Good morning. I'm going to start out this panel session by talking about the revised U.S. Preventive Services Task Force guidelines. What has changed? I have no conflicts of interest to report. I do have funding through the NIH, PCORI, and the American College of Radiology. So, in March of 2021, the USPSTF revised their original guidelines from 2013 in two important ways. First, they reduced the minimum age of eligibility for screening from 55 to 50 and reduced the minimum pack years from 30 to 20. The intended consequences of this have been to increase eligibility of ever smokers in the U.S. to about 14.5 million, whereas previously it was about 8 million adults, which represents an increase of 81 percent. These changes are also estimated to save an additional 10 to 20,000 lives annually and have the potential to increase eligibility in women and racial minorities. The evidence base for the use of CT screening came primarily from the NLST and the Nelson trials, which are the only two randomized controlled trials that were adequately powered to see differences. This table shows six randomized trials that were factored into the task force deliberations. You can see from this that the proportion of males varies from 56 to 100 percent, the number of years of follow-up from just over five years to 10 years, the mean age from the late 50s to mid-60s, and the mean pack years from 36 to 56 years of age. Importantly, the number of screens and the screening intervals were different across each of these different trials. The numbers of lung cancer in the experimental CT arm and the control arm are shown, as well as the number of lung cancer deaths per 100,000 person years. These data resulted in an incidence relative risk that favored a reduction in lung cancer mortality of CT over the control arm of 0.85 in the NLST and 0.75 in the Nelson trial. There was also a trend towards mortality reduction in the CT arm in the ItaLung trial. However, in two of the trials, there was no difference in mortality between the two arms, and in one trial, specifically the UK trial, there appeared to be an excess number of lung cancer deaths in the CT arm. So an important question is, do the USPSTF revised guidelines address disparities? We know from the NLST that blacks are at greater risk of adverse lung cancer outcomes, but benefit the most from screening. Specifically, blacks are more commonly current smokers, have more comorbidities, more are unmarried, and fewer have completed college. And yet, despite these adverse prognostic indicators, blacks had the greatest reduction in lung cancer mortality with a hazard ratio of 0.61 versus whites with a hazard ratio of 0.86. In 2019, the Southern Community Cohort Study was published, looking at patients with lung cancer in southern states to determine which of them satisfied the USPSTF 2013 criteria. This study found that almost 70% of blacks were ineligible for screening based on 2013 criteria versus 44% of whites. The primary disqualification was the requirement of a minimum 30-pack year smoking history. More recently, in 2021, Ritzweiler and colleagues looked at five community practices to see the differences in implementation of the 2021 versus 2013 criteria. They found higher relative increases in newly eligible women versus men and higher relative increases in blacks as well as Hispanics, Asians, and other racial categories versus non-Hispanic whites. So the USPSTF guidelines are a major improvement, but there are still some challenges. First, we know that almost 50% of lung cancers occur in former smokers who have quit greater than 15 years previously. We also know that these guidelines may not necessarily reduce racial disparities. Although they may increase the absolute numbers of women and racial minorities, they may not change the disparities such that early or eligible black ever smokers will probably remain 10% fewer than eligible white ever smokers. We also know that individuals over the age of 80 fall out of screening with the current criteria, and yet the US population is aging and many individuals within this age range can tolerate local therapies like minimally invasive surgeries, SBRT, or percutaneous ablation. Finally, the revised guidelines do not factor other variables that are known to influence. How important are years since quit smoking? This has been informed by a recent cost-effectiveness analysis that compared the 2021 USPSTF guidelines with six alternative strategies and the 2013 guidelines. All of the alternative strategies used a minimum 20-pack year smoking history. The 2021 USPSTF incremental cost-effectiveness ratio per quality adjusted life year was about $72,500. This is cost effective in the United States given that we generally include anything under $100,000 to be cost effective. Interestingly, the most effective strategy began screening at age 55 years with a minimum 20-pack year smoking history and up to 25 years since quit. This yielded a mean icer of $66,500 and yet covered the same proportion of the US population as the current new guidelines. This tells us that cost-effectiveness could be improved if we covered former smokers with a minimum of 20-pack years who have quit greater than 15 years since the onset of screening. The alternatives to rule-based criteria are obviously predictive models. There was a relatively recent review article that looked at 24 risk models that predicted lung cancer incidents and six risk models that predicted lung cancer mortality. Based on analysis of these various models, the evidence suggests that models will outperform rule-based eligibility for selecting who to screen. The challenges of using models are not inconsequential. First, what's the appropriate risk threshold? At what percentage of risk do you determine that you will screen individuals and not screen others? These thresholds will vary based on the population it's being screened and will vary across models. As well, models require the collection of more detailed variables, more detailed information from the electronic medical record. Third, models may end up reducing lung cancer mortality without providing a gain in cost-effectiveness. Consider, for example, a model in which there is a higher relative proportion of older individuals. These individuals have a lower life expectancy, so you may, in fact, reduce lung cancer mortality without gaining in cost-effectiveness. Finally, Blacks have a higher lung cancer incidence. They tend to be younger and have a lesser pack-year smoking history. How do we ensure that we account for these within models to minimize disparities? I'm going to focus on one model, which is the PLCO-M2012 model, developed by the prostate lung colorectal ovarian investigators. This was validated in the PLCO trial and then subsequently externally validated in the NLST and a variety of other populations. The model includes 11 variables that are demographic, medical, or relate to smoking history. This has currently been validated in several countries using several cohorts in the North American and European continents. It's also currently being implemented in public health screening programs in Canada and the UK. In a retrospective analysis of almost 900 lung cancer cases, they looked at models of the PLCO at different thresholds, comparing it to the 2013 and 2021 USPSTF criteria. You can see that in going from the 2013 to 2021 criteria, the percentages of white, black, female, and male ever-smokers increases. But it's only when we begin to use the PLCO model that we see that the percentages, the relative proportions of different racial and gender groups begins to equalize. This suggests that the use of models will be a requirement in order to capture the particular risks that are associated with different sex and racial groups. So to summarize, the USPSTF 2021 criteria do expand the pool of eligible smokers and include younger individuals with a lesser pack your smoking intensity. Relaxing these criteria will expand the number of eligible women and blacks and will partially mitigate disparities. We also know pretty clearly that rule-based eligibility based only on age, pack years, and years since quit will not reconcile ongoing disparities in eligibility. And that models that include critical demographic variables and that do not set limits on age or pack years or years since quit will be important in order to capture the full range of individuals who are at greatest risk of lung cancer. It's for these reasons that the American Thoracic Society in its most recent policy statement suggested that the inclusion of risk models would be important to inform eligibility for lung cancer screening moving into the future. With that I'll end. Thank you very much. Be discussing with you tools for tracking nodule follow-up in lung cancer screening. And so I will be describing a tracking system that we developed at my facility for screen detected nodules and the development of a local lung cancer screening registry. I will identify useful tools for tracking nodule follow-up in these patients. I'll outline a process for identifying patients who have had interval CTs that are also enrolled in screening and describe a process for identifying patients with suspicious nodules to be reviewed at our weekly nodule conference. So we're all pretty familiar I think at this point with lung RADs. And of course the lung RADs categories 1 and 2 are negative screens and so there really wouldn't be nodules there that we would be concerned about needing to have diagnostic follow-up. With lung RADs 3 there will be a need for follow-up usually a six-month follow-up CT. And then the category that we are most concerned about are the lung RADs 4, the positive nodules that are most suspicious. And so here's an example of how lung RADs works. And so on the left you can see that on this patient scan here there was a small nodule. It qualified as a lung RADs 2 and so that meant the patient should come back in 12 months and they did. This is the importance of adherence to annual screening. And so when the patient came back we now have that nodule looking larger actually having some irregular margins and this is now a lung RADs 4b. The good news is here that this was a patient in my program. They did have this resected. It was a stage 1 adenocarcinoma and the patient is really considered cured. Here's another example of how nodule tracking works. We had a patient here with a lung RADs 4a. This was a part solid nodule and this was then recommended that the patient come back in three months and the patient did come back in three months. You can see how the nodule is now more solid and the margins are more irregular and this is now a lung RADs 4b. And this is another good news story of this was resected. It was a stage 1 and the patient is considered cured. So what my facility did, and I will say that our lung cancer screening program resides within radiology at my facility, we developed a system of what we call screen phrases based on lung RADs. The radiologists provide these screen phrases at the end of their reports. These phrases are imported into our local screening registry. The registry then sets the due date for the next CT and monitors compliance with needed follow-up. And then the most suspicious nodules are referred to the weekly nodule conference. So this is a list of our screen phrases. You can see how they would be based then on lung RADs with the screen 1 being your basic screen 1 and the screen 1S being the screen 1 with a significant incidental. The radiologist can also can pick from a pick list in our dictation system to include the appropriate screen phrase. And here's just an example of how that appears. And so on the top we have a screen 2. And so what we have here in parentheses, and I've circled for you, is this screen phrase. And this is what becomes important because all this text is not really incorporated into our registry. It's just that screen 2 wording. And so here this is the screen 2 where there's nodules, benign in appearance. And so a letter is then sent to the patient that indicates no lung cancer was found and that the patient then will be set up to get a reminder letter to come in in 12 months for their next annual. That's as opposed to the screen 3 where this is what is printed out at the bottom of the report. And the screen 3 is what is in parentheses. This is a nodule, probably benign. And here the patient gets a letter that indicates a nodule was found that requires follow-up CT. And then the patient will get a reminder letter that they need to come in in 6 months. Here's an example of the reminder letter that we use at our facility. I think it is extremely important that patients receive this sort of documentation, especially since with screening we are really engaging with the patient not necessarily in a diagnostic setting, but in a screening setting. So I think we have more responsibility to communicate with patients. And we've tried to use wording here that is patient-friendly and understandable and indicates your CT revealed one or more small nodules that require further monitoring and so forth. And then the other thing we do at our facility is each radiologist signs these. They're able to do it electronically within our EMR. But then the radiologist's name is right there. And so maybe just having a little more personalized approach can help for patients to recognize the importance of what they've done and if they need follow-up. The other very important thing that we did, which I think helps immensely in tracking follow-up, is we created a new CT order for the diagnostic follow-up of a screen-detected nodule typically done at 1, 3, or 6 months. Now this is the same CPT code as any other diagnostic CT chest without, so 71250. It uses the same low-dose technique as a screening CT. We developed a specific dictation template within our system that includes a lung RADS category that has to be filled in. It then allows the CT results to be tracked and imported into our local registry. And then the recommended follow-up can be updated. So here's an example of a follow-up CT that was done on a screening CT. And interestingly, what happened was the first CT had a much smaller nodule in a different place in the right upper lobe. But here in the posterior right upper lobe there's this irregular nodular density that has developed. And so this is an example of this CT report that is the CT chest LCS follow-up. And so it does indicate in the history that this was a female for follow-up of a nodule on lung cancer screening CT. And it is the same technique that we use for screening. And then of course there's the body of the report. And in the findings for the lungs it indicates that the original small nodule that was found has actually gotten smaller. But oh, by the way, now there's this new irregular nodule. And so in the impression it's described that this may in fact, because it came up so quickly, it may be inflammatory. And so this was given a 4B and the recommendation was to do a follow-up CT in 4 to 6 weeks. And here's how that lung red prints out at the bottom. And again in the parentheses is the screen phrase. So another tool that I think is useful in tracking your nodules is to be able to look at upcoming CTs of patients that are enrolled in screening. And so our informatics team, and this is nothing fancy, this is not a special software program that we had to buy. We were able to develop this in-house. I know there are wonderful software programs out there and many of you may be using those and that's great because I think they may be able to use some of these tools as well. But one of the things that we found useful was to create this list then, and this comes out at least once a week of the upcoming CTs on patients enrolled in screening. And you can see that some of them are in fact getting what we call the CT Chest Lung Cancer Screening Program is the annual or the baseline CT. But then there are some other CTs listed here that are not scheduled as that. And so we want to double check and see if in fact this should be a CT chest LCS follow-up. And so the navigator then can go in and double check that and change it to a CT chest LCS follow-up if needed. Another important tool that we found, and this comes out every day, is our exception report. And so we can tell if in fact a CT was done but the navigator didn't complete a worksheet. And then importantly if a CT was done and no screen phrase was added. And in this case this was a diagnostic CT done, a high-res CT. And so it may be that this was done for entirely different purposes and probably was. But if the lungs are adequately evaluated and seen, it may be that we could use this in place of their annual screening and all we have to do is add a lung rat. So then the navigator can look that up and then if necessary then we ask the radiologist to add a lung rats and then this can go back into tracking. Now our screening registry process as I mentioned was built in-house. It is a simple SQL database. As I mentioned it imports the screen phrases from the radiology reports, calculates the due date for the next CT and then very importantly it generates a monthly report of patients that are one month overdue for their follow-up CT. And then a reminder letter is automatically generated to the patient with a copy sent to the referring provider. And then also this is the tool that we use to generate the list of cases for the Multidisciplinary Nodule Conference. Now our reminder letters to patients again are very hopefully understandable to patients. And it says in clear language, you are now due for that follow-up CT. And then there's another one for you are now overdue for your follow-up CT. And then our registry is able to produce then a report each week of our cases that need to be reviewed at the Suspicious Nodule Conference. And we have chosen to review only the lung rats 4s. We don't review the lung rats 3s. But it lists the patients, the date, the screen phrase. And then our navigator also does the Tamamagi risk score. And then the provider, these are fake names, the provider is listed. And these folks are all invited to attend the Nodule Conference. And certainly they can do that virtually now. We also have a system of looking at our incidental nodules. And we have something called TRAC-DX for the most suspicious nodules incidentally. And those are also listed in this report. So at the Multidisciplinary Conference we review both the lung rats 4s and the suspicious incidentals. And this is just an example of the conference list that's prepared by the navigator. And they send this out ahead of time. And as I mentioned, the providers are invited. And then after the conference, I think it's really important to close the loop. In case the provider was not able to attend, we make sure that we produce a report and the navigator is responsible for doing this in which they talk about the tissue, what was recommended, whether it was recommended by the radiologist here initially for tissue sampling. And then the conference very specifically said it should be a CT-guided biopsy. Sometimes it will change. And the recommendation from the radiologist was tissue sampling. And the conference will recommend a follow-up CT in three months, for example. So then we also have a tool called Screen Amend. And the radiologist can go in after the conference and update the recommendation. So in summary, lung cancer screening programs need to include tools for tracking the follow-up of screen-detected nodules. I hope I've provided with you today some very practical tools that in my program we have found useful. And I think it's also very useful if our nodule tracking tools can be used to generate the lists of cases for our Suspicious Nodule Conference. Thank you. Hi, I'm Dr. Jared Christensen from Duke University. Today, I'll be addressing some of the challenges and opportunities in lung cancer screening, which have led to upcoming changes in the Lung RADS classification system. That said, what is relevant are my roles as director of the Duke Lung Screening Program, and in particular, as chair of the American College of Radiology Lung RADS Committee. In that role, I have the privilege of working with an amazing group of talented and dedicated colleagues, and the work I'm presenting today has really been a collaborative effort for members of this committee. So let's talk about Lung RADS. So Lung RADS was first introduced in April, 2014, coinciding with the CMS decision to provide coverage for lung cancer screening. An update was introduced in July, 2019. This was version 1.1. And during that time, we've had several studies related to lung cancer, two of which have been randomized control studies. The first was the MILD, or the Multicentric Italian Lung Detection Trial, which demonstrated a 39% reduction in lung cancer-specific mortality. And the Dutch-Belgian NELSON study with the end results published in 2020, which demonstrated an average of a 25% reduction in lung cancer-specific mortality. There have been other studies related to various facets of screening that have informed some of the changes that we're proud to introduce in Lung RADS version 2.0, slated to be released early next year. Now, there's a lot of updates and new content in Lung RADS 2.0. Unfortunately, in our limited time today, I can't discuss every change, so I've decided I'm gonna focus on this first topic, and that is atypical pulmonary cysts. All right, so let's take a look at this. We have a patient who underwent baseline screening, and they've gotten an irregular cystic lesion. So what do we do with this? It's thick-walled, somewhat nodular. Some people treat it as a part-solid nodule, others as a solid nodule. The fact is is that current Lung RADS does not provide guidance on the management of cystic or cavitary nodules. Now, this particular patient, we recommended short-term follow-up. They didn't come back. They didn't even come back for an annual screen. Instead, they presented 17 months later with symptoms, with now this large soft tissue mass, and this turned out to be a stage III adenocarcinoma. We want to prevent this, if possible, and to do that, we've taken a long look at the data related to cystic lesions. So let's talk about atypical pulmonary cysts. So lung cancer presenting an association with cystic airspaces is rare, but we do encounter it in practice, and in the literature, it's reported anywhere from about a 1% to 4% incidence. However, the precise incidence in the screening population has not really been defined, and in many cases, these cancers are not initially recognized as malignant lesions. In fact, a retrospective analysis from the Nelson trial showed that about 23% of cancers that were missed on initial screening were those associated with cystic lesions, and so this is something that we want to be aware of, particularly, as we know, the incidence is increased in our high-risk population, and that many of these will turn out to be cancer. There's not a lot of data on the probability of malignancy associated with cystic lesions. There's an older paper, it's really a seminal study on pulmonary nodules, that did evaluate some nodules that had cystic components, and what it essentially showed was that as the wall thickness of these lesions increases, so does the probability of malignancy, and that's true, especially in patients at higher risk for lung cancer. So, to get us on the same page, we've established some definitions. Some were already established, and others we've defined. The first, a thin-walled cyst. A thin-walled cyst is unilocular, so there's no internal septations, and it has a thinner, imperceptible wall that is typically less than two millimeters in thickness, and there's no overall size criteria for the cyst itself. It's really all about the wall. Here's a different patient, with really a characteristic unilocular, thin, imperceptible wall. This is a thin-walled cyst, and these are considered benign. In fact, we're not even gonna classify or manage these in lung RADs, unless they change over time. Here's another patient. So, this would also include conditions where there's multiple cysts, such as LAM, Langerhans cell histiocytosis, LIP, or other conditions. These would also not be managed by lung RADs, unless one of the cysts had atypical features, which we'll define. All right, a thick-walled cyst is unilocular as well, but it has a wall thickness two millimeters or larger in size. Now, this could be uniform wall thickness, asymmetric wall thickness, or focal nodularity. In this particular example that we saw earlier, the cyst demonstrates multifocal wall thickness and nodularity. So, it is a thick-walled cyst, and we're gonna manage this in lung RADs. Cysts can also be more complex and have internal septations, and these are referred to as multilocular cysts. They can be thin or thick-walled, but really the key are those internal septations. How about these two lesions? So, what is a cyst or a cavitary nodule? Is there really a difference between these two lesions? And at what point does a thick-walled cyst become a cavitary nodule, or a cavitary nodule become a thick-walled cyst? And some of that may be temporal in nature. For example, a cavitary nodule may be a nodule that was solid, but now is centrally necrotic and develop a lucency. But the reality is, is we often won't have that kind of longitudinal information. So, for lung RADs purposes, we're basing the definition and management on the dominant imaging feature. So, a thick-walled cyst is one in which the cyst is the dominant feature, and we're gonna manage this as an atypical cyst based on the wall thickness. A cavitary nodule is one in which the wall thickness is the dominant feature, and these are gonna be treated as if they were solid nodules, and many of them likely started out as solid nodules. Therefore, the management is based upon the mean diameter of the entire lesion. All right, so the lung RADs categories in management, they haven't changed. We haven't introduced any new numeric categories, and we haven't changed the management recommendations. However, the kind of diagnostic criteria, maybe diagnostic isn't the right word, but the criteria within these categories, we have added some descriptors for atypical pulmonary cysts, specifically to lung RADs 3, 4a, and 4b. So, let's take a look. All right, so lung RADs two, as I mentioned, hasn't really changed. So, these are category three or four atypical pulmonary cysts or lesions that are unchanged on short-term follow-up CT, as recommended by lung RADs management. They're considered benign, and these patients are just gonna return to their annual screening schedule. This is unchanged from existing lung RADs. Lung RADs three. So, any thin or thick-walled cyst that demonstrates an enlarging or growing cystic component measured by mean diameter is now going to fall into the lung RADs three category. It's still considered probably benign, but this is essentially a cyst that has a growing cystic component. As we see in this particular case, there's no wall irregularity, and even if there were, if that was stable, the thing that's only changing, the thing that's changing is the cystic component. So, this is gonna be categorized as lung RADs three. And the management will be a six-month load of CT follow-up. Category 4a. So, several things fall into this. So, a classification of lung RADs 4a is given for thick-walled cysts. So, we have this example here where there's this atypical pulmonary cyst with a wall that's somewhat irregular, but the largest portions are at least two millimeters greater. It looks greater than two millimeters. So, this is a thick-walled cyst by definition. These are suspicious lesions, and they're gonna qualify as a 4a. What else is a 4a? Well, we can look at this example here. This is a patient at baseline which over time has developed wall thickening that now qualifies when from a thin-walled cyst to now a thick-walled cyst. So, this is gonna be a 4a lesion. Multilocular cysts. So, either on baseline or if a unilocular cyst becomes multilocular, these are also gonna be 4a lesions. And what is the management for 4a? Get a three-month follow-up or a PET CT if there's a solid component of eight millimeters or greater. How about 4b? So, these would include thick-walled cysts that have growing wall nodularity or thickness. So, we see in this prior study, it was already a thick-walled cyst, but now on the follow-up, we have even greater wall thickness and nodularity. So, this is now demonstrating growth. Thick-walled cysts with growing wall nodularity or thickness is a 4b lesion. Multilocular cysts. So, by definition, a multilocular cyst is gonna be a 4a lesion. However, if a multilocular cyst demonstrates growth, so you don't even have to develop a solid component, it's just that the multilocular cyst is growing over time, this is gonna be a 4a, excuse me, a 4b lesion. What else is a 4b? Well, here we have a multilocular cyst that demonstrates increased opacity or loculation over time. In this particular case, this was taken from the noted publication. It was a patient from the Nelson study. At baseline, this lesion, they thought was maybe some inflammatory changes with scarring, but at a 12-month follow-up, they actually noted that, hey, there's a soft tissue component that has developed within this multilocular cyst that is now gonna qualify as a 4b lesion. And likewise, a multilocular atypical cyst that, although the size hasn't changed, at follow-up, the internal density or complexity has increased. And so this is now also going to be a Lung RADS 4b. And what is the management for 4b? Diagnostic chest CT, PET CT, and or tissue sampling. All right, as always, we have a 4x classification that can be used if there are additional features that would be indicative of malignancy. And that's true for atypical pulmonary cyst as well. So let's see an example. We've seen this lesion earlier in the lecture. This is a thick-walled cyst. There may be a small exophytic nodular component as noted by the arrow, but the most concerning feature here is wall thickening. So this is gonna be a Lung RADS 4a based on it being a thick-walled cyst. Now on this same scan, on the soft tissue windows, we see that there's a right paratracheal lymph node that's enlarged. So there's also media-style adenopathy. This is a concerning feature. And so we are going to bump this up to a 4x Lung RADS classification. And the management will be a diagnostic CT, PET CT, or tissue sampling. This patient went on to have a PET CT. There was some delay in getting it scheduled, but when they finally came back, we see that actually that node has increased in size and has significant FDG activity. So this is highly concerning. In addition, the thick-walled cyst has increased in its wall thickness and nodularity, which also demonstrates FDG activity. And they've also developed some ipsilateral media-style lymph nodes that were new from the prior study, also FDG added. So this patient has all kinds of imaging findings that indicate that this is concerning for malignancy. And in fact, this represented stage 3a adenocarcinoma. Now there are some other considerations. So what about cyst with associated nodules? So, so far, everything we've discussed applies to atypical cysts with wall thickening or nodularity. But what about cysts with nodules that arise adjacent to the wall rather than directly from the wall? And admittedly, sometimes that can be difficult to differentiate, but sometimes it's a little more clear. So cysts can occur with associated nodules that may be solid, part solid, or ground glass. The nodule may arise internally or a so-called endophytic nodule, or it could arise externally as an exophytic nodule. The key to management in this scenario is that the classification will be based upon the most concerning feature. So is it the cyst itself that's most concerning or is it the adjacent nodule? So let's see some examples. Here we have what is essentially a thin-walled cyst with really an imperceptible wall, but asymmetrically, it looks like growing adjacent or exophytic to it is a solid nodule. This measures eight millimeters in diameter. So in this particular case, the thin-walled cyst, that's irrelevant. We're gonna manage this based upon the soft tissue nodule only because that's the most concerning feature. So based on its size, this is gonna be a Lung RADS 4A with a recommendation to give a three-month follow-up or because of the size, we could also get a PET CT. What about this atypical cyst? So there's a focal soft tissue nodule, six millimeters in diameter. Is it an adjacent nodule? Is it endophytic, exophytic? Well, if we base it just on the nodule, we are gonna say this is a Lung RADS 3 based on its size. But if we consider this to be a thick-walled cyst, and I think that there's a couple of areas that we could certainly be concerned about, including the nodule itself, then we're gonna treat this as a Lung RADS 4A because the wall thickness is the most concerning feature. All right, so in summary, we've introduced a new Lung RADS classification for atypical pulmonary cysts, and we classify the cysts based upon wall features, internal septations, the presence of associated or adjacent nodules, increased growth, wall thickness, or internal complexity over time. Today, we've discussed only one of several updates that will be coming to Lung RADS 2.0. There's been a lot of work put into this by the Lung RADS Committee, and I'm grateful for their efforts, and we look forward to sharing all these updates with you in the near future. Lung RADS 2.0 will be released in early 2022. Thank you very much for your time and participation today. I really appreciate it. Great, thanks, Dev and Caroline, for having me, and thanks to all of you for being here. Lung cancer screening is one of my passions, and I'm gonna talk about the role of the radiologists in mitigating the harms of lung cancer screening. And just think about this for a minute. This is an interesting topic that Caroline came up with, and I hadn't really thought about it, but we do serve as important physicians in mitigating the harms of lung cancer screening. We're gonna talk about some of the things that have been discussed, but in a sort of a different light. First of all, as physicians, we take the oath, do no harm. And I think when it comes to lung cancer screening, we really wanna follow the rules. Use the United States Preventative Task Force guidelines. You have to integrate shared decision-making into the visit for lung cancer screening. You have to have a fast-tracked session in order to get patients into smoking cessation referrals. And in terms of the order, and this is really a problem that we've had with the primary care doctors and the pulmonologists, the orders for lung cancer screening CT have to be very precise. It can't say the patient has greater than 20 or greater than 30 PAC years. It has to have exact PAC years. It has to have accurate smoking status, current smoker, former smoker. And a quit date is extremely important. Now, we try to have our ordering physicians put the quit date in, but mostly we have a patient questionnaire when they come in for their screening, and they actually put the date or the year that they quit. This gives us quality information, which is much more reproducible when we get it directly from the patient. We don't screen patients, unfortunately, based on family history, if they smoke cigarillos or cigars or marijuana or vaping. None of these things really add to the smoking history in our practice. This is the most up-to-date information. I know we've already touched on it. The US Preventative Task Force gave lung cancer screening a grade of a B. And what does this mean? This means that third-party payers in Medicare cover this as a provided service. Now, if we go back a little bit in time, we're talking about harms to patients in lung cancer screening. We are using CT, which is radiation. And remember this article, which really hurt most of our practices back in 2007, really decreased the utilization of CT. And really until 2015, when we started doing lots of lung cancer screening, we hadn't achieved the numbers of CT scans since this sort of information became available in 2007. I think this is a very nice resource for your patients and for your providers, just to put where does lung cancer screening fall in the realm of radiation that we all sort of see. And you can see a diagnostic CT scan, about seven millisieverts. The average background radiation is almost double that to a low-dose lung cancer screening study. And that's based on dosages from the National Lung Cancer Screening Trial. I also think it's very important for the patients and the providers to see, okay, what is the radiation? We've been sending our radiation data to our PAC system for almost 20 years. And realize this, that modern low-dose CT protocols are about 40% less in dose than those that we use during the lung cancer screening trial. It's important to use low-dose CT protocol when we do these Lung-RADS 3s and 4s, short interval, less than one year follow-up. And it's important to create new codes. So if you have a nodule follow-up code or a protocol, you may want to create a new follow-up protocol. Maybe we call it low-dose CT follow-up. And it's the same protocol as the screening protocol, rather than the diagnostic protocol. There's really no need to use increased dose to follow a nodule in which you found on a very low-dose study. I think mitigate patient's anxiety. Maybe show them, as a referring provider, show the patient what they're gonna sort of be in for. This is about a seven-second scan. This is me. It takes longer to set up the scan than it does to screen the patient. Notice no IVs, pretty simple. Maybe show the patient what the images might look like. And my pulmonologists and primary care doctors, they love these two slides. I've shared this with hundreds of referring providers to sort of give the patient an idea of what they're in for. Again, mitigating the anxiety of a procedure which really has very low risk. And the patients appreciate the detail of these very thin sections. As Dr. Dyer referred to, the patients really enjoy these letters. And this is an example of one that we came up with. My name is at the bottom of all of our studies. We do about 7,000 screenings a year. And we've been doing that many since about 2015. It goes up about 20% a year. And I've only gotten one complaint from the letter. And one of the complaints that I got was I sent a letter that said that the screening was normal. But in the report, I mentioned emphysema. So only one patient out of tens of thousands of letters did I get one complaint. So I think patients really generally really appreciate these letters. And we have, as radiologists, an experience from mammography. We've been doing this for decades. So it's important to integrate letters into your lung cancer screening program. Again, to minimize the harm, do no harm, we really wanna minimize follow-up testing. And it is confusing, especially for our non-chest radiology colleagues, when to use Fleishner Society guidelines and when to use lung RADs. It's very important to use lung RADs for the lung cancer screening population to mitigate the false positives. With the help of Deb, the ACR has come up with some really great tools. This is the most recent ACR Lung Cancer Screening CT Incidental Findings. It's a front and a back. You can get it on the ACR website. And we had lots of committee meetings to come up with this. This was really driven by the nurse navigators. They didn't want the white papers from the ACR for each organ. They wanted a quick guide. If I see an adrenal lesion, what do I do? If I see a mediastinal lymph node, what do I do? I really hope that if you go back to practice and hand these out to your nurse navigators, it'll be a huge incentive for your lung cancer screening program. Lung RADs. We talked about this. I know Jared gave a very nice talk on the update. The thing about the lung RADs is this is the lung RADs, but below the chart, there's lots of fine print. And you really want to read the details of the lung RADs. It's not as simple as the chart may seem unless you really understand it. Again, mitigating the harms of lung cancer screening. If you're not familiar with the interpretation of lung RADs, whether you're a new attending, you don't do a whole lot of chest, I found in my practice the ground glass opacities cause a great degree of concern and uncertainty among our young readers. I think making an experienced or an expert lung RADs radiologist in your practice is very important. Be available for consultations. Again, the lung RAD system appears to be very simple, but there are details, as Dr. Christensen alluded to, cysts, for example, that are not fully addressed. So make someone in your practice who's an expert available for consultation. Again, read the fine print at the bottom of the lung RADs chart. It is pretty complicated. The nice thing about lung RADs, again, in terms of mitigating the harm to the patient, it gives lots of flexibility. It's not saying you have to biopsy every eight millimeter nodule. It gives the opportunity to get a short interval follow-up, three months, or a PET CT scan. And these are very important parts of the lung RAD system that I hope you use in your practice. Again, mitigating the harms of lung cancer screening. About 60% of our patients are current smokers. We have a combined academic program and a very vibrant outpatient private practice environment. And being able to provide the current smokers with the opportunity to stop smoking, or maybe they wanna switch to vaping, provide an opportunity to stop smoking is extremely important, and we've done it in a variety of ways. The easiest of which is just to provide a brochure, a phone number. Pretty much every state has a quit line, and I think it's important to provide these resources not only in English, but Spanish, or Russian, or whatever language that your community speaks, and make these brochures available. Have the CT technologists give these to the patients as they finish their lung cancer screening study. This is something that I don't think we think about. How do you mitigate the financial harm of lung cancer screening? We do need pre-authorization. Use a correct billing code. If you use G0297, there's no copay, unlike a diagnostic CT scan, or a lung cancer follow-up, a nodule follow-up, a high-resolution chest CT. Shared decision-making has a code. It's very important if you're gonna do this in your radiology practice, or if you're gonna team up with your ordering clinicians to provide proof that you have done shared decision-making. And again, this G code has no copay. It's covered by Medicare, Medicaid, and third-party payers. The other issue is, if you're gonna order a less than 12-month follow-up, for like a three-month or a six-month, again, we're gonna call this follow-up lung cancer screening and use a low-dose technique, which I alluded to, these are often subject to copay, so you wanna let the patients know that. You don't want them to be surprised by billing. And this G code, G0297, is every 12 months, so you can't use a screening code more than once in a year. And these are little subtleties that every practice is gonna have to deal with directly. And I really suggest you just create this follow-up, low-dose lung cancer screening protocol that you can drop down when you're doing your protocols every day. Now, the cost-effectiveness, we've touched on this a little bit, but there are many articles that talk about the cost-effectiveness of lung cancer screening. It turns out, most of the literature that I've read says lung cancer screening is extremely cost-effective. In fact, it's more cost-effective than colorectal, breast, and cervical screening. Now, how about this? The financial implications of lung cancer screening. Is it worth it? The cost of a false-positive workup is extensive, which is why I started this talk with follow the rules. Do no harm. Overscreening lower-risk individuals, there's no scientific evidence that this benefits the patient or the population or has any impact on morbidity or mortality. And realize that in the United States, we have non-curative chemotherapy and immunotherapy are about two to 10 times more expensive two to 10 times more expensive when we compare to Canada. So you can see how easy it is to create an imbalance between cost and benefit to the patient and to our society in general. Now, these are general recommendations from the American Thoracic Society that we should include lung cancer screening in our electronic medical record. Should we hire coordinators? All these things are expensive, but they're things that you need to think about when talking about cost-effectiveness of lung cancer screening. Now, Medicare has been covering low-dose screening since 2015, and I ask you a question. Consider, what's the harm to the patient? We're talking about mitigating the harms to the patient. What about the medical legal implications for not screening? This is something we often don't talk about, but it's something to consider. And there have been some evidence regarding mammography of not offering screening becoming a medical legal problem for primary care physicians. So in summary, my one take-home message is that radiologists play an important role in mitigating the potential harms of lung cancer screening. There are many details concerning the process and the follow-up of lung cancer screening, but it's important that we follow the rules so that we do no harm. Thank you so much for having me. I appreciate seeing the friendly faces again.

lung cancer screening

U.S. Preventive Services Task Force

CT screening

Lung RADS system

racial disparities

radiologists

shared decision-making

smoking cessation

medical legal implications