My presentation will try to cover a lot of the rest of what we do in our endoscopy unit. So, as mentioned, my name is Joel Munzer. I'm at the Medical University of South Carolina. I currently serve as the chair of the ASGE Quality Committee, and the focus of this presentation will be quality indicators in advanced endoscopic procedures and in upper GI bleeding. So, I have no conflicts of interest to disclose. So, my goals are to provide you some background on the structure of quality indicators in general, and specifically the ASGE ACG quality indicator documents and how to operationalize those toward improving performance in your units. I'll spend some time discussing quality indicators for ERCP, quality indicators for EUS, and some of the quality indicators for upper GI bleeding, and hopefully, we'll be able to put it all together at the end. So, by way of background, the reason that the ASGE Quality Committee exists, the reason for the EURP, the Endoscopy Unit Recognition Program, is that we should all be on the same page and united that every single patient should have access to high-quality endoscopic procedures. And a high-quality procedure is one in which a patient receives an indicated and important procedure for which there's no great alternative. A correct and relevant diagnosis is recognized or excluded. Any therapy that is provided is appropriate and done well, and all steps that minimize risk have been taken. And so, we've talked a lot about measurement, and, you know, I sort of think about this all the time. So, Tachi Amada, who used to be the director of the Global Health Initiative for the Gates Foundation, when talking about quality, once said that if you're not keeping score, you're just practicing, right? And so, that's a commentary on the importance of measurement. And we can measure quality, right? We've heard a lot about that already. And we spend a lot of time thinking about how to measure quality in a meaningful way, in a way that reflects the truth about the world, in a way that reflects what we're trying to improve. And on that basis, the quality of care that we provide can actually be evaluated by comparing the performance, the measured performance of an individual or a group with that of a benchmark, right, which is the quality indicator performance target. And we do that in order to identify outliers. I want to identify patients who are underperforming with the goal of intervening in such a way as to help them improve their performance targets. And to be completely honest, sometimes that intervention is that certain people are not able to continue doing that procedure. But in the overwhelming majority of cases, the practice of awareness alone and retraining and educating them can really be helpful in improving their performance. So, in that sense, a quality indicator can be operationalized as the ratio between the incidence of correct or optimal performance and the opportunity for correct and optimal performance. And so, to that end, the first set of quality indicators were actually developed and published in 2006 by a joint ASGE American College of Gastroenterology Task Force on Quality and Endoscopy. And so, the current iteration of the documents were revised and were published in 2015. And as mentioned before, we are currently in the process of re-revising the document with the goal of publishing them in 2023. So, there, as already alluded to, there will be several important changes in the upcoming quality indicator documents. And these are intended to serve as a fundamental resource for your endoscopy units, right? They are intended, they were designed and are intended to serve as the framework upon which you can build your quality assurance infrastructure. And so, using these as the scaffolding is exactly how they were intended to be used. And so, there's really five relevant documents. One applies to quality indicators common to all GI endoscopic procedures. There's a document for upper endoscopy, for colonoscopy, for ERCP, and for endoscopic ultrasound. And for the rest of this presentation, I'm going to focus on EGG, ERCP, and EUS. But it's also important to keep in mind that the quality, the ASGE Quality Committee, has been developing a series of documents focused on interventions to improve performance in all of these procedures, right? So, again, you measure, and it's really important to know where you're at and to compare yourself to published benchmarks. But then, if you want to improve, there are many different interventions that can be deployed in that context. And so, the first of these documents was recently published around interventions to improve colonoscopy performance, specifically how to improve the ADR. And so, those documents are intended to sort of augment these as a way toward achieving high-quality endoscopic care. So, in terms of better understanding the structure of these quality indicator documents, as already alluded to, all of them are divided into three time periods, quality indicators that apply before the procedure, which is anything up to when anesthesia or sedation is administered, during the procedure, and anything that's post-procedure, which begins when the scope is withdrawn through follow-up care. Every indicator is graded, just like a guideline recommendation, and that grade of the strength of the recommendation is based on critical appraisal of the methodological strength as a supporting evidence in the medical literature, right? And this is sort of just a standard format. But just as an example, a quality indicator that's based on randomized controlled trials without important methodological limitations might get a grade 1A recommendation. And so, the benefit for these is clear, and it can be applied as a strong recommendation in most clinical settings. Now, in contrast, there are quality indicators that are based primarily on observational data or low-quality methodological data, and those may get a lower grade of recommendation because the benefit is less clear, and the applicability is not as concrete. And of course, there's always going to be a certain number of quality indicators that for which there's no strong evidence base, either because the studies haven't yet been done, or there's no way to actually study these because of practical or ethical concerns, for example. And so, in these situations, we rely primarily on expert opinion, which of course is important because at the end of the day, we have to make clinical decisions, and we have to guide each other. But all these, you know, should be, or these, the grade 3 recommendations should be, of course, taken with a grain of salt because, you know, experts are often wrong, as we all know. So, an important aspect of these quality indicator documents is for every indicator, for every key performance indicator, they provide a performance target, and this should be the goal. So, the goal for every provider and every unit should be to reach or ideally exceed these performance targets. And just as a quick side note, whenever you see a performance target of greater than 98%, that is intended to denote that this should be done 100% of the time. For, you know, medical, legal, and sort of political reasons, it's challenging to say 100%, but just recognize that the intent of the task force, if you see greater than 98%, is that it should be done every time. And of course, you know, the frequency with which informed consent is obtained and fully documented, you know, that's self-evident that that should be done every time. The other thing to keep in mind is that the task force has identified for every document some priority indicators based on their importance and relevance to the care of the patient. And so, these are the ones that are considered to be the most important on which to focus first. So, as you go down the pathway of quality in your individual unit, if you're sort of on the early end of that, the priority should be to measure and improve these priority indicators. And once that is achieved, then you sort of move down and start to address the remainder of the indicators. And these are sort of, you know, at least as of now, the icing on the cake. So, sort of with that background, let's move into quality indicators for ERCP. And before doing that, I think it's important to take a step back and ask a fundamental question, which is, what is a high-quality ERCP? And everything I'm going to say applies essentially to every procedure, but I think it's important to consider that ERCP is by far the most dangerous procedure that we do as gastrointestinal endoscopists. And so, the stakes are much higher. And so, I think we need to be very considerate, very mindful about sort of the potential benefits and harms related to ERCP. But in my estimation, a high-quality ERCP is one that improves health. So, it's associated with a concrete benefit. There's a ton we can do with ERCP, but doesn't always mean we should be doing it. We only should be, because of the risks of ERCP, we should only be doing it when we're totally convinced that we are going to confer a major benefit, a major improvement in the patient's life. Now, in parallel, a high-quality ERCP is one that results in no to minimal adverse events. So, the risk is minimized. And on that basis, we are trying to always maximize the benefit-to-risk ratio. And ideally, this is all achieved at a reduced cost so that we can sort of maximize value. And importantly, at the forefront should be the consideration of patient experience and patient satisfaction. Every patient should have the right to undergo a comfortable procedure, both physically and emotionally, mentally. And of course, it should be done in an environment and with interactions that convey a lot of compassion and empathy for the patient. So, when you think about quality assurance in ERCP, I think there are two interrelated but slightly different questions. The first is more of a macro-level question, which is, how do we as a community assure high-quality ERCP? And the second question is sort of more on the individual basis, but how do I personally perform the highest-quality ERCP I possibly can? And the second one is actually more nuanced and challenging. But as a quality committee, as a quality initiative, what we care about primarily is the macro-level question. How do we get everybody to regress to the mean and ensure that we maximize care in the largest number of patients possible? And this is done through quality indicators for the most part. And as mentioned, quality indicators can be divided into structural indicators, process indicators, and outcome indicators. And at least in 2014-2015, when the last iteration of the QI documents was published, the focus was on process and outcome indicators. And this will likely change as the new document evolves. But again, these are divided into stuff that happens before the procedure, stuff that occurs during the procedure, and stuff that happens afterwards. And of course, you know, the outcome indicators is what happens to the patient, and we care about that in principle the most. But we can't measure every aspect of outcome. And so we rely on process indicators that we believe, either based on evidence or intuitively, will correlate with better outcomes for the patient. So the first quality indicator in ERCP is the frequency with which an ERCP is performed for an indication that's included in a published standard list of appropriate indications. And this is considered a priority indicator. And in the document for your reference, a list of appropriate indications for ERCP is published. Now, having said that, and I was not involved in full disclosure in the last version, but if you actually go through these indications, one could argue that they're a little bit relaxed, that they provide endoscopists quite a bit of latitude. And I imagine that's going to change because, again, the fundamental principle of ERCP, especially in 2022, now that there are widely available, highly accurate, but much less risky diagnostic alternatives, specifically endoscopic ultrasound and MRCP, ERCP should be a near exclusively therapeutic procedure that should be restricted to patients in whom the risk-benefit ratio is most favorable, right? We should always be thinking along those lines. And so as you look at these currently published indications, you might look at balloon dilation of the papilla. And of course, there are many situations in which balloon dilation of the papilla is obviously necessary and indicated. But if you're balloon dilating the papilla in a patient with unexplained abdominal pain, that's bad news, right? And so you can see how these might end up becoming a little bit more concrete as they evolve. The second indicator, which applies to all endoscopic procedures, is the frequency with which informed consent is obtained and documented. But importantly, there's a focus on ensuring that patients are informed of risks that are specific to that procedure, right? And in ERCP, we worry primarily about posterior pancreatitis, but a multitude of additional complications that are more pronounced for this procedure. And it's critically important in that process to be clear about those. And along those lines, it's important to consider always that informed consent is not a document. It's a relationship and it's a process. And if nothing else, it's important for me to impart on you that it's critically important not to rush this process. Now, we all, you know, many of us work in high throughput units where we're always trying to move the meat. We're all under these oppressive RVU targets. We need to get stuff done, et cetera. And I get that. I empathize more than anybody about that. But I think this is one time where it's really important to take a step back and make sure that you're really connected to the patient. Even if it's just for a few minutes, make sure that the patient truly understands. And part of the reason I say this is because I do a reasonable amount of defense work for as a legal, as an expert witness for medical malpractice cases, you know, on behalf of physicians. And it's always the same story. When you talk, when patients and depositions talk about the rationale for bringing forth legal action around ERCP, it's always that they didn't really get a clear sense of what they were getting themselves into, that they felt like nobody really explained the magnitude of risk. And along those lines, it's important always, especially in ERCP, to keep an open mind to safer alternatives. Is this something that you can understand with an endoscopic ultrasound or with an MRCP? Do we really need to assume the specific and unique risks of ERCP? And then along those lines, it's important always to stratify risk based on patient and procedure specific risk factors, which are widely published and well validated. And so, for example, a young woman with suspected sphincter of OD dysfunction on the basis of recurrent acute pancreatitis, who has a pancreatic sphincterotomy, is not only going to be at higher risk for developing post ERCP pancreatitis in general, but is also going to be at much higher risk for developing severe acute pancreatitis and pancreatic necrosis, etc. And so it's critically important that that patient understands their specifically elevated risk, because that's critically important, not only in their calculus as to whether or not they should undergo the procedure, but also in making sure that they know what they're getting themselves into. And so it's important not to undersell the risks. Moving on, another one of the quality indicators pre-procedurally is the frequency. And you could argue this applies to the procedure itself, but the frequency with which appropriate antibiotics are administered when they're indicated. And generally speaking, antibiotics and ERCP are indicated when contrast is introduced somewhere and then not adequately drained. The reason that is, is contrast is inherently infected because it's gone through a catheter, which has gone through the scope, which goes through the mouth and the rest of the foregut. And so it's picking up bacteria along the way. And so the contrast full of bacteria is going to end up in a place. And if it's not adequately drained, that's bacteria in a closed space. And that's what leads to clinically relevant infections. So situations like PSC and hyaluronic strictures and so forth. And there are a couple of unique contexts in which, in the absence of true obstruction, patients have a higher risk of bacteremia, and these patients with ERP after liver transplant or those who undergo cholangioscopy benefit from at least one dose of IV antibiotics. Moving on, the next two pre-procedural quality indicators are critically important, and they speak to the training and the experience and the proficiency of the endoscopist. And so Raj has already sort of highlighted this critically important point, but the important takeaway message here is that there is a strong association between the endoscopist's procedural volume, as well as that of the center, and their rate of success and their likelihood of causing harm. So this is what's known as the volume outcomes relationship, and this is well established for ERCP. It's pervasive across procedural disciplines and sort of very clearly demonstrated in the surgical literature as well. And so in aggregate, if you look at the volume outcomes relationship, it's unequivocal that lower volume practitioners have a higher failure rate and higher adverse events rate, and in contrast, higher volume practitioners have improved outcomes. And part of the reason that is is because higher volume, more experienced practitioners are more adept at recognizing complications early and addressing them meaningfully. And so if you look at high-performing and low-performing hospitals, and this is basically sort of has been clarified in the surgical literature, but if you look at high-performing and low-performing hospitals, they actually don't differ very much in terms of their complication rates. So those operations have an equal number of complication rates no matter what the setting is. Where they differ is that the high-performing hospitals, which are typically the high-volume hospitals, are better at rescuing patients from serious complications, and that's what explains the variability in death rate. And although knock on wood, we don't see a lot of death with ERCP complications, that concept, I think, is very intuitively applies. The challenge we face is that up to 80% of providers in the U.S. perform less than 50 ERCPs a year, which is sort of loosely considered to be the minimum standard. Only 5% of hospitals perform more than 200 ERCPs a year, and the median annual hospital ERCP volume is 49. And on top of all that, we talk about adequate training, but at least survey studies suggest that most trainees feel or are underprepared at the time of graduation. And so there's no easy solution to this, but as somebody who's the chair of the ASG Equality Committee, this is something that keeps me up at night. And as mentioned, you know, because of clinical reasons and logistical reasons and political reasons, it's a hard thing to address, but I do think it's reasonable for all of us to look in the mirror and sort of be honest with ourselves and sort of recognize that, you know, if we're not performing, if we're not sort of, you know, on the positive end of that volumes outcome relationship, it's a situation where we need to make a change, either in terms of augmenting volume, figuring out a way to do that, or sort of leaving those cases to other providers. So moving on to the intraprocedural quality indicators, Raj discussed the value of deep cannulation. Of course, it's essential. Without cannulation, there's no achieving the actual clinical objective of the case. And so the frequency with which deep cannulation is achieved is considered a priority indicator, and the goal is for it to be greater than 90%. Now, different ERCPs have different levels and degrees of difficulty, and there are scales that have been developed to clarify this to practitioners. And the value of knowing that these are available is to be able to help you better understand your limits, right? So if you're an ERCP practitioner who does a lot of grade one and grade two ERCP, then fantastic. And these will knock on what would be the most number of ERCPs you'll see in your practice and the bread and butter of ERCP. But if you're encountered with a grade three or grade four case, this is a completely reasonable, responsible, and appropriate scenario in which to refer the patient to somebody with more experience or to a center of excellence. Now, fluoroscopy is critically important, right? Because we have to do this for a living, and not only are we exposing ourselves and our patients, but we're exposing the rest of the team. And so documenting fluoroscopy exposure and radiation dose is critically important as a process measure. There's no outcome measure for this because it's impossible to assign an appropriate or reasonable dose of fluoroscopy to practitioners because practice patterns and practices vary considerably, right? How do you standardize somebody who does 600 high-risk ERCPs to somebody who does 80 a year? But the documentation process basically speaks to a general principle of fluoroscopy stewardship, which is we should be using as little fluoroscopy as reasonably possible on a regular basis. And that's something, that's sort of a culture that is promoted by continual measurement. Then numbers eight and nine pertain to the actually achieving the goal of ERSP in the large majority of cases, particularly in community practice, which is to remove stones that aren't terribly large and to stent uncomplicated strictures, right? And so these two indicators are priority indicators because they apply to the large majority of bread and butter ERCP, and the goal for these is to exceed 90%. Now, briefly in the post-procedure phase, it's important, of course, to document the procedure really well in case a repeat procedure needs to be done. And just like all the other procedures, there's going to be a focus on reducing the risk of adverse events and sort of the most important iatrogenic complication of ERCP, despite all the research I and others have done in the last decade or so is that it's still the biggest challenge sort of in my career at the very least. And so there's a priority around reducing complications, particularly pancreatitis. The challenge with pancreatitis and sort of the nuances are a little bit outside the scope of this complication is that even though it's a priority indicator, there's no real way to report a performance target. And that's because post-CRSP pancreatitis rates cannot be reliably compared between different centers, and that's for a multitude of reasons. And so it'll be interesting to see how we approach this adverse event in the next iteration. But nevertheless, as a recap, the priority quality indicators for ERCP are appropriate indications, cannulating deductive interest because that's essential and fundamental, the success rate for the common indications of ERCP, which are not huge stones and uncomplicated strictures, and reducing adverse events, particularly pancreatitis, for which there are meaningful interventions like giving rectal NSAIDs and prophylactic stenting and aggressive value fluids. But just to reiterate, perhaps the most important point is the best way, the most effective way of reducing the incidence of post-CRSP pancreatitis is thoughtful patient selection and restricting the procedure to those who are most likely to benefit, who don't have a great alternative. So moving on to quality indicators for endoscopic ultrasound, again, there is a focus on appropriate indications. There's a list of appropriate indications in the quality indicator document. These are actually a bit tighter than the ERCP quality indicators, and so I imagine you won't see a great deal of movement for these, except for the next version we intend to introduce, interventional endoscopic ultrasound, which is a whole sort of new world of interventions for which we're starting to think about quality, but for the most part, these indications are likely to stand. Again, patients need to know what they're getting themselves into, and they need to know the specific risks of endoscopic ultrasound. One of the quality indicators for ERCP also has to do with appropriate antibiotics, particularly for pancreatic cystic lesions, into which the FNA or FNB process can introduce bacteria, although there have emerged quite a bit of evidence since the last quality indicator document, and so this is likely to evolve. And then again, the training and experience of endoscenographers as it relates to outcomes. Again, you know, EUS is not as high stakes as ERCP, but there is a real risk with EUS of missing something substantial, and that has to do with the training and experience of the endoscenographer, and so in that sense, this is really high stakes as well. So in terms of the intra-procedural quality indicators, there's a focus on understanding the relevant anatomy, on properly staging cancer, and on, importantly as a priority indicator, on your diagnostic rate or accuracy when confronted with a pancreatic mass, and this one is critically important as a priority indicator. And then, you know, just like with the other procedures, there's going to be a focus on reducing adverse events. Thankfully, these are relatively uncommon and well-defined after endoscopic ultrasound, but nevertheless, these should be tracked, and a quality improvement initiative should be implemented if the adverse events rate is too high. So to recap, the quality indicators in EUS are the staging of cancers, the diagnostic accuracy and sensitivity for pancreatic masses, and minimizing adverse events, and just in the last few minutes here, I'll sort of rush through, since we're running a little bit behind, the quality indicators for upper GI bleeding. Now, these are nested within the EGD document, and we'll focus at this time on the upper GI bleeding quality indicators, but recognize that the document is much more expansive than this and addresses things like H. pylori treatment and, you know, bariatric indications and things along those lines. But a priority indicator for upper GI bleeding that's pre-procedure is the frequency with which appropriate prophylactic antibiotics are given to patients with cirrhosis and portal hypertensive bleeding. This is because those patients, because of high quality data suggesting a reduced mortality associated with antibiotic prophylaxis. There's also a couple of indicators that pertain to pharmacotherapy for upper GI bleeding, which is typically proton pump inhibitor therapy in patients with suspected peptic ulcer bleeding, and then octreotide, IV octreotide for patients with portal hypertensive bleeding. It is important to point out that the strongest evidence for PPI is actually in patients who undergo endoscopic hemostatic therapy for peptic ulcer bleeding as a follow-up to that, although there are some data that suggests improved outcomes if it started at the time of presentation. But, you know, for better, for worse, the task force did identify this as a priority indicator for the time being. It's important to document the type of upper GI bleeding lesion and describe it really well and document the location, and that speaks to the risk of recurrent hemorrhage. And so if somebody else happens to do the procedure, the next time you want to sort of give them the best opportunity to succeed, and that's done through adequate documentation. It's also important to document 100% of the time what stigmata were found for peptic ulcer. Was it an actively bleeding vessel, non-bleeding visible vessel, an adherent clot, et cetera? And this basically helps you risk stratify the likelihood of recurrent hemorrhage, which has hugely important implications in downstream management of the patient, right? When can the patient be refed, how long they need to stay in the hospital, when can they come out of the ICU, et cetera? And that all pertains to this classification that needs to be documented. It's important to attempt to treat endoscopically ulcers with high-risk stigmata, right? To go down there and take a look and not attempt treatment is no longer considered acceptable. Everybody should have that training. We're not always going to be successful, but if you see a non-bleeding visible vessel or actively bleeding vessel, the intent would be to provide treatment. And then along those lines, you have to document how often it was treated and hemostasis was achieved. And then one of the intraprocedural indicators is sort of pertains to the use of dual therapy, right? And this speaks to sort of the inappropriateness of just injecting dilute epinephrine into an ulcer. We know that a second modality is necessary. This gets a little bit sort of unclear because clipping alone now has pretty much become standard. And so this may evolve in the next iteration, but the bottom line is nobody should go down and just inject epinephrine into a bleeding peptic ulcer because that's not considered adequate or durable. Same thing is that when variceal bleeding is encountered, the goal should be during that index procedure to band ligate varices as opposed to doing nothing and sending the patient for tips. And this applies to esophageal varices or using sclerotherapy. And in terms of post-procedure indicators, just briefly, for peptic ulcers, it's important that patients are started on appropriate acid suppressive therapy. If H. pylori is present, it needs to be diagnosed and treated because it has major implications on the risk of recurrent hemorrhage. And then this 121 is not a priority indicator, but it's critically important because we know on the basis of high quality randomized controlled trial data that when endoscopic hemostasis is achieved and the patient re-bleeds, the best treatment course for that patient is another endoscopy. And those patients do much better than patients who go to IR and especially patients who go to surgery. And so it's really important that a second look is undertaken in a patient with recurrent hemorrhage. So just in brief, as a recap, the priority indicators in upper GI bleeding have to do with endoscopic treatment for ulcers with bleeding vessels or non-bleeding visible vessels, the plan to test for and treat H. pylori, the frequency with which appropriate antibiotics are given to patients with cirrhosis, and the frequency with which a proton pump inhibitor therapy is used for suspected peptic ulcer bleeding. So in summary, of course, maintaining the highest level of quality, and this is a recurring theme today, is essential for the medical field in general and our specialty as well. I do think it's important not only to read these documents, but to sort of familiarize themselves with them, because again, they were intended to be the framework upon which to build an entire quality assurance infrastructure and apparatus in your units. So please maximize their value. It's important to focus on meeting the priority targets, priority indicators first, and then move on. And if you aren't meeting targets, these can be the focus of quality improvement initiatives. And as mentioned, the ASGE is going to have a whole suite of articles around interventions to improve quality indicators for these procedure types. So with that, I will conclude, and thank you for your attention.

quality indicators

endoscopic procedures

upper GI bleeding

benchmarking

ERCP

EUS

patient selection