[MUSIC] In this video we're going to talk about quality improvement research from a human subject's or IRB perspective. More and more, hospitals and health systems are interested in improving the quality of care that they provide to their patients. And it's important to understand when quality improvement becomes research and when it's not. So it's often unclear when quality improvement activities should also be considered research activities. So during this talk I'm hoping to be able to give you some guidance and information that will help you understand when your quality improvement project might fall into research and when it might not. But I want to start with a caveat that I'm going to provide you information based on the literature and my experience as a member of an institutional review board. But if there's any doubt about what you're doing and whether it should be considered quality improvement or research and where it fits, at least in the United States, within the OHRP guidelines that you should consult with your organization's institutional review board. So what is quality improvement and how do we understand how it differs from research? Some of the key factors that we can use to decide what's quality improvement and what's not are, first, is it based on existing knowledge with the intent to improve care delivery and system processes? What we mean by existing knowledge is you might hear someone use the term evidence-based. So quality improvement projects are those where the methods that are being employed, that would be the intervention that's being implemented, is evidence-based. There is evidence in the medical literature to show that this is a proven process that should result in the desired outcome. The quality improvement project is being undertaken to identify and improve clinical performance or system process issues that are specific to the institution. And by that specific to the institution, the take-home message from that is that if you're engaged in a multi-center study where you are implementing across multiple settings or multiple institutions, you may not in fact be doing quality improvement. Because one of the issues is that you may not be able to, as the next point says, intend or go on making sure that any measurable improvements are sustained over time. But you may also not be able to ensure that, if the quality improvement work that's being done in fact results in an improvement, that it will also result in a change in practice. So these are some of the issues that are kind of gray areas, and so if you have questions, as I said, please consult your IRB. As you think about this, these are some issues that you might want to consider as you're trying to decide whether you're doing QI or whether you're doing research. So will the activities in the project occur within the standard of care? So are you introducing new, untested, i.e.non-evidence-based activities? If you are, if there's not an evidence base that supports what you're doing and if it's not going to occur within the standard of care. And by standard of care it could be a guideline, it could be a literature synthesis that points in the direction if there's no guideline about what best practices are. These are some of the things that are evidence-based, proven, and they're occurring within the standard of care. So if that's not what you're doing, then you may, in fact, be doing research activity. Is there risk? Virtually everything conveys some level of risk. It may be that it's just a risk of patient privacy. And I don't mean to say just, but it may be that it's a risk to patient privacy, it's not a risk to patient safety. So if there's more than a minimal risk, then, in all likelihood, you're not doing quality improvement. There may still be minimal risk and you could be doing research. So you need to think about what those risks are and if there is a significant or sufficient risk, again, maybe falling over into the line of research from QI. Is this project primarily intended to generate generalizable knowledge? So are you creating new knowledge that you want to share in the medical literature, with your colleagues, with the world at large? That's not to say that quality improvement can't create generalizable knowledge, but it's not primarily done to generate generalizable knowledge. Virtually, every successful QI initiative has something that it can teach those in the medical profession. However, it's not being done to get to that, it's being done to improve care at the institutional level. So if you're doing something solely to create generalizable or new knowledge, then you're not doing quality improvement, you're doing research. And finally, does the project involve vulnerable populations? Even if the answer to the first three of these questions really would point you in the direction of saying you're QI. If you're using a vulnerable population, if you're doing a project with children, with prisoners, with pregnant women, you may need to be considered research just to ensure that that vulnerable population is addressed in ways that ensure its safe, its privacy, its confidentiality are considered. So these are things that need to be considered and may point you in the direction of considering that what you're doing is research and may need a higher level of IRB review than, say, quality improvement might. So by the US Office of Human Research Protections, this is a definition of research. Research is a systematic investigation that includes research development, testing and evaluation, that's designed to develop or contribute to generalizable knowledge. So by systematic investigation what do I mean? I mean research uses protocols. You want to have research procedures done the same way whether you're working in one setting or multiple settings. So you usually have a protocol, you may have standard operating procedures, it's systematic. It's not going to change if you see that the results of what you're doing may not, in fact, result in the outcome that you desire. The purpose of doing this is to create that generalizable knowledge. So you're just going to go forward with your systematic and standardized methods to answer your question. So it's a set of behaviors or processes, it's not an outcome. As I said, there's protocols, standard operating procedures, everyone is doing everything in the same way. If you're doing a survey, you're doing the survey at three months, everyone's doing the survey at three months across, as I said, if you're within one clinic or if you're in multiple. Many systematic activities, however, aren't research. For instance, in QI you may have a protocol, you may have surveys that you're doing, and you may want to ensure that every patient or subject answers that survey in the same way. But one of the differences with this is that if you're in quality improvement projects, if you're putting an intervention in place through implementation and you see that it may not be working right. Or you see that in your situation it needs to be modified in some way to be able to be successfully implemented, you can adapt the implementation to the local setting in which it's being done. And that's not something you want to see in research, but in quality improvement what you're really interested in is seeing what it takes to improve care and the best laid plans, etc. Your plan may not be the optimal way that this intervention can be implemented in practice. So there's a certain amount of adaptation that's expected within quality improvement that would be totally undesirable in research. And then finally, generalizable knowledge is an outcome that can result from many non-research activities. As I said, virtually every successful quality improvement activity has something to teach colleagues, the medical world in general, but that's not the sole purpose of why it's being done. And that generalizable knowledge is actually kind of a secondary outcome of successful projects. So you do something to improve care in your setting, and you realize that by sharing your knowledge of what you did and how you did it and what the result was, you can help others to improve care. But that's not the primary reason for doing what you're doing. One way to think about quality improvement is this is what's known as the model for improvement. It's a very famous model and it really, in many ways, is at the heart of what a quality improvement is all about. So first we ask what we're trying to accomplish, how will we know that a change is an improvement? So we're going to measure. And then, what changes can result in improvement? So what do we expect to see and what changes to what we're doing might result in improvement? And the way that this is seen is what's called the PDSA cycles or plan, do, study, act. Remember I said in research you're implementing a protocol, you're not changing it, it's standardized and it's systematic. Well, in quality improvement, we're planning what we want to do, so what are we trying to accomplish? How will we know that a change is an improvement? We're doing it, we're putting it in place, and then we're looking at what the results are in real time as we're doing the quality improvement project. It could be monthly, it could be quarterly, whatever is appropriate for the setting and what your quality improvement intervention is, but we're looking at what is taking place. So that, as I said, you may need local adaptation or you may find that even though the evidence that you're putting in place worked in this place in this way, in your clinical area you may need to make a change. So during that study and act phase, that's where you're doing that, you're looking at what your result is and you're acting as required to make a change. And then you're going through that cycle again, planning, doing, studying, acting, it involves iteration.
