JCO Oncology Practice Podcast

Dr. Pennell and Dr. James Hammock discuss the provision of oncologic services by Project Access safety net care coordination programs.   NATHAN PENNELL: Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consulting editor for the JCO OP. I have no conflicts of interest related to this podcast. And a complete list of disclosures is available at the end of the podcast. Today, I'd like to talk a little bit about the complexities of providing cancer care for patients who are uninsured or underinsured, which is a relatively large percentage of patients in the US. How do patients without insurance receive cancer care? One way is through community programs, including a program called Project Access, a care coordination program connecting patients to specialty medical care at no or reduced cost, including, in some instances, oncology care. But how does it work? Who does it help? And how impactful are this and other programs designed to obtain cancer care for low-income, uninsured, and underserved patients? With me today to discuss this topic is Dr. Jamey Hammock, a resident in internal medicine at the University of Alabama Birmingham. We'll be discussing the paper from he and his colleagues titled, Oncologic Services Through Project Access and Other Safety Net Care Coordination Programs, which was published online July 31, 2020 in the JCO OP. Welcome, Jamey, and thank you for joining me on the podcast. JAMEY HAMMOCK: Hey. Thank you, very excited to be here. I did want to say too that I do not have any conflicts of interest or disclosures for this particular study. NATHAN PENNELL: Why don't we start out by talking a little bit about how big a problem it is for providing cancer care in uninsured and underinsured patients in the US. JAMEY HAMMOCK: It's an enormous problem. If you look at previous studies, they've looked at patients who are underserved, underinsured, or even uninsured with cancer. And these patients actually typically present with later stage disease, they experience delays in treatment, and ultimately have worse overall survival compared to well-insured patients. So just that alone tells you how big of a problem that this is. I think that when you look at cancer care for underinsured and uninsured, you have to break those things up. And you can't really talk about it without talking about the Affordable Care Act. So let's take uninsured patients, for example. If you look at pre-Affordable Care Act and post-Affordable Care Act, there's a great study in 2017 that really broke down these two groups, pre and post. And what they found is with the Affordable Care Act, if you are uninsured across any income level and you lived in a Medicaid expansion state, the percentage of patients who were uninsured decreased from about 5% to 2 and 1/2%. So it really cut that percentage in half, which is pretty impressive. And then if you look at low-income uninsured patients, because they broke that down in the study, the percentage actually dropped from around 10% to 3 and 1/2%. So It just shows you when you talk about absolute numbers and then those percentages, how many individuals are really affected that have a diagnosis of cancer and are uninsured. And it gives you a little bit of insight of what Medicaid expansion has done for that group. And then I want to touch really quickly too on underinsured. So basically underinsured patients, they don't have the means to get the care that they need, even if they have insurance. That's important. And patients with Medicaid, for example, they have insurance, but they have their own challenges. For example, there's been studies showing that they have longer wait times to see some specialists. It's harder to find a physician that takes patients with Medicaid. Lastly, these providers are so few and far between that sometimes these patients are asked to drive very long distances to get the care they need. And you're already talking about a disadvantaged patient population who may not have the means to drive an hour away to get to their visit. NATHAN PENNELL: That sounds very challenging situation, even for people who technically have health insurance, and still don't necessarily have what they need to access care the way it should be given. Can you tell us a little bit about Project Access? I have to admit, I had never heard of that before I read this paper. And it was a fascinating program that something like this exists. Can you tell us a little bit about it? JAMEY HAMMOCK: Absolutely. So Project Access, first off, they do great work. It's a nonprofit organization that really, really works hard to try to get patients who are underinsured and uninsured subspecialty care. So I want to talk real briefly about the history first because I think it helps you understand why Project Access came to be. I think we need primary care pretty well in the US for patients who are underinsured and uninsured. We have things called community health centers, which are federal qualified health centers funded by the government. And they really do a good job providing primary care for patients who cannot get it elsewhere. The problem is that a lot of these patients ultimately will end up meaning a subspecialist. And there does not exist a community health center for subspecialty care that's funded by the government the way that community health centers are. One thing to address this was Medicaid expansion. Medicaid expansion was supposed to increase the amount of patients who got insurance and thus wouldn't be able to obtain the subspecialty care that they need. But we've already talked about some of the shortcomings of Medicaid expansion, including not all states have done that, decided to expand unfortunately. And if you're an undocumented immigrant, unfortunately, you don't have access many times to government programs. So it doesn't do anything for those populations. There's been some other strategies, Dr. Pennell, to try to address subspecialty care in these populations, things like telehealth, and which you would need the technology, things like subspecialists actually coming to community health centers, let's say, every other Friday to see a patient who needs a cardiologist or an oncologist. But the problem with that is it's a little sporadic, it's inconsistent. And sometimes these patients can't be that flexible and come in the only day that the specialist is going to be there. And so really, here enters Project Access to say, you know what, let us negotiate-- pre-negotiate with subspecialists in the community that surround these community health centers and find subspecialists that agree to see x amount of patients a year. And when it comes time to refer a patient to a specialist, you contact us, and the work has been done. And so they sort of broker, if you will, or negotiate between some specialists in primary care. And they do a lot of the groundwork that it takes to get these patients the subspecialty care they need to get the results of the subspecialty visit back to the primary care. They do all of that legwork. And so they really are an incredible, incredible service. I do want to mention, they're more of a local solution. So Project Access Birmingham, for example, it serves the residents of Jefferson County. It's not meant to be a statewide solution. They're very good at serving the patients who are near, who are in the county. And in fact, a lot of them have requirements that you be a resident of the county that they operate in. But they do a wonderful job getting these patients the subspecialty care that they need. NATHAN PENNELL: Well, I have more questions about Project Access. But I think you're going to answer some of them when we start to talk about your paper. So why don't you just start off by talking us a little bit about, what was the purpose of the project that you did and how did you design your quality project. JAMEY HAMMOCK: This project started out as a genuine question I had working as an intern in internal medicine. I would see patients come into our hospital who were uninsured who had a malignancy or cancer. And I would just ask, where do these patients get their care. How are they suppose to get outpatient clinic follow-up? So that's when I learned about Project Access locally here in Birmingham. And as you just mentioned, I had a ton of questions. So I actually went and met with Project Access and just asked them all of these questions. How do you work? How is your funding? Who do you see? What specialties do you provide, et cetera, et cetera. And I decided I wanted to really take an in-depth study and look at our Project Access here in Birmingham. When I began doing the literature review for that, I realized that there was not much out there in terms of this Project Access model. I was told that many other ones exist across the country, but there had not been a lot done in the medical literature describing these places and the wonderful work that they do. And so at that point, I began to zoom out a little bit and look at all of the Project Access centers that exist in the country. NATHAN PENNELL: What did you find out when you started calling and checking in with all of the different Project Access programs? JAMEY HAMMOCK: To kind of bring things back to home, I really was particularly interested in how these Project Access centers offer oncology care because oncology care is a little bit different than other subspecialties in terms of the resources needed to provide such care. And my interest was, how do programs who are nonprofit who are trying to work with underinsured/uninsured pati

Dr. Pennell and Dr. Friedman discuss the variety of ethical dilemmas for health care providers brought on by COVID-19. NATE PENNELL: Hello, and welcome to the latest JCO Oncology Practice Podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org My name is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic, and consultant editor for the JCOOP. I have no conflicts of interest related to this podcast, and a complete list of disclosures is available at the end of the podcast. Today I want to talk about a very serious topic that all of us who care for cancer patients really had at the front of our minds back in the spring of 2020. While it may already seem like a long time ago, when the COVID pandemic was at its peak in the United States, New York City was being inundated with of COVID. And for a while there was quite a bit of uncertainty about whether they might run out of personal protective equipment or ventilators. And there were very serious discussions happening about allocation of resources. I personally remember patients asking me, even here in Ohio, if they might not be offered a ventilator if they became sick, because of their cancer diagnosis. And while this certainly never came close to happening in Ohio, I think it actually came closer than we'd like to admit in places like New York. With me today to discuss this really fascinating topic is Liz Blackler, who is the program manager for the Ethics Committee and Consult Service at Memorial Sloan Kettering Cancer Center in New York City. We'll be discussing the upcoming manuscript from her and her colleagues titles, "COVID-19-related Ethics Consultations at a Cancer Center in New York City-- a Content Review of Ethics Consultations During the Early Stages of the Pandemic," which was published online August 27, 2020 in the JCOOP. Welcome Liz, and thank you for joining me on the podcast. LIZ BLACKLER: Thank you so much for having me here today. I'm definitely looking forward to discussing our manuscripts with you. Just to note, I do not have any relationships or disclosures related to this study. NATE PENNELL: Thank you. So what was it like to be really in the epicenter of the COVID pandemic back in the spring? LIZ BLACKLER: There was a lot of uncertainty. We were all just trying to find our way, to figure it all out. Staff was just reconciling what was happening in real time in the city and the world, and then looking into our own hallways, seeing what was happening there. I would say it was both chaotic and eerily quiet. Our ethics consultation service, as with many ethics consultation services in the hospital, went virtual. So only those people who needed to be on site were there. And the rest of us were working from home. And so I think as a staff, we were adjusting to doing our jobs remotely, and also watching and feeling the enormity of what was happening at the hospital with patients, and feeling just a little bit far away. NATE PENNELL: So you are in charge of the ethics consult service. I think anyone who's ever been involved in a case that needs to involve the ethics consult service knows how incredibly interesting a job that must be, and complicated. Can you just, before we get into the COVID thing, explain what an inpatient ethics consult team does, and who is on that team? LIZ BLACKLER: Sure. So ethics consultations are most frequently requested to help analyze and resolve complex value-laden concerns that arise between or among clinicians, and patients, and/or families. Anyone-- clinicians, non-clinician staff, patients, family members, health care agents, surrogate decision makers can request an ethics consultation. And depending on the situation, the consultant may facilitate communication between the stakeholders. This also involves clarifying treatment options and prognosis. Our consultants also help opine moral reasoning and ethical principles to certain situations. And we spend quite a bit of time confirming and clarifying state and federal laws, and hospital policy, and how it relates to the specific patient at hand. In general, the ethics consultants work closely with all parties to help identify acceptable courses of action. Our clinical ethics consultation team is a standing subgroup of the ethics committee. And the group is voluntary, and is comprised of 10 MSK employees from a variety of disciplines. These consultants are additionally trained in clinical ethics. And currently we have nurses and physician assistants, nurse practitioners, social workers, and physicians representing psychiatry and critical care medicine. So we work in a single-modeled service, meaning consultants work independently, and then reach out to other consultants for assistance as needed. So we are a busy service at baseline. And during COVID, our ethics consultations actually doubled. NATE PENNELL: Yeah, I can see that when you start to delve into your paper, and the issues that came up. And what are the special ethical concerns that arose that might involve COVID in patients with cancer that differed from the usual things you would see patients about in the hospital? LIZ BLACKLER: Sure, it was actually what spurred us to do a retrospective review on our ethics consultation service. We encountered two, I would think, unique issues that came up that we had not previously seen before on the ethics consultation service. Our very first COVID-19-related ethics consult focused on a patient with decisional capacity who was admitted to the floor, and wanted to be discharged against medical advice while he was waiting for his COVID-19 test to come back. In the beginning, it was taking a couple of days to get those results back. Staff was very concerned if a patient would not adequately quarantine at home, while we are waiting for the results. In fact, he said he would not quarantine, that he would be out in the subway, and this and that. So we were called in to assist in clarifying whether respecting this patient's autonomy to leave the hospital AMA outweighed our obligation to keep the patient in isolation, and prevent him from potentially spreading the infection. We had never encountered an issue like that before. So in that case, we were able to support the patient, and help him understand the reasoning why he needed to stay. In the early days of the pandemic, as we were just sorting out what was causing the spread of COVID, I think we would have likely leaned towards figuring out a way to keep him, as long as we could. It's always tricky in that we don't want to override someone's autonomy, unless absolutely necessary. And so there were two cases like this, where we really had to weigh the risk to the public against individual autonomy of the patient. NATE PENNELL: Yeah, I know. It's very interesting to think about something like that. At first blush, it seems as though there would be no legal way to keep someone if they wanted to leave. But then switch it out and say, well this patient has Ebola now, and wants to go out on their own. And suddenly it jumps to the front of your mind that maybe it's not quite so simple. It also, I think, illustrates nicely what the ethics team does, which is not necessarily to come in and deliver an academic treatise on the ethical principles of who's right and who's wrong, but to help negotiate the different parties to come to an acceptable agreement. LIZ BLACKLER: Exactly. And in a similar case, we had a family who was wanting to leave the hospital, and go to a local hotel. But at the time, the hotels were either COVID-positive hotels or COVID-negative hotels. And this family insisted on having their loved ones stay at the hotel that was a COVID negative hotel. And so the staff called a similar consult line to know whether they had an obligation to share the patient's medical status with the hotel. And in a similar mind, we did just what you said. We pulled the whole team together. We met with the patient and family, expressed our concerns, and actually helped identify an acceptable hotel that would make a concession, that was in the geographic location of where they wanted to be, that would in fact sterilize and come up with its own private entrance for this patient. So everybody was happy, right? We knew he would be safe, and the family got to have this loved one closer to home. NATE PENNELL: I'm sure that doesn't always end up with such a good result at the end. But that sounds like a good job. So you had some fascinating consults. So most of your manuscript is describing some of the examples of the types of scenarios that you had to address. So can you take us through some of those, both just like the general themes and then maybe some specific examples? LIZ BLACKLER: Of course. So like I said, we performed a retrospective review of all of our COVID-19 ethics-related consults that happened between mid-March and the end of April. There were 26 consults total performed on 24 unique patients. The most common ethical issue was related to code status. So these were patients. Staff members were concerned about incubating, or performing cardiopulmonary resuscitation, because of the high risk for aerosolizing procedures. If you remember, at the beginning of the pandemic, there was a high level of anxiety about supply shortage of personal protective equipment. So staff was very concerned about whether it was ethically appropriate to provide CPR for our patients with poor prognosis, because many, if not most of our patients at that time, not only had advanced cancer, but they had concurrent COVID-19 infection. They had a poor prognosis. Because there was a lot of risks to providing the CPR and intubation with minimal benefit, and so more than half of our consults came through that were questioning

Dr. Pennell and Dr. Jennifer Tsui discuss the processes that lead to suboptimal EOL care within Medicaid populations and among racial/ethnic minority groups.     Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP. I have no conflicts of interest related to this podcast, and a complete list of disclosures is available at the end of the podcast. Aggressive care at the end of life for cancer patients is widely recognized as poor-quality care. And by aggressive care, I don't mean aggressive supportive care or hospice, but rather inappropriate interventions, like chemotherapy or hospital and ICU admissions, near the end of life that rarely improve outcomes and often actually worsen quality of life. Efforts are being made to educate physicians and cancer patients to try to minimize aggressive treatments near the end of life and to help as many patients as possible benefit from things like hospice benefits and appropriate end-of-life care. However, not all patients receive high-quality end-of-life care, and there may be differences in end-of-life care in various populations. For example, how do race and things like Medicaid status impact aggressive care at the end of life? With me today to discuss this topic is Dr. Jennifer Tsui, Assistant Professor in the Division of Population Science at Rutgers Cancer Institute of New Jersey. We'll be discussing her paper "Racial Disparities in Health Care Utilization at the End of Life Among New Jersey Medicaid Beneficiaries With Advanced Cancer," currently in press for the JCO OP. Welcome, Dr. Tsui, and thank you for joining me on the podcast. Thanks so much. Thanks for having me. I have no conflicts of interest with this study whatsoever. Dr. Tsui, can you please tell me a little bit about what exactly constitutes high or low-quality end-of-life care? Sure. I mean, I think that, in this study in particular, we wanted to focus on guideline-related end-of-life care. So we wanted to see if it was possible to take a look at patterns at the end of life for breast and colorectal cancer and stage cancer cases and see sort of what the patterns were in relation to adherence to guideline adherence and what they should be receiving at the end of life. And so that included a set of measures around aggressive care related to hospitalization in the last 30 days, emergency department visits in the last 30 days of life, an ICU admission in the last 30 days of life, and chemotherapy in the last 14 days of life. These are guidelines that have been discussed and published by national organizations. And we also looked at hospice enrollment. So we looked at whether there was any hospice enrollment and whether there was hospice enrollment in the last 30 days of life, I'm sorry. Are there already data existing for various disparities in end-of-life care among different racial groups or patients of different socioeconomic status? There are. So there have been a few prior publications before our study that have shown that Medicaid patients frequently-- not just for end-of-life care, but cancer care in general-- that Medicaid patients receive lower quality of care. And there were studies done prior to ours that did show, I think, in New York, for example, that Medicaid patients had lower-quality end-of-life care compared to Medicaid and privately insured patients. We have seen other studies also mentioning disparities by race in terms of quality of end-of-life care. However, I don't think-- some of these studies have focused on different populations and cancer sites. So some of the studies I mentioned looked at AYA, adolescent and young adult cancer survivors. Other studies have focused on other cancer sites. And also, these were studies that were conducted in earlier time period. And what we know is that, given all that's happened since the Affordable Care Act and Medicaid expansion in several states, sort of the Medicaid population has changed, but sort of health care delivery has been redesigned in different ways. And so that was really why we wanted to look at this issue sort of in more recent years and during a period that spanned Medicaid expansion within New Jersey. You know, that's helpful to understand what sort of prompted you to do this. So why don't you tell our listeners basically how you designed your study. Sure. So this was a large data linkage that we established within the state of New Jersey to better understand cancer care quality for breast and colorectal cancer patients in general, so beyond just the stage IV cancer patients, the patient's diagnosis at stage IV, but breast and colorectal cancer patients in general. So we worked with our New Jersey State Cancer Registry, identified all our breast and colorectal cancer cases that were diagnosed between 2011 and 2015, and then we linked those with our New Jersey Medicaid enrollment and claims files. So this was a study that was done in partnership with our Rutgers Center for State Health Policy. It was conducted sort of with ongoing input and feedback from both our State Cancer Registry as well as our Medicaid program. They've seen sort of findings related to this and other research questions we've had throughout the process. And what we really ended up with was a very rich data set that not only gave us all the tumor characteristics that are available in the cancer registry, but also the health care utilization patterns and Medicaid enrollment characteristics that are available on the Medicaid claims and Medicaid program data side. And how well did this database capture all of these measures of aggressive end-of-life care, so ED visits and chemotherapy and such? Since we did focus on those who were continuously enrolled in our state Medicaid program, we were able to go through our claims data and be able to, using billing codes, identify things like ED visits, et cetera. This data set only includes cancer cases up to age 64. So we didn't include people who may be dual enrolled in Medicare or have Medicare claims. We also tried to create some other restrictions so that we can get at just the people where we had a definitive diagnosis month and year and follow them through their death. And so we did use the prior studies that I mentioned earlier to see what kind of codes were used there. We have quite a multidisciplinary team of collaborators. I worked with quite closely the first author here, Annie Yang. Soon-to-be Dr. Annie Yang is in medical school here at the New Jersey Medical School. And so we did try to be as comprehensive as we could with the codes we used to identify those utilization patterns. OK, so why don't you tell us some of your findings? So I would say that the overall finding is that 62% of these stage IV breast and colorectal cancer patients received at least one measure of aggressive end-of-life care. So out of those four individual measures, 2/3 received at least one, which seems quite high. They ranged from 27% having at least one hospitalization to 34% receiving chemotherapy within the last 14 days of life. What we found is alarming, and it's sort of a call to action for addressing racial and ethnic disparities in health care, is that we found that our non-Hispanic Black patients had a higher odds of receiving any one of those aggressive end-of-life care measures after controlling for other factors. So we did find this racial/ethnic disparity in non-Hispanic Black patients having more aggressive end-of-life care compared to our non-Hispanic white patients, even though these are all the same Medicaid program. This is within one state. And so it did point to some need to better understand what is going on within the health care system, within the health care encounter between patients and physicians towards the end of life and what needs to be done to address these disproportionate rates in end-of-life care among racial/ethnic minority patients. When you talk about these numbers, like 2/3 of patients having aggressive end-of-life care and 39% enrolling in hospice, how does that compare to what would be considered a more appropriate level, say, the private insured patients? So we didn't compare it to privately insured in our state, but we did look at what was published in other states. In New York, for example, I think we had a slightly higher proportion of Medicaid enrollees with stage IV breast and colorectal cancer having more aggressive care. So we did see higher rates. So while we can't compare within our state alone, we do see that the rates are slightly higher than other published studies. Well, I guess I'm just trying to figure out, is aggressive end-of-life care something that commonly happens to all Americans in general, or is this vastly more in this population than what we would expect? In the general population? Yeah, in the general-- You know, I don't-- yeah, I don't have those rates and what our bar should be at baseline, to be honest. I do think that what we see in the end-of-life hospice literature is that there is suboptimal use of hospice care. And what we found was, again, here also sort of suboptimal use of hospice care in this diverse, low-income, Medicaid population. No, clearly, clearly, definitely so. What are some reasons why Medicaid patients would be more likely to have aggressive end-of-life care, do you think? I think Medicaid patients sort of broadly often have higher rates of comorbid conditions when they're diagnosed with cancer. There are complex social factors related to the Medicaid population in terms of being low-income, in terms of other social determinants of health an

Dr. Pennell and Dr. Jan Franko discuss Dr. Franko’s article, “Effect of surgical oncologist turnover on hospital volume and treatment outcomes among patients with upper gastrointestinal malignancies”   Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at The Cleveland Clinic and consultant editor for the JCO OP. I have no conflicts of interest related to this podcast, and a complete list of disclosures is available at the end of the podcast. Today, I'd like to talk a little bit about the impact that physician shortages can have on cancer care in the United States. While there are some parts of the country, for example Boston or New York, where you can't turn around without tripping over a specialist in some field or another of medicine, for much of the vast geographic expanse of the United States, especially outside of larger cities, there's areas that lack adequate specialty physician coverage, perhaps having either small numbers or even a single practitioner covering large areas. Now, this is very important for patient care because most cancer patients get their treatment in community settings closer to their home and not at large academic centers. But how does this impact care when, for example, specialized surgical services are needed and no one's available close to home? With me today to discuss this topic is Dr. Jan Franko, chief of the division of surgical oncology at Mercy One Medical Center in Des Moines, Iowa. We'll be discussing his paper, Effect of Surgical Oncologist Turnover on Hospital Volume and Treatment Outcomes Among Patients With Upper Gastrointestinal Malignancies, which is currently in press at the JCO OP. Welcome, Dr. Franco, and thank you for joining me on this podcast. Thank you for this opportunity, Dr. Pennell. It's my pleasure. I do not have any conflicts of interest with this work. Thank you for that. So we hear in the media about shortages of physicians, especially in underserved areas. How common would it be that a larger community hospital would lack access to, say, a surgical oncologist? Just to give you an example, the city where I practice currently has about 750,000 people with surrounding suburbs. And we had a shortage of surgical oncologists for about two years, where I can recall that one of the large hospital systems lost entire radiation oncology department. So for nearly two years, until they hired three new radiation oncologists, they actually could not do any radiation. We ourselves have been a flagship for many decades for gynecologic oncologists. We lost one about three or four years ago and since then we can't hire, and then on top of that, I recall that about three years ago, we had one year where 90% of urologists left the town. After 12 urologists, about eight or nine had to leave, and they came back for different practice within the same locality. But it was about a year plus without adequate urology workforce. So these things do happen. No, I could imagine, especially for specialties that are relatively small to begin with. And just to put this in perspective, can you explain a little bit about what exactly is a surgical oncologist, and how does that differ from, say, a general surgeon who may also do some cancer surgeries? So thank you for this question. I mean, I myself am a surgical oncologist. And I suspect there will be a lot of different definitions. For me, it's would be a general surgeon who is focused on a cancer treatment. General surgeons do treat both cancers but also trauma and general surgical conditions, common gallbladders, hernia. But a subset of surgeons have focused on cancer. And the majority of those have accredited fellowship. These surgeons, in my opinion, should maintain a broad spectrum of practice. For example, not only liver and pancreas but liver, pancreas, and stomach and esophagus and other organs. And what's also very important for them is to cultivate multi-specialty understanding of how to transition the care between an operation, systemic therapies, and radiation oncology so they can maintain a momentum of cancer control and [INAUDIBLE] surgery or avoid an operation. And when it comes to the question be able to execute even the complex operations. And given the complexity of cancer care these days and how multidisciplinary it is, I would imagine that most surgical oncologists are centered around academic university hospitals as opposed to working out in more rural areas or community hospitals. Is that the case or are they pretty much available everywhere? So indeed, you are right. It, in fact, was published in the Annals of Surgical Oncology around 2018 and 2019. An absolute majority of surgical oncologists are centered at the university hospitals or NCI-designated cancer centers. The number varies, but for example, in Iowa, more than 80% of such a workforce is concentrated in the single university center, which is outside of our town. And that number ranges from approximately 65% up to 90% of surgical oncologists working for the university, not the community hospital. That makes sense. If you were a patient who needed specialty surgical care for, say, pancreas cancer or esophageal cancer and you didn't have a hospital with a surgical oncologist nearby, what do they usually do? Is this something that's handled by a local surgeon or do they travel to academic centers to get that care? So this is subject of lots of research. And I think there is a dramatic geographical variation. And also there is a variation depending on the patients and their socioeconomic status and understanding of the situation. Plus, another question which is not discussed, how long is it reasonable to travel? How far? So I do think that complex surgical therapy should be done by people who do have experience in that. And what is experience that can be defined by number of cases, but does doing 10 pancreases improve you in operating on the stomach as well, I would believe there is some degree of cross-fertilization. Is it reasonable for people to travel for an operation 100 miles, 150, 200? Probably not reasonable, as long as they get a quality care closer to home. Yeah. It certainly would put a burden on them, and you could think that their follow up care might be compromised by being so far away as well. Yeah. I agree with that. One has to understand that the discharge from the hospital after operation by far doesn't mean end of the surgical care or at least it should not. Patients are these days discharged from operations very quickly. Various tricks, sometimes surgeons let them stay in the town in a hotel, which I don't know how good discharge that is. But then they're coming back for unexpected postoperative either complications or troubles, which do not amount to major complications, that has to be readily available. So there are mechanisms how people can do that, but can you really do it on a distance of 100 miles? With that in mind, can you take us through your study? What were you trying to show? Thank you. This was almost classical before-and-after study. But it was not only before or after but was before the last surgical oncologist and the short period of time that we didn't have it. And the largest period of time when we actually regained surgical oncologist, which is how I came to the local practice. And I'm still practicing here for about 12 years. So the whole study spanned over about 15 years, between 2001 and 2015, and looked at the patients who are typically taken care of by a surgical oncologist and not focusing on the technically rather simpler procedures on, let's say, skin cancer. So we focused here because of complexity and inherent risk on the esophagus cancer, gastric cancer, and pancreatic cancer. For reason of this study we looked at carcinomas only and excluded neuroendocrine tumor, benign conditions, gastrointestinal stromal tumors, and others. And we only focused on those conditions which could be potentially resectable, because otherwise there is no practical influence of surgical oncologist for a majority of therapy. So for esophagus and gastric cancer, we looked at stage I through III and for pancreatic cancer on stage I to II. Stage III, in general, historically was never considered for an operation. Might be changing currently, but it was not in the past. So in 2006, our prior very excellent surgical oncologist simply retired. And the next two years, very clearly, there was no surgical oncologist in the hospital. And they observed the proportion of these diagnoses, and they observed that during the time that there was no identifiable surgical oncologist responsible for advising and executing surgical care on those patients, the number of referral cases dropped dramatically down. Some went down from about 12.2% of these cancers diagnosed within this hospital as compared to the state, to down to only about 6.7% of all state cancers being diagnosed in that particular hospital, which at that time was missing surgical oncologist. Once the new surgical oncologist, which was myself coming back, was able to restore those services or perhaps the confidence of referring physicians and the society at large better, and it returned back to the prior numbers, again diagnosing and treating approximately 12% of the state volume of these neoplasms. We also wanted to see if we could not compare that to SEER database within the state of Iowa, that we obviously asked the question, did the number of these cancers for those two years somehow decrease in the state of Iowa? And it did not. So at the state level, there was maintaining of the trend of the annual diagnoses, but in the particular hosp

Dr. Pennell, Dr. Khosa and Dr. Marshall discuss the recent JCO OP publication, “Gender Differences in Faculty Rank and Leadership Positions Among Hematologists and Oncologists in the United States”   Welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO podcast network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. my name is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic, and consultant editor for the JCOOP.   Today, I'd like to talk about sex disparities in academic oncology. Despite increasing attention in recent years, sex disparities in academic medicine clearly persist, and are most noticeable at the more senior and leadership positions within academic centers. While these disparities are well recognized, in general in medicine, what exactly is known about sex disparities in academic leadership in oncology specifically?   With me today to discuss this topic are Dr. Faisal Khosa, Associate Professor in the Department of Radiology at Vancouver General Hospital, at the University of British Columbia; and Dr. Ariela Marshall, Associate Professor of Medicine and hematologist at the Mayo Clinic in Rochester, Minnesota. We'll be discussing their paper, "Sex Differences in Faculty Rank and Leadership Positions Among Hematologist and Oncologists in the United States," published online in the JCOOP in February 2020.   Welcome, Faisal and Ariela, and thank you for joining me on the podcast.   Thanks so much for the invitation. We're glad to be here.   So how big of a problem is sex disparities in academic medicine, in general?   I can speak to that a little bit, and then certainly Dr. Khosa also is a world leader in this area. So he can add on to what I have to say. So I think we well know that this is a problem across the board, regardless of specialty, regardless of whether we're talking about academic rank, or position on editorial boards, or any number of other leadership positions. So we see the huge drop-off between our current medical school population, which is actually over 50% female as of the last couple of years, but then a sharp drop-off over time when we get up the ladder to then in the associate and then the full professor level, as well as positions like being hospital CEO, department chairs, and any number of other leadership positions. And I'd certainly like to hear what Dr. Khosa has to say as well.   Nathan, thank you for inviting my participation on this very important topic. I would also like to add that I have no personal or institutional conflicts of interest with this publication that we are discussing, or this particular interview that is being recorded now. I would also like to thank Dr. Irbaz Bin Riaz from Department of Hematology Oncology at Mayo Clinic, who spearheaded this project successfully, and is also the first author on this manuscript.   Yeah. Thank you for clarifying that.   I agree with Ariela's comments. Women are underrepresented in high academic ranks and leadership positions, in spite of more than 50% matriculants from medical schools across North America, US, and Canada are now women. But they represent fewer than 20% of medical school deans and department chairs. Furthermore the American Association of Medical Colleges data reveals that female physicians make $0.76 for every dollar earned by their male counterparts. And this is even after adjusting for age, experience, and discipline of practice.   Women report difficulty finding mentors and are significantly less likely to receive sponsorship. Now let me explain the difference. Mentorship is critical to the development of leadership skills or abilities, while sponsorship is a necessity to enter into leadership positions.   No. That certainly makes sense that that would be a significant barrier to academic success. I think it's interesting you mention that women now make up approximately half of physicians in medical school. I went to medical school starting in 1998, and already more than half of my class was women. Why do you think they're still seeing this disparity 20 years later?   That's a great question, and I think we can delve maybe a little bit into our paper here, in terms of what we found in hematology oncology. Because I would imagine that some of these findings are kind of similar across the board. And so what we observed here in this study is that we did see that sharp drop-off in number of associate and full professors. So what we saw, about 45% of women were assistant professors. Only about 36% of the associate professors were women. And only about 22% of the full professors were women. So there's definitely that drop-off over time. And also only about 30% of department leaders were women.   And so one thing that people bring up a lot is just time. Right? So the time to go from assistant professor to associate professor to full professor, is not measured in months or even a couple of years. It's measured in the 10, 20, 30 year time frame. So somebody say that that's probably a big driving factor, is that what we're seeing in medical school has not yet caught up, with what we're seeing in leadership positions that take years-- probably 20, 30, 40 years to achieve.   But the other thing that we can talk about a bit later is it's not just time. It's the fact that people who have those positions may stay in them for 10, 20 years, and not leave room for other people to get into those positions. And also there is differences in how long it takes women to get promoted. And if you have to achieve a certain academic rank to get one of these leadership positions, then there may be delays of women being able to do that for a number of factors that we could talk about.   There is one more factor, which is less obvious, but equally challenging, which perpetuates the problem that we are discussing here. If you look at appointment and promotions in academic medicine, and I have been fortunate that I've practiced in Europe. Then I practiced in US. And now I practice in Canada. And all my practice has been in academic institutions. Whenever somebody is being shortlisted, selected, interviewed, appointed to an academic leadership position; the sole or entire or 90% or 99% of the focus is on that individual's performance of publications, of grants, of collaboration.   Nowhere is the consideration given to a person or individual's track record, for advocacy for equity, diversity, and inclusion. Now such an individual gets into the leadership position, now they are handed a memo saying, you have to ensure equal opportunity, and you have to make sure that minorities are appointed, women are appointed, they are promoted. Now such an individual does not have innate interest, or understanding, or even expertise in equity, diversity, and inclusion.   So previously what was a bottleneck of barriers to entry for women and minorities, has now become a bottleneck and barrier to promotion and leadership positions. And this is a subtle undertaking which people overlook when they are selecting people for appointment positions.   No, I think that's a-- I hadn't thought of that. But that's a very significant factor I would think. And this gets to the larger topic of how we choose our leaders in academic medicine. We don't necessarily choose people based upon skills in leadership, and training in leadership, but rather on personal success in whatever their academic field is, which does not necessarily lend itself to being able to do the job that they've now been appointed to. Can you take us through how you designed your study?   So we started off with publicly available data. And the first thing we did was here [INAUDIBLE] we went to the website, looked at institutions that offered residency and fellowship training, because those were academic institutions by default. From there, we actually downloaded or created the lists of programs, and then visited the website of each program to obtain the list of their faculty from department chair down to the level of assistant professor in hematology and oncology. We looked at leadership positions-- director, associate director, division chief. We also looked at practice type, whether it was university, whether it was community, whether it was a combination of the two. We looked at a number of trainees. We looked at the geographic location, like state of the practice.   In addition to that, we also looked at whether it was an MD or DO, whether it was an international medical graduate faculty, the year since medical school, year since the residency, number of publications, the number of grants, the number of clinical trials, the number of first author publications, number of citations. So we made it as comprehensive as possible from our experience of what it takes for academic appointments, and what is considered vital for academic promotions and to get people into leadership positions.   Yeah, that was one of the things that I wondered, is how one really measures this. And it sounds like you did a wonderful job of trying to identify, as best you could, objective measures. There probably isn't really a way to measure bias about sex differences in appointments. So you would have to look at this using these objective measures.   I agree, Nathan. And let me add to that. What is normal? You know, we talk about normal. Normal is an illusion. What is normal for the spider is chaos for the fly. So there are many things that are tangible. Then there are many things also that those are intangible. So we can only study what is objective or objectively can be calculated or measured. But in this equation, I'll give you an example. You look at the interview panels, and most of them are males, right?   Now how are you want to configure bias in that room when a female comes in to interview? Automatically

Dr. Pennell talks with Dr. Daniel Richardson discuss physician burnout and the author’s curriculum designed to mitigate burnout and foster solidarity among fellows. Support for JCO Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-US.com. Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP. Today, I'd like to talk about a topic that's at the front of many people's minds, burnout. With what seems like constant stress and increasing demands on our time, many clinicians are feeling increasingly exhausted, cynical, and like their work lacks meaning. These elements are part of a condition known as burnout. And it feels like everyone's feeling it to a greater or lesser extent these days. While employers and training programs are increasingly aware of the issue of burnout, what are they doing to reduce it or to prevent it from happening in the first place? With me today to discuss this topic is Dr. Daniel Richardson, hematology/oncology fellow and AHRQ postdoctoral research fellow at the UNC Chapel Hill Lineberger Comprehensive Cancer Center. We'll be discussing his and his colleagues' paper, "Development of an Art of Oncology Curriculum to Mitigate Burnout and Foster Solidarity among Hematology/Oncology Fellows," which is part of a special series at the JCO OP on physician wellness burnout and moral distress. Welcome, Daniel, and thank you for joining me on the podcast. Thanks for having me. It's really a privilege to speak with you today. I'll start off just by noting my conflicts. I have no financial conflicts of interest to disclose. However, my institution was involved in the study that we'll be talking about. All right, thanks for that. So burnout is something I think most physicians and other clinicians can relate to. But would you mind just kind of giving our listeners a little brief overview of what exactly is burnout in physicians and how big of a problem is this right now? Sure. So burnout was first described really as a metaphor to talk about an extinguishing of a fire or smothering out of a fire. And it related to this loss of capacity that many feel to make a meaningful and lasting impact with one's life or career. More recently, it's been further clarified to cover several domains of this initial concept, including emotional exhaustion, depersonalization, and loss of meaning or purpose at work. And burnout really has been shown to lead to profound of personal and professional consequences-- anxiety, depression, and in the professional realm, attrition among physicians and oncologists and decreased quality of care. And the problem is pretty pervasive, as most of us are aware. Our most recent studies show that nearly half of practicing oncologists are experiencing burnout and about a third of residents, fellows, and medical students even are experiencing burnout. Yeah, this is what, I think, a lot of our listeners might be interested to hear about. There may be a conception out there that burnout is a function of time-- you know, being exposed to something over a long time maybe later in your career. But what you're saying is that this is something that people can start to experience almost immediately, even in medical school and during residency. And I find that really interesting, although potentially disturbing as well. Yeah, I agree. And I think what we're seeing is probably the results of a larger change in our culture. We're seeing kind of a loss of sense of meaning and purpose and connectedness to the community in the larger culture. Increasingly, we're seeing that medical students, residents, and fellows are lacking a deeper sense of meaning and purpose in the broader community. And that's really playing out in their role as an oncologist as well. So I'm curious what led you and your fellowship program to developing this kind of a curriculum to try to combat burnout. Sure. Prior to medical school, I completed a master's degree in philosophy of religion and ethics. And it allowed me the opportunity to think a lot about virtue ethics and also the moral foundation of medicine. And virtue ethics is really focused on human flourishing and really claims that the path to human flourishing is developing character and virtues that can lead to that. And so I thought a lot about who I was becoming as a medical student, who I was becoming as a physician in medical school and then into residency. During my first year of fellowship, I was thinking a lot about the culture of medicine and how I was developing in the midst of that. And I really became aware that there was a clear lack of direction on how to help fellows develop into oncologists that would be able to thrive in their careers. We didn't really talk about calling. We didn't talk about purpose. We didn't talk about who we were becoming. We were being trained as oncologists with the right answers about treatment. But as one of my favorite authors, C.S. Lewis, puts it, we were at risk of developing into oncologists without chests-- that is, without a deeper understanding of the meaning and purpose of what we did each day. It really kind of started with this bigger understanding that we were going through this big process, and we were becoming oncologists without really thinking about what that process was looking like and how that was happening. Wow, I think that is-- that's fascinating. Well, in any case, since this led you to design the program, can you take me through the design of the Art of Oncology program that you designed? And what are you hoping to show as a result? Sure so as I had mentioned, I was really thinking a lot about who we were becoming as oncologists. And so one of the first things that I thought about is, how can we foster a sense of meaning and purpose in our fellows. I thought that this was really a place where we are seeing a lot of burnout is that there is this lack of meaning and purpose among fellows and oncologists in general. And so we wanted to target that. So we landed on a curricular intervention that used narratives, really to promote a shared mental model of meaning and work, which all that really means is helping all of us have a discussion to understand where we are coming from, our experiences, and how we are being shaped in the midst of kind of caring for patients. And our hope in kind of starting from that point and developing a narrative model was really that we could help fellows understand where they sat in caring for patients, their calling in doing that, and then also their position as a part of a broader community that had a bigger vision for caring for patients as well. So we decided that we would use personal and published stories, mostly about caring for cancer patients, to spark discussion, reflection, and then really a deeper understanding among fellows of this shared calling. And we had faculty or, often, patients come and share their story or one of the narratives in those sessions. We planned eight sessions throughout the year, which took place during the traditional didactic lecture times. And the narrative took place over the first 15 minutes or so. And then the point was really to foster this deeper discussion and reflection on meaning, identity formation, and moral development in medicine. So a lot of this really was based, then, upon selecting the different essays and other pieces of literature that you were discussing. So how did you end up picking those? That's a great question. And I think we wrestled with it a lot. I think initially, we, as a group, found those essays that were most meaningful to us. And we felt like they would really speak to the fellows. But as we thought about it more, we really wanted to collect them around a few themes. And as I've been talking about, I fundamentally believe that finding meaning in caring for suffering patients is essential to mitigating burnout. So this was kind of the primary theme that I focused on. But we also, in the midst of the program, wanted to equip fellows with skills to foster their sense of purpose in medicine. So we had a session focused on cultivating virtues of resilience and self-care, as well as sessions on caring for dying patients. And we really understood that the experiences of most fellows were very hard, given the immense amount of suffering that they experience. So our initial hope would be that really, this session and this program would be an avenue to redeem some of the suffering that the fellows were experiencing through their patients. We hoped that it would lead to a deepened sense of community or solidarity is the word I use in the paper, among our fellows, and that this sense of belonging in one's profession really becomes vital for the sustained success. And I was really hoping that this would be fostered in the program as well. You had mentioned earlier about what you were hoping for. Although we knew that we wanted to target a reduction in burnout among fellows, we recognized that burnout is really a multifaceted concept. So we knew that a small pilot program would be unlikely to see a substantial improvement in burnout. But we wanted to really shoot our or our aim our intervention really at the roots of developing burnout over a career. So how did you try to measure that? So I mean, first of all, I've got to say, this sounds amazing. And I could say it may have value just in and of itself, because it's such an interesting and cool concept. But as scientists and trying to study things, how would y

Dr. Pennell and Dr. Lisa Lowenstein discuss decision coaching in the LDCT setting and how it provides an opportunity for patients to confirm their screening decision by ensuring they are truly informed.   Hello and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs, covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP.   Lung cancer is a huge public health issue. It's our number one cause of cancer-related mortality, and a big reason for that is the lack of a widespread screening tool which results in most of our patients ending up with advanced disease at diagnosis. Although, low-dose CT screening has been proven to reduce deaths from lung cancer for a number of years now, uptake among eligible patients in the United States is very low, well under 10%. Part of the problem may be a poor understanding of the risks and benefits of screening CT, despite broad recommendations for shared decision-making between providers and patients.   Why is uptake such a big problem, and can shared decision-making be improved to help increase screening rates? With me today to discuss this issue is Dr. Lisa Lowenstein, assistant professor in the Department of Health Services Research at the University of Texas M.D. Anderson Cancer Center. We'll be discussing her paper, Implementing Decision Coaching for Lung Cancer Screening in the Low-Dose CT Setting, to be published in the February 2020 JCO OP. Welcome, Dr. Lowenstein, and thank you for joining me today.   Thank you. It's wonderful to be on.   So can we start out by telling our listeners a little bit about the landscape of screening for lung cancer today and the role that shared decision-making plays in this process?   Yes. I think we're in a very exciting time in terms of lung cancer screening, because this is the first time that we have a screening test for lung cancer which is the number one cause of cancer deaths among men and women in the United States. It's really notable that CMS included shared decision-making in their policies for lung cancer screening, because they recognize that, unlike breast cancer and colon cancer screening, we're changing the game a lot of bit here. So we're saying that only high-risk individuals should be screened. So it's not all-comers, and I think telling people about the potential benefits and harms is beneficial. So they go in being a little bit more informed about what the next steps will be, and it is a complex process, and overall, it's still in its infancy.   Yeah. I think a lot of people found it interesting that, in order to reimburse for lung cancer screening, that CMS required this documented shared decision-making visit which on the surface seems like a very reasonable thing. But do you think that's really helping, or is it hurting?   Lung cancer screening is really in its infancy, and it's a complicated process. So we're not just talking about you just show up, and you show up for a scan. Right? We're not where breast cancer screening is. We don't have mobile scans out there. It's taken decades for those programs to get where they are, and I think shared decision-making is just adding one more step and just emphasizing that it's really a program that you're committing to.   And the other aspect is that we really want to highlight that it's not lung cancer screening is enough to prevent lung cancer. Right? It's just detecting it, if you have it. But the best way you can reduce your lung cancer risk is by not smoking, and I think by inserting the counseling and shared decision-making visit, we're reiterating that message to our high-risk smokers and former smokers. Primary care providers, or any providers, aren't even talking about lung cancer screening.   Two, not a lot of facilities may be listed in the American College of Radiology Lung Cancer Screening registry, but their volumes are very low, and they may not actually have the proper equipment or machines to conduct the lung cancer screening. Third is that, if there is to be something to be found on the scan, we don't have processes in place to deal with all the abnormal findings. So I think those are all the things that providers and networks are trying to figure out, and they're trying to figure out like the cost benefit from the reimbursement issue. Because CMS reimburses this scan for a very low cost, and it's lower than what's reimbursed for breast cancer screening.   That's interesting, and in your paper, you mention that, as of right now, something around 6% of eligible patients are getting screened for lung cancer. Which is disappointing, because the studies have been out for a while now. You mention about some of the institutional issues and awareness and providers. Are there any other reasons out there that are limiting this? Because this is something that should be saving lots of lives, and so far, it just seems like it's not making much impact.   I think so, and I think it's misguided in some sense. The reimbursement is not-- you don't have to submit a reimbursement for the counseling and the lung cancer screening. A screening facility can still be reimbursed for the scan without the 1 to 1 ratio of a counseling in shared decision-making billing code, if that make sense.   That's interesting. I didn't know that.   Yeah. So the reimbursement is definitely not going on 1 to 1. I just think, it's a complicated process, and if you were doing a study in Texas and we're serving as many screening facilities as they can in Texas, and I can tell you, a number of them are not doing a high volume of scans. And a lot of primary care providers are trying to find screening facilities that are doing low-dose CT, and it's really hard to navigate the American College of Radiology Lung Cancer screening facility to find a facility. It's about 15 to 20 clinics or something like that.   Wow.   So we tried to look for it on a number of occasions, and it takes us multiple tries every single time.   Well, it's obviously a complex issue, and there's more than one reason for the low uptake. What was the specific issue that led you to do this particular study, and do you think that improving shared decision-making can improve uptake on lung cancer screening?   I think the main issue that we were trying to address here is that, one, we recognize that primary care providers may not be the best-suited individuals to provide the counseling shared decision-making visit. Instead, they may just want to do more of a referral process, like what they're doing in the Cleveland Clinic. Right? Where they say, somebody's potentially eligible, so I'm going to send you to a one-stop shop type of setting. And our radiologists who are leading our lung cancer screening program really wanted to start building this and test it out as an alternative delivery model for the counseling shared decision-making visit which wasn't proposed by CMS or the task force recommendations.   So can you take us through your study design?   Sure. So it was really a pre/post kind of study, really with a quality improvement mindset, as well as using some elements of implementation science, so we can make it relevant more generalizable in our findings. But we first had our period of where they just did what they normally do, where the patients show up. They go and have their scan. They have their normal intake process, and that's it for the lung cancer screening. Then, in our post, we embedded a tablet interactive decision aid, decision coaching module.   So what happens is the patient has the iPad in hand, and they have some patient-facing education talking about the benefits and harms. It's very fast and quick. Patient can get through it and two to three minutes, five minutes if they're not tech savvy. And then we have an advanced practice provider sort of talk about what do they know about the benefits of lung cancer screening? What did they know about the harms, and what are their primary reasons for wanting to be screened, just to kind of confirm their issue, confirm their decision to be screened.   And so what did you end up finding with the intervention?   What they found is that, one, with the decision coaching aspect of it, the advanced practice providers can deliver all the key elements that are required for the counseling and shared decision-making to defer CMS reimbursement. So I think that's really important, in the sense that so much of what we already see in the literature, providers talk a lot about the benefits of screening, but they don't note any potential harms. And it's really important to notice that screening is not without its downsides, and that with an abnormal finding, there is inherent risk. It's not like you're just getting a picture taken. There are steps that need to be followed afterwards.   And the other thing is that what we really like and what our clinical operations people appreciated is the fact that this embedding entire new process did not increase the throughput time for the time that the patient checks in to the time that that patient checks out. Because every institution is paying a lot of attention in money, as to what is throughput time and making sure that it's not too long. And from a patient's anecdotal evidence, the patients appreciated that additional process, because it broke up the time between the waiting periods in between each step.   Yeah. I think that's an incredibly important point that you point out, that they didn't really increase the visit time, but how did that work? The intervention took place during a time that they'd normally be waiting or doing something else?   That's basically what it is, because we did time-motion studies in the pre and in the post. S

Dr. Nathan Pennell, Dr. Muhammed Beg and Ms. Erin Williams discuss improving the time-to-activation of new clinical trials at an NCI-Designated Comprehensive Cancer Center. Read the article: https://ascopubs.org/doi/full/10.1200/OP.19.00325   TRANSCRIPT [PIANO MUSIC PLAYING] DR. PENNELL: Welcome to the latest Journal of Oncology Practice podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, I'd like to talk about clinical trials, specifically the complex process that goes into opening a clinical trial and the surprising amount of time and individual steps that go into what might otherwise seem like a straightforward process. And while we all agree that trials are critically important for patient care and making scientific advances, as a clinical investigator, I can tell you that they can be quite a challenge to open and sometimes take a surprising amount of time and resources, which can be frustrating. With me today to discuss this topic are Dr. Shaalan Beg, associate professor of medicine in the division of hematology and oncology at the University of Texas Southwestern Cancer Center, and Ms. Erin Williams, associate director of clinical research operations at the Simmons Comprehensive Cancer Center. We'll be discussing their paper, "Improving the Time to Activation of New Clinical Trials at an NCI-Designated Comprehensive Cancer Center," to be published in the November 2019 JOP. Welcome, Shaalan and Erin, and thank you for joining me on the podcast. DR. BEG: Thanks for having us. DR. PENNELL: So can we start off by talking a little bit about what's involved in the clinical trial opening process and why this ends up being such an important issue that leads to projects, like what you describe in your paper? DR. BEG: Yes. It's a pretty complicated process. And I think I say it a lot, like, how a bill becomes a law. So how does a trial protocol become an open clinical trial available to our patients? So when you have a document which embodies the principles for the clinical trial or the clinical trial protocol, you have a consent form that will be a patient-facing document that the patient sees, which summarizes, in layperson's terms, what the procedures will be for the study. And then these documents have to go through multiple steps of approval within individual institutions. For example, the institution review board will look at the document in terms of risk management or risk assessment for the institution. Scientific committee will review the scientific integrity and see whether it suits the patients that that specific center is taking care of. And then, in parallel, you have a group of experts who want to see if that trial is something which they can feasibly execute. So hypothetically speaking, if a trial needs treadmill tests, do we have a treadmill to actually do that? So really the rudimentary, sometimes, feasibility questions. And then, as the studies are becoming more complicated, some of these studies have biomarkers which we want to identify patients for, and we need to test patients before we can find the right patients for the clinical trial. So that entire process is becoming more and more complicated. DR. PENNELL: That all sounds like it makes perfect sense, but I know a lot of our listeners might be surprised to learn that this entire process from beginning to end can take a long time-- sometimes six months or longer. What are the consequences to an institution of taking a long time to activate a trial? MS. WILLIAMS: So this is Erin. Well, the consequences can mean our access to clinical trials, right? So it can also mean access for patients to the clinical trials. So both of those things. If we take too long to open the study and a lot of other centers around the country or around the world have a study open-- and specifically, there are a lot of trials that are open internationally, and sometimes it's easier to open trials internationally more quickly-- then our patients lose access to those trials as the spots for enrollment fill up and the study goes closer and closer to its enrollment target. But in addition, sponsors, industry sponsors, pharmaceutical companies that are bringing trials to their cooperative groups in which we participate-- these are NCI-funded large-cluster groups for phase III clinical trials, we participate with those as well-- they're looking at how long it takes us, as an institution, to activate a new study. And if we start to take longer than most other institutions, they may not favor us for a particular trial to offer that trial to us. DR. PENNELL: This is such an important process, and I think this is really going to resonate with lots of people who work at centers that open clinical trials. So why don't you take us through the process? So what exactly did you do there? MS. WILLIAMS: So this is Erin again. We convened a group of stakeholders, along with a leader from our institution's Lean Six Sigma program, to really map out the process. So we convene about four or five hours of a day for everyone to come in. And it didn't just include cancer center stakeholders, but it included stakeholders from our sponsored programs administration office at the institution, our institutional review board, human research protections office, our hospital review committee. We really wanted to gather together all those people who touch the process in some way throughout the course of the time to activation. And so really with Patrice's help, who is our Lean Six Sigma expert, she really kind of started the process out, and we did kind of what your traditional Lean Six Sigma mapping might look like-- use sticky notes and words on sticky notes, mapping out the process on the long board, and then ultimately creating what the map looks like. And I think what it did was allowed everyone who was in the room to really take a look at the process and how sequential everything came out to look. One of the biggest impacts that we identified and that we highlighted in the paper is what you really saw was this gap between our scientific review committee submission and the IRB review, and then everything else in the process, because a lot of steps hung on IRB approval and didn't want to move forward, including hospital review, contract execution, things like that, until the IRB had given their stamp of approval, which of course is the review board for patient safety. So what we tried to do is, immediately, you could kind of see this visible gap in-between the steps, and that really showed us that potentially aligning that scientific committee review with the IRB review and allowing that IRB approval to happen more quickly might trigger some of the other steps. DR. PENNELL: One of the things that I found really interesting when you were talking about the various steps in the process was when you chose to start the clock, because I know that there is a lot of attention paid to how long it takes to open trials. And, you know, in my experience, I have heard that there are institutions that somewhat game their numbers by not starting their clock to opening until they've actually gotten a lot of steps already done before they do, say, a regulatory submission. And then it looks as though they're opening the trials quite quickly, but they may have already had the protocol for many months ahead of time, working on things ahead of this. And you guys chose to start from the time you actually receive the regulatory packet and the protocol to start, which makes sense. I mean, that's really when, I think, you, as an investigator, would think the clock would start. But did you ever get any pushback from your leadership or others to starting that early? DR. BEG: No. I think it's a matter of being consistent with how we report our numbers. Similar to you, we are an NCI-designated center. We report these to our advisory boards and to the NCI in regular intervals. I think whenever we're measuring numbers and we set metrics for any target, we run the risk of people trying to cut corners and gaming the system to make the number look good. I think that's pretty well-documented in any industry. And our time-to-trial activation has become this shared quality metric across the cancer center, across the institution. And we were worried that it may start being that way, that folks are trying to, "well, should we take out the weekends, those aren't really work days, or how about the time the sponsor has the packet, or--," you know? And I think, as humans, we all have tendencies to try and come up with ways to make our numbers look better. But the advantage of publishing this to a journal like the JOP with transparency on how we're measuring it, and, you know, I think we had faith that our audience would recognize when our time is-- when our time clock is starting. And there wasn't any pushback. MS. WILLIAMS: I'll just add to that. The reason why I think it's so important to be transparent with these numbers is because-- being in an administrative role and an operational in a clinical research office for a long time, investigators who are bringing a trial forward for us to activate, the calendar has started as soon as they bring me a trial that they want to open. And if I tell them that a study only took 60 days to open, and their recollection is nothing near what I'm telling them my metric is, then they're not really going to trust what I'm telling them overall. And I think it's important that I recognize, and that we recognize as an operation, that what really matters is that once we get the study, we're starting the process. It just makes the numbers more useful to you, int

Dr. Nate Pennell talks with Dr. Joel Segel about “Coverage, Financial Burden, and the Affordable Care Act for Cancer Patients.” Article available online at Journal of Oncology Practice. TRANSCRIPT Support for Journal of Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at astrazeneca.us.com. [MUSIC PLAYING] Welcome to the latest Journal of Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor at the JOP. Medical care can be very expensive in the United States. And a diagnosis of cancer can be a huge shock, both physically, mentally and financially. Medical expenses don't just impact financial lives, but may also impact treatment outcomes, as even patients who are cured of their cancer may be left with a significant amount of debt. One of the primary goals of the Affordable Care Act-- so-called Obamacare-- was to increase the number of citizens covered by health insurance, so that these financial burdens would be lessened. And we know that as the result of the Affordable Care Act, overall insurance coverage did increase. But how well did this work for patients with cancer specifically? And what impact has it had on financial burdens? With me today to discuss these issues is Dr. Joel Segel, assistant professor of health policy and administration at the Penn State University. We'll be discussing his paper, Coverage, Financial Burden, and the Affordable Care Act for Cancer Patients, to be published in the October 2019 JOP. Welcome Dr. Segel. And thanks for joining me today. Thank you for having me. So can you start, for our audience, just by putting the general landscape into perspective for us. What are the financial burdens that cancer patients go through, especially those who are in lower incomes? Sure. So there's certainly been a lot of evidence that cancer patients face, obviously, a number of medical care and health burdens, but also financial burdens. And in some cases, the financial burden can be pretty significant. We also know that certain groups are probably disproportionately affected. So we know lower income, especially sort of racial and ethnic minorities, and especially some of the younger cancer patients can face significant financial burdens, but it also varies quite a bit. And so the evidence is certainly mixed in terms of how it's measured, how a financial burden is experienced by these different patients, but it can be as extreme that there is evidence that 2% to 3% can experience financial bankruptcy. So these can be pretty significant financial burdens. And I guess the last thing would be there's probably two ways in which a patient can face a significant financial burden. So one is, and the one that we actually focus on most in our paper will be, the financial burden that results from medical care costs. We can also think about that, obviously, cancer can affect an individual's ability to work. So there can also be an additional financial burden if they're unable to work or they have to cut back on their hours, and that leads to a reduction in their income. And is there evidence that patients' insurance status factors into their financial strain and burden? Yes, there's certainly evidence that patients that have more comprehensive coverage, especially those that are higher income, that may help to mitigate much of the financial burden, whereas patients-- and that's one reason why younger patients sometimes have less comprehensive coverage. And they also may have less in savings and be less prepared to deal with some of the financial burdens. And I think that makes perfect sense. And so what was in the Affordable Care Act that was designed to help patients deal with this? The Affordable Care Act is an extensive law with a whole bunch of different features. I think there are several that are probably particularly relevant for cancer patients. So one is the one that's probably talked about a lot, which is the Medicaid Expansion. So initially, states were required to expand Medicaid. Due to a Supreme Court case, it became optional. So certain states decided to expand Medicaid, and that meant that they expanded who would be eligible. So primarily lower income adults, particularly ones without children, became eligible for Medicaid in certain states. So that's one piece. I think the other one that's come up a lot, especially in a lot of the news stories, would be the restrictions on preexisting conditions. So certainly leading up to the Affordable Care Act, one major concern was that individuals, particularly-- cancer was one of the prominent examples would be if they had previously been diagnosed with cancer, they might have trouble either obtaining health insurance coverage or being renewed for health insurance coverage. So the Affordable Care Act made it so that regardless of what health care conditions an individual had, they were guaranteed renewability of the health insurance or the ability to purchase a health insurance plan. And I think the last two general sections that might also affect cancer patients would be, one, they set up a number of state-based health insurance exchanges to allow individuals to purchase health insurance, and particularly for individuals who are buying individual plans and not through their employer, prior to the Affordable Care Act, especially for those with cancer, might have had difficulty purchasing a health insurance plan. So these state-based exchanges were an opportunity for individuals to purchase health insurance, and depending on their income with subsidies. So there were both subsidies for the premiums, or what an individual would pay each month for their health insurance plan, as well as cost-sharing subsidies. So for lower income individuals, they could become eligible for additional assistance to help cover some of their medical care costs. And then, I guess, the last part would be that the Affordable Care Act placed limits on what an individual would have to pay out of pocket, both in terms of within a given year, and also, they got rid of some of the lifetime limits to health insurance. OK. So it's obviously a complex law with a lot going on. But fundamentally, ultimately, the hope was that more people would be insured and that fewer people would suffer the consequences of having to pay for expensive medical care without having the insurance to help them with that. So with that now put into perspective, take us through your study. How did you design this? And what were you hoping to look for? So what we wanted to do was to take a look at, in particular, the non-elderly population who had been diagnosed with cancer. So what we did is we took a look at a large nationally representative data set, the Medical Expenditure Panel Survey, which follows a random sample of individuals across the United States for a period of two years. And within that, we then try to identify a non-elderly-- and by non-elderly, that'd be ages 18 to 64-- who had been previously diagnosed with cancer, or who, in the data, we could observe that they had some utilization for which there was a diagnosis of cancer. And we then further restricted it, for much of our sample, to the lower income population. So that would be individuals who lived in a family that was at less than 400% of the federal poverty level. I guess to give a bit of a sense of that, that would be about $48,000 for an individual or $100,000 for a family of four currently. And we specifically chose that threshold, because that's the threshold by which individuals qualify for premium subsidies on the state-based exchange. In particular, what we're going to look at is, first, we're going to look at coverage, so the number of months an individual spent either uninsured with Medicaid coverage or with private coverage. Among those with private coverage, we also took a look at whether they were enrolled in a high deductible health plan. We also looked at spending in terms of both their overall spending and also their out of pocket spending. And then, finally, to get a better sense of some of the financial burdens that families might face, we looked at both the change in what this family had to pay out of pocket for their health insurance premiums, so just the part that the family or individual pays as well as the fraction that a family pays for their health care costs, and that would be both the medical costs as well as the out of pocket premium. And our last one, in addition to the fraction of income spent, would be whether they crossed a threshold of 20% of their family income spent on health care costs, which is a commonly used measure of high medical burden. OK. So I think that makes sense focusing on that group. So what did you find? So we look at a couple of different samples, both the lower income cancer population as well as the higher income cancer population. And we look at sort of how those outcomes changed from before the Affordable Care Act to after the Affordable Care Act. And in addition, we were going to make some comparisons to try to get a better sense of whether these changes looked different for different groups, so whether the higher income cancer group, how do they compare to the lower income cancer group, how the different cancer groups might compare to a population with a similar income level, but without cancer. Similar to other studies, we see a significant improvement in health insurance coverage among the low income or the lower income sample with cancer. We find that that's driven largely by both an increase in Medicaid coverage as

Dr. Nate Pennell discusses "How to Know if a Somatic Tumor Mutation is Targetable" with Suanna Bruinooge, the director of research, strategy, and operations at ASCO's Center for Research and Analytics, or CENTRA, and Dr. Richard Schilsky, senior vice president and chief medical officer at ASCO. Read the related article "Determining If a Somatic Tumor Mutation Is Targetable and Options for Accessing Targeted Therapies."   [DR. NATHAN PENNELL] Welcome to the latest Journal of Oncology Practice Podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, I want to talk to you about an increasingly common scenario encountered in clinical practice. Molecular testing for biomarkers to help guide treatment of patients has now become a standard part of treatment for many types of cancer. For example, HER2 testing and breast cancer or EGFR mutation testing in lung cancer. But testing is also increasing in other cancer types often using broad, multiplex assays surveying hundreds of genes. Clinicians are being presented with a report that may seem dauntingly complex and hard to interpret. And even when you have a drug recommended, that may be off-label for its use or even experimental, leaving patients and clinicians perplexed as to how to access them. With me today to discuss these issues are Suanna Bruinooge, the director of research, strategy, and operations at ASCO's Center for Research and Analytics, or CENTRA, and Dr. Richard Schilsky, senior vice president and chief medical officer at ASCO. We'll be discussing their paper, "How to Know if a Somatic Tumor Mutation is Targetable-- Options for Accessing Targeted Therapies" published in the August 2019 JOP. Welcome Suanna and Rich, and thanks for joining me today. [DR. RICHARD SCHILSKY] Thanks for having us, Nate. [SUANNA BRUINOOGE] Thanks. [DR. NATHAN PENNELL] So Rich, give me a little background on the problem that you were hoping to address with this paper. Why did ASCO feel it was important to provide a guidance to oncologists about interpreting testing reports and accessing these drugs? [DR. RICHARD SCHILSKY] Well, I think you actually framed the problem very well in your introduction. Obviously there's a lot of tumor genomic profiling that's going on these days, oftentimes for very good reason to identify actionable alterations that are known targets of effective anti-cancer therapies. And what we've been seeing, of course, in more recent years is the more widespread use of genomic profiling, oftentimes for people who have advanced cancer, who no longer have any standard treatment options available. And the physician is looking to see whether or not there's something that might be considered actionable in the tumor genome that could provide a therapy option that wasn't considered. We're also seeing that the testing itself has become much more expansive. So instead of testing for a few genes, many tests are now testing for hundreds of genes. And, of course, they can be many different alterations that could occur within any given gene. So the amount of information that's being provided to oncologists in these test reports is enormous and very difficult to interpret. The nomenclature is difficult to understand. The biological relevance of the alterations is difficult to understand. And whether or not they really lead to a potential course of therapy is oftentimes difficult to figure out, because a lot of what turns up in the reports is difficult to understand and difficult to interpret. So one of our goals in putting this short paper together was to try to provide resources to oncologists to help them navigate these test reports to help them have resources available to, in essence, look up the abnormalities that are being detected and try to figure out whether or not that's something that might be targetable with a particular drug. And then, of course, secondarily as you pointed out, to help walk them through the various strategies they can use to actually obtain the drug that seems like it might be a good choice for their patient. [DR. NATHAN PENNELL] So if I'm looking at one of these reports now and seeing these alterations, how do I decide if that truly is actionable or not? And how do we decide what level of actionability, whether this is something that's really a standard of care now or something that's much more lower level of evidence? [DR. RICHARD SCHILSKY] Yeah, it's a great question. So, I mean, there are actually some conventions regarding the level of evidence to assign to genomic alteration to determine its actionability. And in fact, ASCO working together with the College of American Pathologists and the Association of Molecular Pathology published a paper a couple of years ago, now, sort of assigning levels of evidence. But the convention goes something like this-- if the alteration is the target of an FDA-approved drug, then that's a high level of evidence that the alteration is of clinical importance. It may or may not be of the same level of importance in a histology that is outside of the FDA-approved indication for the drug. Best known example that is often described as BRAF mutations in patients with colorectal cancer, which do not respond nearly as well to BRAF inhibitors, as the same mutations respond when they occur in patients with melanoma. But nevertheless, a BRAF mutation occurring outside of the melanoma indication has still might be considered to be sort of level two evidence of potential actionability. Then as you get further and further away from FDA-approved therapies or FDA-approved indications, then you get into lower levels of evidence. So you have, as you mentioned earlier, variants of unknown significance. These generally are alterations that are detected in the genome that truly are of unknown significance. They have not been well-characterized. It's not clear what their biological relevance is with respect to being related to tumor initiation or progression. It's not clear whether they represent markers of response or resistance to therapy. They're just alterations where really more research is necessary to determine their actionability. Nevertheless, I can tell you that we often find that many physicians think that it might be worthwhile to target APUS sort of just to give something a try. Then at the lowest level of actionability are the germline alterations. Now, even there, it's complicated because, of course, there are some germline alterations that actually direct you to use an FDA-approved drug, like germline BRCA mutations used to direct therapy with PARP inhibitors. But generally speaking, germline alterations or alterations that have been well characterized and known to be functionally benign, there, the evidence for actionability would be considered to be very low. [DR. NATHAN PENNELL] I've certainly seen people treated with targeted drugs for variants of unknown significance and, otherwise, actionable genes, such as EGFR mutations but well outside the tyrosine kinase domain. And it really depends a lot on how well it's presented in these reports as to how easy it is to figure out what's actionable and what's not. [DR. RICHARD SCHILSKY] Well, that's right. And one of the reasons we included in the paper that quite expansive table of knowledge bases that are available is to help oncologists help participants who have elected a tumor board determine where to go to look up an alteration that might actually give them useful information as to, has it ever been reported before in human cancer? If so, is it an alteration that is likely to be biological significance based upon the nature of the alteration and where it's located in the DNA? How close it is to other known ontogenic alterations and so on. So hopefully, readers of the article will find one or more of those knowledge bases' valuable resources, particularly in the context of a molecular tumor board discussion. [DR. NATHAN PENNELL] Absolutely. This is a fantastic resource. And I've got a couple of these bookmarked on my own desktop so that I can look things up, such as mycancergenome.org, for example. So I think our readers hopefully will check into that. So now that we have identified an actionable alteration, and we have a recommendation for a particular drug, what are our options for going about accessing these drugs for our patients? [SUANNA BRUINOOGE] Thanks, Nathan. This is a really good question. And I think we created a figure in the manuscript to really help clinicians and patients walk through what the options are laid out in front of them. And as you can see from the figure, it really does depend on the initial question being, does the targeted drug have FDA approval? And as Dr. Schilsky mentioned earlier, it may depend on whether the indications specifically include the cancer type or histology that your patient has. But let's just say, then that case, it would be considered an on-label indication, and largely be reimbursed by insurers. But let's say, the indication-- the cancer type is not specifically mentioned in the label. In that case, it would be considered an off-label indication. And so in that situation, there is a chance that the company or other researchers are already looking at whether the drug works for that same alteration and other cancer type. In other words, research on off-label indication. And in these situations, as trials have been completed and results are published, they might be noted in either clinical pathways or drug compendia. Or it might be published in scientific journals, like the Journal of Clinical Oncology and Journal of Oncology Practice. So in those situations where there is published data, and tha

Dr. Pennell and Dr. Kircher discuss the push for increased price transparency among stakeholders in an effort to control the rising costs of healthcare. Read the related article on ascopubs.org.   TRANSCRIPT: Welcome to the latest Journal of Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Americans are very familiar with comparison shopping for goods and services based on the price. I can buy anything from a car or a television to life insurance to hiring a contractor to remodel my home. And I could expect that the price of that good or service is going to be easily available. It's going to be accurate. And then I can compare it to their competitors prices. So I can then make my decision based on that price and the quality of the goods or services. But what if you wanted to shop around for your health care? How easily can we determine the true out-of-pocket costs for, say, a hip replacement or a screening colonoscopy? In truth, I bet aside from a purely cosmetic procedure, most people don't ever recall being told what the price is of a medical procedure before having it done. So why is medicine different? And how does this impact the cost of health care? And what can we do to improve price transparency? With me today to discuss this issue is Dr. Sheetal Kircher, associate professor and GI medical oncologist at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Dr. Kircher is a member of the ASCO Health Equity Committee and was a recent ASCO Health Policy Fellow from 2018 to 2019. We'll be discussing her paper, "The opaque results of federal price transparency rules and state-based alternatives", to be published in the August, 2019 JOP. Welcome Dr. Kircher, and thanks for joining me today. Thanks for having me. So first of all, can you briefly kind of review why aren't health care costs like other goods and services? And why isn't it easy to understand and compare between them? There's a lot of reasons that health care costs are really just fundamentally different than really almost any other goods or services that I can think of. Taking your example of shopping for a TV, when you know which TV you want, you to go to multiple stores. You check to see if there's free online shipping. And you choose the lowest price. Even if you don't know what TV you want, you can see what the cost is going to be. And this cost is going to be inclusive of tax, shipping. And you can even see what that cost will be if you had a coupon or promo code. In addition to the cost of these TVs, we will see ratings, hundreds, thousands of people with commentaries on their experience with that exact product. So many times, you could even return it. So as we can see, health care is just really different. The stakes are higher. So even when we use this word, cost, shopping around for health care, and things like that, already that kind of seems like a misnomer. For the individual case and the actual cost of a service, it's complicated. It's difficult to figure out because almost nobody pays what we think of as like the list price. The literal list price for hospitals is called a charge master. A charge master is really just the list prices out the gate that a hospital comes up with and becomes a starting point for negotiation for payers. And then each plan will have a different contracted rate for that service. And this is problematic, isn't it? Because the charge master is sort of the-- when people start, at least say with the federal regulations, that's the price that they're sort of trying to get people to put out there. But that's not necessarily all that helpful. Exactly. And you know, in addition, because there's such variation in what the patient will actually pay at the end of the day after their insurance coverage kicks in, when you look at the hospital list of prices, it's difficult, even for myself with a medical degree, to understand what I'm looking at. For example, if I'm thinking of a single service, like a colonoscopy, there could be many components to a colonoscopy, such as the doctor fee, facility fee, pathologist, anesthesiologist. So even if you saw the word colonoscopy on one of these lists, it's impossible to really know if that's inclusive of all the components of that procedure. So say a patient was able to actually get a hold of these contracted rates instead of the lowest prices. And then they were able to know all the components of that service. They would still need to understand the specific cost sharing details of their insurance plan, such as like how much the deductible is, what's their copay, what's their coinsurance. In my experience, and I think it's well-published in the literature, that most patients even struggle to just know what the definition of those things are, like your deductible, let alone what their actual amounts are. You know, it does sound complicated. And obviously, I think a lot of doctors are familiar with the multiple different charges and whatnot. But at the same time, given the complexity of modern technology and whatnot it doesn't sound to me undoable for a particular hospital to bundle all of the costs of a single procedure together and to somehow link to what your insurance company should cover for that kind of thing. It does not seem to me like this is an undoable technological fix if someone wanted to do it. I agree. There's been a lot of attempts, both at the state level and federal, to really address this issue. I mean, even taking a step back even further, institutions have tried to, at least for their patients, provide more accurate down at the patient level estimates of their costs. And as simple as it sounds, it is actually quite difficult. And the reasons are because a lot of people contracting from payers as well as insurance it still is very opaque, even in people that are highly skilled and trying to figure this out. So if you are an actual patient, I mean, I think that the challenges just become even greater. But some states have taken some more kind of in the weeds active approach to improve price transparency in health care as a whole, including oncology. [INAUDIBLE] states have implemented or at least passed laws where they create something called an all-payer claims data set or APCDs. What these are it's still a list of prices. I think it tackles some of these issues that we just talked about, because what these lists are, they account for the negotiated price, as opposed to the pre-negotiation charge master. So basically, it's the price after the coupon. You know, it's like the real price. Most of these data sets, or at least many of them, have incorporated quality metrics. Now, I would have to say that the quality metrics between states is all over the map. Nobody has agreed on these quality metrics. But it's at least one more tool to help the patient in addition to cost to make decisions. I think a kind of interesting point this all brought up as we were doing this work is almost like a bigger question of do patients want to comparison shop for their health care. So I mean, if my primary care doctor, who I trust and I know, and I've known for 15 years, recommends a procedure, so say a colonoscopy, I'm likely to choose the doctor and the facility that she recommends. I don't even remember if you go to get a procedure, they usually don't even tell you ahead of time what the cost is and ask you if that's something you're interested in paying. Usually you just schedule it, and you do it. And you get a bill after the fact. That would have to be a pretty big shift in the culture of how we approach paying for health care if we were going to start comparison shopping. You'd have to understand that you needed to do that to begin with. You'd have to know how to do it and how to compare these things. It's certainly not undoable. It's something, again, that we do for almost every single other thing that we buy, but it would require quite a major change. Absolutely. And there's an even larger price transparency kind of movement going on. In relation to we were just saying about a patient-- say an oncology patient is starting chemotherapy. Federally, there's multiple different efforts that are trying to improve price transparency. So the oncology care model, one of the 13 kind of pillars of that care plan, one of them is delivering out-of-pocket costs before treatment starts. Now, in oncology specifically, this is problematic and very challenging. You know, kind of trust me, we've tried. And we continue to try because when you think of the drugs we give oral chemotherapy, targeted agents, and then IV chemotherapy, we're not only dealing with totally different modes of treatment. We're talking about different payment structures of how cost sharing works. So typically, IV chemotherapy is on our hospital outpatient benefits, while oral chemotherapy is covered by our prescription drugs. Now, both of those, in say Medicare for example, are completely different cost sharing structures. So the experience for a patient picking up their oral chemotherapy is at essentially a retail pharmacy or if it's perhaps a specialty pharmacy. But there's a cash register. And you're paying for it there. The experience of paying for your IV chemotherapy is just like you described with the procedure, where you get it done. You get the bill at home. And just the experience alone is really different. So federally, for this specific charge master display, so as of January 1st, all hospitals must publicly display their charge master. You know, like I said, these were never intended for consumer viewing. So they were fir

Dr. Nathan Pennell and Dr. Jennifer Ligibel discuss weight management and physical activity programs for patients with cancer. TRANSCRIPT: Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. I'm sure everyone who listens to this podcast is aware that obesity and lack of physical activity are major health problems in the USA, and they contribute to multiple medical conditions such as heart disease, diabetes. But how much do patients and oncologists know about how obesity and lack of physical activity impact cancer incidence or treatment or outcomes? And how do physicians manage these issues in their practice? With me today to discuss this issue is Dr. Jennifer Ligibel, associate professor at Harvard Medical School and medical oncologist at the Dana-Farber Cancer Institute, where she also serves as director of the Leonard P. Zakim Center for Integrative Therapies and Healthy Living. We'll be discussing her paper, "Oncologists' Attitudes and Practice of Addressing Diet, Physical Activity and Weight Management with Cancer Patients, Findings of an American Society of Clinical Oncology Survey of the Oncology Workforce." Welcome, Dr. Ligibel, and thanks for joining me today. Thank you so much for having me. So just to set the stage for our listeners, how big of a problem is obesity and physical inactivity among cancer patients? Is this something that is generally mirroring the larger problem we see in America, or is there anything different about our cancer patients? Well, we know that obesity and inactivity are risk factors for developing a number of different malignancies. The International Agency for Research in Cancer and the World Cancer Research Fund have both analyzed observational data linking obesity, inactivity, poor dietary quality to the risk of developing malignancy, and have demonstrated really consistent evidence that there is at least 13 different malignancies where obesity, in particular, increases the risk of developing the malignancy. So if you think about the fact that obesity and inactivity are pretty prevalent in the United States, in general, and that these factors also increase the risk of developing malignancy, we find that an even higher proportion of cancer survivors are obese and inactive as compared to the general US population. We also know that treatment that patients get for some malignancies can contribute to weight gain, and also can contribute to inactivity. So you put all of these factors together, and a very large proportion of cancer survivors are at risk for obesity, inactivity, poor dietary quality, or all of those factors together. I mean, the number that you and your co-authors mention is that almost 1/3 of cancer survivors are obese. That seems like a huge number. So clearly a major problem. Yes, that's true. And that number has increased significantly over the last decade. So I know that obesity contributes to cancer risk. But is there data that even treatment of cancer can be impacted by these issues? Yes. So we know that obesity has an impact on treatment-related outcomes and, likely, on the risk of recurrence and mortality in many different diseases. Breast cancer has been the best studied, where we know that women who are obese when they're diagnosed with breast cancer actually have a 35% higher risk of dying from breast cancer compared to women who are of normal weight when they were diagnosed with breast cancer. Similar data are emerging in other malignancies. Colorectal cancer, there has been a strong link with obesity and cancer outcomes. Prostate cancer, gynecologic cancers, there's emerging data as well. So we know that these factors can impact the risk of recurrence and mortality. But there's also evidence that suggests that people who have excess adiposity, have metabolic complications of obesity, are at higher risk of complications like poor wound healing after surgery. They're at higher risk of lymphedema and some malignancies. They may be at higher risk of things like peripheral neuropathy related to chemotherapy. So there are a lot of poor outcomes associated with body weight in cancer patients. Now, I know even dosing of chemotherapy, I believe, obese patients are at risk for under-dosing because people are afraid to give them proper weight-based dosing. So lots of reasons to pay attention to this issue. Is there data, though, that changing that-- intervening with helping patients lose weight or patients at risk losing weight, or increasing their physical activity-- mitigates these risks? That is a great question, and one that will hopefully be answered within the next few years through a number of large-scale, ongoing phase III trials that are looking at the impact of weight loss, increased physical activity, better dietary quality on cancer recurrence and mortality. We don't have data from randomized trials, at this point, looking at the impact of lifestyle change after diagnosis on outcomes. But we do have a lot of observational data that suggest that individuals who are physically active are at lower risk of recurrence in malignancies like breast cancer, colon, and prostate cancer. And we do also have a lot of information from randomized trials that are smaller in scale that demonstrate that losing weight, exercising more has an impact on shorter-term outcomes, like quality of life, cancer-related and treatment-related side effects like fatigue, neuropathy, joint pain. So we know there are benefits of lifestyle change after cancer diagnosis, but we're still awaiting these large-scale trials that will show us whether changing these behaviors actually reduces the risk of recurrence and mortality. So already enough evidence that it's important that we address it, but hopefully, we'll have more convincing evidence soon. Can you take us through the ASCO survey? What was the background to doing the survey, and what did it try to assess? So in 2014, ASCO launched an obesity initiative that really sought to educate the oncology workforce about the connections between obesity and related factors in both cancer risk and outcomes, and to provide tools and resources to help oncologists talk to their patients about physical activity, weight management during and after cancer treatment. There was also a part of the initiative that focused on research and advocacy. We were interested, given that 2014 was a number of years ago, to look at what were the current attitudes of oncology providers toward these topics? What was their practice? Were they talking about weight? Were they talking about physical activity and diet with their patients? And what did they perceive as barriers to really implementing behavior change after cancer diagnosis? And so we designed a survey that would be delivered to individuals that were currently seeing oncology patients. And they could be physicians, they could be nurse practitioners, they could be dietitians or anyone that was currently working with oncology patients and was an ASCO member. And then we asked them questions about their practice, about the attention that they paid to these topics, about what they felt got in the way. And then thinking more broadly about how important did oncology providers think that these topics were in the scope of their practice. Why don't we just jump right into the results? So what were the results from the survey? So first of all, we found that the people that filled out our survey were pretty typical for the general ASCO membership. So about 2/3 of the people that filled out the survey were based in the US. The other 1/3 were international. We did have a higher proportion of medical oncologists, partly because this was limited to people that were actively seeing patients. We had a nice balance of private practice and academic centers, and we had individuals that were treating all different kinds of cancer. So we were happy with the population that filled the survey out as being fairly representative of oncology providers in the US and more broadly. We found, when we asked the providers what were their perspectives on issues related to obesity and cancer, that there was a very strong agreement that obesity impacts treatment outcomes in cancer patients. And in fact, more than 90% of the survey respondents strongly agreed or agreed with that statement, which we were very excited to see. There was also high agreement with addressing a patient's weight should be a standard part of cancer care. And most of their respondents felt that it was the responsibility of the treating physician to recommend healthy diet, regular activity, weight management for patients in whom that was relevant. But there was much less agreement that the oncology workforce felt that they were prepared to be either delivering those interventions or that they had enough information or enough training to really feel comfortable in their skills to help patients start to make these changes. So I thought that was very important that there was high agreement that these things were important, but also a feeling of there needed to be other parts of the health care team that could help patients once these issues were identified in really helping them to make the changes that needed to after diagnosis. We then asked providers about what they were doing now, and we found that the vast majority of providers that completed the survey indicated that they were asking patients about their physical activity patterns, about their diets. They were assessing patients' weights. And this was both during and after cancer treatment. There was a much lower proportion of survey respondents that were actually making referrals to dietitians, to weight management services for their patients. So although there was a lot of discussion and there was an assessment, there wasn't necessarily the next step, which was helping patients actually incorpo

Dr. Pennell talks with Dr. Patrick Conner Johnson, hematology oncology fellow at the Dana Farber Cancer Institute Massachusetts General Hospital fellowship program about his and his co-authors' new study titled "Potentially avoidable hospital readmissions in patients with advanced cancer." Hello and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Potentially avoidable hospital readmissions are a major target for reducing costs in the health care system. However, for cancer patients, the issue goes way beyond cost. Many of our advanced cancer patients have a limited lifespan. And every unnecessary day they spend in the hospital is one less day they spend at home with their loved ones. The reasons behind cancer patient readmissions may differ from other types of patients. And so broad efforts to reduce hospital readmissions may not apply quite as well to this population unless we understand the specific reasons behind readmissions for our vulnerable population. Today we're going to be talking about this topic with Dr. Patrick Conner Johnson, hematology oncology fellow at the Dana Farber Cancer Institute Massachusetts General Hospital fellowship program about his and his co-authors' new study titled "Potentially avoidable hospital readmissions in patients with advanced cancer," which was published in the May 2019 JOP. Welcome, Conner, and thank you for joining me today. Nate, it's truly an honor to be on the podcast. I appreciate your time and [INAUDIBLE]. So first of all, can you give us a little bit of background on why hospital readmissions are a topic that people are talking about? How big of a problem is this and what's the scope of the issue? To start with, just hospital admissions period are a major topic within cancer care and all of medicine. If you go back to the health care cost and utilization project report since 2009, more than 4.5 million cancer related hospitalizations amongst adults. So that's hospitalizations. Some percentage of these are potentially avoidable both in the general medicine literature and in the oncology literature. and both from a cost and value standpoint and from quality of cancer patients' lives, I think these are important issues to think about in terms of addressing. And then when we looked, particularly in our study, we focused on readmissions by which we define having a panel of patients who already had admission once and then looking at subsequent admissions after that. There is a fair amount of literature out there looking at causes of hospital readmissions as a target for improving value based care. What do you think is different about cancer patients that makes this something we need to study uniquely in them? I think, in general, amongst a variety of different subspecialties, there's an importance in focusing on targeting each individual population to understand the nuances of that population, whether that's a literature on COPD or heart failure. And oncology in particular is still a wealth of drugs with a wealth of potential consequences and with a sub-population within oncology of advanced cancer patients who have defined limited lifespans. There's a whole host of factors and different unique circumstances that could potentially affect their readmission profile a little bit different than other general medicine populations. And I think the greater understanding we have of each subset of patients within a number of disciplines is probably going to target our interventions to be more likely to be successful. And I think that makes perfect sense. One of the other things you mentioned in the background section of your paper is that many of the studies looking at potentially avoidable readmissions have not incorporated patient reported outcomes. And why do you think that would be an important thing to include in the study? I think looking across oncology care, the study by Dr. Schrag and Dr. [? Basch ?] and colleagues comes to mind. There's been an increasing interest in incorporating patient reported outcomes in order to better pair these with our other outcomes. And I think that our hope with this was to gain a greater understanding of what kinds of symptoms and other things patients report and trying to identify if there is any correlation with admissions. And the same thing's being done across a number of different facets of oncology care. Yeah. I'm not sure people outside of oncology understand that there's a significant percentage of our inpatients are admitted for symptom control specifically as opposed to general medicine problems like pneumonia or blood clots. And so definitely in that case being able to assess their symptom burden makes perfect sense when you're trying to do the kind of study that you're doing. So speaking of your study, can you walk us through the design? How did you put this together? So this was a longitudinal cohort study of consecutive patients that were admitted to the hospital. And patients were enrolled. And as part of their enrollment, their symptoms were assessed at the time of their enrollment. So this was a one time symptom assessment within two to five days of their hospitalization when they completed a symptom burden questionnaire essentially. We took available data that we had. And we had two coders go back, review the medical record with a focus on the discharge summary to try and understand the reason for hospital admission. And then we had a peer review system to try and identify which readmissions were potentially avoidable. And we used some adaptive criteria, which has been utilized in some other studies in leukemia an GI cancer. And that process was essentially two physicians doing an initial coding review using these criteria. And then anything that was considered potentially avoidable by either of those physicians went to a panel that included two board certified oncologists. Yeah. I'm curious about this. I know that there are published methods for how they do this. But can you give us an example? How do you determine if a patient had an a potentially avoidable readmission? What's an example of something they might find. There's no question that it's a challenge. And it's rife with some subjectivity at times. In order to try and minimize that, we have defined criteria. For an example, one of those is premature hospital discharge, which in this study was defined as being readmitted within seven days of discharge with identical symptoms to the prior admission. And that's by a review of the hospital discharge summary. OK. That makes perfect sense. And you would think that that would be a significant risk for patients since the length of stay is such a big target for hospitals to try to reduce costs. And also our patients typically want to go home. You know, we have to sometimes convince them to stay when we think they need to stay. OK. So if they were readmitted within seven days with the same symptoms that's how you determine that. So tell us some of what you found. Thanks, again. Major points from our paper are, first, similar to some other studies that try and look at potentially avoidable hospitalizations at large. More than 30% of the admissions were qualified as potentially avoidable readmissions, which I don't think is anything that has ever been described. Again, that's fairly consistent with actually the general medicine and with some other oncology literature, but it speaks to the importance of the topic and the sizable possibility of interventions down the road. And the two major important risks that we identified in a multivariable model were marital status, and which we think is a proxy for social support and was protective against potentially avoidable readmissions, and higher physical symptom burden. And those with higher physical symptom burden were more likely to have potentially avoidable readmissions. And finally, when we looked at the most common reasons as using our criteria for potentially avoidable readmissions, those were premature discharge from a prior hospitalization and also not having what's called a timely follow up, which was a seven day follow up. And so that speaks in our mind to the hazardous time period that is the discharge is fraught with a lot of possibilities of difficulty in terms of making that transition. Yeah. I think that makes perfect sense. I know our institution in particular has instituted a mandatory call from the outpatient team to a patient the day after they're discharged to just check and see how they're doing. And then we try to get everybody an appointment within seven days although that's not always possible. Are there any other interventions that you think would come out of what you found that might help reduce potentially avoidable readmissions? I think from the social support side of things, given that social support can be challenging, there is an idea that if we identify patients with that limited social support that that might be the patients that we target for patient navigation programs, more intensive social work involvement programs, or a specially designed care transition programs at hospital discharge as well as potentially patients who have a higher physical symptoms. And the association with higher physical symptoms also makes perfect sense, although that's always a challenge to address appropriately. I know that there's a lot of focus certainly in solid tumors about integrating palliative medicine and [INAUDIBLE] of medicine support for patients with solid tumors to control that. Is that something that you think could be helpful in this setting as well to help reduce readmissions? Absolutely, Nate. I think that the hope would be that this also raises a possibility of identifying a patient population that may already be plugged in with palliative care. But if they're not, this could help identify another group of patients that can benefit from

Dr. Pennell talks with Dr. Ray Page about efforts to address the opioid crisis impact onthe care of patients, and what role oncologists can play on this issue.   Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. The opioid crisis continues to be a major public health issue, with increasing attention at both the state and national level. Efforts to address this issue are highly relevant to oncologists, because we treat a unique population of cancer patients for which opioid prescriptions are an established standard of care. So how will these efforts to address the opioid crisis impact the care of our patients? And what role can oncologists play on this issue? Today, we're going to be talking about this topic with Dr. Ray Page medical oncologist and hematologist at the Center for Cancer and Blood Disorders in Fort Worth, Texas, who currently serves as chair of ASCO's Clinical Practice Committee, is on the ASCO Government Relations Committee, and is the current ASCO delegate to the AMA House of Delegates, about his new editorial titled, "Opioids and Cancer Pain, Patients' Needs and Access Challenges," which will be published in the April 2019 JOP. Ray, thanks for joining me today. Thank you. So can you start out by giving our listeners a little background on the magnitude of the opioid problem in the US. Sure, Nate. Let me just first say, the opioid epidemic is real and is startling. The CBC reported that in 2017 that over 72,000 in the United States died from drug overdoses. And this included over 47,000 people who involved in drug overdoses of opioids. And most of us have heard from the media that the biggest increase in use is through that synthetic opioid fentanyl. And it's often laced with heroin. And the recent volumes that have confiscated at the US border are enough to kill ever single US citizen. And the escalation of opioid abuse is really complex societal issue. And it includes contribution from all of those social determinants of health and mental illness. And when policymakers sometimes they like to look at a one size fits all kind of solution, which means they oftentimes want to largely focus on physician prescribing habits and just regulating patient access to opioids. Is there evidence that this kind of solution of targeting opioid prescriptions is impacting opioid prescribing in cancer patients? There is a negative impact there. But let me just say that cancer pain is very real and it's very frightening. And we know that cancer pain is historically undertreated. 8 out of 10 advanced cancer patients experience moderate to severe pain. And about 55% of cancer patients and 40% of cancer survivors experience chronic cancer related pain. So upwards of 43% of cancer patients and 10% of survivors use opioids to manage chronic cancer pain. Because of the heightened media awareness about the opioid epidemic, cancer patients are really experiences a lot of fear firsthand. Many of my patients have expressed to me that they actually have a fear of dying from taking opioids. And there's also of addition. And then on the other hand, they also have a fear that they may not even be able to get their hands on pain medicines at all. That actually is a really interesting topic that I hadn't thought of because I have the same problem with my patients worrying about taking opioids. You think that this being so much in the public eye is really influencing cancer patients' ideas about whether they should be taking opioids or not. They feel like they're at risk for addiction and contributing to the problem. Our cancer patients I think do have those real concerns and they have fear over it. And we're actually seeing that about a 1/3 of cancer patients and survivors are actually having difficulty to getting access to their prescribed opioid medications. And that has continued to increase markedly since just a few years ago in 2016. And the vast US oncology practices are concerned that restrictions on opioid prescribing is going to ultimately result in undertreatment of cancer pain. So it's these kind of dynamics what makes it difficult for physicians to treat pain, particularly cancer and cancer survivors. And while judicious prescribing is important, patients with cancer and cancer related pain, they need to have consistent access to pain control. Well, I think we can all agree on that. Before we talk about how we can protect cancer patients' access to these drugs, can you talk a little bit about what is being done sort of at the state and national level to address the opioid crisis and sort of how that's impacting our cancer patients? Yeah, absolutely. The opioid epidemic will continue to be a bipartisan priority for both state and federal governments with currently over 100 state bills that are out there that are identified. In a lot of upcoming state legislative sessions, there will be consideration of bills that are related to such things prescription fill limits and prescription drug monitoring programs and opioid prescribing guidelines. And we're all expecting to see bills that are going to be related to the identification of outlier prescribers and bills that are promoting the utilization of opioid alternative therapies in the cases of both acute and chronic pain. Just on the federal level, you know in 2016, President Obama, he signed the first major federal addiction law in 40 years. And that was the Comprehensive Addiction Recovery Act. And that bipartisan legislation authorized evidence-based prevention and treatment programs and recovery programs and law enforcement initiatives to help prevent overdose death and proper prescriptions. And as you had asked, in 2017 when President Trump came into office, he announced that his administration was declaring an opioid crisis and made a national public health emergency under federal law. And as a result, the White House office of the national drug control policy directed numerous federal agencies to address the opioid problem. But that was largely within their current budgetary confinements. But I think actions by both administrations had positive impacts on the opioid problem primarily just by initiating activity in our government agencies. So when the various laws and policies are passed, do they have built in protections for vulnerable populations that need access to opioids, like cancer patients? Yeah, that's one thing that we've pushed a lot for. And in general, most of them do. And so President Trump signed a sweeping legislation in 2018 that was touted as the single largest bill to combat the drug crisis in our countries history. And there was a lot of efforts to do things like expanding access to treatment for substance abuse disorders and those kind of things. But, for example, January 1st of this year, as part of that law, it included new opioid prescribing policies that will impact Part D beneficiaries and the prescribers. And this includes such things as real-time safety alerts on pharmacy dispensing of opioids and drug management and utilization tools and the improvement of communications between the pharmacists and the physicians. But as you asked, one important note about this legislation that was passed is that residents of long-term care facilities and those that are in hospice care and patients receiving palliative care or end of life care, and patients being treated for active cancer related pain, they are exempt from a lot of these interventions. Well, it's good that at least someone is considering our patients in this. But I know that certainly-- I believe ASCO has quite a bit of concern about maintaining access to patients. So what role is ASCO playing in this issue? You know, Nate, ASCO is very sensitive to the needs, to address the opioid crisis and to support thoughtful and evidence-based interventions aimed at decreasing substance misuse and abuse and overdose death. However, ASCO really continues to advocate for appropriate access to pain medications for cancer patients, recognizing that that typical one size fits all solution risks oftentimes marginalizing our cancer patients and their needs. And so in 2016, ASCO released an ASCO policy statement on opioid therapy which emphasizes the unique pain management needs of patients with cancer and especially those with advanced disease. And in this policy statement, ASCO points out a lot of core principles to balance public health concerns and cancer patients' needs. Well, I really like the fact that ASCO is focusing not so much on specific individual needs, but rather making sure everyone recognizes that there is no one size fits all solution here and also you know acknowledging that there is a real problem with opioid misuse in the United States, but that our patients need to be considered carefully in this. One of the things I liked about your editorial was focusing on how physicians might actually be able to learn about managing pain in cancer patients and not necessarily just focusing on the use of opioids. Can you talk a little bit about that? Yes, sure. You know, just in general, as we all know, as oncologists, we rely heavily on the use of opioids. But we should never rely solely on the use of opioids. And we need to determine if opioids are indeed the right drug for particular type of cancer-related pain. And so ASCO published recent clinical practice guidelines for chronic pain management in cancer survivors that gives advice on careful assessment of pain and its effects on function and of the possible risk associated with an opioid. And so I generally recommend that clinicians review some of these practice guidelines because many of these recommendations can help reduce opioid prescribing and actually consider other good, viable non-opioid alternatives, such as using pain specialists and other interventional procedures. Yeah, I think everyone would benefit from bei

Dr. Pennell talks with Dr. Genevieve Digby about the importance of timely care for cancer patients, and more specifically, lung cancer patients.   Hello, and welcome to the ASCO Journal of Oncology Practice Podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. On this month's podcast, we're going to be talking about a new study from the JOP Quality and Action series, titled Improving Timeliness of Oncology Assessment and Cancer Treatment Through Implementation of a Multidisciplinary Lung Cancer Clinic, published online in the JOP, January, 2019. Joining me today on this podcast is the author, Dr. Genevieve Digby, assistant professor in the division of respirology at Queen's University School of Medicine, where she's also the clinical lead for the lung diagnostic assessment program. She has an active interest in quality improvement projects, which is what led to this paper that we're going to be discussing today. Dr. Digby, thank you for joining me. Thank you so much for the invitation. Obviously, everyone likes to be seen as quickly as possible when they're trying to get into the doctor, but can you give us just a little bit of background into what led you to do this particular quality project? Why is the timeliness of care more important for cancer patients or, specifically, lung cancer patients? So great questions, Nate. Timely care is very important for patients, as you pointed out. In fact, the Institute of Medicine has timeliness as one of the six dimensions of quality. And for lung cancer patients this is particularly important, as we know that there's evidence to show that patients who have delays in their diagnosis or delays in treatment, that this is associated with progression of disease, and there's evidence to show that more advanced disease is associated with worse outcomes. And as we know from the lung cancer screening trials, earlier detection of disease is associated with better outcomes. Not only is timeliness of care important for patients from the point of view of getting their treatment underway, but it also is important in terms of the anxiety and distress that patients have. So we know that the longer delays are associated with more distress, and lung cancer patients to begin with are some of the patients who have the highest levels of anxiety and distress amongst oncology patients. So for us, the study arose because of an identification locally that there were delays in our care processes in regards to transitioning patients from the diagnostic phase of the lung cancer pathway to the treatment phase and a desire to improve those care processes. I think that that really resonates with me. I know at my institution we've been paying attention to the time to initiate treatment for a while, and it's not like going to see the dermatologist. When you're diagnosed with cancer, you really have a lot of anxiety, and you want to get in to get treatment as quickly as possible. And of course, as you've mentioned, especially for early stage lung cancer, there's pretty good data suggesting that the longer someone waits to make a diagnosis, the more likely they are to have their potentially earlier stage cancer turn into a later stage cancer with worse outcomes. So I applaud you for addressing this. And in your particular project, you focused on the establishment of a multidisciplinary clinic. And this is something where I think a lot of the literature out there on looking at processes and time to treatment has focused on that. So is there data suggesting that multidisciplinary clinics specifically are a good intervention for improving timeliness of care? So that's a good question. And the literature varies in terms of its robustness based on the type of cancer that we look at. So my group published a systematic review looking at multidisciplinary clinic models in lung cancer specifically. And we were surprised, actually, by the relative paucity of data in terms of what the optimal catalytic characteristics are, even just in terms of the number of studies that's actually evaluated a multidisciplinary clinic, per se. In other cancer types, there is evidence that multidisciplinary clinics lead to better collaboration between specialists. There is some evidence, even in lung cancer, that perhaps there's better compliance with staging guidelines and guideline-based care when care is delivered in a multidisciplinary clinic. And there's also some evidence, though limited again, especially for lung cancer, surrounding the patient experience and patient satisfaction with their care when it's delivered in a multidisciplinary clinic model. Yeah. Honestly, I don't think I've ever heard anyone argue that there's a downside to a multidisciplinary clinic. But I do appreciate studying measurable metrics that may demonstrate benefits because, of course, you have to get support for these sorts of things. So why don't you take me through your project's design, and what were the goals that you tried to achieve? So this is a quality improvement study. We started by identifying what our overall goals and outcome measures were and how we would go about achieving those goals. For us, the focus was to improve our transitions from the point of care of receiving a diagnosis of lung cancer through to starting treatment with an oncologist. So this particular setup was due to the fact that in our center we have a separate thoracic surgery program where patients with suspected early stage disease directly go to a thoracic surgery program and those with more advanced disease or suspected non-operable disease are initially managed by a respirologist, and then are seen through with the appropriate thoracic oncology specialist subsequently. So for us, we looked at our data, and we actually identified that that time from transition, where a patient receives a diagnosis of lung cancer, to when they're first assessed by an oncologist was upwards of about two weeks. The time then to go on and start their first treatment for cancer was in the range of 40 to 45 days. And we identified that there was room to improve and set a target of reducing both of these individual time frames by about 10 days. We hypothesized that if it could improve timeliness to seeing an oncologist from about 14 days to closer to 4 days-- 3 to 4 days-- that we would similarly lead to maybe about a 10-day improvement in time to treatment on the other end. So our improvement plan was to launch this multidisciplinary clinic. And we used a quality improvement called plan, do, study, act cycles, or PDSA cycles, to help facilitate that and fine-tune our multidisciplinary clinic along the way to make it even more efficient. That sounds great. It sounds like a very worthy project. So what did you find? We found that by implementing a multidisciplinary clinic, even within a very short time of implementing it, that we were able to significantly reduce the time from a patient's lung cancer diagnosis to when they were first assessed by an oncologist. In fact, just with the implementation of the clinic, we led to about a 10-day improvement. We fine-tuned our processes to help create sustainability of the teams. Initially, there was still some variability. And we were able to maintain about a 10-day improvement overall over time. What we found though, and what was really interesting, was that as we went about our change processes, we had ongoing improvement in time to treatment, so that time from lung cancer diagnosis to time to first treatment. With our initial clinic implementation, we had about a 10-day improvement in time to treatment as well. But as we noticed, as we fine-tuned our processes, that improvement actually increased such that we overall reduced time to treatment from about 40 days at baseline to 15 to 20 days by the end of our quality improvement initiative. And that is incredible. I think, to me, was the most impressive thing is not so much that you, by moving up your evaluation by 10 days, you improved time to treat by 10 days, which makes perfect sense, but that somehow implementing this entire project, you greatly exceeded your expected improvement in time to treat. And so, did you look at what specific interventions might have led to that even better improvement than you expected? So that's a great question. And as you said, what surprised us was the extent to which timeliness, in terms of receiving first treatment improved, even beyond just time to seeing an oncologist. And when we considered the data, some of the things that came out were likely the increase in collaboration that we were seeing amongst specialists, particularly medical and radiation oncologists in terms of being able to decide on a treatment plan a bit sooner and get that plan up and running. In fact, when we looked at the data, the patients that had the greatest improvement in time to treatment were those with stage 2 and 3 lung cancer, and also including patients with stage 4 lung cancer. And those are often-- especially stage 2 and 3-- where patients are most likely to need a concurrent chemoradiation, where the treatment plans are often decided together amongst the radiation oncologist and the medical oncologist. And so having that ability to discuss the treatment plans and come up with a clear plan sooner is what we hypothesized is leading to be faster kind of treatment. To evaluate this further, we actually also have recently completed a qualitative study, where we interviewed physicians, and including patients and caregivers, about the impact of a multidisciplinary clinic. And while I don't want to give away all the results yet before it's published, one of the themes that comes up certainly for the physicians and particularly oncologists is just the overall ability to collaborate and have real-time discussions with each other and with the patients about what their treatment plans would be, leading to a faster implementation o

Dr. Pennell talks with Dr. Sushil Beriwal about guideline variability and how care pathways might play a role even in situations where the best practice seems clear.   Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the Journal. The best available evidence for cancer treatment seems to change at just a staggering pace. And yet, as physicians, we're expected to keep up with these changes and always give the most evidence-based treatment, which is obviously an incredible ongoing challenge. Guidelines from major organizations can play a role in helping us stay up to date. However, considerable variability exists, even in situations where the best practice seems to be clear. This creates an opportunity where things like care pathways might play a role. Today, we're going to be talking about this topic and about a new paper titled "Lag time between evidence and guidelines-- can clinical pathways bridge the gap?" which will be published in the March 2019 JOP. Joining me today for the podcast is the senior author of the paper Dr. Sushil Beriwal, professor of radiation oncology at the University of Pittsburgh and deputy director of radiation services at UPMC Hillman Cancer Center. Dr. Beriwal, thank you for joining me today. It's my pleasure. Thanks for having me. So why do you think there is so much variability in care, especially around things where a lot of people have broad agreement? So the example in your paper that you use is hypofractionated whole-breast radiation, which has been part of a major guideline since 2011. And yet, it seems as though many people don't use it. So we do see variability in the cancer care. And hypofractionated radiation therapy is one of a good example. What is exactly? It's hard to pinpoint. But I think it's for multiple reasons. Could be a physician is used to practicing a certain why. They don't want to change the practice. They're not aware of the newer data and guidelines. Or it could be the fact that they're concerned about increased side effects and toxicities with this newer approach. They may not have technology or resources to do it. And last, but not the least, sometimes the fee-for-service model may have a detrimental effect in accepting a shorter course of treatment. Oh, I hadn't even thought of that, but that's a good point. So can you take me a little bit through your study? What was the problem that you were trying to solve? As you know, there have been various studies which have come out in the last 5 or 10 years, looking at adoption of hypofractionation for breast cancer care, even though the randomized data suggests that hypofractionation is similar for cancer outcome and possible less side effects, [? with ?] the adoption rate based on the National Cancer Database analysis, or some keyword industries, or some state data, it's somewhere within 10% to 50%. So there is wide variation and acceptance and adoption. And we were trying to figure out a way to make it more uniform so the patient get similar kind of care based on the best available evidence for that patient. Is care pathways or clinical pathways something that you've had experience with working with before? And I guess, maybe just for our listeners, kind of explain to us what a clinical pathway is. Clinical pathways are like additional [? aid ?] tool which basically guides the physician to decide about the care of the patient based on the stage, grade, and other factors associated with that patient. So we at UPMC Hillman Cancer Center started the clinical pathway in a very rudimentary form about 14, 15 years ago. It has come a long way from being a paper trail to an electronic format. The way it works out is anybody who sees a patient in our network of 25 sites has to enter a decision to-- in the care pathway model created by this company called Via Oncology, which was initially part of UPMC, but this year, it was bought by somebody. Well, it was an outside company called [INAUDIBLE]. So say, for example, if I see a patient in my clinic, I go to care pathway website. And automatically, it will ask me for stage, grade, and what needs to be done. And then it gives me the option of what to do. So if the option for that patient is hypofractionated radiation therapy, that's what I have to choose. I see. And how do you decide what goes into these care pathways? Is this determined by an outside group? Is this something that you get to determine within your own institution? When we started, it was within our own institution. But now we have oncologists from all over the country who participate, who are part of the same care pathway module. We have chair and co-chair for each site. And we have committee members for each site. So we meet every six months on a regular conference call. And whatever evidence has come out in the last six months, we try to incorporate that in our discussion and make changes accordingly. So initially, the agenda is discussed. The committee decides and discusses. It goes back and forth. And once the committee agrees, then it's sent out to all the members for voting. And once everybody agrees in the voting, then it is implemented. And that becomes the care pathway for that disease and stage. And so what were the results of your intervention? So we went by a very stepwise manner. So initially, the 10-year data for hypofractionation from the UK group came out in 2013. So when that came out, we as a group decided to mandate hypofractionation for somebody who is 50 and above, like postmenopausal women with early-stage breast cancer. When you're trying to keep breast or just [INAUDIBLE] level to use. And we found when we assessed the outcome that there was a very high acceptance rate of hypofractionation. But one of the concerns we found that the physician had in accepting hypofractionation was how best to do it, because those papers and the data did not define fully the best way to deliver the dose, how best to achieve dose homogeneity, what should be the [INAUDIBLE] and the hard dose. So within our own network, we came up with a very good guideline of how best to achieve dose homogeneity to deliver this dose safely and make it better for the patient. Once we got success with that, then we took the next step of implementing this for younger women. And since we already had the track record, we found that the resistance to the acceptance of hypofractionation was much-- there was much wider acceptance, because people knew how to do it from the previous experience. And the acceptance was much more wider and much more-- the numbers were close to 95% to 100%, which was very reassuring and which was very gratifying to see that patients across our network were getting similar kind of care. No, actually, the numbers are staggering. I mean, in 2015, the number was only 4.2%. But by the second intervention, you said it was 96.5%. So were the doctors actually mandated to use this? Did they have the option of changing it if they wanted to? So the way our system works is the only option we had was to do hypofractionation, but they can change it. But they need to have an evidence-based discussion of why they want to change it. And see, I'm department director for the breast. So anybody who wants to do something different, then he will send an email to me, that he doesn't agree with the pathway recommendation. And these are the reasons why he wants to do it. If the evidence-based discussion is consistent, then we say, go ahead and do the conventional fractionation. Well, it clearly was very effective. I'm curious if you saw pushback from the doctors in making this change? Did people have a problem with being directed towards this particular treatment? Initially, I did. Initially, when we did it for the first time, there was a lot of communication back and forth. And people made different kind of arguments, like we only have 10 years' data. We don't have 20 years' data. And we don't know whether it is safe or not. Or [? they could ?] quote previously have done studies which have shown poor outcome. But they were done with different techniques and different philosophy. So there were a lot of discussions back and forth. And to alleviate some of the concern, I did a [INAUDIBLE] conference in our network, where we mandated all of our physicians to participate and listen to the [INAUDIBLE] conference, where we defined how best to do hypofractionation in terms of dose homogeneity, in terms of heart and lung dose. The most important factor was dose homogeneity. And once physicians understood that the dose homogeneity is the more important component than the fractionation, and they could see the results from the patient's perspective and from physician's perspective, the adoption became like a no-brainer. The other thing that is remarkable to me about the pathways at the University of Pittsburgh and the people who use the Via Oncology Pathways, so my own institution at the Cleveland Clinic, we also come up with our own evidence-based care paths. And we try to educate people about them. But there isn't really a good way to track how well people adhere to them. How important do you think having the web-based monitoring, where people actually have to track what they're doing, is to adherence to these care pathways? Well, it definitely helps us, because there are two ways we monitor it. One is like the [INAUDIBLE] tool. Then anytime you go off pathway, it comes to the pathway director as an email for him to respond to the rationale behind our pathway and whether he or she agrees with it. And if he agrees with it, then it goes into the system as "On Pathway," even though the track was not on pathway. And the second thing is you may say you're doing something, but you may not be doing it. So we have an audit system built in where we have one of our staff members audit the charts randomly across our network and mat

With the care of patients with cancer strewn across numerous settings, are electronic health records (EHRs) meeting the definition of interoperability according to the 21st Century Cures Act? Dr. Pennell speaks with author Wendy Rubinstein. Read the related article "CancerLinQ: Cutting the Gordian Knot of Interoperability" on JCO OP.   Hello and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Most oncologists in America today use an electronic medical record, or EMR. But for a number of reasons, few of us are able to access records for patients outside of our own practice, a concept that's known as interoperability. Today we're going to be talking about a new editorial published as part of a series called "The State of Cancer Care in America." This editorial is titled "CancerLinQ-- Cutting the Gordian Knot of Interoperability," published in the January 2019 issue of the JOP. Joining me on this podcast is the author Dr. Wendy Rubinstein medical geneticist and Deputy Medical Director at CancerLinQ, LLC. Dr. Rubinstein, thank you for joining me today. Thanks for having me. So I know that this is not going to be a surprise to any of our listeners, but would you mind just kind of giving us a little background on the issue of EHR interoperability, and how did we end up with the scenario that we have today? Well, sure. Of course, electronic health records systems weren't built with interoperability in mind. The overarching goal for hospitals was documentation to support billing, and it hasn't been a priority for hospitals to make it easy for their patients to interact with other health systems. But to be fair, people didn't talk much about interoperability 10 to 15 years ago. And I'm not even sure an official definition existed. So now the 21st Century Cures Act provides a definition. So basically, electronic health information should be able to be securely exchanged with other health information technology. And there should be no special effort required by the user, especially and including patients. And the data exchange for the authorized use, it needs to be completely enabled under applicable laws, and any information blocking is prohibited. So what this comes down to, basically, is that a patient should be able to have care at one medical office, and then go to a separate system across town, without having to fill out another paper form with their complete medical history, medication list, and review of systems all over again. So part of the article talks about, and you mentioned, the ASCO Oncology Practice Census. And in 2017, the practice census found that 40% of practices were unable to accept any patient information from other practices. And you might think that the problem is getting better with attention to it, but actually, it's getting worse. In the 2016 practice census, 34% of oncology practices said that their EHR was interoperable with hospitals in their region. But in 2017, only 10% were interoperable with regional hospitals. So in oncology, this is especially important because cancer patients typically have their care strewn across multiple specialists, surgery, radiation oncology, medical oncology, and more. So with their care being decentralized and being complex, how can we really subject our patients to recounting their entire history every time they come to a new specialist? And we're relying on them to be savvy about their cancer history and to be accurate about it. And this is often the worst time of their life. So without quite saying it to them, we're basically letting them know that we don't communicate with our other doctors. And I have to say, sometimes my own medical profession embarrasses me. Yeah, it's interesting. I mean, it's a couple of different issues, the first being of just simple interoperability and having access to your patients' records when they're not within your system. The traditional way of doing this is you've typed up a letter or a note from what you've done, and then you mail it to the other physicians who are either the primary care doctor or the person who referred to you the patient. And strangely enough, that's still mostly how this happens. I have a sophisticated electronic medical record that puts together a sophisticated note filled with all kinds of important information, which gets printed out and put it in an envelope and mailed to someone, rather than sending that electronically and having it available whenever they need it. They have to somehow come up with a way to scan that into their system so that they can read it. So it's really remarkable that we're still in that system. And I now have limited interoperability with other people through my own EMR, and it's just astonishing how much easier it is to keep track of people with that. Once you start to get a taste of the potential of that, it's really hard to go back and not be able to access patient's records anymore. Everyone I think is a little bit aware of this issue and becoming increasingly aware of this issue. What are the barriers out there to making EHRs interoperable? It just seems like such an obvious thing to do, and yet it somehow is a difficult process. To attempt to maybe take something complex and bring it to some basic issues, I can call out a couple of issues. One is extreme customization, and the other is that we need a common language that can speak across different implementations of electronic health records. So with extreme customization, and this is how I would characterize it. So customization is very effective at locking up health information and preventing it from being exchanged. And for any EHR vendor, offering a way for clinicians to customize their reports, their documentation, it really is a great way to satisfy them. And in fact in my own experience, my cancer genetics practice became very efficient by creating templates for notes and letters about genetic testing and managing patients at high risk of cancer. But if you think about it, when I recorded a diagnosis of colon cancer in a letter to the patient or the clinician, it wasn't mapped to any standard vocabulary or code. It can't be shared other than as a TXT file. When you talked about bringing in scanned documents, yes, you can look at them, but they're not machine computable. In fact, if you like to know how many ways you can say total neutrophil count in an electronic health record, CancerLinQ was in the unfortunate position of figuring this out. So in the first 30 oncology practices that CancerLinQ received data from, there were 76 distinct ways to say total neutrophil count, like white blood cell count or WBC. And that means that there were more than two names per organization on average, even within an organization. There's no agreement on what to call this. So it's certainly true. We, as human beings, we can all semantically process different terms for total neutrophil count, but a computer can't. It can't do that, unless we provide a mapping or we create it. So this basically locks up the data and reduces its value. So to extract the value, we apply natural language processing and human observation using interfaces. But that's expensive, and the problem is it doesn't help at the source. You still have the EHR, it's not really aggregated together yet, and in the day to day workings, you're not really doing anything to solve the problem. So the other problem which is very much related is we need a lingua franca. We need a common language to make the proper use of the data that we have in EHRs. And so on a higher level, ASCO and CancerLinQ have convened a volunteer stakeholder group, and this represents diverse perspectives in oncology, different specialties coming to the table. And the purpose is to create a core set of data elements from oncology called mCODE. So mCODE stands for Minimal Common Oncology Data Elements. And ASCO is aligned with other medical organizations, as well, and the Biden Cancer Initiative, so that together we can inform oncology EHR vendor design. We can inform their decisions and, hopefully, prompt interoperability to improve cancer care. One of the things that's-- of course, you now work with CancerLinQ. Can you tell us just a little bit about CancerLinQ and how CancerLinQ can work to overcome some of these issues? Sure, I'd love to. So CancerLinQ is a major initiative at ASCO. And the goal was to create a learning health system for oncology. So first and foremost, CancerLinQ is a quality measurement and reporting system. We have over 100 health care organizations. These are large and small, they're community and academic, that are participating in CancerLinQ. And so far, we've established data flows with 47 organizations, and we've integrated data for over a million patients with cancer. And that reflects their comprehensive longitudinal record of health. So by doing this, the reason to do this is we're enabling practicing oncologists to measure, and report, and improve the quality in patient care. So when you look at, for example, the 2017 ASCO Oncology Practice Census, about 25% to 30% of practices, they called out quality measurement and reporting activities as a top burden for them. In order for them to do this, they have to actually do manual extraction from electronic health records, if you can wrap your mind around that. You have to pay to do that. So the CancerLinQ platform reduces the reporting burden by displaying the quality measures for MIPS, MACRA reporting and also supports ASCO's QOPI certification. And what this means is that clinicians can actually see the time window they have left to take specific actions to meet the quality benchmarks. The other part of CancerLinQ is that we provide statistically de-identified data sets from the cohort to researchers and to FDA. And in that way, we're trying to accelerate discovery and scientific improvements to cancer

Dr. Thomas Knight talks to Dr. Pennell about a major issue in cancer care: financial toxicity. Read the related article.   Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. The rising costs of medical care is on everyone's mind these days. But while policymakers or physicians tend to discuss this more of as a societal or economic problem, the real consequences of the high costs of cancer care are ultimately being felt by our patients. But how do we measure the financial burdens of cancer care? And how does this impact our patients' lives and ultimately their outcomes from treatment? Today, we're going to be talking about a new paper titled, Financial Toxicity in Adults With Cancer Adverse Outcomes in Noncompliance, published in the November 2018 JOP. Joining me for this podcast is Dr. Greg Knight, medical oncologist at the Levine Cancer Institute in Charlotte, North Carolina. Greg, thanks so much for joining me today. Thank you so much for having me. So I thought this was a really interesting paper. Can we just start with a little bit of terminology? So what do you mean when you're talking about financial toxicity? I've heard people use this term bandied about. I think it's a term that oncologists are used to dealing with. And obviously, we know that health care is expensive. But this implies that there is a harmful element to this. Yeah, sure. The term financial toxicity is still a relatively new term. We first started to use it probably around 2013. Dr. Zafar at Duke published a paper first looking at this in terms of the costs and the harm to patients. And the idea behind it is we want to be able to quantify what we're doing in terms of harm to the patient with the costs of treatment. As oncologists, one of the things that we're really good at is grading toxicities. So we worry about nausea. We worry about neuropathy. We worry about hair loss. But one of the things that we weren't very good at was also looking at the harm we were doing to patients with the costs of our treatment. And when I refer to cost of treatment, this term actually encompasses a lot, in terms of not just what we usually think of, which is offices, it's medications, hospitalizations, all those bills that they get from us, but there's other costs that go along with having a cancer diagnosis. Those are things like transportation, clothing, lost wages, child care. All of these things are impacting our patients. And we need to quantify this because it does have implications on their treatment and how they're going to do. Well, that makes perfect sense. And I think that's something relatable to everyone who's treating cancer patients today. Can you give us a little bit of an idea of the magnitude of this issue in the United States? Is there existing data before your particular study came out? There were some both small scale papers and some large database looking papers. And the general consensus was, at the time when we started this study was about 1/3 of patients are going to have severe or catastrophic financial difficulties associated with their treatment. Wow. That's a huge number. So why don't you tell me a little bit about your study and what was the intention of the study and how did you go about it. One of the things we really wanted to do with this study, which was part of a much larger study we had at the University of North Carolina, was we wanted to evaluate both prevalence of this financial toxicity. Because again, there had been some database studies. There had been some smaller scale studies. But we wanted to get actual patient reported data on the prevalence of this financial toxicity and in a wide variety of cancers. But we also really wanted to look and see other things. How did it impact health services? Basically what are targets that we could intervene on to try to improve this? And so really with this study, what we did was we went into the clinics of all of the oncology clinics at UNC, and we embedded researchers in there and approached pretty much any patient that came to the clinic. Wildly successful actually, we had over 52% of our approached individuals actually enrolled in our study. And then within two weeks of that enrollment, we had interviews conducted by our staff using basically a computer assisted telephone interview. Now as I said, this was part of a much larger project. And what we were trying to do was basically get this comprehensive database of both clinical and interview data. And then we paired that with biologic specimens and tumor tissue. However, our piece of it was we were really trying to delve down on this financial question and then look at quality of life and how it impacted their care. Are their existing instruments that look at financial toxicity? Or is this built into existing PRO surveys? At the time when we started this, there actually was not. Dr. De Souza at the University of Chicago actually developed the cost measure, basically posted that after we had started with us. Having said that, and I love the cost measure. I think it's a fantastic. It's a nine question survey basically looking at grading financial toxicity. One of the things that we really were hoping to do with our primitive attempts at this was to find maybe one question things we can do in a busy clinic to try to identify high risk populations. And so with this one what we used was actually a statement from the PSUA team, which was, you have to pay for more medical care than you can afford. And then patients were asked to respond to the statement basically strongly agree, agree, uncertain, disagree, or strongly disagree. And we dichotomized them as basically exhibiting financial toxicity if you strongly or agreed with that statement, or not exhibiting financial toxicity with any other response. That sounds like a pretty clear and straightforward question. Was there like a free form portion where they could talk about, did this affect their ability to take their medicines, or go to doctor visits, things like that? There was. And we actually did a couple of different things. So we both did standardized questionnaires, so we did things like the fact GP, which is looking at multiple facets of patient well-being. We also looked at other health related quality of life issues. We also had developed our own access to health care questionnaire, which was looking at certain things like, were you having problems getting to your appointments? Are you being able to pay for your medications? We did several questions about paying for lab tests, paying for office visits. And then also, we really wanted to make sure that we knew if the reason you were missing these things was because of cost, or if there were other reasons. Because obviously, we don't want to attribute this all to cost if that's not what's causing the harm. OK, yeah. So it sounds like a lot of information gathered. So what did you find? In our study, we had almost 2,000 participants. And we had over a quarter, so 26% agreed or strongly agreed that they had to pay more for medical care than they could afford, which is in line with other studies. I would have thought it might have been higher than that. But it sounds like this is a nice validation that your survey was a pretty accurate instrument, even with such a simple question. Unfortunately, what we found is that when you take this population, the population that tells us that they are having financial toxicity by our definition, what we were finding was much higher rates of noncompliance. And that was a very scary thing when you're talking about cancer patients. Our patients who had reported financial toxicity were much more likely to report needing but unable to afford prescriptions, over-the-counter medications. They were also reporting noncompliance due to cost concerns for medical care like doctor's visits, medical tests, mental health care. All these things for the majority of patients undergoing active chemo is a really scary thing. And there's been some really good research in this area recently. There was a recent study where they were looking at imatinib and CML, and it found that individuals who had copayments greater than $53 a month were 70% more likely to discontinue within six months. So it's real world implications of this concept. Absolutely. And were there any other factors that were associated with financial toxicity, things that you might be able to use to screen or predict for this? In terms of the predictor, we basically validated what it had been thought of before, which is that there were certain factors that seem to be more predictive for exhibiting financial toxicity. The ones that we really know of are age less than 65 years, being non-white race, less education. All of those things had been previously described. It was nice to see with a large population model that we could validate those findings that would have been found in smaller studies. But it does seem that those patients are at much higher risk for financial difficulties. Yeah, and the less than 65 is interesting to me. So I assume that that's probably related to Medicare coverage, that that somehow makes it less of a financial burden. That's what it looks like. And I think that, obviously, Medicare is a nice protection for a lot of our patients over the age of 65, in that they don't see a lot of some of the costs our younger patients, especially our underinsured patients see. However, there was a recent study where individuals with cancer that were insured by Medicare alone were incurring mean out-of-pocket costs that were 1/4 of their household income. So I would say even though they have probably less bills for a lot of those patients, they're on fixed income. There is not other income coming in. So a lot of the folks over the age of 65 are still having financial toxicity even with the better insurance

Dr. Pennell and Dr. Schapira discuss the risks and benefits of online communities and provide recommendations for improving communication between clinicians and patients about the use of online resources.   Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic and Consultant Editor for the JOP. So it won't be news to any of the listeners of this podcast that living with cancer and dealing with the sequelae of cancer treatment is a terribly stressful proposition and that cancer patients and their caregivers benefit from support services and survivorship programs. Most of us, however, think of providing these support services for cancer patients in terms of in-person interventions, but increasingly, people are looking online for these kinds of support. I suppose that's probably true for many other aspects of our lives as well. Online communities have been forming in an effort to improve access to support for cancer survivors. But how much do we really know about these communities, and what evidence is there that they are genuinely helpful? Joining me today to talk about this fascinating topic is Dr. Lidia Schapira, Associate Professor of Medicine at the Stanford University Medical Center and Director of Cancer Survivorship at the Stanford Comprehensive Cancer Institute. Dr. Schapira is also the Editor in Chief of ASCO's patient information website, cancer.net, and is a fellow of ASCO. Today we'll be discussing her paper titled Online Communities as Sources of Peer Support for People Living With Cancer-- A Commentary. Lidia, thanks so much for joining me today. Thank you so much for the invitation. So first, this is obviously too big a topic for this podcast, but explain a little bit about why cancer support services in survivorship is important for cancer survivors. And I guess more importantly, where is there an unmet need, that people might need to seek that somewhere else, such as online? Sure. So we think of support as something that is delivered in person. And certainly in traditional medical settings, we offer support, I hope, through empathic communication, through referrals to social services, through programs. We are very much aware that going through cancer alone is much harder and that support is both important just strategically to get through it but also emotionally. I think that increasingly we also realize that people are seeking support in other ways that are not traditional and have been less well studied, and that's where the online services and supports really are playing a very important, an increasingly important, role for many patients and caregivers as well. This is coming up actually a lot among patients of mine, especially younger patients. So can you just tell us a little bit, when we talk about an online community, what exactly is that? So there are two words and each one is really important here. Community means, really, a group, so it's not just a one time exchange, but belonging to something, a sense of belonging to a group. And the group shares a common interest. In this case it's something related to cancer. And online refers to where this group, or this community, meets. It could be through instant messaging. It could be through other new media or platforms. It could be through email. It could be through a website. And that is going to change as technologies change. What we're basically saying as a way of meeting people not in person but meeting over time and through a shared expressed common interest. And there's lots of different examples of kinds of online communities that you described in your paper. Can you tell us a little bit about them? I know that there's some that are a little bit more formal and structured and others that are really kind of left up to the patients to moderate themselves. Exactly. And to somebody who is not a digital native, like myself, this has been a real interesting process of discovery. We tend to think, perhaps incorrectly, that online means improvised, and it's anything but improvised. A good online community that is mature, that keeps the interest of its members over time, requires some management, requires some decision, requires some effort on the part of the people who are starting the community. And so we learned that there are different types. There are different media. Some have actually some formal facilitation with social workers and really function similarly to the way an in-person support group functions. And some are much more informal, people sort of coming together. So there are some online communities that are sort of offered through large advocacy organizations like the American Cancer Society or CancerCare. And there are others that are not, and those typically occur in spaces like Twitter or Facebook. And now there are even some privately sponsored online communities such as Smart Patients. And we reference Smart Patients because their headquarters are in Mountain View, California, and we got to do a visit and really learn a lot about them just, again, to get a better understanding of what's available for our patients. Well it's nice that there's so many different options. How do patients even find these? Do you know? I think patients just find information in ways that come naturally to them. There are lots of groups for young cancer patients and survivors that have fun names, Stupid Cancer and so on, that are terrific. And there are some that are more formal through other societies. Facebook and Twitter are probably places that people go to, and they're just basically looking for others with a shared diagnosis. And so it's hard for me to answer that. It depends a little bit on how familiar people are searching for things and then what pops up when they are actually looking for something. And one of the things that, as an experienced oncologist, I always worry about is how safe they are. I think what first comes to mind is, oh my goodness, people may be misinformed, or they may have exaggerated ideas about one treatment or so on just by asking these questions without really doing some formal research. But it's amazing actually how much good information is also transmitted through these very informal groups, some of which are absolutely not monitored. But people just really push each other to learn and to look for information in addition to giving each other support. When we started this, the driving question that I had-- and my co-author was then a chief resident at Stanford and is now an oncology fellow. The question we had was really, are people looking for information about cancer and cancer treatment, or are people really looking to connect with each other and help each other through a difficult experience? And what we found actually is that it's both, and it was very difficult to tease out where the good information becomes also a source of support. I would say that this sounds wonderful, and taking it at face value is probably fine. But because we are academics, we always look for data. And so is there actual data? Are there studies on the benefits and risks of patients participating in these online communities? Unfortunately, I would say there is little rigorous data. We looked for it, and we were hoping to be able to find sufficient numbers of well-designed randomized controlled trials or other good trial designs where we could actually study this. And one of the things we are interested in is, of course, is it safe? And also, if it is helpful, in what way is it helpful? I mean, do people cope better? Do people feel that they're better able to handle their illness, in other words? Could we find measures of self-efficacy or coping or information or something that was measurable? And we found many studies done but, unfortunately, few that were of high quality and few that were high quality and relevant to cancer. So what we found was actually not sufficient to come up with either a sound recommendation or to go a little deeper and do a systematic review or some more rigorous review of evidence. Yeah, it's interesting. You cite in your paper a few studies that have shown some improvement, at least in things like self-efficacy and decreasing anxiety or at least perceived improvements in these, and then some that are worse and many that really don't seem to show a significant difference. Is that something that you think can change? Are there plans to do more rigorous research? Our group has actually been very interested in trying to find the proper design for a study. And we've brought together social scientists, mental health scientists, and oncologists, and people who really understand the technologies, and we're trying to figure out how one could possibly study it. We think it needs to be done, and I'd be delighted to collaborate with others who are looking into this. I mean, we know social media can help patients find each other or find, perhaps, centers where they're doing research. Certainly, patients with rare diseases find that it's a very useful way of connecting with others. But what we were really interested also in trying to identify how much-- what is the dose of social media? What is the best venue? Is there a way of matching a patient to group so that he or she may find what they're looking for, and when is this benefit transmitted? Our hunch is that it's probably early on in the cancer experience that people derive the greatest benefit from feeling connected and that what actually happens is that they feel some validation. They feel better able to handle it. They actually learn how to ask better questions. But it would be wonderful if we could actually find a way of studying it. As you may well imagine, it's hard to study something that people are already doing, so finding the proper study design and population is what I think is keeping us still from being able to answer these questions. Sure. So when you see a patient w

Dr. Pennell and Dr. Nancy Lin discuss whether prior authorizations reduce overall health expenditures. Read the related article "Increasing Burden of Prior Authorizations in the Delivery of Oncology Care in the United States" on JOP.   Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, we're going to talk about a topic that I think is going to resonate with just about every clinical oncologist in America-- prior authorizations. Although these have been around for longer than I've been practicing, it really seemed to me over the last couple of years that more and more claims have been denied by insurance companies, more requirements for prior authorizations, and often for things that really didn't seem like they used to need prior authorizations, such as inexpensive medications. And now, based on data from the 2017 ASCO Oncology Practice Survey, we have some hard data that isn't just my imagination. This is a real phenomenon that is putting stress on an already stressed health system. Joining me today to talk about this topic is Dr. Nancy Lin, associate professor of medicine at Harvard Medical School and director of the Metastatic Breast Cancer Program at the Dana-Farber Cancer Institute in Boston. She's going to discuss her and her co-author's editorial titled "The Increasing Burden of Prior Authorizations in the Delivery of Oncology Care in the United States." For 2018, the JOP is publishing a series of papers on the state of cancer care in America, and this is part of that series. Welcome, Nancy. Thanks for joining me. Thank you. I know probably most people listening to this are familiar with prior authorizations. But can you talk just a little bit about, what is the intended purpose of prior authorizations? And is this something that ever made sense before the current craziness? Sure. Before I start, I would just like to acknowledge my co-authors on this editorial, Harvey Bichkoff, the CEO of Marin Cancer Care, and Dr. Michael Hassett, a medical oncologist at Dana-Farber. So together, we run the spectrum between academic oncologists, community practices, as well as Dr. Hassett has an interest in health policy-- so kind of running the gamut of interests here. You know, I think we can all agree that the cost of cancer care continues to increase-- I don't think that's a controversy at all-- and that continuation along this trajectory is not sustainable in the long term. So insurers, whether they are public or private, are struggling to keep premiums down while keeping up with all the new advances in diagnostics and treatments, and many of these are quite expensive. So, you think prior authorizations came out of this, which is that an attempt to try to maintain some cost containment in a way that, at least at the outset, the hope was that this would be in a fashion that would lead to the use of treatments in a medically indicated fashion and reduce the use of non-indicated treatments. That sort of makes sense, doesn't it? If people are doing things that don't have a lot of data behind them or are using the most trendy, expensive test or medication, it might actually make sense to have some control to make sure that they're following some reasonable practice or guideline. Yeah, I don't think that what is most upsetting oncologists, or oncology nurses, or front-line staff is denial of unproven or unuseful treatments. I think it's really the many and what seems to be increasing hoops that one needs to jump through in order to get testing or treatments that are really the right thing to do for patients that are really well within the standard of care. So while the PA system might have started with good intentions, I think as it is often currently constituted-- I don't want to lump all the systems together in one. But I think it contributes in a way to sort of a siege mentality. So I think if you talk to any practicing oncologist, you will hear stories of the kinds of struggles they have had getting very standard treatments approved in a timely fashion. And while in the short term, most of us make these heroic efforts to get things approved, I think that process really as set up is really counterproductive in terms of the long-term health of our health care system. So at the institution I work with at Dana-Farber, we tried to actually do a project where we quantified some of these kind of gestalt feelings. And so what we did is we actually looked at all prior authorizations for outpatient medications originating from the breast medical oncology practice over a six-month period of time. And we focused only on outpatient medication. So we're not talking about scan authorizations or IV chemotherapy but just outpatient oral medications, whether antineoplastic or not. And we found that we had to process over 300 PAs over a six-month period of time and that 97% of the PAs that were requested were approved on the very first try. We went back, and we coded whether the medications were being prescribed in accordance to NCCN guidelines. And yes, most of the time they were. And strikingly, we actually found that 15% of our PA requests were for generic medicines, like tamoxifen, aromatase inhibitors. These are medicines where there's just absolutely no debate about the efficacy or importance of the treatments. They've been around forever-- maybe not forever, but for many, many years. They're available in generic form. They're inexpensive. And then seemingly random treatments, no matter how much we appealed, we couldn't get through the PA process. And this includes a scopolamine patch for refractory chemotherapy-induced nausea or Lupron for the purpose of ovarian suppression. And I think that when clinicians deal with this on a daily basis, they see that almost 98% of their prior auths go through the first time, that you get these sort of bizarre requests for all sorts of paperwork for tamoxifen, for goodness sakes. It really gives a sense of being besieged by paperwork and process and not really being able to see a clear benefit of the PA system. And I think that really is what contributes to this burnout and the sense that the prior authorization process is broken. And it's not just your colleagues in Boston. I know, certainly, I've had that sensation here. But now we have some national data suggesting this is a problem being felt everywhere. I know that the most recent ASCO practice census, and maybe you could give us a little background on what that is, seems to show that this is a burden everywhere. ASCO actually conducted an oncology practice survey. So they've surveyed about 395 practices in 2017. This actually represented about almost 60% of the US hematology-oncology workforce. So was is a pretty big survey. There were 7,200-or-so respondents. And what was found, the key point was that payer pressures were actually the most important pressure that was felt by practices. And this was felt across all types of practices-- academic, physician-owned, rural, urban-- and that prior authorizations were actually the most commonly cited pain point, and they were cited by 78% of the respondents. So this is really something that people are feeling, truly, on a daily basis. And this is not limited just to oncology. There was a related survey by the American Medical Association. This covered not only medical oncology but primary care and other specialties and, basically, found very similar findings. Prior authorizations are a huge burden on practices. In fact, in the AMA survey, 90% of practices reported delays in care because of PAs. Almost 80% abandoned treatment plans at least some of the time because the PA is too burdensome. So these are things that have direct effects on patients. Oh, absolutely. And I think what was striking to me about the practice censuses, you may think this has always been a major issue, but this is a real change in the most recent year's survey. It was, I think, the third or fourth top concern of practices until this survey where, suddenly, it's now far and away the top burden on practices. And there is also some data I see here looking at quantifying the amount of time that it's taking staff and money, that practices are having to invest in trying to work around this pretty significant burden. There are some studies that suggest that US practices spend nearly four times as much money interacting with payers than do practices, for example, in Canada, which has obviously a very different health care model. In some studies, the costs have been estimated somewhere in the $80,000 to $90,000 per 1.0 full-time FTE physician per year just to deal with prior authorization. And in the ASCO survey, the 2017 survey, the [? hema ?] practices that were surveyed reported a requirement for an average of 6.1 FTE staff to manage prior authorization. So that's a huge burden. And I think what's important is that, more importantly than sort of the-- obviously, there's a bottom line to practices. You have to pay for these FTE. But the reality is that leaves practices to have to make decisions about how they're going to allocate their money, right? So how much are you going to support a social worker, a program nurse, a practice coordinator? How much are you going to support all of the staff required for PAs? And what proportion of the front-line physician staff, nurse practitioner staff, PA staff will be spent during office hours-- because, often, that's when one needs to do these-- interacting with payers versus providing direct patient care? So I think that this doesn't all happen in a vacuum, and that's also very important. And when you spend money in one place, you're making trade-offs in other places. Oh, absolutely. It's something that no one can ignore now. Do you know, is their actual data showing that all of these denials and prior auths, does that actually save money in health care?