Thank you, everyone, for staying with us. It's been a fantastic two days, but it has been a long two days, so I will do my best to keep us efficient and keep everyone engaged. I have no disclosures. My objectives today are to review the screening tests that are available for colorectal cancer and be brief as a way of setting up the article. We'll review the article, we'll take a look at the media response. As we heard from Dr. Call this morning, the media response to seminal articles in GI is not always accurate, and unfortunately, for most of our patients, that is their main source of information. Then, based on the media response, I want to help prepare you for your patients. We want to make sure you know everything you need to know about this article, be prepared for their questions, and also be prepared for your referring physicians' questions, so you can be the true GI expert that we know you can be, and also to use this article as a format perhaps for future articles that come out, and perhaps you can even lead your group locally through a response to your community if needed. For those of you who were on yesterday, this is a repeat polling question, but we have some from members of our audience that are only on for today, and I think it's an important question. I think it's quite an easy answer, and for those of you who have not read this, think through it carefully, and we'll make an important point. Colonoscopy is the only colorectal cancer screening test that can detect and remove adenomas and early colon cancer in the same setting. Excellent, excellent. An important point, especially as you discuss colonoscopy with your patients. Polling question two, and if you've not read the article, perhaps not very familiar with the article, just take a stab at it. It's all about learning here today. Nearly 30% of endoscopists included in the Nordic trial did not meet the adenoma detection rate of 25%, which is recommended in the United States. True or false? The answer is true, and this is a really important point that we'll touch on as we go through the talk. If you take away nothing else from this talk, this one slide really is the most important. The best screening test for colon cancer is the one that gets done. Although colonoscopy, based on data and based on expert opinion in the field of GI, is the best test for a number of reasons that we'll outline, we know many people don't want to do it because of the prep and the invasive nature of it. If they choose to undergo FIT, a multi-target stool DNA test, commercially known as ColoGuard, do that test. The best test is the one that gets done, so please keep that in mind. Screening tests that are available and commonly used in the United States include fecal immunochemical test, or FIT, multi-target stool DNA test, or a trade name known as ColoGuard and colonoscopy. Let's talk about FIT first. FIT is a tier one test. The United States Preventative Services Task Force a few years ago outlined a tier system for colon cancer screening. There were two tier one tests, colonoscopy and FIT, and they were put in that category based on their sensitivity for colorectal cancer and advanced adenoma, with colonoscopy being a little bit higher on the sensitivity scale than the FIT test. The advantages of FIT test are that it's easily used by patients. We can reach a large population of patients, and so that makes it easy and also it's inexpensive. The disadvantages of the test is many times the test is done in improper conditions, perhaps consuming some foods that could create a false positive, perhaps it's done in people that are on aspirin and anticoagulants or thionopiridines, or even less desirable. It's done in patients who are not fit, who are not appropriate for screening based on either age or comorbid illness. Another disadvantage of FIT is if it's positive, sometimes we are not very, patients are not very good about following up to complete the colonoscopy, which is indicated after a positive FIT test. You're all familiar with the multi-targeted stool DNA, again, known as ColoGuard. It is a tier two test, so it's not as sensitive as our tier one test based on the recommendations from the United States Preventative Services Task Force, however, it is a widely used test. Once again, the advantages of this test like FIT is it is non-invasive. We can reach a lot of people. It's relatively easy to use, however, it is a bit more expensive than FIT. But not as expensive initially as colonoscopy. The disadvantages of the test is we do have a higher degree of false positives on this test. Remember, ColoGuard is a combined test of FIT plus multi-targeted stool DNA. Another disadvantage with the FIT test is that if patients don't follow up, we have not completed the screening process, which then becomes diagnostic and possibly therapeutic if this test is positive. And again, we have the misuse of this test in the wrong patient population, leading to overuse of tests. I'm an endoscopist, you are a GI advanced practice provider, so colonoscopy is a test that we believe is the best and we base that on its tier one ranking and the wide array of data to support its use as a screening tool and as an effective and sensitive screening tool. Because of its invasive nature, we do have a disadvantage of that for this test. Its advantages, one, its high sensitivity for cancers and advanced lesions. As we stated out in that polling question, we can both diagnose and remove polyps, specifically adenomas, advanced adenomas and early cancers, all in the same setting, as opposed to FIT, which is done yearly if it's negative and the ColoGuard every three years if it's negative. If the screening colonoscopy is negative, it's not repeated for 10 years. So that's a very nice timeframe for patients. Disadvantages is it is invasive. And as we've talked about with the PrEP throughout the course, the PrEP can sometimes be difficult for patients. It's certainly not desirable for any of us who've undergone colonoscopy. So that's a bit of the background I want to set up before we get into the article in the Nordic trial. The title of it was The Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death. And for the next few slides, I'm only going to focus on what comes out of the article. We'll get into some of the details and the response by our experts a little bit later. The aim was to quantify the benefits of colonoscopy in a screening population. It was a multinational study. The Nordic group is Poland, Norway, and Sweden. There was an invited group, and the invited group was defined as those who were invited to undergo colonoscopy as screening. And then there was a not invited group. They were not invited to undergo colonoscopy and underwent usual care. The primary endpoints were the risk of colorectal cancer and the rate of colorectal cancer and related death. So in the article, there were 28,220 participants. About 11,843 patients underwent colonoscopy, and that's about 42% of the population in the invited group. So 28,000 people invited to undergo colonoscopy, 42% underwent colonoscopy. There were 56,000 in the usual care group or the not invited group. In the invited group, there were 265 cases of colorectal cancer, and in the usual care group, there were 622 cases of colorectal cancer. So what came out of this study? What did we learn? In the intention to screen analysis, and you should view the intention to screen analysis as taking the results of a randomized controlled trial and basing those on only the initial treatment assignment group. So that would be colonoscopy in this case. The intention to screen analysis risk of colorectal cancer over 10 years was reduced by 18% in this group. The risk of colorectal cancer death in the invited group, 0.28%, and in the usual care group, 0.31%. Overall, there was a relatively small reduction in the risk of colorectal cancer in this colonoscopy group or the invited group, but there was no significant reduction in colorectal cancer death. So those are really the main points. So what happened with the news media as it relates to the NORDIC trial? And again, gets to Vivek's point this morning about the media's interpretation and is it accurate and our concern that this is our patient population's main source of information for seminal and landmark studies. So there was great consistency, ABC, CBS, NBC, NPR, CNN, Fox, I could go on and on, but it really focused on the fact that in this study, colonoscopy did very little to reduce colorectal cancer and had no impact on reducing colorectal cancer death. So they only focused on those two issues, which for us in GI, it's a concerning message because unlike screening for breast cancer, for example, and cervical cancer, our numbers are lower. We've done better over the years, but we are not at the level we should be at. And our health news media did not get it right. I viewed Medscape, I looked at health news, I looked at Kaiser Health News, and they all focused on those two issues that I talked about. The only media outlet that I could find that got it right in health news was Helio, and I'll explain why I think they got it right. So why is the media response important? I'm going to repeat it again because I think it's important. It is our patient population's main source of information. So if they hear a summary that colonoscopy isn't as good as we thought it is, we already have a test that they're reluctant to do, and that could really turn them off and lead to reduced volume in colonoscopy screening for colon cancer, which is worrisome. We have to look at the source of the article, and many of these articles in the media, and this is not to be disrespectful or dismissive to our colleagues in internal medicine or family practice, but many of the media turn to experts in internal medicine and family practice to give them a summary of these articles. Unfortunately, they are not the experts in gastroenterology like the gastroenterologist is, and they don't approach and view evidence and review evidence-based data like we do. Why do you need to know about the media response? Because your patients will ask questions, they view you as the GI expert. You've heard me talk about this over the last two days to gain the respect of your patients and trust your patients. You want to be the expert, you want to show them you're their advocate, and you do the best by showing them that you're a quality provider, which I know all of you are striving to be and will be. And we want you to be prepared to answer questions. All right, so let's talk about what you should know as an APP. First let's look at the 42% of participants that underwent screening colonoscopy. That's actually a very small number or small percentage compared to other studies, so there's concern that there was a low number of patients that chose to undergo screening colonoscopy, so that could have skewed some of the results. If we look at the adjusted per protocol analysis of the colonoscopy, another way of analyzing the data, it was estimated to reduce colorectal cancer rate by 31% and death by 50%. Now, this wasn't talked about in the media, but if you really look at other cohort studies, it is very similar to what we find in other studies. So when we look at this analysis, it's really not that different. But here's a very important point. Approximately 30% of endoscopists did not meet the adenoma detection rate of 25%. As I said yesterday, the accepted adenoma detection rates in the United States are 20% for women, 30% for men, and 25% overall. In the United States, the average adenoma detection rate is 40%, way higher than the average of 25%. We don't know a lot about the data of the other 70%, so unfortunately, I would view at least a third of these and likely more as low-quality operators for colonoscopy. Once you get above that 40% range, you're starting to talk about high-quality colonoscopy operators. So once again, that point shows us that colonoscopy is highly operator-dependent. The higher the adenoma detection rate, the better the outcomes, and we'll get to some data on that when we talk about what you should tell your referring physicians. There was an interesting piece with the Polish participants. Some data from the trial suggests that high-risk persons and patients in Poland tended to choose to go the colonoscopy option. So high-risk patients are not included in our screening. So if there was a family history of colon cancer, if they had symptoms of bleeding or weight loss, that could absolutely skew the data in a way that could affect outcomes and may lead to undesirable results. Patients with another point, I think it's important for everybody to know that patients with a family history of colorectal cancer or advanced adenoma as well as personal history of adenomas or personal history of colon cancer should not undergo FIT or multi-targeted stool DNA test. We should all understand very clearly that FIT or multi-targeted stool DNA tests are screening tests only. Although I would say that FIT test is probably one of the most misused tests in medicine and certainly the most misused test in GI. You see it all the time being used in people with GI bleeding and in inappropriate circumstances, and we see similar trends with the ColoGuard as it relates to the patients I outlined above. And one last comment on the Polish participants, this was supposed to be a screening population. So anybody who sneaks through that's high risk or has symptoms, they're not a screening population. And then all of a sudden, we're not comparing apples to apples with previous studies. So a little concerning if that was the case. So what should your patients know? And as I think about what we respond to our patients, we turn to our societies. When seminal studies like this come out, and it's also helpful for your education, our societies individually and then typically collectively offer a society statement to tell us what we need to take away from these seminal studies. We then see an enormous amount of expert opinion from true experts in the field of colonoscopy and colorectal cancer in gastroenterology. Then finally, we see an editorial. So as I put all of this together and try to outline this for everyone, that's what I used. And if you look up the Nordic trial and put in editorial, you'll see an excellent editorial by someone named Jason Dominance, who is one of our thought leaders in colorectal cancer and is also another excellent educator in the field of colorectal cancer. So that's how I think you can learn the data that you'll need when future landmarks and seminal studies come out. So what do we tell our patients? One, that this study does not detract from the overwhelming data that colonoscopy saves lives and that that is very clear, especially in patients 50 and older. We know that patients younger than 50 appear to be behaving differently and that is evolving on what's happening in our younger patients. It saves lives by detecting and removing pre-cancerous polyps or adenomas, so explain to them what a pre-cancerous polyps means, and early cancers, that some early cancers can be removed all in the same setting. And again, use very simple, straightforward language to our patients. Another point to stress is colonoscopy requires far less screening than other colorectal cancer tests. So if they have that first initial test and it's negative, they're up again in 10 years, and there's likely to be more false positive with repeated tests other than colonoscopy, so we can avoid that pitfall. You should clearly explain adenoma detection rate, and in this study, the low adenoma detection rate. As I said yesterday, you don't want to discuss individual physician rates, discuss the rate collectively of the group, but in this study, emphasize that the overall adenoma detection rate was only 25% or less in a third of the doctors in this study, whereas in the United States, it's 40%. So stress that point. Again, highlight that it's colonoscopy is highly operative-dependent, building on this adenoma detection rate. I'll give you some data in a moment that gets to this point, but simply explain to patients, we know that the higher the precancerous polyp detection rate and removal, the lower the risk of a future colorectal cancer. And again, stress average risk colonoscopy, that is negative, it's every 10 years until age 75. And there is some repetitive nature to my slides, and that's by design, but you're going to, I just want to introduce the language a little differently, the way you would interpret it, the language you would use to explain to your patients, and the language you would use to explain to your referring physician. If patients do not wish to undergo a screening colonoscopy, then make sure they discuss it with their primary provider, or if they're in your office because they don't want a colonoscopy, and they came to you to discuss other tests, make sure you clearly outline the benefits and the advantages and disadvantages of the other tests, and then you can make a good informed decision together. The average risk colorectal cancer screening, if the fit is negative, it's a yearly fit, make sure patients understand that, that they will undergo yearly testing, and that due to the nature of false positives and maybe improper setting of the test, that could increase the risk of needing to undergo colonoscopy. Same goes for average risk screening in the MTSDNA or ColoGuard, if that's negative, it's every three years, and just emphasize the appropriate use of that test. I stress the importance of the need for follow-up colonoscopy if the fit or multi-target stool DNA is positive. I think this is probably the second most important point in this talk. So many times over my career, I've seen someone have a fit that was positive, or more recently, a multi-target stool DNA test that was positive, and they don't show up for two or three years, and unfortunately, we then find their colon cancer. So, emphasize to patients, if you choose to undergo a fit or MTSDNA and be supportive of that decision, emphasize and stress that they must come back to have a colonoscopy if those tests are positive, and also stress to the patients, if they do these tests, they need to do it the right way. If they had a colonoscopy a year ago, they are not candidates for this test. If they've had an advanced, if they've had an adenoma or advanced adenoma or colorectal cancer, they are not candidates for this test, so make sure they clearly understand the pure screening nature of these tests. Okay, what should your referring physicians know? And you are the experts. No disrespect to our colleagues in internal medicine, family practice, or OBGYN who's dealing with a lot of these patients, you know more than they do. I assure you that you are the experts in this area, and so you should be perceived as the experts. Make sure they understand the importance of the low adenoma detection rate in this study, and emphasize how good the national rate is, and how emphasize how good your group rate is. Emphasize the point of operator-dependent excellence. A study that was from Poland, and I think it may have even been from this group a number of years back, showed that for every 1% increase in adenoma detection rate, that was associated with a 3% reduction in the future of colorectal cancer. So think about that. For every 1% above 25%, there's a 3% reduction in colorectal cancer in the future. Think about that with a national rate of 40%. That's an enormous reduction. More importantly, there was a 5% reduction in colorectal cancer deaths. So intellectually and using your data, explain this to your referring physicians if it comes up. Explain that in the adjusted per-protocol analysis, there was a decrease in incidence of colorectal cancer by 31%, and a decrease in colorectal cancer death by 50%. And so make sure they understand that this is very similar to prior cohort studies. Make sure that they know that colonoscopy is the only test that detects adenomas, and emphasize that in the average risk screening. It's one every 10 years, and that's a big point to emphasize to our fellow physicians. And again, talk about average risk screening, negative the appropriate intervals for both fit and multi-targeted stool DNA. Stress the importance of colonoscopy for positive fit and positive multi-targeted stool DNA. This is a real potential risk, a medical legal risk for referring physicians. If they do a fit, and it's documented positive in their record, or if it's a ColoGuard, if it's documented positive in their record and the patient doesn't follow up, and they haven't documented that they did everything they could to get the patient they follow up, that could be a source of medical legal risk. So you can use that to help your referring physician to make sure they document correctly and get their patients for colonoscopy. Stress the importance of surveillance colonoscopy and appropriate surveillance interval for positive colonoscopy. It's a really important point overall for GI. We do not want to overuse surveillance. We should really steadfastly adhere to our surveillance guidelines and make sure you emphasize the current guidelines to your primary care colleagues, and also clearly explain who should not undergo fit, and I emphasize not, and who should not undergo multi-targeted stool DNA. We want to minimize misuse and overuse of these tests, which leads to misuse and overuse of colonoscopy, all of which costs a tremendous amount of money. In summary, I think we've clearly explained what the results of the Nordic trial were, but how we have to be very careful of interpreting the results of the Nordic trial, and I pointed out some of the limitations. I really want to emphasize the media's response to seminal landmark studies and how important it is for us to understand that our patients, this is their primary source of GI education, and very few are really sophisticated to get into what's being said by true experts. Look at both the traditional and health media and make sure we do our best to educate our patients and our referring physicians on the accurate results on the seminal and landmark studies, and I urge you to kind of use this as a template as these future studies come out, always turning to our society for the statements they'll make on these landmark studies, for the expert opinion that you'll see on social media, and for the editorials you'll see. And with that, I will say thank you, and I want to thank John and Jill for allowing me to make one last comment before we move on to our kind of our wrap-up section. I want to for the one last time review all the resources we have, just give you a tiny bit of history, and I'll keep this brief. There are six of us who've been part of this process from the beginning. We started in 2020. We're all a very energetic group and really inspired by you as the audience, by what you bring us. I mean there were over 300 questions, or about 300 questions today, which I mean you could feel your enthusiasm for learning through those questions, and we thought we really needed to have a focused education platform for APPs and include APPs in this process. Our first course in 2020, we had 78 attendees. We were thrilled. This year, in our fourth course, we had 271 participants, and for that we thank you. In addition to this course, which will be an annual course, we have the we have an APP symposium at DDW. I realize many of you may not be at DDW. If you are, please join us, but get your physician collaborators to attend this course. That's a real target for us. We're going to be talking about some of the things we talked about on this course, including work-life balance, how to build teams, how to build subspecialty teams, things I think that are important to your physician collaborators, so please encourage them to attend. We already talked about the APP EOE course. We've got the APP ANGLE and IGIE and Practical Solutions, and so we encourage you to send articles, original articles, clinical research or practice operations articles to IGIE, and then we have our APP Case of the Month in Practical Solutions. I encourage you to contact Sarah, me, or any of us if you want to get involved in the APP Case of the Month. I've already had a few people contact me over the last couple days. We will make our best effort to get you as co-authors on these case. We want you back as participants. We want you part of the process in teaching. We really want you part of what we view our team. Again, you are our colleagues, and we want you part of this team, both from the learning standpoint and the teaching standpoint, so again, thank you all for attending, and stay in the loop. I'll now pass this over to John and Jill to wrap things up.

colorectal cancer

screening tests

colonoscopy

adenomas

FIT

informed decision-making