously, that is a very unethical thing to do. The fortunate thing is that when those things have happened, and it's a very small percentage, I want to leave you with the wrong impression that it's 50 or 60 percent of the research work that's done out there. We're talking 5 to 10 percent, and even that may be a little higher than what it really is. But fortunately, what happens is other scientists who are not associated with the unethical research come forward and expose the research as research malpractice. And that happens over and over again. Sometimes when an article gets into a journal, for example, researchers from other universities, from other institutions, from other research teams will begin to pour over that research article, and they will find things that are suspicious or inconsistent. And those things are typically brought to the attention of the journal that published that particular article. So science polices itself, and it's very, very good at doing that because scientists want to make sure that the data that we have is as accurate as possible because we're making decisions and we're making projections based upon that data. When an individual gets ready to do clinical research in a hospital setting, before they can even send their proposals to the Institutional Review Board or the IRB, they have to go through a very substantial amount of training that talks about how to actually work with individuals who are potential participants in research. And a very large part of the training is devoted to going back in time to a very reprehensible period back during World War II, when not only prisoners of war, but in fact, even civilians were used in hideous experiments that were carried out on them against their will. And you can see a few of these here that I've outlined for you on the slide. The breaking of bones, and then grafting those bones, doing testicular and ovarian radiation exposures. These were things that were done because the individuals who were waging the war felt that they needed this information, but they were getting this information without explaining to their patients what was going to happen to them. And without obtaining informed consent. It was reprehensible. It was hideous. And again, we want to learn from these instances so that this never is repeated again. One of the positive things that came from this very violent period is the Nuremberg Code of 1947. And in this code, it stated that if participants were going to actually take part as participants in a research project, the individual had to provide informed consent. The participation had to be voluntary. You couldn't coerce these individuals into doing this. I mean, this seems to us today to be common sense, but there was a time when this was not common sense. And again, we want to take special care to make sure that this never happens again. That's why we devote time to this. And this is why we're having this discussion now, because it's important. Experiments have to be useful. They have to be necessary. Human experiments should be preceded by animal research, if possible. Sometimes that's possible to do. Sometimes it isn't. Physical and mental suffering should be avoided at all costs. Death and disability should not be an expected outcome. Only qualified individuals should conduct research. Those qualified individuals have to demonstrate by virtue of their training that they know how to proceed, that they know how to keep patients safe, and that they're going to place patient welfare ahead of everything else, including the research project itself. Participants should be free to end an experiment at any time and still receive excellent care. And this is extremely important, and it's something that all ethical researchers subscribe to.