I apologize in advance. This slide is a little busy but I think it's a really important slide and a really important table to share because it really helps to provide across a number of different domains and considerations what's human subjects research and what's quality improvement. So again, we can look at the purpose. Human subjects research is designed to contribute to generalizable knowledge, whereas quality improvement is really done to improve care processes or care delivery based on proven intervention. So again, that evidence-based care. Where is the starting point for your research. So when you're doing human subjects research, you're going to do a lot of background research trying to come up with your question and your hypothesis, so that what you're developing is being done to answer that question. Whereas in quality improvement, the knowledge-seeking is really being done to understand how you can change care within the system in which you work. On the design again quality, rather human subjects research, a rigid protocol that's going to remain unchanged that standardization throughout the research project versus quality improvement where it's adaptive and it's iterative because it needs to be. If we're doing QI and our goal is to improve care in the setting in which we work, then we need to be able to ensure that it will work in a setting in which we work, so we're going to adapt it, we're going to do that PTSA cycle to see whether the modifications that we made were successful, if not we're going to make some more little tweaks. Again, going through those iterations of that cycle to ensure that the implementation that we're doing is working in our clinical setting. The benefits in human subjects research, you may or may not benefit subjects. It's not certainly done with the plan to benefit the subjects or the patients who are participating, but it's intended to benefit future populations of patients and others. In QI you want to directly benefit the system or the process where you're doing the work. It may or may not benefit patients as you're doing the intervention. But through those PTSA cycles and through your planning, once you've established what your order set or the other way that you're going to standardize care based on that intervention is, you're going to be benefiting future patients. The risks, human subjects may put subjects at risk again, those may be risks of privacy or confidentiality. They may not be really substantive risks to person or life. Quality improvement research by the virtue of the fact that it's using evidence-based proven methods should not increase the risk to patients. Again other than perhaps privacy or confidentiality but it should not put patients at risk because it should not be making new unknown changes to care. The participant obligation in human subjects research, there is no obligation to participate. In QI, QI in general you want depending upon what your method is and what you're looking at. You want as many patients as possible to participate and in fact it may be that every patient who's admitted to the unit in which you work or every patient who is seen in a primary care practice with a certain diagnosis is a participant by virtue of the fact that the implementation and the intervention that's being done is going to affect their care. The end point, again, answering a research question in the human subjects research and quality improvement, it's improving a program process or system. So it is directly affecting the way that care is delivered. In human subjects research, often statistical methods and it may be sophisticated statistical methods are employed to prove or disprove your hypothesis. In quality improvement, you're really looking at comparing based on established standards. Often it's not sophisticated techniques, you may be using run charts, you may be looking at change over time, certainly not needing to do some sophisticated multiple regression analysis. So the statistics that are used to analyze a quality improvement project are much simpler in general. Adoption of results. In research you hope ultimately that if you are successful, that your methods and your intervention will be adapted or adopted, but you're not really under any obligation to have that happen quickly. Under QI of course the work is being done to improve care, and so you really want to have, once you know that you have a successful program and it's delivering what you want it to deliver in the way that you want it to be delivered, you really want to have that become the standard of care. The way we do things around here in your clinical area and you want that to happen quickly. Again, for publication and presentation, in human subjects research, it is an expectation that investigators will share their results. In quality improvement, it's not an expectation. As I said, most QI projects have something to teach others and so QI practitioners are encouraged to share a systematic reporting of what they found and there are guidelines that exist that help you to do that in a really responsible and scientific way. But it's not an obligation and it's not an expectation. So is QI sometimes considered research? Well, yes it is. And again, here we're gonna go back to the office of Human Research Protection in the United States and their guidance says if a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care, but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also be considered non-exempt human subjects research under the Health and Human Services Regulations. So again, you see there it's an untested clinical intervention. So it's not evidence-based, we don't know that it will be successful. Really important, if you see that your research, that your project is going in this direction, you're probably doing research, you should submit it to your IRB. Even if you're doing quality improvement, you may have a requirement to submit to your IRB, but the level of review, and then the requirements for follow-up with that review board are less for quality improvement than they are for human subjects research, or quality improvement research. So when my QI be research again doesn't implement existing knowledge, following that research methodology design, fixed protocol, the risk for the intervention to participants are greater than normal, and often research is funded. So if you had to go to the National Institutes of Health or the Food and Drug Administration in the United States to get research support to fund the project that you're doing, most likely you're not doing quality improvement, you are doing research. So I want to give you some examples to help clarify and make it a little clearer what might be QI and what might be research. So these again are coming from OHRP so this is an example of quality improvement. A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected. So again, they're implementing a procedure that's known to reduce pharmacy prescription error rates. They are collecting data but the data that they're collecting is determining whether the medication error rates have decreased as expected given their intervention. And also they're looking at adherence to the procedure to make sure that the quality improvement intervention was implemented as expected. This is where those PDSA cycles come in. I think it helps to make it clear that when you're assessing adherence, that's where you may need to make modifications or adaptations to your method of implementation to achieve the desired result. Another example, a radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce overexposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over exposures have decreased as expected. So again, a practice that's been demonstrated to reduce overexposure incidents. Patient data is collected and it's analyzed to determine if the over exposures have decreased as a result of the database that monitoring and forecasting radiation dosimetry. So two good examples of what's quality improvement. So now let's look at what's quality improvement, but also was research. So the Department of Internal Medicine at Mercy Grace Hospital decides to do retrospective chart review of patients seen in their clinic in the past two years who presented with the flu. They want to use this information to ensure that they are meeting the needs of their clients when planning for next flu season, but also may use this information to contribute to a larger study with various hospitals about the prevalence of the flu in the metropolitan area. Although the products of this project are intended to assess and eventually improve internal practices and systems. They are also designed to contribute to generalizable knowledge. So when they're adding their data to that larger database with other hospitals to look at the prevalence of the flu, they're seeking to expand generalizable knowledge and it's crossing over that line. And again it's considered research but in the United States anyway, that just means that it requires a higher level of review and follow up. Not that it can't be done and not that roadblocks will be put in your way because you've moved from QI to research. And another example, a project examined the implementation and feasibility of a multi-level primary care nurse-led prediabetes lifestyle intervention compared with current practice in patients with prediabetes with weight and glycated hemoglobin, HbA I c as outcomes. So this would be something where if they achieve success because they are examining the implementation and feasibility as well as those outcomes, this would be directly affecting quality improvement. So this is the type of quality improvement research that's done to get that evidence that other teams can then employ in their clinical setting in a quality improvement project. So I hope this helps really to see, I think it's a great example to really show how this is research, but then how it's feeding into that quality improvement work that is so important to help improve healthcare delivery. So again, I hope this has helped you to understand some of the differences between quality improvement and research. Again, just want to end with my caveat, if you're not sure how to proceed, please consult with your local IRB. Thank you.
