Welcome, everyone. So today, I'll be talking about conveying the benefit, clinical trials versus clinical practice. So let's start with a clinical scenario. Mary Skeptic is a 55-year-old woman with a 30-pack year smoking history who recently quit smoking. She's in overall good health and has been reading up on screening and tells her physician some of the information she found out and would like to discuss whether screening is right for her. So these are some of the things she's found out by looking on the internet and reading. And she found out that for people at average risk that are eligible for screening, you need to screen over 300 people to save a life. And that maybe for people like her, which are on the lower end, it may be even as high as 2,000, 3,000 people you need to screen to save a life. And then she finds out that even if lung cancer is found with screening, that still people with it will die four out of five times. And she says, you know, this doesn't sound that great. Doctor, what do you think? So let's talk about this. Let's just talk first about the concept of shared decision-making as opposed to other types of interactions clinicians have. There's sort of the paternalistic, which is the general thing that physicians do. They kind of, you come in, you have an infection, they prescribe antibiotics. There's not much discussion there. It's a one-way conversation. The physician makes a recommendation. There's informed consent, where the physician tells a person something, and the person then decides. And then there's shared decision-making. And shared decision-making is reserved for those areas where the decision is not clear-cut. It's not sure that the benefits outweigh the harms. Maybe there's a little benefit, but there's many options. And here you try to enlist the patient's values, understand what they're thinking, so that they can help manage their decision about whether it's really beneficial for them. That's where shared decision-making comes in. So why do we do shared decision-making in lung cancer screening? What's been the rationale for it? Well, the rationale has always been that there's concern that on balance there's no strong evidence that the benefits outweigh the harms. That was the rationale for doing it. Keep in mind that when Medicare first was making their decision about endorsing screening, their expert outside review panel recommended against it. They said, we should not be doing this. Eventually, Medicare decided to do it, but they put on top of it shared decision-making because they felt it could no longer be a simple recommendation, but instead required shared decision so as to allow potential participants the opportunity to more fully weigh their own preferences for this sort of borderline benefit examination. And in fact, for CMS, it was the very first time they required a shared decision-making to accompany a screening examination. And it was described as a national experiment to put shared decision-making on top of screening. So how have we done with this experiment so far? Well, here's the results. This is out in 2021. Here's the state of California, for example. Percent of eligible screening participants, people that enroll in a screening program, 1.4% of those eligible to be screened have actually been screened in a state like California where there's no concern about availability of scanners. There's plenty of CT scanners there. Only 1.4%. State of Florida, 3.7%. New York State, 5%. Nationwide average is somewhere about 5%. To me, this is not a good result. In fact, this is terrible because just keep in mind that screening, even if everyone was screened, you'd only get 25% of the people that ultimately develop lung cancer. So now you're talking about, in California, 1.4% of those 25%. I mean, this is really bad. So when thinking about screening, there needs to be some first-order considerations. It needs to have a benefit. You have to have a benefit before thinking about anything else. There's no sense in doing it. If you go to the FDA with a drug, the first thing they ask is, what's the benefit? If you have no benefit, don't even think about it. So you have to have a benefit. And then secondly, once you see that there's a potential benefit, you have to weigh the harms against the benefits. Those are the sort of first-order considerations. And then when thinking about talking to a person about screening, you need a way to present the information to that person in a meaningful way so that they'll understand and they can make a rational decision, which oftentimes requires translating the results from a clinical trial into something meaningful for a patient to understand. So as a starting point, if you were to think about a person interested in screening, what's the key information that a person would really want to know if they're going to make a decision? And I would suggest that these are the following things. What's the likelihood that they're going to develop cancer over the period that they're eligible for screening? What likelihood would they have of getting it? And then if they get it, how likely are they to be cured? That's what I'd want to know. If I'm going to get cancer, if I'm not screened and I get the cancer, how likely am I to be cured? And if I get it with screening, how likely? Because that's where the balance of the benefit comes. So that's the kind of questions. There are other things that also might be known, comorbidities, things like that. But to me, these are the key questions that a person would want to know. So let's just see what's gone on. As we all know who are interested in screening, the National Lung Screening was in all essence the reason why the U.S. Preventive Services and Medicare has endorsed lung cancer screening. It was basically because of the National Lung Screening Trial. And what was the result of that trial? Well, they expressed the results in two ways. They expressed relative mortality reduction and they expressed absolute mortality reduction. And everybody's familiar with this relative mortality, which is expressed in terms of deaths per 100,000 person years. Not a simple thing to convey to a person, deaths per 100,000 person years. And the result they got was that there were 20% fewer deaths in the screen arm compared to the control arm. That was in essence the result, the relative reduction result. And the absolute reduction, they expressed slightly differently. That's expressed in terms of deaths per participant, deaths per participant. And the result there was 0.0031 deaths per participant, fewer deaths per participant in the screening arm. That's the result of the trial. And that you can take the reciprocal of that and it turns out to be 320 participants to prevent one death. That's the result of the trial. Those are the two main parameters that you get from the screening trial. Now, people recognize that you can't go around telling people things like deaths per 100,000 life years or deaths per participant. You need to express it in a more clinical way so a person can understand. So they try to convert those relative reductions and absolute reductions into something that's meaningful to a patient. And I emphasize they try to convert. So the 20% mortality reduction, they convert to mean only 20% of the screen detected cancers are cured. And here's what, for example, the American College of Chest Physicians recommends you tell a person interested in screening. They say you should tell a person who's interested in screening that four out of five people who are going to die of lung cancer will die of it even if they are screened. Screening prevents one in five deaths from lung cancer. So that's what eminent organization says you should be telling a person. And they translate that 0.003 deaths per participant into the following, 319 out of 320 people will not benefit from screening and some may experience harms. And again, it's probably even more like, thousands of people. And for all of you who are doing screening, there are shared decision aids. This is the common one from the AHRQ and here's 1,000 people screened and here's 1,000 control and you can see 21 lung cancers in both sides. You'll save three, three lives will be saved in the screening and you'll have all these harms, false positives and 18 invasive procedures for no reason. And that's what they suggest you weigh. So this is what's being said. This is the result of the clinical trial. So if you accept these as inputs and they're correctly derived from the trial, would you do it or recommend it to a family member if that's the only input you got? You really should think about it. Is this worth doing? And then the second question I ask is are those NLST translations that they did meaningful for clinical decision making? That to me is the absolute critical question about whether or not a person should be screened. Is what's being told regarding that clinical trial meaningful on a clinical level for a person trying to decide whether or not to be screened? Let's start with some background information here. Results from screening trials reflect not only inherent properties of the cancer, meaning its frequency in the population and how curable it is with early treatment. It reflects not only that but it also reflects the parameters of the trial. In particular, the number of rounds of screening you've done in the trial and the length of follow-up that you've done on the patients without screening. It reflects that as well. The NLST did three rounds of screening and a total of six and a half years of follow-up. If you change that, if you did longer follow-up, for example, in the NLST, let's say they didn't stop at 6.5, they kept going, the mortality reduction goes down. And in fact, we've already seen that. The mortality reduction now in the NLST is below 16%. If you had done more rounds of screening, you would have had better results. The reason they picked the three rounds was nothing based on science. It was based on money, how much money they had to put into the trial. There's no magic about the three rounds. They could have done four, five, 10 rounds of screening, which other trials, and they would have gotten better results. Patients don't understand this. That's not explained. Those trials' results cannot be directly translated to answer those fundamental questions about number of people, risk of lung cancer in a population, or how curable the lung cancer is. The NLST provides virtually nothing in regard to those fundamental questions. So let's reconsider those questions in a more clinical way. People have talked about the cure rate of screen-detected cancers has been reported to be as high as 80% in some studies. 80%, and there are many studies that have shown this. Japanese studies, the LCAP study, we show approximately 80% cure rate. Now, people say, oh, how can it be an 80% cure rate when the NLST only shows a 20% mortality reduction? There's nothing incompatible about those results. You can have a clinical trial with a 20% mortality reduction and have an 80% cure rate. In fact, you can have a clinical trial where the screening cures 100% of the cancers. 100% of the cancers would be cured if you're screened and still only have a 20% mortality reduction because remember, you're doing a lot of follow-up, counting all the deaths that occur even when you're not doing screening. That's part of the follow-up. There's no screening going on, and that's what's happening in the NLST right now. 20% down to 16%, I've heard numbers now, it's down to about 12%, and it'll keep going down as long as you keep following up without screening. So this is very important. So what's the important thing for a person to understand who's interested in screening? How would it affect their considering screening if you said to them, instead of four out of five times you'll die, four out of five times you're gonna be cured? What would Mary's skeptic think if she said, hey, if you are one of those people that get lung cancer, we're gonna cure you four out of five times instead of dying four out of five times? To me, that's an enormous difference. Now what about this risk, this 320 people, or 3,000 people need to be screened? Here's the way you can think about it in terms of their lifetime. You can think about a person's lifetime risk of getting cancer, and that's approximately 10% for smokers, heavy smokers. 10% lifetime risk. And let's just say, forget the 80%, let's just say you're gonna cure it 50% of the time. Let's be conservative here. The number needed to screen in this scenario is 20. You divide the frequency by the cure rate, and you get 20 number needed to screen. Now think about that. So if I tell my patient, no, no, it's not 300 or 3,000 people to save a life, it's 20 people. Every 20 people we screen that enter a screening program and stay in it for the lifetime of their eligibility, we're gonna cure you, we're gonna cure one out of 20 people. I should say, of 20 people enrolled, we'll save the life. One person's life will be saved, as opposed to needing 320 or 3,000 people. To me, this is an enormous difference. And in fact, it's not even so much that the patient understands this. What's, I think, even more important is the physicians who they're discussing with need to understand this. If they believe those clinical trial inputs are the clinically relevant features, that's a problem. They need to understand what's clinically relevant for a person who's considering being screened, and the numbers are vastly, vastly different. And in my view, this is one of the key reasons lung cancer screening has not been adopted in a much more serious way, is that there's this general sense that the benefit is marginal. So in conclusion, the balance between benefits and harms are often presented as being marginal, thus requiring shared decision-making. Clinical trial results are highly dependent on trial design, and they're being presented in a misleading way when attempting to directly translate them into the type of clinically meaningful information that is necessary to understand when considering enrolling in a screening program. And I would also just say that unfortunately, this approach occurs in many types of screening, not just in lung screening. Mammography, we're seeing the same sort of thing happening. And it leads to a serious underestimate of what the true benefits are, in terms of a person enrolling into a screening program. Thank you very much. This is a very important public health issue in the United States, and I'm delighted you're here. I'm not a radiologist. I'm a thoracic medical oncologist, as Matt outlined. And I've been asked to talk as this panel from a patient-centric point of view. And we just heard a very compelling presentation from Dr. Jankielewicz. And I'll hit some of the same issues, but I think from a slightly different perspective. So the clinical construct here is, what does somebody really wanna know about screening? So my person is Joe Everyman. He's a 52-year-old real estate agent who started smoking while training as an, while smoking in training for the military, where he served as a logistician in Desert Storm, but never deployed. He stopped smoking in 2012 to train for a marathon with his softball team. He's now inquiring about lung cancer screening after his former platoon buddy had his screening at a local VA. So the question for today is, what does Joe really want to know to assist his screening decision? What should he know about lung cancer? What should he know about the harms and benefits, as we just heard? What are the alternatives? Should he be screened? That's the primary issue. Now, I'd also ask you, as opposed to other screening modalities, if this were COVID-19, what would the shared decision-making process look like? In shared decision-making, is it educational about screening, or is it making people think twice about screening? And it's kind of an interesting topic. So much of the information that I'll share to you today is from the CMS, the Center for Medicare and Medicaid Services website, because they're the federal agency that's responsible for deciding about the funding of this screening service. As many of you are aware, the U.S. Preventive Services Task Force just re-looked at the current data supporting the implementation of screening from across the world, and they made a recommendation that, again, you're aware of that I'm not gonna be talking about in any detail. But basically, they said that the data from the two adequately sized randomized trials that have been reported to date with adequate follow-up were suggestive of mortality reduction benefit, as Dr. Yankovic talked about. So that's the NLST. And the NELSN, there's a whole slew of other trials. They have not been adequately powered to see a significant difference in terms of mortality reduction benefit. So U.S. Preventive Services Task Force is aware of them, but does not use them to inform their current advice that's embodied in their proposal. But their proposal does take eligibility from the eligibility criteria outlined from the NLST, and extends it to the eligibility criteria embedded in the NELSN study, which includes people who are younger, 50 years old, we'll talk about this, and lower PAC years. And so when they discussed their current decision, which they just put out on the website a few weeks ago, this is the data that influenced their current position. And they point out that for screening, what you have to have is a big mortality burden. And they show here on the slide the aggregate estimated new cases and estimated deaths for the major cancers. And as you can see, lung cancer mortality, 159,000 per year, far outstrips by two-thirds the next highest cancer mortality. And then as you all have seen in your textbooks, the issue is, is there a benefit to finding earlier? And then they show this data. And this data from CDC that they used basically shows that people with earlier stage disease do better with lung cancer. And we've heard about that from the previous presentation. So as Dr. Goncalves outlined, in their initial approval of a national coverage decision, or their initial formulation of national coverage decision to pay for lung cancer screening when the first US Preventive Services Task Force, B recommendation came forward, they had imposed this shared decision-making experiment, as David outlined, in the setting of people receiving lung cancer screening. And they said, what is shared decision-making? It's a patient-centered healthcare tool. It's a process in which clinician patients work together to make a decision, select tests, treatment plans, et cetera that balances risk and expected outcome, particularly for that patient's preference. So this is a simple thing. And it appeared that this was prudent in this new setting. However, there's a couple things about this. The national experience for shared decision-making in the setting of screening was zero at this point in time. This was an experiment that Dr. Chen talked about in editorials that came out subsequent to that. He's one of the leaders at CMS who was involved with this process. And here's what happened. This is also from the CMS website. This is how they implemented screening shared decision-making. And so you start taking what is actually shared decision-making, and the decision scientists get involved, and they talk about all the elements of it. And so this simple one-paragraph thing becomes this dense text, which continues. And so for you that are familiar with discussing these issues with the patient in any kind of clinical decision-making, the longer you talk to them, the more afraid they are that what they're doing, considering doing, is very, very disconcerting. And so the medium is kind of the message in this shared decision-making process. Now, that was from 2015. This was the core justification from CMS and their position, as David related. Since the NLST was the only trial with several trials and observational studies in the past to show benefit, there's no improvement in health outcomes from lung cancer screening using lung cancer, you know, low-dose CT, in other populations. So they were concerned about the generalization about this from the NLST to others. The interesting thing was, and as acronym people are well aware of, the NLST was put together very quickly because it was concerned that the window for screening in the United States was gonna close like it had for prostate cancer. So they did not know how to optimize diagnostic management within the screening context, no one did, back in 2002 when they were implementing the study. So they decided to just use community standards for all the sites in terms of how they would approach the diagnostic workup. And I think, as you're well aware, because a lot of people were new to this, it was done a lot of different ways. It wasn't particularly efficient. A few years later, when the Nelson started, they had a very, very well-prescribed diagnostic workup that was only done at the three centers that they used to conduct that study. So we saw, from the time that screening started to now, there's been unbelievable innovations and process improvements along the way. So that the statement for the 2015 was appropriate from the CMS. However, when we move forward to the current decision in which they have modified slightly the shared decision-making, they've made it more liberal, they say it can be done by anybody designated in the screening center, not a physician, not a nurse, or advanced practice nurse. And they said, we're doing this back in 2015 because we believe that the counseling and shared decision-making addresses the benefits and harms and we believe that the initial counseling and shared decision-making supports identification of individuals who would most benefit from screening. Now, I wanna just share with you the perspective that CMS has a charge to use evidence to guide their decision-making for funding. We believe is not evidence. This is we believe. CMS does not have the ability to fund based on their beliefs. They have to fund based on evidence. So they were kinda, as I've said, doing an experiment. So we have this new proposal from CMS that just came out. And in it, they changed the eligibility, they changed the PAC years, as I briefly alluded to. And it's very interesting. And when you get into the details, they say, in addition, we wanna simplify the requirements for shared decision-making and we wanna make it less restrictive. Now, that's good, but there's still kind of a problem. As Dr. Yankovic outlined, we have nationally 5% of people over the last several years that have availed themselves to lung cancer screening, even though the evidence from the first time to now has radically improved. The long-term follow-up from the NLST was solid in terms of mortality reduction benefit. The additional information from the Nelson was very compelling. In addition, a number of trials from Italy, from China, from other sources have pointed to a mortality reduction benefit well in excess of 50%. So now we have more evidence that this is beneficial and we have the most lethal cancer on the planet in which other options are palliative care. So they still have included this and they have focused on these four things. Shared decision-making to determine you're eligible for the screening. Shared decision-making to talk about the importance of adherence and other types of things like that. Counseling about smoking cessation. So the question is, what is the purpose for doing this shared decision-making that doesn't already happen in routine clinical practice? And David talked to you about informed consent. The informed consent is outlined here. It's a process that we use routinely in clinical care. I outlined the elements that basically address all of the concerns of CMS in a routine setting and this is what's done every day for breast cancer screening and colon cancer screening. And those are screening processes that have vastly more acceptance in our population with higher rates of not only participation but persistence. And so why do we ignore that enormous body of successful implementation? So here's another perspective. This is an IL-CAP study that was performed by Dr. Gene Galovitz, Claudia Hansky, others in this audience, in which they reanalyzed the baseline CTs from IL-CAP from 52,726 individuals. And they found in that analysis, just under 24% had evidence of COPD emphysema from mild to severe. And that three quarters of those people had no idea that they had any problems with their lungs. Well, COPD is the fourth leading cause of death in the United States and across the world. And there's enormous effort going on, led by NHLBI and others, to advance detection of early COPD. We have this tool that is finding early COPD in 24%. And if you believe the reanalysis that was just presented at the RSNA from the NLST group, when they did the same thing, this is Dr. Pinsky, Gerardo, and others, when they did the same reanalysis of baseline NLST CTs, they found a rate of emphysema in that NLST population of 30%. So we're talking about a disease prevalence, fourth most lethal process in the world, that is found 20-fold or more frequently than lung cancer in the lung cancer screening setting. And they're not even talking about that. And so it's kind of disturbing, because lung cancer, COPD, and coronary artery disease are all known to be tobacco-related, heavily tobacco-related, and they occur in this population, whether they're 30-pack years or 20-pack years, 50 years old or 55 years old, all over the world. Why aren't we focusing on the additional benefit of doing that annual CT evaluation in a high-risk population of current and former smokers? So we've been focusing with the American Lung Association, the Prevent Cancer Foundation, and others, on what should be done in the setting of somebody who gets a lung cancer screening study and finds out that they have early COPD. Well, there's important things to be done. In addition to the obvious, enhanced efforts at smoking cessation would be incredibly evidence-based in this setting. Lifestyle modifications in the pulmonary world are profoundly important. Physical activity drives much better respiratory dynamics and allows people to maintain function and has been shown in enormous numbers of studies, not only in the pulmonary context, but also in the cardiovascular context. And we are identifying these people that were completely unaware of the fact that they had lung cancer, COPD, and potentially coronary artery disease, and this has been well-published. So there's also additional drug therapy that are developing in these settings, focused on the inflammatory response of the host to tobacco that relates to the comorbidity of lung cancer and COPD. So where is thoracic CT going? At RSNA, we're seeing how it's going to be done in a much more automated fashion. There's much improvement in terms of the workflow, implementation of these advanced imaging processes to find these comorbid conditions. And so I would submit to you that if you were Joe Everyman or Jane Everywoman, what would you really want to know about lung cancer screening decision? And I think there's a host of new issues that suggest benefit far in excess of harms that should be considered. Thank you very much. Thank you for joining us today for the RSNA session on Engaging Patients, Opportunities and Challenges in Lung Cancer Screening. I'm Anita McLaughlin, Director of Economics and Health Policy from the GoTo Foundation for Lung Cancer. I'm excited to share some perspectives from patient advocacy. Before we jump in, a bit about us. We are a national nonprofit founded by patients and survivors and serve the lung cancer community by helping people navigate the paths of early detection, diagnosis and treatment with a mission to increase survivorship. This is an overview of today's talk. I'll briefly go over the background and I'll also unveil the top three screening implementation barriers rank ordered by our GoTo Foundation and the screening centers of excellence sites and then share three hypothetical patient stories reported by screening centers, some prevalent challenges and key strategies and solutions. Lung cancer screening with LODOC-T is the only procedure proven to reduce lung cancer mortality in individuals at high risk for lung cancer. It's recommended by the United States Preventive Services Task Force, the Centers for Medicare and Medicaid Services, the American College of Radiology and numerous national patient advocacy organizations, medical professional societies and other federal agencies. Both the National Lung Screening Trial and the Dutch-Belgian Randomized Lung Cancer Screening Trial demonstrate that screening using LODOC-T leads to a reduction in lung cancer mortality, underscoring the importance of implementing effective screening programs. Despite strong supporting evidence, national data indicates screening uptake in the US at around 5% as of 2015. I'm excited to share with you today some of the key strategies for screening uptake based on boots on the ground insights from our screening programs across the country. This is a poster my colleague presented at the National Lung Cancer Roundtable that shows the screening centers of excellence or SCOE network data on program strategies for maximizing stage shift. Of note, more than 50% lung cancers were found early among our SCOEs. The GoToFoundation Screening Centers of Excellence Network is comprised of the US-based screening programs committed to responsible high quality screening. These programs are approved based on adherence to defined screening program standards and best practices. The magic of this network is its learning collaborative approach, including community-based and academic hospitals, which is an ecosystem that accelerates robust peer-to-peer screening implementation and support resources. To better understand screening program implementation, the SCOE network was surveyed to assess major barriers and effective strategies to improve screening uptake and adherence. The survey includes topics around program structure, barriers, screening rates, patients, workflow, capacity, and also reimbursement. In 2019, 100 SCOE programs responded to the survey representing almost 88,000 patients screened. The survey is designed to baseline participants by collecting both quantitative and qualitative data and deployed on an annual basis, allowing for longitudinal analysis. Today, we will discuss the survey results and focus around barriers and strategies. Through a couple of open-ended questions, we asked programs to tell us what they see as the barriers hindering patients from being screened, including initial uptake and the need for their annual screens. Then in a subsequent question, we gave them defined categories of patient barriers to screening and asked them to rank order in terms of how significant they were from one to seven, low to high. The top three barriers to screening implementation were found to be adherence and getting patients to return for their annuals, staffing limitations, and significant lack of support from referring providers. We'll come back to this barrier at the end of our talk when we discuss strategies and solutions. Today, I'll weave in three hypothetical patient stories that screening programs reported over the last year and also as recent as a few months ago. I'll share stories of an individual who currently smokes, a patient who's asymptomatic, as well as a new patient. You'll notice a theme as all three of these patients were denied a screening referral from their primary care provider, even though all three were screening eligible. Here is patient one, a current smoker. They meet all of the screening eligibility criteria. They are also in a current screening program and due for their third annual low-dose CT screening. However, the screening referral is denied by their PCP. Here's the reason why given from their PCP. Since the patient continues to smoke and has shown no interest in discontinuation of their tobacco habit, I see no reason to continue lung cancer screening at this time. Despite increased awareness around lung cancer, the stigma associated with the disease remains an issue for the lung cancer community. Dr. King's research revealed that beyond the known psychosocial issues associated with stigma, that both patients and oncologists feel that stigma can affect the level of care a patient receives and lead to worse health outcomes. And here is the study that Dr. King co-authored, published in the Journal of Thoracic Oncology. This is a snapshot of their 10-year cross-sectional analysis that looks at whether attitudes toward lung cancer and the stigmatization of those diagnosed have changed over a decade. The study results showed clear improvements and availability of treatment options and awareness, but levels of stigma remained unchanged. Notably, patients perceived more stigma in 2018 than in 2008. Case study two. This is an example of an asymptomatic patient. And once again, this patient meets the screening eligibility criteria. This individual's health literacy is above average. They were informed by their community health educator. They were at risk for lung cancer and screening eligible. This is a patient who scheduled an annual wellness visit with their primary care physician and they asked their doctor for a screening referral. However, the screening referral was denied by the PCP. Why? Well, here's the PCP's response. You do not have any signs or symptoms and do not need a low-dose CT. Instead, I'll order you a chest X-ray. Low-dose CT is the only recommended screening test for lung cancer. Here's a link from the CDC website where providers can take a quiz. The CDC does not recommend a chest X-ray for lung cancer screening eligible population. They also include a true false question as to whether lung cancer screening can find cancer early and before symptoms start. The correct answer here is true. The audience is likely familiar with the ACR's appropriateness criteria, which also indicates low-dose CT lung cancer screening as an appropriate test for the at-risk population. ACR further indicates there is no evidence to support screening with chest radiography. And here you see chest X-ray listed as usually not appropriate. And here is the last case study, which is an example of a new patient. This is a Medicare beneficiary. They were also informed by a community health educator they were screening eligible. This individual scheduled a new patient wellness visit with their primary care physician. During their visit, they asked for a screening referral. However, the screening referral, it was denied by their primary care physician. What is the primary care physician's reason? Here's their answer. Once I get to know you better, I'd be willing to discuss a referral for a screening, but at a future visit and not at this time. So here is the regulatory definition for an IPPE or Medicare wellness visit. It clearly states screening referrals for preventive services are indeed defined as part of the Medicare wellness visit or the IPPE. Going back to Screening Centers of Excellence survey results on program barriers, there's a clear parallel to these case studies. Lack of support from referring provider. It's at the forefront. There's evidence that PCP education and training is needed regarding the benefits of lung cancer screening, eligibility criteria, shared decision, stigma, annual adherence, et cetera. But looking at the ranked barriers and peeling back the layers, lack of patient awareness is at the top of the list, but it's important to understand why. The next two ranked barriers may shed some light. It's not just PCP or provider's level of awareness, but even more so for the PCP buy-in to the screening process. Healthcare provider awareness, it's necessary, but not sufficient to improve screening rates. So for many programs, expanding and strengthening their base of referring healthcare providers is also a high touch process. Patient awareness and understanding of screening and PCP awareness and willingness to refer on the other are clearly interconnected, reinforcing one another's influence to hinder or advance screening uptake. When we asked an open-ended question about what hinders adherence to annual screen, it was mentioned insurance issues, co-pays, and cost. Programs also discussed a range of general issues around patient's unwillingness to be screened from not understanding or buying into the need to go in every year for their screening, to not wanting to come back because of fear of diagnosis. And again, lack of PCP encouragement, it's key and feeds into the other barriers because if the PCP doesn't remind the patient of the need and importance of their next screen, or doesn't mention or inquire, hey, why haven't you gotten screened again? The optics and patient perception is that screening may be not so important after all, because you know what, my doctor didn't bring it up. These lingering factors may remain, hindering patients from being screened in the first place, and may still be present when they do, in fact, go in for that initial screen. Screening programs are using strategies, not just to drive uptake, but to keep those patients coming back in annually. In looking at program drivers, over 50% overwhelmingly rely on patient and PCP outreach engagement and education. Approximately one-fifth also use personalized patient navigation, and 12% of programs mention they take steps to address barriers around billing and coverage. There are so many complexities around lung cancer screening, and many feel that predictors of screening uptake remain unclear. Our patients and survivors have coined the term scansiety, which includes fear of getting diagnosed with cancer, stigma, access barriers, lack of knowledge around cancer risks, treatments, screening benefits, smoking cessation, shared decision, and cost issues. But if you're looking at the most consequential barrier that has both the ability to lock and unlock screening barriers, all roads point to the PCP and ordering clinician. The PCP is a clear predictor of screening uptake, a key to and a vital partner in advancing screening and adherence. This is reflected in all three case studies, as well as the Screening Centers of Excellence annual survey for the past three years. We know what's working for screening programs across the country, including community settings, and their key strategy to increase screening and adherence is through PCP and patient education and training. But to attempt and persuade with education materials, it's not enough to be effective screening implementers. The magic happens when everyone's North Star is lung cancer survivorship through early detection screening and adherence. Screening Centers of Excellence programs are engaging PCPs with not only knowledge and education, but effective outreach and partnerships. In case study one, the screening program tracked and followed up with their screening patients, as well as the respective PCPs to ensure patients returned for their annual screens. It was through this internal tracking structure combined with an impressive patient advocacy and persistent PCP communication, were they able to get that patient back in for their third annual screening. Case studies two and three also achieved successes, but again, through screening program navigation and implementers, advocating for those patients, working with the community health educators, and creating screening pathways for patients by partnering with PCPs and active engagement with lung cancer screening. While it's important to understand and address all barriers to screening uptake, the common theme we discussed today is perhaps the most consequential barrier because it's also a key solution. How can you be proactive in addressing PCP screening education engagement? The next several slides include provider-facing and patient-facing lung cancer screening tools, education, and resources. Here, the American Academy of Family Practitioners supports low-dose CT lung cancer screening. This was posted and published earlier this year. Here are several healthcare provider education and training tools from our partners at LUCA and CHESS that are free online resources, including topics on screening, shared decision-making, patient follow-up, smoking cessation, treatment advances, and survivorship care. The GoTo Foundation has a number of online screening resources. This is a screenshot of our short four-minute video regarding screening along with a companion brochure. Both are free and available in English, Spanish, and Chinese to better reach diverse and underserved populations. We also provide a number of patient support services, truly connecting communities. I have to add that November is Lung Cancer Awareness Month and hope you can join us in advancing screening and adherence through patient and provider engagement, education, and partnerships. Thank you for your time. Here's my contact information for any questions.

lung cancer screening

shared decision-making

Medicare

National Lung Screening Trial

screening participation

patient education

provider encouragement

lung cancer survivorship