JCO Oncology Practice podcast

Player FM - Internet Radio Done Right

137 subscribers

Dodano thirteen lat temu

Treść dostarczona przez ASCO Journals and American Society of Clinical Oncology (ASCO). Cała zawartość podcastów, w tym odcinki, grafika i opisy podcastów, jest przesyłana i udostępniana bezpośrednio przez ASCO Journals and American Society of Clinical Oncology (ASCO) lub jego partnera na platformie podcastów. Jeśli uważasz, że ktoś wykorzystuje Twoje dzieło chronione prawem autorskim bez Twojej zgody, możesz postępować zgodnie z procedurą opisaną tutaj https://pl.player.fm/legal.

State Secrets: Inside The Making Of The Electric State

1
Family Secrets: Chris Pratt & Millie Bobby Brown Share Stories From Set 22:08

23 dni temu22:08

Na później

Listy

Polub

Polubione

22:08

Host Francesca Amiker sits down with directors Joe and Anthony Russo, producer Angela Russo-Otstot, stars Millie Bobby Brown and Chris Pratt, and more to uncover how family was the key to building the emotional core of The Electric State . From the Russos’ own experiences growing up in a large Italian family to the film’s central relationship between Michelle and her robot brother Kid Cosmo, family relationships both on and off of the set were the key to bringing The Electric State to life. Listen to more from Netflix Podcasts . State Secrets: Inside the Making of The Electric State is produced by Netflix and Treefort Media.…

JCO Oncology Practice Podcast

Udostępnij

Źródło serii•Feed

JCO OP: Put Into Practice highlights new research published in JCO OP related to cancer care delivery, quality, disparities, access. Host Dr. Fumiko Chino, MD FASCO interviews thought leaders in oncology to give listeners practical knowledge that can be used in day-to-day practice along with solution-oriented discussions and care innovations.

94 odcinków

#Oncology #Fitness #Cancer Care #American Society of Clinical Oncology (ASCO #Science #Medicine #ASCO Journals

JCO Oncology Practice Podcast

137 subscribers

updated 20 dni temu

Udostępnij

Źródło serii•Feed

94 odcinków

#Oncology #Fitness #Cancer Care #American Society of Clinical Oncology (ASCO #Science #Medicine #ASCO Journals

Wszystkie odcinki

1
Prior Authorization: How Did We Get Here and Where Are We Going? 32:05

20 dni temu32:05

32:05

Dr. Chino discusses the past, present, and future of prior authorization in cancer care with Dr. Michael Anne Kyle, a health policy expert with a research focus on utilization management and patient burdens from prior auth. TRANSCRIPT Dr. Fumiko Chino: Hello and welcome to Put Into Practice , the podcast for the JCO Oncology Practice . I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity. On today's episode we'll be discussing prior authorization in cancer care. Prior auth has been a recent focus of healthcare policy and reform, given rising demands seen by both providers and patients. I'm excited to welcome an expert on prior authorization to the podcast today. Dr. Michael Anne Kyle is an Assistant Professor in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at UPenn. Her work focuses on defining and measuring patient administrative burden in cancer care delivery with a focus on prior authorization and how it impacts cancer care delivery, including patient wellbeing and outcomes. She holds a Ph.D. from the Harvard Business School, an MPH from the Harvard T.H. Chan School of Public Health, and a Master's in Nursing from the UPenn. Our full disclosures are available in the transcript of this episode, and we've all already agreed to go by our first names for the podcast today. Michael Anne, it's so great to speak with you today. Dr. Michael Anne Kyle: It is so great to speak with you too, Fumiko. I'm really excited about this conversation and our shared interest in improving prior authorization. Dr. Fumiko Chino: I love it that you've taken time out of your day to talk to me. To start us off, can you tell us a little bit about yourself and your career? How did you transition from being a nurse into a health policy researcher? Did you always plan on a career in research or was there some specific event or transition that put you on this path? Dr. Michael Anne Kyle: There was not. And so for anyone who's listening, who isn't sure what they want to do, I guess I have a good story to show that you actually don't need to know in advance. I started out as a critical care nurse and I still actually work as a critical care nurse. But as I think anyone who is a clinician who's listening to this knows, when you work in the healthcare system you just see so many things that could be different, that could be better. You notice the ways that the systems like really aren't set up for us to do our work or to take great care of our patients some of the time. And so that's really what sparked my interest in policy and in research. So I had really no background. After working in a hospital, high acuity critical care, a lot of oncology, I spent several years working in community-based programs in New Jersey and this is before the Affordable Care Act. We were focused on access to medication, trying to get people more access to Medicaid, and did work around the initial rollout of the Affordable Care Act. And that experience where I spent a lot of time helping people enroll in social programs really gave me like some of the first insights into how much paperwork and how much time and how tedious it is to figure a lot of this out, even if you had someone helping you it’s still challenging. And that sort of stayed in the back of my mind as I went to grad school. And really what got me interested in like all the non-medical side of patient care is just like my friends and my family talking to me about it. And I think it's something we all just experience in our lives, but there just wasn't a ton of research. And so I've really been motivated to try to put some, like, numbers and evidence beside all these experiences that we know very deeply. Dr. Fumiko Chino: So what I'm hearing is that you learned yourself by doing the work, how difficult the work was to actually obtain services for your patients, and so you decided you needed to go upstream to try to address some of the policies that were fundamentally broken, causing these horrible situations for your patients. Dr. Michael Anne Kyle: So well said. Yes. Dr. Fumiko Chino: Now, I heard that you just moved from Boston to Philly. How's that transition going? Dr. Michael Anne Kyle: It's great, it's great. Many of the same familiar faces and also exciting to meet new people, learn new things, try new restaurants. So yeah, overall I feel very lucky. Dr. Fumiko Chino: Well, with that background, we need to dive into our actual topic, which is prior authorization. It's unlikely that anyone listening to this podcast has not encountered prior authorization in their practice or due to interactions with insurance for themselves or for their family members. Can you give me a quick overview about prior authorization? What it is, what it is not, how did we get here? Dr. Michael Anne Kyle: Oh, so every healthcare system needs some sort of coverage policy. What services are we going to cover and at what cost? And there's many ways to do this. There are countries that sort of set this up nationally. Here in the US, we do not do that. We do it prescription by prescription, and that's how we end up with prior authorization. So basically, prior authorization is a request you submit to get approval for coverage for a drug or a service that you want to give your patient. And so you may need to submit, and again, I'm sure everyone listening knows this well, but it can range for something very quick like, “Yes, this person has like the genetic target for this drug. Check, they can have it,” or it can be a more complex, protracted exchange. That is the sort of intellectual side of this. And I want to separate that from like the actual decision making from the other huge piece of prior authorization, which is how we operate it. And that is the bureaucracy and the fax machines and the time on hold, which has a separate bucket of problems. And so I just want to sort of carve out those two categories when I think about prior auth and what we need to do. Dr. Fumiko Chino: One thing I always try to say is that even with prior authorization, even when it is working as functions, it is itself not a guarantee that a claim is even going to be approved. You can obtain prior authorization and then still face a denial for the actual claim, which is even more frustrating. And I think this kind of cumulative burden of suffering seems to me to be at an all-time peak. So can you give me a little bit of background about how the US healthcare system evolved to include prior authorization? Like why does this really even exist? Dr. Michael Anne Kyle: Great question, and you'll get a different answer depending on who you ask. But overall, we need as a society to make a decision about the services that we are going to provide to one another. There's many different elements to that decision. One of the challenges in the United States is that we have little to no policy around cost. So when our healthcare can cost an unlimited amount, that makes it higher stakes and a trade-off is that there can be other restrictions on access. So we really don't have any constraints on cost in the U.S. other than administrative tools like prior authorization. And so that leads us to use it, I think, in ways it wasn't designed for, because there is a clinical use of prior authorization that's very appropriate, that we are doing complex things with patients that may or may not be a good fit, and we really want to figure out if this is the right match. That is separate from healthcare is very expensive and unaffordable and we have no way to try and solve that problem except to try and put more restrictions in place, like making people go through a bunch of approvals and either discouraging them from going through that process or, you know, causing attrition through the process. So I think one big element to how did we get here has to do with healthcare being very expensive and I think that dominates our minds. And I think there are other rationales for prior authorization that are very appropriate. But I think to your point, it's hard right now to see the times where it makes sense to go through this review process because so often you're experiencing prior authorization for treatments and medications where it just doesn't make any sense. Dr. Fumiko Chino: One thing I've heard you speak before about is the Medicare Part D protected status that requires coverage for all or substantially all of drugs in the anti-cancer therapy treatment. Do you mind speaking a little bit about how that affects utilization management? Dr. Michael Anne Kyle: Yes, great point. So one of like the most strictest restrictions you could put is exclusion - so you could just not cover a drug or a service. And we often don't think of that as a coverage restriction, but of course it is. But as you said, there are certain types of treatments and services where we have put in place policies to prevent exclusions because we thought these were important treatments and we didn't want them to be excluded from coverage. And in the Medicare program in Part D, which is the outpatient drug benefit, there are several categories of medications that are protected classes, and one of them is oncology drugs. So that means oncology drugs cannot be excluded from the Medicare Part D program unless there's a substitute. Like for example, if the drug goes generic, you could just cover the generic, but otherwise you have to cover everything. So that means that the only mechanism available to try and influence decision making and influence utilization is prior authorization. And that, I think, contributes to why we see such tremendously high rates of prior auth in oncology drugs in particular. Dr. Fumiko Chino: So you're saying that a policy that was put in place in theory to help protect people with cancer may actually be placing disproportionate burden on them? Dr. Michael Anne Kyle: Yes. Dr. Fumiko Chino: Ironic. Dr. Michael Anne Kyle: Yes. Dr. Fumiko Chino: Virtually all patients and providers that I have talked to have felt like prior authorization has gotten worse in the last five years. Is this just a feeling or an emotion or does the data support that we're dealing with higher prior auth burdens more than ever before? Dr. Michael Anne Kyle: Yes. So I think one reason prior authorization has come to the forefront of people's attention is because the prevalence is increasing. The reason for that seems largely to be driven by some larger changes in coverage, notably increase in managed care. So most of the Medicaid program is now in Medicaid managed care. In Medicare for older adults, Medicare Advantage is now a huge proportion of that program. So as managed care coverage becomes more prevalent, with that comes more utilization management tools. So then you face it more and more in your clinical practice and for your patients. So that's one major driver. And then the other thing is that as the cost of drugs goes up, so does the effort to contain costs. Dr. Fumiko Chino: The downward pressure for cost management. Dr. Michael Anne Kyle: Exactly. Dr. Fumiko Chino: Now, you said managed care. And I just want to clarify for our audience, when you say manage Medicare or managed Medicaid, what do you mean? Dr. Michael Anne Kyle: Thank you for reminding me to clarify. So in the sort of classic Medicaid or Medicare programs, or how insurance used to be when those programs first started in the 1960s, is, you know, you would like get your insurance card and you can just go around to anyone who takes that insurance. Managed care is just like a more active type of insurance where you'll have like a defined network - these are the doctors who are in your plan that you can go see, otherwise, you have to go out of network or these are the services that are covered, or these are the drugs that are covered. So managed care basically means the insurance company is taking a much more active role in the design of the benefit and so then that's why you'll see more utilization management. Dr. Fumiko Chino: So instead of, for example, straight state Medicaid, which would be a state provided, federally funded plan, it's a private company who's actually providing those services through a contract through the state. Dr. Michael Anne Kyle: Yeah. Dr. Fumiko Chino: And similarly for Medicare Advantage plans, it's a private company who has decided to take the money from the federal government and then ends up providing your health care as someone who's over 65 who signed up for an MA plan. Dr. Michael Anne Kyle: Yes. And there's two reasons that contracting ends up happening. One is that it's easier for budgeting purposes for the state, just kind of like issuing a contract. But the other thing is that states don't have the capacity to administer complex benefits. And so there aren't really like people to implement prior authorization or this type of complexity, like in the government itself. And so that's why we tend to see these kinds of practices more in insurance companies. Dr. Fumiko Chino: Yeah, I was shocked. You know, one of the great wins of the, for example, Affordable Care Act was expansion of Medicaid, which seems great, you know, to provide health insurance to more people. But then along with that came the rise of the managed Medicaid programs, which is essentially, it sounds like states kind of got overwhelmed and could no longer manage their patients on Medicaid. Does that seem accurate? Dr. Michael Anne Kyle: I think there's a couple of things. So one, this is the time period when I was still working in a lot of like, on the ground Medicaid public health work. So Medicaid expansion happens like still kind of in the aftermath of the Great Recession. So there had been tremendous layoffs in like, reductions in state capacity, while at the same time there was this huge expansion and like their scope of work. And so I think like a lot of the reason that managed care arose was that like they're just, you know, there had been these huge layoffs and there weren't people left in the Department of Health or in the Medicaid office. And so it was necessary to bring in external partners because the government had been understaffed. Dr. Fumiko Chino: It's such a good point. I actually love this little bit of history you taught me because I'm always trying to tie the red thread to the red thread. Like this policy led to this either benefit or deficit. And I think, you know, stepping back one click further to say this was the environment in which these policies were enacted is so helpful when we put these things in context. It has like the benefit of talking with someone who's really a policy expert, that really helps me understand these things better. Now, most of the data on prioritization has been really physician survey data. It shows that we hate it, it wastes our time, it increases staff allocation, it causes endless frustrations for us. Now, your work has mostly been focused on the burden on patients. Can you share what research has shown about this? Dr. Michael Anne Kyle: I decided to focus on patients because there was just no evidence. And so there's not a ton, but there is some evidence about the experience of physicians, and everything you said is spot on. But my work finds that like you think that the pie is just what the physicians are dealing with or what the health system is dealing with, but actually like the pie is even bigger because there's this whole other chunk of work that patients are doing that we haven't really accounted for. Because of course you are spending your time after hours on hold, doing peer to peers, but at the same time, like letters are getting sent to the patient's house and they're trying to figure out what does this mean and they're also making phone calls, trying to understand what happened. So I started this work with a national survey of adults 18 to 64 who are insured. This is just like people off the street, like not necessarily any particular health issues. And 1 in 4 people said they had delayed or foregone care in the past 12 months due to an administrative barrier. And one of those barriers was prior authorization that patients reported. And the structure of that question is the same as the way we ask questions about access barriers related to cost. And so the magnitude of barriers related to these administrative burdens is about the same as the barriers that people are reporting related to cost. And I think that's really important because we all have this sense that it's a hassle or a problem. I think it's only recently that we're understanding that it's not just frustrating, that it actually really does affect access. So that was like one step. Then I have another piece of work building on that where I thought, okay, so patients are reporting that this is a problem and candidly that's sufficient because they're stressed and they don't feel well. But I looked at oral anti-cancer drugs and said, “Okay, like can we observe in data this phenomenon that patients are reporting that they're having issues with delayed and foregone care?” One of the challenges with claims data is you only see the claims that got billed. So we can't even see the people who got a prescription and never filled it. And I'm sure that you have many personal experiences of that with your patients and so do many of the people listening. But I'm not even able to see that in claims. So I just looked at people who were already taking a medication, already taking an oral anti-cancer medication. So we think, “Okay, they're consistently filling it so we know they're like on this regimen, and then their plan introduces a new prior auth policy on that drug and what happens to them?” And we find that people do experience delays in foregone care, that people with a new prior auth introduced on this drug they were taking have an average of a seven-day delay in their next fill after the prior auth, and that they have about seven times the odds of never filling that again. And this is for people, remember they're already taking this medication, which means they're connected to care, they have a doctor who's following them and there are policies saying in Medicare, and so this is in the Medicare population and there are Medicare policies which say, you know, you're supposed to just like roll people into coverage. If they already are on this medication and there's a prior auth, you're just supposed to continue and not impose a new prior auth on them. And that may be true, but in practice that policy isn't working because there's a delay of some kind. We don't really know what's happening in that time. We just know there's a disruption. And whether it's because they have to do a prior auth anyway or they found out they didn't need a prior auth, the point is like there's an administrative barrier that's arising for people who are then not taking their imatinibs, not taking their erlotinibs, not taking their abiraterone. So like it's really concerning and that does not get us to health effects. One of the challenges in studying health effects is that the sample sizes get smaller and smaller and it's hard to attribute outcomes, especially for people with complex illnesses, to like one particular event or one particular cause. So that's something that sort of remains on my bucket list and hopefully on other researchers' bucket lists. But I think that you as a physician and the other people listening get a contextual sense that these are drugs that you really shouldn't be going off without, like a planned clinical reason. Dr. Fumiko Chino: You know, the research that you just discussed was published last year in JCO , and I remember when I was talking to you about the study that you said something along the lines of you couldn't do an updated analysis now because this was a plan that didn't have a prior auth, that now needs a prior auth. And so you were looking at these transition points, whereas, by the end of the study period, basically every single plan had prior auths. Dr. Michael Anne Kyle: Yes. So that study we looked at data from 2010 to 2020, I believe, or 2021. But most of these switches of like introducing new prior auths were happening in the first five years, usually before 2015, 2016. So I was trying to look at newer drugs like you said, but they're all coming onto the market with prior auth, and I can't study the new stuff because there's no variation to study. So thank you for mentioning that. Dr. Fumiko Chino: So you can't document the harm of prior authorization because the best case scenario of no prior authorization doesn't exist. Dr. Michael Anne Kyle: It's getting rarer and rarer for the oral cancer drugs, that's for sure. Dr. Fumiko Chino: Now transitioning a little bit, there were many people, myself included, that were anticipating that prior authorization reform would make it into the lame duck session closing out 2024. Do you have any policy updates or insight into this? Dr. Michael Anne Kyle: So I think the updated Improving Seniors’ Timely Access to Care Act, I've been following that for a couple of years and I think the latest iteration is quite good. It really focuses on these, like, administrative improvements that I think are really an urgent priority because there's no reason that we need to be having all these hassles with paperwork in 2025. I just want to mention this bill includes actual phrasing like a facsimile does not count as electronic documentation. And I was thrilled to see that. So what I like about this bill, and I hope it will survive and endure, is that it speaks to a bunch of priorities that I think are important. One, everything needs to be automated or everything needs to be electronic. We’re still doing way too much fax, way too much paper. The bill doesn't mention whether the electronic requirement includes appeals, and it really should. If I was going to have one strong piece of feedback, it must, because I'm concerned that if we make the initial application process online, it'll just get denied and then appeals will be on paper and then we'll be back to square one. It also will really increase reporting and data access which will be helpful. One of the challenges in studying prior auth is that it's hard to get good data. Like I said, claims data, we only see things that were billed. We don't really have a great sense of payer policies. And this bill would require reporting from payers to say like what their prior authorization requirements are, denials, appeals, grievances and so on, which will be very helpful. Although I want to highlight on this point, there's some new work on billing, which I don't think will come as a surprise to any of us that there are unfortunately inequities in the appeals process. And so this is work by Alex Hoagland and Michal Horny and colleagues and they looked at preventive services which are supposed to be covered under the Affordable Care Act. So you have some like objective sense of what the bill should look like. And they look at errors and then they look at appeals. And there are inequities by race, there are inequities by education and income in who is even appealing an erroneous bill and then how successful you are in appeal. And so while I think more transparency throughout this process is great, I remain concerned that like relying on patients and physicians to recognize and initiate appeals places disproportionate burden on our patients who can least afford it. Dr. Fumiko Chino: I was personally very disappointed that the Improving Seniors’ Timely Access to Care Act, which is the world's longest House and Senate bill title, wasn't part of the end of year spending package. I was really hoping we could pass it through the finish line, especially because it has a zero-cost dollar from the CBO, which was a major point of resistance before. And I know this is something that both our ASCO and ASTRO, our large societies for oncologists, have really been trying to rally support around consistently and it really does seem to have bipartisan support. So outside of federal legislation that did not make it into the spending package, how do we fix this? You know, I was rereading your New England Journal of Medicine 2023 Perspectives, highlighting some potential consequences and barriers to prior authorization reform. Can you discuss this as well as whatever specific federal, state, institutional policies or even really provider level advocacy that you feel like could get us out of this mess? Dr. Michael Anne Kyle: Sure. I still have hope for the Timely Access to Care Act because it's been kicking around for a few years and it keeps getting worked on, improved. So hopefully 2025 will be our year. The perspective that you're talking about refers to a CMS rule that at the time was open for comment but has since been passed and is scheduled to sort of go into service in 2026, 2027. And that incorporates a lot of the same elements as the Timely Access to Care Bill. So for example, it requires that these processes be electronic. Again, the question of appeals is a little bit vague, but making them electronic, requiring the reason for denials to be provided, providing paperwork to the patient and to the physician about the status of the application, and if it's denied or has a problem, why. There's a whole like IT element of this where there's a patient portal piece so that patients would also be able to log in and track the process themselves. On the one hand, I think that's nice for people who want to, you know, follow along. On the other hand, you know, if you don't feel well with cancer, ideally this should be getting addressed without you having to log in and check up on it. You could be like resting, recovering, enjoying your family. But overall, I think there's an understanding that we have to move away from this very analog process that we have now. So that I guess is going to come online starting in about 12 months. And then there's a bunch of work going on at the state level. Some states are requiring electronic PA, which I think is terrific. Throughout these bills, there's also some time deadlines on these decisions. So I think having a turnaround time, whether it's like 72 hours or seven days, whatever it is, I think it's good to put those into place. I worry about an unintended consequence will be that if they can't meet the deadline, they would just deny it and you would go to appeals. And again, coming back to my fixation on like, what does the appeals process look like, but I think overall it would be very helpful to have some like, better definition and better clarity. One thing I haven't seen in these, but I hope that policymakers and advocates will become interested in is I would really like to see some more standardization of these forms across payers. Obviously, the dream would be like standardization and actually like the parameters. But even if we can't get there at least like the paperwork could look the same because there's a lot of duplicated effort in filling out the forms and submitting these. This is really unnecessary, like it should all just look the same. And we keep reinventing the wheel which slows everybody down. And I think there's a huge policy opportunity there to promote standardization that if we have to do this, like at least it could be less painful. Dr. Fumiko Chino: Absolutely. And I always try to highlight when I think about state level legislation, things like Gold Card Acts to my knowledge have not included any cancer services as part of what you could be gold carded for. At least not, again, not that I'm aware of at the various states where they have passed Gold Card legislation, which is a promising way of facilitating approvals. But so far, cancer patients are still kind of left out of that. Have there been any institutional policies that you've noticed seem like they help with prior authorization? Dr. Michael Anne Kyle: No. And I think a lot about my research, like who my audience is and its organizational leaders and policymakers. And I would really like to see clinical organizations advocate for more standardization and more process improvement. I understand the emphasis on like we don't like prior auth and we want less, but I think there's an easier win in asking for this system to work better. And I'd love to see some of our health care organizations put their weight behind that. Dr. Fumiko Chino: I have to say, since transitioning institutions to MD Anderson, I've actually been very pleasantly surprised within our radiation oncology department how streamlined the process is. And I think it's because we had a motivated faculty member who went deep into the prior authorization process and why the plans were being denied, got all of the constraints that would trigger an approval and basically built them into our planning process. So it's been really streamlined, but it was a lot of investment upfront to kind of get it to the point where it is now. Well, I think we are wrapping up our time together. Do you have any last thoughts about prior authorization or have what we already said has it been disappointing enough? Dr. Michael Anne Kyle: Well, let me finish on a positive note. I think what's exciting about this is that we've spent many decades on trying to improve the cost challenges in healthcare. We have the Affordable Care Act. I don't think we've yet put the same effort into non-financial costs. And so I think there is a lot of hard, hard stuff ahead. But I think there's also a lot of these challenges I think exist because no one has looked at them yet. Like how much prior authorization is like a strategic decision? And I ask this to everyone, how much is it of it is a strategic decision versus how much is like the manual is lying in someone's cubicle and hasn't been updated in years and if only someone with decision making authority looked at it, they would be like, “Oh, yeah, you can take prior auth off it”? You know, like, I just think that there's a huge opportunity to do better here because we haven't paid it enough attention. So I think we should be hopeful and I want to do better for our patients. Like I want to feel prouder of the healthcare system that I'm a part of. Dr. Fumiko Chino: 100%. No, I love that. And that's a great hopeful end, which is that with data maybe we can start to work our way out of this. And so that's maybe a siren call for researchers coming online to think about galvanizing yourself to provide data as to what we can do to improve. Well, thank you so much for such a robust conversation today about such an important topic. So many thanks to both Dr. Kyle and to our listeners for your time today. For listeners that are interested in advocacy, I would encourage you to visit the ASCO ACT Network where you can send pre-drafted letters to your lawmakers on important legislative issues impacting cancer providers and their patients, things like prior authorization. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear from the JCO OP Put Into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. I hope that you'll join us next month for our next episode. Until then, keep fighting the good fight for our patients. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement. Guest’s Disclosures: Dr. Michael Anne Kyle No relationships to disclose.…

1
Optimizing the Electronic Health Record for Patient-Centered Cancer Care 38:55

7 weeks temu38:55

38:55

Dr. Fumiko Chino talks with Dr. Aditi Singh and patient advocate Liz Salmi about how this essential tool for documentation could be optimized to be more patient-centered. This discussion will be based off the JCO OP article published in late 2024, “ Re-Envisioning the Electronic Health Records to Optimize Patient-Centered Cancer Care, Quality, Surveillance, and Research ,” on which Dr. Singh served as the lead author. TRANSCRIPT Dr. Fumiko Chino: Hello and welcome to Put into Practice , the podcast for JCO Oncology Practice . I'm Dr. Fumiko Chino , an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity. On today's episode we'll be discussing our friend, the Electronic Medical Record and how this essential tool for documentation could be re-envisioned to be more patient centered. This discussion will be based off of a JCO OP article published in late 2024 called, “ Re-Envisioning the Electronic Health Records to Optimize Patient-Centered Cancer Care, Quality, Surveillance, and Research . ” I'm excited to welcome two guests, the first author, as well as a patient researcher advocate, to the podcast today. Both are passionate about improving how we use the EMR to communicate and provide care. Dr. Aditi Singh is an Assistant Professor in Clinical Medicine and Hematology Oncology with a focus on thoracic malignancies, particularly neuroendocrine tumors of the lung. She also serves as the Director of Clinical Informatics for the Abramson Cancer Center at the University of Pennsylvania. Her work focuses on optimizing the EHR to enhance provider efficiency and provide high quality cancer care. She also serves on the NCCN Guidelines Committee for non-small cell lung cancer, thymic malignancies and mesothelioma. Liz Salmi is the Communications Inpatient Initiatives Director for OpenNotes. In this role, she helps clinicians, hospitals and the health system understand the changing nature of patient-clinician communication in an era of growing transparency. As a person living with a malignant brain tumor, she is active in research and advocacy to ensure that the patient voice and patient-centered care is prioritized. Our full disclosures are available in the transcript of this episode. And we've all already agreed to go by our first names for this podcast today. Aditi and Liz, it's so great to speak with you today. I hope you guys are both staying warm. Dr. Aditi Singh: Hi. I'm very happy to be here. Liz Salmi: Thanks for having me back. Dr. Fumiko Chino: Our topic today is about how we make the electronic medical record more patient-centered. To start it off, I'd love to actually ask a hopefully non-controversial question to both of you. What is patient-centered care? How do you personally define it? Are there key characteristics or is it something that it's commonly mistaken for? Or is it like the Supreme Court's definition of pornography - ‘I know it when I see it’? Liz, do you want to take that first? Liz Salmi: Sure. Yeah. So, I've been living with a malignant brain tumor or a grade 2 astrocytoma for 17 years. And when I first got into this space, I'm a person with a communications background originally, so when I would hear that term, I'm like, “Yeah, of course, patient-centered care - like what were you doing before that?” And then in the last 11 years I've been working in healthcare and the last eight years specifically with the OpenNotes team at Beth Israel Deaconess Medical Center. So, when I would hear that term, I was like, “What were they doing before that?” Like still even more frustrated. So, it to me sounds like jargon, like a bad form of jargon. And I think that there's new words we could be evolving into over the next, say, decade, maybe sooner. Dr. Fumiko Chino What are those words, actually, just out of curiosity? Liz Salmi: I want to co-design that with patients. Dr. Fumiko Chino: I love it. So that's still a work in progress. I love it. Aditi, what's your take on patient-centered care? Dr. Aditi Singh: I couldn't agree more. It should just be synonymous with good care. It should just be very obvious. It's a no-brainer. In 2025, it's sad to me that when I was thinking about this question, I'm thinking, “Yeah, what did we do before that? What is it called? What is the opposite of patient-centered care? Shouldn't certainly not be provider-centered or like hospital-centered care.” So, I'm all for it. I'm glad that this generation of medical students, nursing students, everybody's going through learning this concept, even though it should really be something just so organic. But I'm glad that we're putting an emphasis on it, that there is no other way. This is the only way of providing good care. The more agency patients have and for them to be empowered to fully participate in understanding their care, fully participate in their care, I think that's what it means to me. I think sometimes I see misinterpretations of it in the sense that, well, that means that everything the patient says I have to do as a provider. And I feel like it's a partnership, it's not a restaurant where they're saying, “Okay, I want that. And I just make this up.” It obviously has to be within your professional understanding. You're still trying to do the best for the patient in front of you. But within that, because we know there's so much gray area in medicine, not everything falls neatly in our evidence-based guidelines and algorithms. That's really where all the nuance is and that's where we can do a better job at taking care of people, if we work together. Dr. Fumiko Chino: Absolutely. I think you said the key word for me, which is ‘partnership’, because it really is. It's not like the patient as a consumer, it's a partnership. And I think patient-centered care for me really emphasizes this concept of shared decision making. And again, yeah, it blows my mind that this is like a newer concept that we didn't really, in the paternalistic world of healthcare, the patient was just sort of an afterthought. It was the receiver of care and not the person who was living with an illness. Liz Salmi: Just to throw in there, there's a very well-known palliative care thought leader, Dr. Ira Byock, who wrote a book called The Best Care Possible about patient-centered care, we could say that, or ‘the best care possible’. And it's a bummer that ‘the best care possible’ was coined and really developed by a palliative care doctor. And I hope people in the oncology community will pull a page from the playbook of all of palliative care, because to me, all of oncology care should be palliative care and that's disease treatment but also pain and symptom management. So, I just got to throw that shout out to all of palliative care in this podcast. Dr. Fumiko Chino: 100%. I feel like there's a lot we can learn from palliative care for pretty much everything that we do in medicine, including enhanced communication. Aditi, do you mind giving us a quick overview of the article that your multidisciplinary team published in JCO OP last year about how to make the EMR both more patient-centered but also work better for research and surveillance? I'd also just really love to hear about how you got interested in this topic altogether. Dr. Aditi Singh: Yeah, absolutely. So, the National Cancer Policy Forum convened this workshop in 2022. It's a two-day workshop which focused really on improving EHRs for oncology care, surveillance and research. And we had discussions and talks from various stakeholders, experts in their fields, just putting our heads together and hoping for a better way than what we have. I think there was general agreement that we are very glad for EHRs as an advancement over paper records, but I think we all kind of felt that EHRs haven't really realized their full potential in all the great care that can come through them. And we all identified certain challenges that EHRs have brought with regards to EHRs really being formulated as primarily billing scheduling tools in the 1970s, and now it's this all-encompassing system that we use to do everything. All of our interactions are through the EHR, kind of this like thing that comes in between, sometimes we feel, like us and the patient. As providers, we talk to different stakeholders like oncologists and providers, patient advocates, patients, the federal agencies, EHR vendors. So, all of us kind of coming together, researchers, quality improvement advisors, to really figure out what are the challenges and what we can do moving forward to get to a better place. And I think my own personal journey on how I got interested in EHRs and how to use them to kind of harness their power, so to speak, to provide better care and to improve provider wellness was another one. I trained in India. My medical training was in India, where the system is fairly traditional and paternalistic. And then moving to the US and seeing just a lot more time spent with patients and involving them in general, there's a lot more we can do. But just coming from a place where there wasn't as much of it, it was really cool seeing that. And then through my training, just watching my colleagues struggle with how much we had to interact with EHRs. I think none of us went into medical school thinking that I'm going to sit in front of a computer all day and spend less time actually talking with my patients or always have this thing in the background when I'm talking to my patients. And so, I think seeing my colleagues and myself struggle through that and hoping for a better way to just achieve that “work-life balance,” or doing what you love without getting bogged down by the administrative tasks that just keep piling up. And then I think my own life and my own struggles with fertility, having a late miscarriage, having a traumatic birth, and then now being a parent, once you're on the other side, it changes the way you think about these things. And I think being a patient can be so lonely and so scary. Here we're talking about cancer, and you're so vulnerable in that moment. Even as a parent, I say, you know, all your medical training goes out the window when you have a loved one that's sick. You both have beautiful stories on how you've learned from your own experiences. So, I think that was truly telling, that it changes the way you see the person in front of you once you've experienced it yourself. So, I think that's how I got into this space to hopefully move forward. Dr. Fumiko Chino: There's a quote from the paper which was, I thought, was very telling, which was that “EHR development was driven by regulatory requirements rather than a focus on the user experience.” So that's either providers or patients. They're both using the EHR, correct? It was not really built for either of us on either side of the computer, basically. And so, I love the idea of how there could be steps along with each kind of stakeholder to make things a little better. Liz Salmi: One thing I didn't necessarily see in the paper was that patients are actually the biggest user of the EHR through the patient portal. And so that needs to be acknowledged as well. And as you said, Aditi, like the user experience of these portals, is not great for clinicians and it's terrible for patients as well. So, I think both patients and clinicians can come together to co-design the future of that user experience for sure. Dr. Aditi Singh: 100%. Dr. Fumiko Chino: And that actually segues directly into my next question, which is Liz, to kind of start off by saying, congratulations, you just won this recent award from the Society for Neuro-Oncology. And I know that your day job and your personal passion is to improve communication between providers and patients with this kind of central tenet that patients should be both encouraged and supported to be fully engaged with their medical care. Do you mind just kind of briefly discussing your career arc and how this really intersected with your diagnosis and your medical care for a malignant brain tumor? I know you mentioned a little bit already. Liz Salmi: Sure, yeah. None of this is pre-planned. It's just all happened. I think clinicians perhaps come into medicine, maybe not all of us, but “Oh, I want to be a doctor.” And then you kind of figure out your path along the way and how you become leaders. I mentioned earlier that my background originally is in digital communications. And then at age 29, I had a massive grand mal seizure and then found out I had a brain tumor. And then jumping ahead, you know what I'm doing today and I can fill in the gaps. But today I work on the OpenNotes team at Beth Israel Deaconess Medical Center, which is one of the Harvard Medical School teaching hospitals. But the OpenNotes team, we've got researchers around the country and around the world, are really focusing on how transparency and transparent communication improves care. And so, when it's some defining words, we say when a clinical note is shared with patients, they become an open note, lowercase. And then our team is OpenNotes, a proper noun. And so, for the last 12 years, and this is before me, I've just been the last eight years, but for the last 12 years, we've kind of created this new field that's focused on research around how open and transparent communications improves relationships between clinicians and patients. And we just remain motivated by evidence that shows that when healthcare professionals offer patients and families ready access to these notes, how that improves actually safety of care as well, because you can spot errors in the record or, you know, just have more open dialogue. And so how I got here, grand mal seizure, communications, digital design. Really just sometimes people become patient advocates quite often because maybe they had a bad experience, a terrible experience, and they want to fight the system or co-design a thing with the system. I had the opposite experience. I had great care. I just was so curious about what was going on from a neurological perspective, from a neurosurgery perspective, move along around the lines. And then things started to change when I became a patient. It was the ‘do not google the information in your records’ era. We're talking about the 2000s and then late 2000s. And then my magical change moment is when I had to change health systems and request a copy of my medical record to like the new location. They said, “What do you want from your record?” And I was like, “All of it?” I don't know what's in it because I had really never seen it before. And so, God bless Kaiser Permanente Northern California for really giving me all of the record on like a DVD. And I had to pay for that. And so, I, of course, as a curious person, just threw that DVD into my computer and started looking at a 4800-page medical record. And I was like, “Oh, my gosh. They've been talking about me this whole time.” I'll try to summarize it now, but I just didn't know that notes were part of the thing. And so that ultimately launched me to the OpenNotes team, the OpenNotes journey. Finding out that researchers at other hospitals are starting to study that. And so, I was like, “How do I get involved in that movement?” And so here we are seven, eight years later for me being part of the team and they're so wonderful academic clinicians, it's all about teaching and like training the next generation. So, I've been taught and trained and now I'm involved in the co-design research. Dr. Fumiko Chino: You know, I think you're underselling yourself because you as a patient PI, I think you've been on the ground floor of this concept of we need to be co-designing research around the patient experience. You've won, as part of your team, multimillion dollar grants to study quality of life and even this, I feel like this most recent award and I am not trying to paraphrase the SNO Annual Meeting, but I think you had asked, “Oh, is there registration or something for patients?” And they're like, “No, this isn't for you.” Advance six years later and they're giving you an award! So, I feel like you've been on the ground floor of all of this very important move towards collaborative work with patients. Liz Salmi: Thank you for highlighting that. Yeah, I think what I've learned in this experience is if someone tells me ‘No’, I want to work harder to prove them wrong. Dr. Fumiko Chino: It's that punk rock mentality. Liz Salmi: There we go. Dr. Fumiko Chino: Now, there's been a lot of consternation from both institutions and providers regarding the release of test results immediately to patients via the 21st Century Cures Act. These releases may actually even come before the primary team has been able to discuss the results and their clinical context with the patient. And I know a 2023 JCO OP article showed that 75% of surveyed oncologists felt like the immediate release of clinical information had a negative effect on their practice and/or their patients. I've certainly personally seen how the immediate release seemed to have fostered some anxiety for some of my patients. And yet I truly believe, and this is a direct quote from the manuscript, “Health records fundamentally belong to patients.” Liz, I'd love to hear your perspective on this because I know that you were a first author of an ASCO Education Book . The chapter was called “When Bad News Comes to the Portal: Strengthening Trust and Guiding Patients when they Receive Bad Results before their Clinicians.” Liz Salmi: Yeah, that was a fun one to work on. It's open access, I believe, so people can go find that. But in that book chapter, we cite a couple of papers, specifically one of the papers and anyone can look this up. It's in JAMA Open, so it's open access. But well, we cite our own paper or I cited our paper with wonderful people. I was like fourth author or something like that. So, it's not just me. Saying that, all of those caveats, we cite this paper called “Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal.” And what we did with that study is we surveyed patients at four sites around the country and really, we learned, despite clinician reservations, about getting immediate access to these test results, 96% of patients still want immediate access to the test results. And that stayed true even among those who received non-normal test results. Could be scary. And we actually asked them, "How did this make you feel? Were you more nervous? And they said, “Yes, but we still want it immediately.” Knowing that and knowing that we can't put the genie back in the bottle for Cure's rule and everybody has decided people should have access to their information immediately, there are benefits to people having access to the information. So, if it's a note thing, they can find errors in the record. When it comes to their test results, they can plan ahead. And I think in the oncology perspective, I believe for folks who have an active cancer diagnosis and they kind of understand their current experience like I do, I see these immediate results, I see the immediate MRI results and I'm like, “Yeah, I still know I have brain cancer. That is not surprising to me.” But I think where things are kind of troublesome, is like a new diagnosis or somebody sees something through their primary care, general care setting and then something, probably an imaging result says something worrisome and then the patient is going to Google or use ChatGPT to kind of understand their situation. And I think that this is a situation where, and this was also mentioned in the ASCO book chapter where Daniel McFarland coined the phrase, ‘truth jumping’. What do we do if people have access to all the information, they feel unsupported in their care. And I think that there's a way to mitigate that, especially in like primary care settings where the ordering clinician of that test, whatever that test is, can really create some anticipatory guidance around it and say something very simple when they're ordering the test and I'm pulling a quote directly from a book chapter and other things, but it's like, “I am ordering a test. You might see the result before me. You have a choice, patient. You can look immediately or wait to hear from us. And what questions do you have?” So really laying, “Here's what's happening. Now, I'm ordering the test.” And so, it creates context around. Dr. Fumiko Chino: Aditi, do you have any additional thoughts about this? About, for example, how to release test results effectively? How could it potentially help or harm their relationship with their oncologist? Dr. Aditi Singh: Yeah. Before the 21st Century Cures Act, we all had the same reservations that, “Oh, my gosh, having cancer is hard enough! Hearing it through the portal and not through trained physicians or providers who know how to break that news with some empathy and context on immediately following it up with what's next is going to be so jarring for patients. It's going to create so much anxiety.” And I kind of still believe that. Yes, I've seen people who've gotten their results and it has created anxiety and it has been stressful. But at the same time, I think that's their choice. They get to decide that. We're all adults here. Obviously, it's different when you're making a decision for someone else. But we're taking care of adult patients who get to choose. And now you can give, just as Liz said, actually setting expectations as the ordering clinician and saying, “I'm going to order this,” and, again, as an oncologist, most patients, like Liz said, it’s really about, “Is my disease progressing? Is it back?” And patients have understood that they can read that if your impression says, ‘no concerns for cancer’, you kind of get that - they are like, “Okay. I'm good.” Or if there's something concerning, you understand that, and it's not mind blowing. You kind of know, well, there was a percentage of chance that this would be good or bad. I think setting expectations, especially when we think it might be a new diagnosis, that this could be something that is as bad as cancer. If you are getting a colonoscopy, a screening colonoscopy, and we find something there, and the pathology is looking for abnormal cells or cancer cells, you can opt out and say, “I don't want to look at this,” or you can. The other thing I encourage patients to do is just kind of see when their next appointment is scheduled because, I for one, as a patient would hate that I see something online and now I'm not seeing my provider for the next two or three weeks. So, giving enough time, a reasonable amount of time for the test to be read so that I am prepared, so I have had a chance to look at it for the patient so we can have the best discussion. But at the same time, once the patients understand that, and I think many patients do now, and I have both types of patients, some people say, “I don't look at it until you tell me.” And there's people who look at it and then there is a lot of sometimes back and forth and we try to set these expectations that if this is something bad, if it's something really bad, where I need you to come to the emergency room right now, you're going to be hearing from me. But at the same time, it's nice that patients have that agency where they can say, “Hey, I just want to make sure I didn't get missed because I know you get a lot of test results and I hope you saw this, but this doesn't look good.” You're empowering patients again to fully participate. And if you are someone who finds it helpful to ChatGPT or Google, from reliable sources- that's another thing, as a provider, I can give them reliable resources like, “Hey, this is a good website. This one, not so much. You can look at it and then you can come prepared for your visit and say these are the things I looked up. I have some questions now that I can better participate in this conversation.” So, I think in general I firmly believe that the patient health record really does belong to the patients. They get to decide how and when they want to look at these things. But just as providers, we can help them set appropriate expectations and boundaries. And we sometimes get a lot of back-and-forth messages and we have to say, “Hey. This is non-urgent. I promise I'm going to talk about this at our visit. But just to provide good care to all my patients, I can't be in a back-and-forth kind of text message about this result.” And then the other thing is that we can now use cool new technologies like natural language processing and these large language models where we're looking at- one of the things we get a lot is, “Oh, my God. My esophagus has collapsed.” Because that's the normal way for the esophagus to be in the body unless you're eating. So, it would be nice if maybe we could have cool technologies where someone can hover over their test result and kind of translate this to me in something that a layperson can understand who's not in medicine. That includes that your esophagus is collapsed, which is its natural state. Nothing to worry about. So, some of these things we can do better with just technology. And I think one other thing I'll say is the onus of all of this can't only be on the provider. I think we need to make sure that the providers are supported to do the right thing because it is the right thing to provide patient-centered care and give patients the answers they want and help them through their journey of whatever diagnosis they have. So, if you have competing interests where there's profit-based companies telling you, “You need to fit in more patients and you need to see 30 patients a day and you need to make sure you bill appropriately.” Because none of us are thinking that way. We went into medical school to help people and interact with people. But if you don't give providers the time, they need to have these discussions, the support for some of these questions to be handled by their staff and it can be a triage nurse who can then immediately call the patient and say, “Hey. Don't worry. Dr. Singh looked at this report and she said that this part is totally fine. She's going to talk to you more about it,” but you have to have a whole team that helps the provider do that for them. Dr. Fumiko Chino: One thing I think that struck me about your article was this idea that by providing more support to providers, so by making the electronic medical record system work better for providers, you are actually making it more patient centered. You are basically loosening up that chokehold that sometimes the EMR has on providers to actually give us more time to have those difficult conversations or to make those phone calls and not just to be constantly documenting. Now, Liz, I recently read one of your many research articles that you're a co-author on. This one was in a Medical Informatics Journal from 2021 and it showed that after OpenNotes implementation, oncologist notes overall seem to become a little longer and easier to read. Yet some consistent feedback I hear from patients remains that the use of abbreviations and medical jargon stymie their understanding of their notes and their results. Do you have any thoughts on concrete steps that we can do to improve the use of the EMR as a tool to provide patient-centered care? Liz Salmi: Yeah, for sure. How do we make these portals more friendly? I mean, they're not friendly for the docs and clinicians and they're not friendly for the patients. I mentioned earlier, the biggest user of the EHR through their patient portals is patients, and so these portals have not been designed well at all. Things we can do to make that portal easier for the patient user, knowing that now we have access to this information, we're seeing our test results before our clinicians and then we're going to message our clinicians and ask them questions. Some health systems are actually implementing penalties on patients. Like they're going to get charged for these patient messages and that's still up in the air. But with that in mind and all of that context and the amount of information that's available, some concrete next steps are to get people on the portal before something bad happens. So the proactive thing, people are used to using these tools and then from there you kind of learn the rules of the road or like what's okay or not okay or you kind of learn a bit about, “I know this question could be better asked in the clinic as opposed to through the portal because I've been dinged in some way.” And it's unfortunate to get dinged in some way through those portal things. Or it's like if you keep asking me more questions, this becomes some sort of a digital visit and you might get charged for this. So, like figuring out that murky space, I feel like I'm talking about in a horrible way, but that still is like a place where getting things figured out. And then the thing is like the things that people like to use, things like social media are sticky and are pretty well designed. The patient portals have not been well designed. Can we pull a page from the playbook of digital tools that are working well that people like? And so that's like another ripe opportunity for co-design. And the people who build the patient portal tools, the people, the EHR vendors, I go to their conferences from time to time. Sometimes I have an abstract that gets submitted and then I get to learn what those vendors are doing and they don't partner with patients in the co-design of those things. I'm just talking about they in general but you can kind of guess who I'm talking about. But they are early phases of you know when I am at the conference and I'm the person who stands up and asks the room, “Did you involve patients in the co-design of your tool?” And they're like, “We're figuring that out.” And so, it's sad that that hasn't happened. So, we could say it's sad for the clinician side but definitely sad from a patient user side especially if like that some of the systemic issues from a clinician strife perspective is, “Ah, my patients are over messaging me.” And then another thing is we could bake in, we should be doing studies of how people are, especially people with cancers and kind of scarier conditions that make you message more, bake in things about studying what kind of maybe AI related tools to help us when we're in those kinds of scary situations. So, you know, shout out to our team as we are kind of focusing on some studies on that right now. But of course, the study is in progress and I would love to tell you the results right now and then I can't. So, it's like how do you kind of give really from a dissemination perspective how do you kind of say, “We're in progress, this is what we're learning so far.” And so, from the ‘what can we do right now’ perspective as all of these things are going on, the Cares Act has happened, patients can see their test results. But something that has been well studied at least in the OpenNotes universe is we know from 12 years of research and 12 years of studies on the concept of when patients read their notes, they better understand their care and are more likely to follow up with what their doctor said, there's a whole body of work there. And the big tips are to patients and things you could communicate to patients are after the visit's over, reread your note. That is the concrete conversation. That's everything we talked about today. Read it. Encouraging reading your notes after a visit. And then another tip from Liz, super patient advocate, is before your next visit, read that last visit again. It may have been three months, it may have been six months, it could have been a year. Read that before your next visit. Because I know hopefully the clinician is doing that like 10 minutes before the visit. But it's like I'm going to read that and go, “Oh, this is what they said. I totally forgot that. I actually didn't do that or I did and it hasn't been fixed.” So, the idea of reading the note and then reading it again later because that's what the clinician is doing as well. So, it really kind of puts us all on the same page. Dr. Fumiko Chino: I love it. Aditi, I'd love your perspective on this as well. As a provider, as a researcher, I think fundamentally we often don't think of notes as being education tools for patients and we need to balance this patient-centered care with other advances. Even in your paper, we're trying to get advances in quality surveillance and research. But again, there's this concept that maybe those advances in those things can be very patient centered as well. Where do we go next for this? Dr. Aditi Singh: Yeah, the culture shift. Because I know a lot of people have said, well, these notes traditionally were not really patient facing. So, we would write a lot of things and sometimes we would take it just too far where sometimes, like I can't understand what my colleague in ophthalmology is saying. I've tried to interpret sometimes hearing tests and I was just like, “Wow, I don't know your abbreviations. Mine are different from yours.” And so, I think it's a good thing that we're in general saying that these notes should be more readable because for everybody, even within the medical community, I think there's been an issue with note bloat. And some of our notes, especially oncology notes, and there's been research on this, are just some of the longest, not necessarily the best quality, notes, but just very long where it's just really hard. When our patients get admitted to the hospital, sometimes a hospital team has a hard time understanding what was going on outpatient. Your note goes on for 30 pages and I can't find out what I need to find out. And same thing for patients. So, I think, in general, it's a good thing to just push increased readability and just teaching medical students and us, as hard as it is to change. But it's a good reminder for me and say, “Hey, I wrote this. Does this make sense to someone who doesn't practice oncology?” And if it doesn't, how else could I say it where it doesn't necessarily take me an extra hour finishing my note, but it's still succinct. It's not going to have all the education that patient needs. I'm still going to have supplementary material that is very specifically patient facing because it will have more information. And then I still have my people resources, my human resources that are going to do a, say, chemo teach visit for someone who's starting a new therapy. And I have my pharmacist who's going to do that, too. But how do we use all of that so that the patient in front of me feels as prepared as they possibly can to get this treatment, go through the scanxiety that comes with scans and go through this journey feeling that they have some sort of– We're all looking for that sense of control where we have none in some of these situations. So just helping each other out this way. So, I think, yes, absolutely, need to make our notes more readable. We can do some of it ourselves, some of it our technology does. So, we have an autocorrect in our EHR that I use heavily and I still sometimes will write in shorthand and it just auto corrects all the words that I'm used to writing in and it just fixes all of that for me. So, use the technology. And some things we're learning too, and we talked about this in our article too, how certain things we said were using stigmatizing language, sometimes inadvertently, and how some of these biases get perpetuated. And we've just been saying that and now someone said it in a different note that got copied and pasted and now we've just perpetuated this thing that was completely inaccurate about the patient. So absolutely, more power to patients to read that and say, “Uh-uh, that is actually not what I said. And actually, can we have a meaningful conversation on what this meant?” So I do think we can do better as a community and I think if we and the EHR vendor, if they continue to use these newer technology, a lot of us are testing ambient listening and I think that'll be really cool because if I can just sit and look at my patient and not have to type anything, and I have this AI tool that kind of summarizes our interaction and makes sure that we put in all the important information in that patient's note. And then it's a great reference, like Liz said, for the patient and for me when I look at that note next time. Because there's also research that's shown what the patient says and what you actually type is often you just filter out so many of the things because I'm in my medicine brain, you're filtering out as people are speaking because you're also trained to recognize the worst-case things and, “Not dangerous, not dangerous, not dangerous. Okay, I'm going to write the one that sounds- chest pain. I'll write down funny tingling in your toe that happens like once every once in a while.” I keep on going because I need to also focus on things that I think I can triage in my head. But this is cool. This way we get to hear the whole story and I think have more open-ended discussions as opposed to these short, “Do you have chest pain or not? Constipation, yes, or no?” But actually saying, “Hey, Liz. What's your story? Very different question. Dr. Fumiko Chino: And I think that just to kind of point to this concept of the patient reported outcome and the tingling in the toe that does happen every now and then but has consistently happened for the last 10 years. I feel like PROs can really potentially actually capture that better. I would just like to give a little last time at the end in case there's anything that we didn't touch upon that you feel like is really relevant or pressing before we say goodbye. Liz, anything that we missed? Liz Salmi: Not a miss, but just a quick thing is a little bit about LLMs or AI tools in the exam room. And I just want my doctors to know that I'm also using those tools. And it'll be an interesting next few years as the patients are users and the clinicians are users and I don't want them to just talk to each other. So how do we design this stuff together? Dr. Fumiko Chino: Sometimes I feel like patients and providers are just on the world's longest blind date. We're just trying to find enough about each other to have a meaningful relationship. Liz Salmi: That's cute. I love that. Dr. Fumiko Chino: Aditi, any last thoughts from you? Dr. Aditi Singh: I love this quote by Ram Dass where he says, “We're all just walking each other home.” We're a team. That's how I think most of us oncologists think. I love my patients. I want to do what's best for them. I think most of us are that way and I wish for our regulators, our payers, our healthcare systems, to all get on the same page so that- we want more of this. We want more of this interaction, that mutual respect and trust that is just invaluable. And we want all of those other stakeholders to come together and help support this. And I think that support’s the biggest mission here. Dr. Fumiko Chino: I love that. What a great way of ending this conversation. Thank you so much for this wonderful conversation. Many thanks to both Dr. Singh and Ms. Salmi, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice Podcast , please take a moment to rate, review and subscribe wherever you get your podcasts. And I hope that you'll join us next month for Put into Practice's next episode. Until then, stay safe. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.…

1
Debt or Dying: The JCO OP Financial Toxicity Special Issue 30:51

11 weeks temu30:51

30:51

Host Dr. Fumiko Chino sits down with co-editor and health outcomes researcher Dr. Ryan Nipp, and contributing author Dr. Kelly Shanahan who is living with metastatic breast cancer to have a candid conversation about financial toxicity, the lived experience for patients, and what we can do to move the needle on affordability in cancer care. TRANSCRIPT The disclosures for guests on this podcast can be found in the show notes. Dr. Fumiko Chino: Hello and welcome to the inaugural episode of Put into Practice , the podcast for JCO Oncology Practice . I'm Dr. Fumiko Chino , an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. In today's episode, we'll be highlighting the special issue of JCO OP focused on financial toxicity. I'm delighted to serve as an editor for this special issue, and I'm overjoyed to welcome two guests who were instrumental in creating the issue. The first is my co-editor, Dr. Ryan Nipp. He's a Medical Oncologist focused on GI cancers at the University of Oklahoma Stephenson Cancer Center, where he also does cancer outcomes research. I'm also pleased to welcome Dr. Kelly Shanahan, who is an author of a narrative piece for this issue. Dr. Shanahan was a practicing OB/GYN in Lake Tahoe, California when she was diagnosed with stage 2B breast cancer in 2008. She has now been living with metastatic breast cancer since 2013 and serves as a patient advocate and research advisor. Our full disclosures are available in the transcript for this episode and we're all already agreed to call ourselves by our first names for the podcast today. Kelly and Ryan, so great to speak with you today. Dr. Kelly Shanahan: Likewise, Fumiko. Dr. Ryan Nipp: Thank you so much. Dr. Fumiko Chino: To start us off, I'd love to just set the scene about financial toxicity, our topic. Ryan, do you mind sharing an overview of financial toxicity, what it is, what it isn't, and how you got involved in this type of research? Dr. Ryan Nipp: Absolutely. Thank you. So I always start with the idea that the NCI website, I remember when this came out a few years ago, they provide some helpful information on this topic. The definition that they provide I think works nicely. It states that financial toxicity describes the issues patients may have related to the cost of medical care. The high cost of medical care, in addition to the cost for missed work, loss of employment and travel and lodging for care, can cause financial problems and may lead to debt and bankruptcy. Financial toxicity can also affect a patient's quality of life and access to medical care. For example, a patient may not take a prescription medicine or may avoid going to the doctor to save money. Research also suggests that patients with cancer are at risk for experiencing financial toxicity potentially greater than people without cancer or other medical issues. Financial toxicity is also sometimes called financial burden, financial hardship, financial distress, financial stress, economic burden, and economic hardship. So it goes by a lot of different names. Throughout my career and my research to date, I developed an interest in financial toxicity as I'm particularly interested in improving care delivery and outcomes for patients impacted by cancer and this continually became an issue as I was growing and training in oncology, noticing that the financial toll of having a cancer diagnosis can be remarkably problematic and concerning for our patients. Thus, I wanted to find ways to study this issue and ultimately develop strategies to address the problem. So just to give a little bit of background on the current JCO OP special issue , we wanted to do this special issue for numerous reasons. We're fortunate to work at JCO OP or work with JCO OP, JCO Oncology Practice which has a unique interest in this topic. We've been working to address this issue of financial toxicity throughout our careers, I say me and Fumiko, and we felt that the current time represented a unique opportunity to take a look back and see what progress has been made, also, what problems are persisting. We are extremely proud of this special series as we've had numerous unique viewpoints captured and I think this series provides a relatively comprehensive overview of the current state of the science in this field related to financial toxicity and oncology. And looking back over our notes over the past couple of years, while we were planning this issue back in the summer of 2023, we had wanted to have a broad array of articles specifically focusing on the state of the science of financial toxicity, understanding the health insurance landscape, health policy issues related to this, cost of care discussions, social determinants of health, financial assistance programs, and financial navigations. We also wanted some unique perspectives on financial toxicity with regards to geriatric oncology, a global and international perspective, and we wanted to have as many articles as we can relate to the patient perspectives on this topic, which we’ve got very fortunate for. Specifically we wanted one to give an overview of the foundational work in this field. Number two, highlight knowledge gaps that still exist. And number three, compel the field forward to encourage interventions and innovations necessary to move oncology into a more equitable and affordable space. We are blessed to have so many phenomenal colleagues that were willing and able to share their experiences, expertise and insights for this special issue. So thank you. It was a long winded answer, but I'll stop there. Dr. Fumiko Chino: I Love it. I 100% agree with you. I feel so blessed to have worked on this issue and it really is sort of where we are now, how did we get here, and what the future should hold, how can we be doing better for financial toxicity. Now, Kelly, your piece “Debt or Dying?” was a real highlight of the issue for me. Do you mind speaking on the lived experience of financial toxicity and how costs have really unfortunately driven some of your treatment decisions and your options? Dr. Kelly Shanahan: Yeah, thank you Fumiko. Thank you, number one, for inviting me to contribute to this issue and for your kind words about my piece. I come from a place of privilege. I was a physician when I was diagnosed, but both with early stage and metastatic cancer. Yet I still suffered significant financial impacts. When I was early stage, I had the option, obviously, of either a lumpectomy with subsequent radiation therapy or a mastectomy. Well, I live at Lake Tahoe where we have zero oncology services at my end of the lake. And so for me to have a lumpectomy, I would have to drive 45 minutes to an hour each way, five days a week for radiation therapy, for, at that time, five to seven weeks. We didn't have accelerated courses of radiation back in 2008. I had a then nine-year-old and I was in solo private practice. So if I had chosen radiation therapy, that would have been time away from my practice, loss of income, having to make sure my husband or somebody else could pick up my daughter. So I chose to have a mastectomy and that was my primary reason for choosing that type of surgery. Then five years later when I was diagnosed with metastatic breast cancer, again, no oncology services in my town, except for someone I was ironically subletting my office to one day a week who recommended combination IV chemo, hoping to get me closer to the starting line so I could perhaps live longer. My daughter at that time was in 10th grade, a sophomore in high school, and I would have done absolutely anything to try to make it to her high school graduation. So I did the chemo which included a taxane, which left me with permanent chemotherapy induced peripheral neuropathy. Now, it's a little challenging to be an OB/GYN with numb fingers because I know I wouldn't want somebody trying to catch my baby or wielding a very sharp scalpel over my anesthetized body who had trouble feeling their fingers. So I had to stop practicing medicine, which was a huge, huge impact. I will remain eternally grateful to the men I started in practice with way back in 1991 when I finished residency for insisting that I get a disability policy because that is the only reason that my family did not have to declare bankruptcy was the fact that I had a long term disability policy. But it still made a lot of impacts on things we chose to do. I remember I was diagnosed prior to the advent of CDK4/6 inhibitors and I was diagnosed early stage, prior to the advent of the Affordable Care Act, which was a whole other thing. But I remember thinking, “Oh, my gosh. If I have to go on a CDK4/6 inhibitor that's going to cost $15,000 a month, I'm going to have to pay a 20% co-pay.” And that's a choice between putting that towards my daughter's college education. I would have chosen not to take that medication. Those are huge things, and that seems cheap. Now, I am currently on a medication that was approved a year ago that is $28,000 a month. Fortunately, I have Medicare due to disability. I'm still not quite old enough for Medicare, that covers my expenses. I met that $3,400 medication deductible within the first month of being on that medication. But that has eased the financial burden. I also chose to participate in a clinical trial last year when my cancer progressed. And I live in a ski resort town 200 miles away from a major academic medical center. So it was 200 miles each way to participate in this clinical trial. And again, I had the wherewithal to be able to put a hotel or an Airbnb on my credit card, to pay for the gas and then wait for reimbursement. Not everybody can do that. We wonder why we can't accrue to clinical trials. We wonder why we don't have the diversity that we want. Well, these sorts of financial issues are part of the reason. Dr. Fumiko Chino: Thank you so much for that overview of what you've had to deal with during the course of your disease treatment and that realization that, ‘oh, this is with privilege’ that I know what struck a chord with me as a cancer caregiver. I was brought into the field of financial toxicity as being the primary caregiver of my husband. He was diagnosed with cancer, again before the Affordable Care Act, and we had these caps on his health insurance payouts. And so we ran up against his lifetime payout cap and essentially had to pay everything out of pocket after that. And even just for people with long disease courses or who were treated before the Affordable Care Act, they've seen a huge sea change in terms of financial toxicity. But sadly, the Affordable Care Act hasn't made actual cancer care necessarily more affordable as we continue to produce more effective treatments, but they come at these great expenses. And I think we are now at, I would say a liminal point where we're at accelerating drug discovery and also accelerating costs. One of the reviews in this special issue focuses on the social and legal needs. Things like housing or food insecurity, transportation barriers, unemployment and psychosocial needs. They have a bidirectional impact on financial toxicity. And Dr. Hussaini and his team really put together a nice overview on this topic for the issue. Kelly, I know you've already spoken a little bit about this, about the transportation barriers, about the difficulties being unemployed. Again, coming from that position of privilege, can you talk about how hard it's been to even just navigate the healthcare system even with your incredible knowledge base as a physician expanding on what was hard for you, if it might have been harder for other people within the larger community of people with metastatic disease? Dr. Kelly Shanahan: Yeah, I mean, I'm a physician and I know the healthcare system and I had a hard time figuring things out. And some of this, I realize now, when I was a practicing physician, I didn't know what things cost because what things cost depends on what your insurance is. And that's true of the cost of an office visit, of a procedure and of medications. That was challenging as a patient knowing who to call to find out to get a patient assistance program. And then when you have Medicare, again, whether it's because of age or because of disability, you hear all these things about, “Call company X if you need financial support for our great drug,” but that's not accessible if you have a federally funded insurance. So I think that was really challenging to figure that out. Fortunately, a great clinical pharmacist at UCSF really helped me with that process. And I think that's something that we don't realize as patients is there are other resources. Our doctors don't know all the nuances of the financial aspects. If you are being treated at a larger academic medical center, there should be a financial navigator. But considering the fact that most people with cancer are treated in the community, and especially if you're treated in a private practice versus one that might be affiliated, let's say with a community hospital, they may not have an oncology social worker, they may not have a navigator. And I really wish there were more programs available like the one at Levine Cancer Institute that has a financial navigation program, a multidisciplinary program to help patients. There are a lot of resources available to patients. I am on the board of directors of METAvivor. Our primary focus is raising money for metastatic focused research. We fund research, but we also offer resources that we can connect people with on our website, connect them to places where patients can get financial help. There is a fabulous organization, the Lazarex Foundation, which used to provide financial support to help people do a clinical trial, support for housing, support for transportation. And I know their funds are limited and that has sort of gone by the wayside, and that's really unfortunate because we want more people to participate in trials. And I think we have to move away from this, “Oh, yeah. We, the pharmaceutical industry, the sponsor of the clinical trial. We’ll reimburse you.” Number one, they do not tell you that upfront. I knew that. I know that from the relationships I have with some people in the FDA. I know that that is allowed. So I specifically asked about that. But most patients don't know that. And I think any patients that might listen to this, if you're contemplating a clinical trial, upfront say, “I know that reimbursement for my travel related expenses and trial related expenses are allowable under FDA guidance. So how are we going to do that?” But I also think that this needs to be not retrospective, not a reimbursement, but for a lot of people it needs to be an upfront payment. Even things like to cover the Uber for them to get from where they live on one side of a major city to the cancer center on the other side. So we need to do that. And recently, at the San Antonio Breast Cancer Symposium, in a session for advocates with the FDA, I asked that question: Does the FDA preclude payments before the fact? Do you consider that inducement? And the answer was “No”. There's no rule that says you can't do that. So again, we as patients need to be educated that there are resources available to us and don't take ‘no’ for an answer. Dr. Fumiko Chino: I love all that information. And I know certainly when I was a caregiver, when my husband was sick, we had evaluated all the clinical trial options and found one that was potentially an option for him in California. But the travel expenses were too great for us to overcome the upfront cost because at that time he was out of work, I was out of work, we were both out of work, we had no income coming in. And so those travel expense barriers were one of the main reasons why it was a non-starter to even think about the clinical trial enrollment for him. It's just depressing to think that that could have made a difference. But I know that clinical trials work. That's how we discover new treatments. Dr. Kelly Shanahan: Yeah, and the more people that participate and the more diverse a population– If the only people doing clinical trials are old white women, then how do we know it's going to work for young black women and men or other ethnic groups? We need diversity so that we know how the drugs work, what side effects they have in diverse populations. Dr. Fumiko Chino: Now, Ryan, I want to pull you into this. What have you found can be helpful to help assist patients who may be struggling with their social or legal needs or even just having difficulties making ends meet? Dr. Ryan Nipp: Yeah, Kelly, I had worked in the past too with Lazarex Foundation and found them to be phenomenal and the opportunity to get more patients onto clinical trials was a no-brainer and such a valuable resource. So I think for this question, I do love this question, I think it depends as Kelly was kind of hinting at too. It depends on insurance, depends on the person, depends on the specific needs. But again in thinking about this, I think there's some growing evidence supporting things like financial navigation. Like you said Kelly, not every place has it. I'm actually very fortunate now at our cancer center in Oklahoma, we do have financial navigators and I always thought that was extremely forward thinking for them. We also have great social work assistance, knowing that that's a limited resource, but we have amazing social workers which I often sometimes get their expertise and help for this. There's some research out there showing that financial assistance with things like travel, lodging and co-pays could be beneficial for our patients. Again, trying to find those resources and is it sustainable? That is a tough question. We also have an article in this special series focused on financial assistance programs by Dr. Raghavan which is phenomenal. It's an editorial on this topic I would encourage people to look into when this comes out. I've also just lastly admired recent work that shows that there's an intervention that, I think, I'm not quite remembering where it was tested, but it's a financial hardship screening intervention where they were asking people about financial hardship and then over time were able to find that by just asking and then bringing in whatever resources might be available, this could address the issue of financial toxicity in that study and it was an extremely impressive compelling outcome with that kind of a model. What I think is the future is that we need to continue to see those types of models put into routine practice and how can we actually implement those in our day to day practice. But that to me was very promising when that came out in recent years. Dr. Fumiko Chino: Absolutely. I think you're referring to Dr. Blinder's piece in JCO from last year. Dr. Ryan Nipp: Yes. Dr. Fumiko Chino: Dr. Blinder was one of my amazing colleagues at MSK before I transitioned down to Texas. Dr. Kelly Shanahan: Yeah, and Dr. Blinder is working on a new proposal. I am one of the advocates on that proposal again about the financial screening. And again, just even asking the question can make a difference. Dr. Ryan Nipp: Yup. Dr. Fumiko Chino: Absolutely. I know you both kind of pointed out that there are limited resources, but this idea that it's sort of depressing that someone who might be in need will not actually get the assistance from their physician or their physician team or their cancer center, but they'll have to reach out to other patients, and I'm so glad that that information is being shared. But it seems like we could be doing better. More orderly assistance, more navigation, more direct help to patients who actually need it in the way that they need it because it's not one size fits all. Now, switching topics just a little bit, I had the pleasure of working with Dr. Littman, who is a resident at NYU, on a review in this issue about the role of cost conversations to decrease financial toxicity. And I know from my own prior research that only about 5% of oncologists say that they've had any training on discussing costs and that cost conversations seem to be rarely happening in clinical practice. Certainly from my own perspective as a cancer caregiver, I can say that cost conversations, despite incredible financial toxicity from my husband's treatment, were just not being had. Now, Kelly, have you ever had a discussion about cost with your treating team? Dr. Kelly Shanahan: I have never had my treating team ever bring up costs. Now, as I mentioned before, when at one point I was contemplating going on a CDK4/6 inhibitor, I did say, “If I need to go on a CDK4/6 inhibitor now with this huge co-pay, I'm not going to do it.” But I didn't get that, “Oh, here's some resources that we can have.” I was sort of like, “We'll figure that out. You don't need it right now.” And fortunately, I did not need it until I was able to get on an assistance program and then had Medicare. So it wasn't prohibitively expensive. Although I did fall into that catastrophic donut hole one year. That was not fun. But I think this is something that we patients talk about frequently. People, they're worrying about paying their bills, about paying their medical bills, do they pay their hospital bill or their doctor's bill or do they buy food? Do they pay their utility bill or do they pay the co-pay for their medication? And we should not, in the supposedly richest country in the world, be having to have these conversations. We share resources about people who have unused medications. If you have progression of your cancer and you have to switch medications, but you still have two months of a three-month supply, how can that be legally distributed to other patients? And there are organizations that can do that. We try to let people know about that. But yeah, patients frequently talk about this. It's so heartbreaking when someone has to do a GoFundMe to pay for their medical care or to pay for their funeral or the funeral of a loved one. Dr. Fumiko Chino: Yeah. My standing joke, which is not really a joke, it's more of a ‘ha-ha sob’, is that GoFundMe is actually the US's largest cancer insurance provider, which is fundamentally very depressing. And I think one of the points that you pointed out about just even just eliminating waste- so if I have a drug that I'm no longer using, how do I donate that to the next needy person? When my husband died from cancer, we had a supply of Zofran that we had paid very dearly for. He was past his pharmaceutical benefit. We were paying $35 a pill. This is when Zofran ondansetron was still on patent. And I was like, these pills are very expensive. And I turned them over, actually, to my mom who's a physician to distribute in her clinic because I wanted people to not have uncontrolled nausea. I know now, working at world leading cancer centers that there's no actual way of doing that here, but a community cancer center can do it. I think we just- trying to get more efficient all across the board is so important. Now, Ryan, how do you broach the topic of affordability with your patients? Do you try to preemptively discuss costs or really just wait for when there seems to be a problem with affordability? Dr. Ryan Nipp: Yeah, I knew this was coming up. I think it's a bit of a touchy topic at times because you don't want to presume and like to bring it up. In some ways, there's this option of, at least in Oklahoma now, where people are traveling a long distance often to see us here in Oklahoma City. And so sometimes you can just start to broach the idea of like how much trouble was it to get here? Do you think you'll be able to make these trips every two weeks? That two hour drive, how's that going to be? But in general, I think I am talking more in recent years about the issue of financial toxicity. I agree with Kelly. It's rare when it does come up, but in recent years it's coming up slightly more often than maybe zero like it used to be. And I think, for one, it's because patients are bringing it up more. I think they're feeling more empowered to talk about it. It's more you're able to have that opening to bring this up to me. I would welcome the opportunity. Of course, I'm passionate about this topic. And then second, I think there's increasing awareness of the available resources. There actually are things that are being studied and there may be options. Whereas in the past, perhaps we were totally just at a loss, like if our patients would bring it up, we would feel awful for them, but there wasn't a lot we could offer. And again, in Oklahoma now, we have phenomenal social work that is available to us at all times, as well as that financial navigation as I was hinting at before. But also, Kelly, you mentioned this before and thinking about this, the fact that we have clinical pharmacists in clinic with us that are just sitting right next to us in clinic has been a priceless resource for me. I found their insights and expertise to be very helpful in finding ways to address financial toxicity. Are there other ways that we can help this person? They brought up that this new anticoagulation pill that they're getting is super expensive. What can we do to help them? Things like that. They're with me. They're willing to look into are there other things that we could be doing again? Also at University of Oklahoma, when I got here, actually, they were already doing some work on this idea of financial toxicity screening, meaning: Can we preemptively be asking patients about their financial hardship or financial needs? And then when things are identified, again, we have cancer center navigators who are available to us for those positive screens to help put people on whatever paths we have available to address those things. Again, in our special series that we have coming out in JCO Oncology Practice , we have a few articles that also talk about this idea of utilizing screening tools and questionnaires to identify patients who may be at risk for financial toxicity. And then some of the work that's growing with regards to once you identify somebody who screened positive, what to do with that positive financial toxicity screen. Dr. Kelly Shanahan: And you know, you bring up that idea of bias and stigma, and I think that can be easily eliminated by asking every single patient. Doesn't matter whether somebody rides the bus in or they roll up in a Rolls Royce. If we ask every single person: Are you having any financial hardships related to your cancer treatments? Then we normalize it, we remove that stigma, and then we can help more people. Dr. Fumiko Chino: And I've definitely seen that, I'm sure, from your own practice as an OB/GYN, like STI screening, we ask every single person about STI screening and it's not targeted towards youth. We ask everyone in a cancer center for falls. Have you had a fall? That's just part of our routine screening. So I feel like integrating one or two questions about financial toxicity could be a real avenue for helping identify financial toxicity earlier. Hopefully, intervening before it gets to the point at which it's end stage of financial toxicity, so to speak, when people are not showing up for their appointments anymore at all. Now, we're heading towards the final part of our conversation today. I just wanted to give a little bit of space for open topic conversation. Is there anything that you feel like we really just should address for the future of financial toxicity? Whose voices are here, whose aren't? How do we make actual meaningful change to stop describing the problem but actually start to fix the problem? Dr. Kelly Shanahan: Well, I certainly think the payers need to be pulled into the mix because they're the ones that are leading to denials. They are the ones that are requiring prior authorization for antiemetics for highly emetogenic chemotherapy. So I think they need to be pulled into the mix. I think our physicians, our care team, need to be pulled into the mix as well as the patients and caregivers. Dr. Fumiko Chino: Ryan, anyone that you want to have more involved in this conversation, any way to expand it? Dr. Ryan Nipp: You mentioned it there at the end, Kelly, is the caregiver. I think we haven't done a lot of work looking at that. Again, back to the research part and describing the issue, we haven't really done a lot looking at the caregiver side. The other piece that I think as we were putting together this special series was the international global perspectives that we did have a little bit of trouble trying to find. It's just different across different geographic and global areas so that's something else that should be studied more. We kind of hinted at it today, this idea of pharmacists being involved. We haven't seen a lot of work in that space. The other thing to think about is, at least in the places where I've practiced the APPs or the individuals seeing our patients a lot of the time and also empowering them to bring this up and have some tools and just bringing them into the research realm and to future intervention development. The last thing I'll say, because we have brought it up a few times today, but I do think a wide open area is what do we do about clinical trials and the affordability of being on a clinical trial and making that more available or able for patients to be going onto clinical trials. I think that's an interesting space to continue to research. Dr. Kelly Shanahan: Yeah. Step number one, every single patient with advanced cancer should be offered a clinical trial. Again, no assumption should be made. And number two, we need to make it so that everyone can afford to, time wise, money wise, to participate in clinical trials. It was a great privilege. I am so grateful that I was able to do a clinical trial and I look forward to doing others in the future. Dr. Fumiko Chino: Absolutely. I really think that this idea of travel burden is such a huge barrier for many of our patients for getting even standard of care treatments, but much less enrolling on a clinical trial. And every piece of data that I've ever seen shows that you will actually get more enrollment and a more diverse patient population on your clinical trials if you just open the clinical trial closer to where the patients are actually living and getting their cancer treatment. So decentralized trials or trials within community practices, trials within the NCORP or the NCI's Community Cancer Center, or even again within regional centers affiliated with academic medical centers. These are always, I feel like, decreasing that travel burden. Dr. Kelly Shanahan: And I just thought of one really simple way to decrease financial burden on patients. Just going for tests, imaging, doctor's visits - a patient should never have to pay for parking. Dr. Fumiko Chino: Now, you're beating a drum that I can dance to. The parking ridiculousness. It led to, honestly, I think, at this point probably my most read research topic, which was just evaluating parking costs. And it is such a stupid thing to study. The fact that parking could be a barrier to receiving optimal medical care is so frustrating, infuriating if nothing else. And yet it is so common. I saw it in my practice in New York where they just couldn't afford to travel into Manhattan for anything that had to be done on the main center. It's a ridiculous barrier. Dr. Kelly Shanahan: $5 an hour to park at UCSF to go see your doctor, get imaging, or get labs. Dr. Fumiko Chino: Absolutely. And the funny thing is that the travel and the parking then must be balanced with the time toxicity, which is consolidating all appointments down could at least decrease your parking costs. But then you're literally at the cancer center the entire day and then you need to buy your lunch at the cancer center or you missed out on another day of work potentially. And so really thinking about this from a very patient centered framework is so essential to just move forward. And it's one of the reasons why I've been so honored and privileged to collaborate with patient advocates like Dr. Shanahan. Well, I will wrap it up. I want to thank you so much for having such a robust conversation today about such an important topic. I can't really think of a better focus for our first podcast issue. I really want to thank both of our guests and also our listeners for your time today. You can find links to the papers that we discussed in the transcript of this episode. And if you value the insights you hear on the JCO OP: Put into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. As a new podcast, we really do depend on you, the listeners, to spread the word that we're out there and we'll hope that you join us next month for our second episode. Until then, please stay safe and warm in 2025. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Disclosures: Kelly Shanahan:Consulting or Advisory Role: Pfizer, SeaGen, Sermonix Pharmaceuticals, Jaguar Health/Napo pharmaceuticals…

1
Oncologic Services Through Project Access and Other Safety Net Care Coordination Programs 20:10

4 years temu20:10

20:10

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 patients provide care that require so much resources. So that was really one of my objectives is to tailor my approach to oncology care, specifically, while also describing the programs in general. And so what I found was that out of about 30 programs that I found, roughly 2/3 offered care medical oncologists. And then out of those 2/3, about 1/2 of those programs actually offered chemotherapy. Fortunately, everyone offered radiographic studies, such as MRI, CT, PET scan. So they could at least assist in diagnosing or helping to diagnose suspicion for a malignancy. Obviously, that doesn't include a biopsy, but could at least sort get the ball rolling, if you will. And then the other thing I discovered is, as I mentioned previously in the podcast, there was a lot of heterogeneity between the programs. So some programs offer transportation, some programs offered interpreter services, while others did not. Some programs required small co-pays. It seemed that everything was really tailored to their respective local community and what worked best for that community. In terms of Medicaid expansion, which was sort of another thing we were looking at with this study, what we found is about 2/3 of the states that have not expanded Medicaid have a Project Access center. And if you compare that to states that have expanded, only about one third of those have Project Access centers. And so our study suggests that the need for pro bono care is a little higher in Medicaid non-expansion states. And I think that that's intuitive. The percentage of uninsured patients with cancer in a non-expansion state is as high as 13%, depending on what their income is. And that's compared to about 2% to 3% in a state that's expanded Medicaid. So those are drastically different numbers and drastically different needs for patients, depending on if they reside in a state that has expanded Medicaid. NATHAN PENNELL: But it seems as though the difference between areas that had programs that offered cancer care and those that didn't probably revolve around whether they're able to find practitioners who are willing to provide those services. And it looks like you did some investigating of programs that did and did not offer cancer care. So what were the differences between those? JAMEY HAMMOCK: The next step of my project was to interview those program coordinators of the centers who were not able to offer medical oncology care. And three common themes emerged as I talked to these program directors. The first of those themes was cost. And I think that that's intuitive. And it did not surprise me. Medical care is expensive. Oncology care is expensive. And these programs, they're mostly nonprofit and rely on donations and such. And so the first barrier to offering this is cost. The patient see the medical oncologist, and they prescribe chemotherapy, someone has to pay for that chemotherapy. And a lot of Project Access centers were not prepared to do that. One in particular I spoke with, they had actually considered it. And when they ran the numbers, it would account for over half of their annual budget. So it just was not feasible. The second barrier that emerged while I was talking to these program directors was the concept of continuity and a longitudinal commitment. So for example, if I'm a medical oncologist and I decide that I want to take part in this and donate some of my services, and I see a patient that has a new diagnosis of cancer, and we treat the cancer, what happens if they relapse or what happens in five years that they need a medical oncologist again? And I don't think many oncologists were comfortable committing to a situation that had no clear end date. That's in contrast to a patient that has COPD and the primary care physician is referring them to a pulmonologist to get recommendations on maintenance inhalers and what might work best for this patient. That's more of a one and done visit. The third area barrier emerged as I talked to these patients was the concept of multiple physician buy-in. And so, as you're aware, many patients that have a cancer may require care from multiple subspecialties, whether that be surgical oncology, medical oncology, radiology, diagnostic radiology, and even palliative care. And so it really is a disservice to a patient if you can offer them not the full scope of oncological care that they need. A lot of Project Access centers were not comfortable providing some of the care without providing all of the care, if that makes sense. NATHAN PENNELL: I mean, all of those make perfect sense. I mean, although in some ways they relate partly back to the first issue, which is that things cost more if they take a long time and have to continue indefinitely over time. So I'm curious, for the places that did offer chemotherapy, and actually even though it was a relatively small percentage, it was not trivial, chemotherapy is extremely expensive. As you mentioned, some of them looked at it and decided it was going to be something like half of their revenue for the year would be taken and providing this. How did those that covered chemo actually cover the cost of that? JAMEY HAMMOCK: That's a great question. I had the same question. And so what we found is that most of the programs who were able to offer medical oncology and then services, and then taking the next step to offer chemotherapy, they were affiliated with very large hospital systems in the area. So I'll give you an example. Here in Birmingham, our Project Access center works with UAB. And they're able to offer these services because UAB takes the baton, if you will, and carries the care forward, offers that chemotherapy that is needed. So it's done through large affiliated hospital systems. If that does not exist, or if that relationship is not there, then what my study has shown is that it's not feasible. NATHAN PENNELL: Right. That makes sense. I mean, individual oncology offices that order their own chemotherapy could probably never afford to just donate that, whereas large systems have other ways to do that. And of course, the large nonprofits also have to give back to the community and may just consider that part of their community service. What's the next step to extend this? I guess, the larger question is, it'd be great if perhaps everyone had health insurance. But until that happens, what steps can be taken to provide something like this more broadly? JAMEY HAMMOCK: Yeah, so that is exactly what I was thinking. Medicare for all is the answer. And ultimately I think we need a centralized universal health insurance policy. But that's not the topic of this podcast. So until then, Project Access is stepping into the gap and doing this great work. And I really wanted them to be recognized just as a organization, broadly speaking, and then on an individual basis. They are on the ground doing the hard work, making the phone calls, making the partnerships, raising the money. They're really doing incredible, incredible work for people out there who have no other options. It's not enough. As I mentioned earlier, these are local solutions to statewide issues. If you look at Alabama, it's a non-expansion state, unfortunately. The patients in Jefferson County here where Birmingham is, they benefit from Public Access, but the patients in Shelby County might not. So it's a statewide issue for the states that don't have Medicaid expansion, and then even a small population in the states that do. One thing that we can do is we can look at the examples that have been set by Project Access centers who have partnered with these hospitals and collaborate and say, listen, we're a Project Access center that has not had any luck. Please share with us how you were successful in providing oncology care to your patients. My hope is that this project provides a list where collaboration can begin. And these places can learn from each other. NATHAN PENNELL: Well, I think that this is fantastic. And I'm really happy that we're going to be able to highlight Project Access and your manuscript so more people are aware of this and hopefully can start shining lights on their own local Project Access programs. JAMEY HAMMOCK: Right, right. NATHAN PENNELL: Well, Jamey, thank you so much for joining me on the podcast today. JAMEY HAMMOCK: Thank you for having me. I thoroughly enjoyed it and love talking about Project Access and access to care. And I really appreciate it. NATHAN PENNELL: Until next time, I also want to thank our listeners for checking in on this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts, or wherever you listen. While you're there, be sure to subscribe so you never missed an episode. JCO OP podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org. The full text of this paper is available online at ascohubs.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice signing off. PRESENTER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care. And is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles, please visit us online at jco.org. This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.…

1
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 26:35

4 years temu26:35

26:35

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 that, this idea of non-beneficial treatment. NATE PENNELL: Well, I guess it's hard not to stop, and talk about that a little bit. So you've got a patient with advanced cancer, who presumably wants to be full code, but is COVID positive. How do you even start to address something like that with the patient and the staff who are worried? LIZ BLACKLER: As you know, many of our patients with advanced cancer and respiratory distress, it's quite hard to have conversations with them for lots of reasons. I think complicating the situation was we had a zero visitor policy at that time at the hospital. So all hospitals in the state had zero visitor policies. There was no family or caregivers or agents at bedside. We had family at home listening to the news, and they're recognizing how important something like a ventilator was for patients with COVID, as a bridge to recovery. And many family members very much wanted to give their loved one an opportunity to recover from COVID, despite something like a stage 4 lung cancer diagnosis with no [INAUDIBLE] And so as you can imagine, on a day-to-day basis pre-COVID, we do a lot of goals of care discussion. So we spend a lot of time with patients and families trying to help them understand the limitations to treatment at the end of life, and what is ethically and morally appropriate, and what may not be the right thing to do. And so we had to apply all of those same tactics in a very expedited fashion, talking with family who were isolated and removed from the situation, who could not be at bedside with their loved one to try to help them come to terms with what was happening. What you may not know is New York state has a law that says full code, cardiopulmonary resuscitation is the de facto intervention for all patients, unless they consent specifically to a do-not-resuscitate order. So we were obligated by law to perform cardiopulmonary resuscitation on all patients with families who wanted it. And so we spent a lot of time talking with our families to help them understand what's happening. And some of those patients did have cardiopulmonary resuscitation, and others understood the gravity of the situation, and were more amenable to do-not-resuscitate orders. NATE PENNELL: Yeah, it must have been incredibly challenging. But any other themes that arose in terms of the consults that you received? LIZ BLACKLER: Interestingly we had three or four consults that came through by staff that were concerned that patients were requesting a do-not-resuscitate order prematurely, that it was not standard of care for their clinical situation. What we suspected that it was the converse of what was happening. Patients and families had this altruistic response to the local and national focus on scarce resources. So saying, wow, we understand how difficult things are right now. We're OK. Please focus your resources on someone else. NATE PENNELL: Wow. LIZ BLACKLER: So that was-- NATE PENNELL: Yeah, I can imagine that would have been-- well hopefully, I guess, that might not have been quite as challenging. Because maybe some of that might have been a lack of understanding about the prognosis, and people who actually did have a reasonable prognosis might-- I don't know if they were convinced to change their minds, or they generally just supported their decision. LIZ BLACKLER: We did a little of both. I think in two of the situations, we were able to help families understand the nuances of the situation, and they agreed to a trial intubation. Other families were insistent that this was not in line with their loved one's wishes, which might have been separate from the COVID-19 pandemic. One thing we did do with the hospitals early in the pandemic, we requested, mandated if you will, that all outpatient oncologists communicate and document the goals of care conversation with their patients on admission within 24 hours. And so each patient that was admitted to the hospital had a discussion. All those who could had discussions with their outpatient primary oncologist about diagnosis, treatment options at present, and what their wishes were regarding goals of care. And that very much helped the ethics consultation service and the services in the hospital provide care that was aligned with not only treatment options, but the patient's and family's wishes. NATE PENNELL: That's really interesting. Because many people were listening to this podcast might think, well, gosh. Shouldn't you do that anyway when someone gets admitted to the hospital with advanced cancer? But perhaps the pandemic offered an opportunity, because patients were thinking about it now, as opposed to oftentimes when they get admitted and it suddenly is a bit of a shock to be presented with the question of what they would want if they needed to be resuscitated. LIZ BLACKLER: Agreed. I think it's a natural opportunity for us to continue to strengthen our need for and goals of care conversations for all of our patients, whether they're stage one cancers or stage four cancers. And so I think it was this natural time where everybody was talking about it. And it just felt it was-- it was just made sense for us to do. And it is something that we've been trying to continue as a hospital. These conversations are hard to have. Patients and families are not always receptive. Clinicians are not always ready to have those conversation either. And so if anything, the pandemic brought us all together, and we all recognize in the anticipation of scarce resources how can we best take care of these patients. What's first and foremost is we have to have a better understanding of what our patient's wishes and preferences are. NATE PENNELL: One of the things that continues, at least to some extent in a lot of places, is the restrictions on visitors and caregivers in the hospital, although perhaps not as strict as it was back in the spring. How did the inability of caregivers and powers of attorney and things like that to physically be present impact your job? And I guess more broadly, how does being forced to work over a sort of video conferencing impact these conversations? LIZ BLACKLER: Sure. I think the level of distress secondary to the limited or lack of visitors at bedside, was palpable. So the nursing staff, the clinical staff, and non-clinical staff who were in the hospital at bedside every day were very upset. It was an incredibly sad time. And that in itself led to more ethics consultations, the amount of distress. And so we as a consultation service, worked hard in our virtual platform to provide extra support to staff who were trying to manage these patients to really take care of them in a way, in a kind and compassionate way in the midst of all of this chaos. We started something called a virtual ethics open office hours. We actually set up a virtual Zoom twice a week where my consultants would sit on the Zoom call and just field questions, general questions that were coming up from staff. Because there was a lot of anticipation of what was to come, and how the hospital was prepared, how we were prepared to take care of patients, if we were to not have enough ventilators, or if we were not have enough blood products. And so the anticipation of all of that was very extremely stressful for staff, and I think compounded by the fact that there was no support at bedside for the patients. I would say as a consultant service, going virtual certainly had its hiccups at first. But I actually think in the long run, we were able to really support patients and caregivers in a different way. There were more families that were able to participate in some of the family meetings, if they were scattered around the tri-state area or the country even. And so once everybody was acclimated to using these platforms, staff and family alike, then there were more opportunities for families to engage and participate in these family meetings. We were able to outfit many of our rooms with video access so that the patients who were able to participate were also able to participate, to be there [INAUDIBLE] NATE PENNELL: It sounds like you did the best with what you could. And certainly it was tough on our patients, because they didn't have anyone to be there with them. But I can see the benefits of bringing people in who otherwise might have had trouble participating. So I wanted to just briefly touch upon something that I'm not sure if everyone realized this. But in anticipation of being completely inundated and running out of ventilators and whatnot, some hospitals were putting together protocols on how they would allocate resources. And it sounds like you may have been part of putting something like that together for your hospital. I know it was never needed. But can you talk a little bit about that? LIZ BLACKLER: Sure. I think one of our obligations as an ethics committee is we have a duty to plan, and a duty to steward resources, and a duty to be transparent about it. So early in the pandemic, the ethics committee was asked to draft allocation policy in the event that we had a scarcity of equipment, or staff, resources, blood products. I remember being sent home from the office to start writing that policy. And I actually haven't been back since. What I will say is although an incredibly difficult policy to write, it was heart-wrenching for all of the reasons that you can imagine. It felt important to at least have a framework in place just in case. And so we made a decision as an ethics committee and consultation service to model the framework after the New York State ventilator guidelines that were published in 2015. We made some slight modifications to address our unique cancer patient population. We chose the New York State guidelines, because they were developed just a few years before with support from our state government. The guidelines were also publicly available, and we assumed had passed with public support. There are no perfect guidelines. And so for us, in many ways we were lucky to have had a blueprint, something to work with in our state. While acknowledging that without state support, we were fully aware that if the crisis standards of care were needed, they needed to be implemented statewide with consistency. We also struggled with trying to recognize that the policies needed to take into account inequities in access and delivery of health care, with special considerations for inherent bias, based on socioeconomic, racial, ethnic, age, and others with disabilities. I think as a bioethics community, we're working to update allocation policy that acknowledges and begins to rectify such bias. And so we're able to think about that now, looking back on what's happened a few months ago. But in real time, what we had with the New York state guidelines, which I think is a good start, those guidelines are your classic guidelines that look to maximize benefit of resource in order to save as many lives as possible. The [INAUDIBLE] is given to patients for whom resources would most likely be lifesaving. We put into place a classic triage process that was grounded in a clinical scoring system. And we also made sure to remove the triage decisions from the bedside clinician, instead relying on a triage committee that would be made up of critical care physicians, administration, ethics consultants, or committee members, and other senior staff from the hospital to help make these determinations based on this clearly spelled out criteria, knowing that there were flaws in those criteria. And so we did put together a policy. We thankfully did not have to implement that policy. But we have the policy put into place. NATE PENNELL: And that, I think, leads us really nicely into my last question, which is really what did you learn from all of this going forward? So if this happens again, hopefully not with COVID, but another emergency or something that leads to strained resources; what take-home lessons can you take from this that will make that perhaps an easier situation the next time? LIZ BLACKLER: Sure I'll approach it from a macro and a micro standpoint. So within the hospital, one of the things that we learned is that our clinician's preoccupation and distress when confronted with these difficult choices in the pandemic, with the anticipation of a scarce resource, was palpable. And that as an ethics consultation service, we have an obligation to put together a center-based initiative to really support staff in real time. And so going virtual quickly, setting up services for staff that are proactive instead of reactive, it has been very helpful. And so I mentioned the virtual ethics clinics or office hours as one way to reach a lot of staff quickly, and to provide support in real time. I think the other issue I touched on briefly, and that is working within the state and the country to come up with acceptable allocation policies that acknowledge bias, that acknowledged disparities in health care, and delivery of health care, and access to health care are extremely important. So one thing that has come out of this that I'm very proud of, as a hospital we at Memorial Sloan Kettering, we reached out to all of our colleagues in the city and upstate New York, and have recently just for formed an Empire State Bioethics Consortium. So all of the chairs of the bioethics departments from around the state, we now meet on a regular Monday night phone calls, to talk about what's happened, anticipation for future, and really working on a broad range of ethical issues that affect New York State. NATE PENNELL: Liz, thank you so much for joining me on the podcast today. LIZ BLACKLER: Thank you so much for having me. I really appreciate it. NATE PENNELL: I'm glad we're going to have the opportunity to highlight your manuscript, which I think is really going to be beneficial to people who hopefully will not be presented with this in the future. But if they are, it's something to get them thinking. And until next time, I want to thank our listeners for listening to the JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcasts, or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode. JCOOP podcasts are just one of ASCO's as many podcast programs. You can find all the recordings at podcast.asco.org. And the full text of this paper is available online at ascopubs.org, backslash journal, backslash op. And this is Dr. Nate Pennell for the JCO Oncology Practice signing off. Thanks for listening. SPEAKER 1: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles; please visit us online at jco.org. This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.…

1
Racial disparities in health care utilization at the end-of-life among New Jersey Medicaid beneficiaries with advanced cancer 18:37

5 years temu18:37

18:37

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 and social needs that increase barriers to care or barriers to high-quality care or continuity of care. In another paper that we published that focuses on this data linkage in the population and this data linkage, there was a lack of primary care utilization prior to cancer diagnosis as well as a lot of the cancer patients in Medicaid enrolling in Medicaid upon diagnosis, right? So I think that there are sort of just several multi-level factors that contribute to why there may be higher rates of aggressive end-of-life care. I think, from a patient perspective, there is a literature out there on the need for communication tools and sort of interaction and inclusion of caregivers that are a part of the decision-making in end-of-life care. Certainly, we've seen in the literature for a while the issue of providers and providers not only being sort of culturally competent or racial and ethnic concordant, but having the tools that they need, both for the physician or the health care team, to have these end-of-life discussions. So I think it's very multi-level and certainly not just either on the patient or the physician. Even within the Medicaid population, so independent just of the, say, the financial pressures that would lead one to enroll in Medicaid, what you showed was that non-Hispanic Black patients had a much higher rate of aggressive end-of-life care even than the overall Medicaid population. And why do you think that would be true? Yeah, so after we finished the analysis for this, we definitely did reach out to other colleagues who have worked in the communities more closely within New Jersey, within the non-Hispanic Black population across New Jersey. We've also talked to our state Medicaid program to, one, think of sort of action items for how to better understand what we're seeing in the quantitative administrative data here, and then two, how to engage communities to understand what to do next about this. So from the literature and from sort of racial/ethnic disparities literature, we do know that there is often mistrust of the medical system. There's underutilization of preventive screenings, and there are physician biases and structural biases that occur along the way, so again, the multi-level factors that impact why there may be disproportionate aggressive end-of-life care in the non-Hispanic Black population. You know, we can't answer those questions with Medicaid claims and enrollment files. We can identify these patterns. And I think what our research team has been in communication with our state Medicaid program to do next is then figure out, how do we talk with some of these communities across the state to figure out what the appropriate community-level education tools might be needed to improve an understanding of what end-of-life options are, but also to focus on the hospitals and health care systems that may be disproportionately seeing some of the-- that may be seeing higher proportions of non-Hispanic Black patients, and how can we engage the health care teams within those settings to figure out what can be done at the health care delivery level? Do you think we have enough information to make interventions now? I mean, are there-- how do you think, aside from further study and trying to understand it better, we might, in the short term, improve rates of quality end-of-life care in these high-risk patients? We've seen-- and we've talked about this, I think, in this field somewhat-- is, one, there are guidelines. And just having health care teams, providers, hospitals understand where they are, sort of tracking where they are in rates of aggressive end-of-life care and in hospice enrollment, and having that feedback and audit loop to kind of look introspectively within the health care delivery setting, I think is one option that we've seen in terms of trying to increase quality and increase adherence to guidelines for other things. And then I certainly think that there might be a need for community-level interventions around, what are the barriers to hospice enrollment? Or where is the lack of awareness and knowledge around end-of-life care options? And what does it mean to reduce interventional care, right? And what does it mean for communities? I think that targeting those aspects and having a dialogue that is responsive to the community-level needs are probably ways that we can start. I think that makes sense. I mean, as an oncologist, a city with a high minority population, I think improving the cultural competence and being able to establish a level of trust with patients who may have an inherent distrust of the medical system, especially when you're talking about something like that's as counterintuitive as trying to recommend not doing more aggressive care, it's certainly a complex conversation and definitely would require a level of trust and communication in order to do that properly. So I completely agree with you that I think, on the community level, the interventions will have to involve that if it's going to be effective. So Dr. Tsui, thanks so much for joining me on the podcast today. Thank you for having me. And until next time, thank you to our listeners for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode. JCO OP podcasts are just one of ASCO's many podcasts programs. You can find all the recordings at podcast.asco.org. The full text of this paper will be available online at ascopubs.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice, signing off. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles, please visit us online at jco.org. This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.…

1
Effect of surgical oncologist turnover on hospital volume and treatment outcomes among patients with upper gastrointestinal malignancies 18:39

5 years temu18:39

18:39

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 hospital they were not apparent there. So we assumed that they out-migrated to other institutions. And empirically and by discussion by other physicians who were here in this time, they clearly out-migrated to different systems and out of town. They were simply not present with this hospital. We looked at the overall survival as perhaps the most important measure of efficacy of therapy. And we were able to restore the surgical oncology quality to the point that survival after the new surgical oncologist came was not worse, perhaps even improved in some situations. And there also was more of a higher proportion of patients undergoing multidisciplinary therapy. That means either chemotherapy or radiation or combination of those in addition to surgery. That will be expected general trend over the last 15 or 20 years, but it was very reassuring. We could actually see it to be restored back once the surgical oncologist services became available. And how well do you think the overall state SEER numbers reflect the real results that you would see in your patient population there? I think it reflects very tightly about the reality. Now, SEER has been demonstrated on a nationwide level to be very effective and very precise with a very low rate of the errors. Interestingly, and many don't know that Iowa was one of the original states where the SEER Database has been established and participated in the program since 1973. And to some degree, it could be driven by the fact that there are not too many hospitals which actually have cancer registry. So in reality, you don't have to train that many registrars. But those registrars and individual cancer centers actually support both the SEER Database and other databases, including the National Cancer Database. So there is historically, for perhaps some nearly 50 years, of consistent reporting of data. So I have a lot of trust in the data reported, especially from Iowa. In the paper, I noted that you, over time, as we get closer to the modern time, that the outcomes seem to improve. At least compared to the time before the previous surgical oncologist was there, is that because the new surgeon was more skilled or is it that outcomes just overall are improving as we move on and have new treatments? I think it's completely explained by the overall improvement of care of the years and multidisciplinary treatment. I had a distinct pleasure to, for about two or three operations, operate with a surgeon who continues to work in Iowa-- he's in mid 70s-- in the minor procedures, and that's an excellent surgeon. Definitely could observe it. So while many people like to think that it is because of one person or one surgeon, there's not one surgeon. It is really the whole system maintain adequacy compared to improvements, which we experienced over the last 15 years in the care overall. So I think it's the whole team, as it would be expected, gets better over time. I think you did a very nice job of illustrating the major impact that losing a surgical oncologist has on our health system. Dramatic changes in the numbers of patients treated over time. So is there a message that health systems who maybe have only one or a couple specialists in various fields can take from this? How should they be addressing potential loss of their relatively small numbers of crucial specialists? I think this is great point, and all that I can advise would be consideration and planning. And while I do think that some specialties with low frequency of practitioners, like surgical oncology, are at risk, there are many other specialties. And, in fact, every single specialty could be at some degree of risk, because a medical oncologist, the level of the knowledge which is required to practice with all the molecular studies and immunotherapies is enhancing, essentially doubling every year or two. So sub-specialization within even medical radiation oncology is also ongoing. So I think every health care system is at a risk of losing some portion of its common skill if a key individual is to leave. So surprisingly, as I mentioned at the early parts of our podcast, we actually lost, not in our hospital but in another large hospital, an entire group of radiation oncologists. Hard to believe that it occurs in a city of 750,000. But it did happen. So I think that planning and perhaps more research and attention into who delivers care, not only how, but who delivers the care, into how do we cultivate our cadre of nurses, physicians, nurse practitioners, or extenders, it becomes extremely important, perhaps at least as important as the buildings, because it's really the professionals who create the program. And those gaps-- you know, I definitely experienced this gap. I came and I thought I would take over a working practice. There was no practice. That is not necessarily important about me, but what about the community which actually experienced this decline? And I would submit that every health care system in some form or another, whether large or small, is in some degree of a risk if they do not address the planning, career transition of the services which are often perceived as granted and available until those who do them are actually not present. Dr. Franko, thanks so much for joining me on the podcast today. Thank you very much, Dr. Pennell. It was my pleasure. And for the listeners out there, until next time, thank you for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode. JCO OP Podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of this paper will be available online at asco.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.…

1
Gender Differences in Faculty Rank and Leadership Positions Among Hematologists and Oncologists in the United States 22:12

5 years temu22:12

22:12

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 people going to presume, oh, she is married. Automatically people are going to presume, oh, she may have kids, or may she may not be able to do justice to this leadership position, this chair position or what have you. And those are things that are going on in people's heads. There is no way that you can shine a light on that. Of course. Of course. Although, in a way you do that by trying to match everything as objectively as you can, and seeing if there's still a significant difference at the end. OK, so why don't you start taking me through what you found? So I talked a little bit about what we had observed in terms of that drop-off in the numbers or the percentages that we see women who were of higher academic rank, and the associate professors, and then only 22% being full professors, and only 30% being leaders of their departments. We did also find that women had lower h-index. So what we could tell in terms of an objective measure of research productivity, although of course that's not by any means a perfect measure, and they also had fewer years of professional experience and fellowship; which again speaks to the fact that while there is parity in gender in medical schools currently; in terms of practicing physicians, there's still this gap. And then we looked at the odds of obtaining full professorship or leadership of a division, after we adjusted for how long somebody had been in practice, what their productivity was; again measured by the h-index, so not the most perfect measure. And we did not find actually any differences based on sex and the odds of obtaining either professorship or divisional leadership. So again, one could call this a, quote-unquote, "negative study," and that, OK, if you correct for enough of these factors, there don't appear to be sex disparities in women being able to achieve leadership or to obtain higher academic rank. But I think a very important thing to note is that's not the point we want to be making with this study, is that, oh there's no gender difference. There's no sex disparity here. We want to point out that this is the real world. In the real world, we don't correct for things like clinical experience and academic productivity. You can't do a mathematical correction. What we need to see is why are there things like difference in academic productivity. What are the factors that may make it more difficult for women to be able to achieve these ranks over time? What are the barriers that they're facing, and how can we try to overcome them? Because we're not in a mathematical world, where we just correct for these things, and we need to help our system change to allow women to achieve these positions of leadership. Yeah, I'm glad that you pointed that out. Because my first read of the paper was actually, wow, they're actually concluding that there isn't a big gender difference, or a sex difference in senior leadership. But as you actually read in, there clearly could be disparities in terms of women being able to achieve the same numbers of publications, and equally high h-index and grant funding that would get them to the point where they would be in a position to get these leadership positions. So the disparity extends well beyond those positions themselves. There's a lot of data out there that women are funded at lower rates for initial grants. And of course, you know that once somebody gets a grant, they're more likely to get other grants in the future. So putting that barrier in place from the beginning makes it harder for women to get grants over time, makes it harder for them to get published. We know that editorial boards have a lot of sex disparity. We know that as Dr. Khosa also said, there are sex disparities in leadership who are making decisions about who gets promoted. So there are all these unseen variables that we can't account for that are probably barriers to achieving these higher leadership positions. This is something that always comes up when we talk about barriers to women moving up in leadership roles, that they may be earlier in their careers focus to some extent on raising a family, or even if they are continuing to work without a break, that they have a disproportionate share of family and home care obligations, and that this may lead to lower academic productivity. And therefore some of the measures that go into leadership promotions may not be as prominently featured on their CVs for these reasons. And so do we need to think differently about the criteria that go into promotions? Exactly. And that's one of the points that we both wanted to make while talking with you today, is that as the saying goes we need to fix the system, not the women. For a long time, when we were told you just need to work harder, be more productive, you need to essentially "be like a man," quote-unquote. We're in a system that was developed by men, run by men, and have criteria that allow men to get promoted. And so if we apply the same criteria to women, we're essentially telling them, you need to behave like a man in order to succeed in the system. So we don't need to tell women to be like a man. We need to change the system to be more friendly for everybody. And so that does involve things like changing what criteria we look at for promotion. As Dr. Khosa was saying, why are we just looking at the number of publications on a CV? There's a lot of other things that women do that actually make a big contribution, whether it be seeing a higher number of patients, whether it be serving on committees. We know that women are more likely to serve on committees than men, and committees are things that are unrewarded on your CV that take quite a lot of time and effort to do. So there's all these unseen things that women are doing that don't make it onto the CV as a criteria for promotion that we really need to take a much harder look at. And at the same time, we also need to be changing the system, and to say, what are we doing wrong that allows women to be paid less than men for doing the same tasks? What are we doing wrong that we are funding women at a lower rate than men when they submit grants? What are we doing wrong that allows our editorial board and journal reviewers to continue being primarily men? So we need to really make some changes to the system, both from what supports women, and from how we judge people on a criteria for being promoted. How do we do that, though? So I think now I mean it's hard to escape that this is a real thing. I mean you've objectively shown differences. It's been well-documented. What do we do in order to make this actually change? I recently published a paper on Canadian health authorities. And out of the 30 manuscripts that I've published and 50 more that I'm working on, this was the only manuscript which showed clarity. There was no disparity, gender disparity. And the reason for that is because it is the governments that have mandated. And there are carrots and sticks. So if an institution's annual evaluation, or three yearly evaluations does not show progress, that institution's funding, government funding, grant funding, capsizes. And these are the metrics that are applied across health care authorities. These are the metrics by which progress is measured. Giving out policy and not following it through, or not having repercussions is rewarding bad behavior. The best apology is actually change the behavior. That is what best apology is. Similarly, remedial action has to be avoided, and those who could persist with this behavior have to be taken to task. That is the only way. I'm a huge fan of Dr. Julie Silver from Harvard Medical School, who is a world leader in gender equity research, very well published in this area. And she always says that if you can't measure it, you can't see it. And it's so important to measure these things. Because number one, as Dr. Khosa said, it gives a baseline for improvement. But number two, it really opens people's eyes to say, hey, we do have a problem. I think if you are trying to go to leadership and convince people that we need to implement some changes, we really need to be bringing some data with you. You can't just say, oh, we have a gender equity problem, because everybody knows it. You need to say, this is our percentage of women who are in leadership positions. This is what's changed over time. This is what hasn't. And here's what we propose to do to fix it. And here's how we're going to measure our success. So you really need that data as a starting point, and as a measuring stick to see how well your interventions are working. Well, I think that's a wonderful summation. So Dr. Khosa, Dr. Marshall, thank you so much for joining me on the podcast today. Thank you so much, and god bless. Have a nice day. Thanks so much for inviting us. Until next time, thank all of our listeners for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcasts, or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode. JCOOP podcasts are just one of ASCO's as many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper is available online at ascopubs.org, backslash journal, backslash jcoop, posted February 2020. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.…

1
Development of an “Art of Oncology” Curriculum to Mitigate Burnout and Foster Solidarity Among Hematology/Oncology Fellows 19:13

5 years temu19:13

19:13

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 you measure this kind of improvement? Yeah, so that is probably the fundamental challenge, to be honest. And I, first off, want to say, I 100% agree with you. I think it's a first principle of medicine that we need to, as a community, think deeply about how to care for patients well. And we need to help each other to thrive in medicine. So I don't know how you'd necessarily capture that on a scale. There are well-developed burnout scales, the NBI being the most prominent. We worry a little bit about having our fellows go through extensive surveys in the curriculum. So we used a couple surrogates. So there are three one-item measures that we used at the beginning and then the end of the curriculum. And then we really wanted to capture the experience of the program as well. So we had fellows fill out basically subjective surveys about their experience with the program. And then also, we captured their attendance in the program. Our aim was really to establish, first off, is this something that is possible to do, good fellowship programs do this. And then really, did fellows enjoy and participate in the program as well. You mentioned about not wanting to put a bunch of surveys on top of people. And so one of the first things that occurred to me when I was reading this paper is, were you concerned when discussing adding this that fellowship curriculums are already quite busy and filled with lots of sessions and other duties and whether this might actually make their burdens worse by adding extra sessions and requirements? Yeah, for sure. We didn't really know what to expect. And we didn't even know if the Fellows would show up and participate. There is fear within our culture of being vulnerable, of owning that the suffering of our patients is getting to us and that we need some help. And I was really afraid that fellows would feel like the sessions were cheesy or forced and that the fellows would be uncomfortable being honest in the sessions. There is a perpetual concern about adding more into the lives of fellows that will lead to greater burnout. You know, it's the running joke about filling out a weekly 25-question burnout survey among our fellows. So we really wanted to design a program to limit the requirements. Fellows really just had to show up and participate. There is no required readings or homework. And we limited a few didactic sessions that used to be in the place where the Heart of Oncology sessions were in order to make room in the schedule. And we tried hard to make the sessions adaptable to any environment so that it was really just having a narrative prompt, getting people who care for cancer patients together, and thinking deeply about some of these issues that was really at the heart of the program. So we tried to limit a lot of those extra requirements for the program. Well, it sounds like you definitely thought about that and tried to make it as least burdensome as possible. And it sounds like you were able to do that. So tell me, what did you learn from this first year of the program? Well, it was really fun at first. And so as a fellow myself, I was able to participate with the other fellows. And that was really wonderful. I had a great time with them and learned a lot about them and felt like it was really enriching for me. We saw, really, that the fellows really enjoyed the curriculum as well. They really loved the opportunity to think more deeply about these issues and also to hear how their colleagues were wrestling with them and to dialogue about some of the issues that we often don't talk about. They felt it improved the sense of community among the fellows and helped with some of the daily challenges of dealing with the suffering of their patients. They pointed to some practical skills that they took away from the sessions, including managing work-life balance, communicating bad news, and having a better understanding of the challenges faced by patients. Surprisingly, many of the sessions were really emotional for the fellows, where they were able to share their stories about losing patients or family members to cancer. We didn't see a statistically significant improvement in burnout. And as I mentioned previously, this is a pilot intervention. So this is not wholly unexpected. As you mentioned prior as well, that with such positive comments from the fellows that the sessions were beneficial in and of themselves, and really that we would hope that there would be long-term benefit as well. I don't know if such programs to foster moral development would actually be expected to result in immediate improvements in burnout. So the goal was really to begin to cultivate the virtues that will have lasting impact over a career in medicine and not necessarily to impact the burnout that follows were experiencing in that moment. So you are describing the first year in your paper here. So what are the next steps? And based on what you've learned, are you planning any changes? Yeah, so Dr. Collichio and I sit on the ASH ASCO Milestones committee, which are working to develop some metrics to capture fellow well-being at each fellowship program. And so we are hopeful that these metrics begin to lay a foundation to expand the art of oncology programs and other fellowship programs. We've been in contact with other programs that are eager for such an intervention and to get it rolling. And so I welcome other fellowship programs to join in as well. The ideal study design to test this intervention is a multi-institutional cluster randomized trial. But really, I think we're still at the nascent stages of the development of such interventions. So this will likely be something that will happen years from now. And again, I think we realize that while we want this intervention to really impact on burnout, we want the intervention to have something deeper in terms of developing the character of our fellows. And so rolling it out among fellowship programs is going to have benefit across the board. So what changes are we making to the program? We're in the second year of the pilot. And we haven't had too many changes, apart from, again, limiting the amount of requirements that we have for the fellows. Last year, the fellows really loved having patients come and speak and share their stories and how they interacted with the health care community. So we increased the number of times that patients would be coming. And we started to have more of our senior oncologists come and share their journey in medicine, kind of a career perspective to the fellows, and allow them to really begin to build some mentoring relationships. Well, Daniel, I think this sounds absolutely fantastic. I wish we had something like this when I was going through fellowship training. So Daniel, any closing thoughts before we wrap up? I'd like to comment that programs like these are simply part of a larger whole. Much of the increase in burnout we are seeing in medicine, as I mentioned, is part of larger societal epidemic of the loss of meaning and purpose for individuals. I believe that the epidemic of burnout in medicine is not going to simply be reversed by programs, but rather by a deeper change in the culture. As an oncology community, we need to recapture our calling of service to suffering patients. We need champions who can lead the way in this and serve as mentors for fellows on how to care for patients well and to model how to find joy in their careers despite the suffering and losses they experience. It is only by recapturing this deeper calling that we can inspire and train fellows to do the same. And I'm hopeful that programs like this one and other similar programs across the country to bring fellows together to think deeply about their calling, their personal calling, and then also their calling in the midst of the oncology community, will serve to do this as well. So Daniel, thanks so much for joining me on the podcast today. Once again, this is such a privilege. Thanks so much for having me. And until next time, thank you for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode. JCO Oncology Practice podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper is available online at ascopubs.org backslash journal backslash JCO OP, posted in February 2020. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.…

1
Implementing Decision Coaching for Lung Cancer Screening in the Low-Dose CT Setting 16:53

5 years temu16:53

16:53

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. So we followed patients from the time they checked into the time they checked out, and we cataloged what they were doing. And what we saw when we looked at that data in more granular level is that the time was shifted from waiting periods to active time. That's great. That's really important that you were able to show that. I thought it was interesting that you commented in your paper about the different elements of the shared decision-making visit. That in fact, what we might think of as the primary reason for doing it, which was the element of reducing mortality or their chance of dying of lung cancer, was actually the least important part of the shared decision-making visit. Why do you think that was? I don't know if it was the least important part. It's just that we had some slides dedicated to it for the decision coaching, but there are so many more harms to talk about, and it's also an artifact of the context to where this intervention took place. So we took it, we were dealing with patients who had already been scheduled to be screened. So we were just confirming their decision, and I think the advanced practice providers knew that. So they might have glossed over the benefit, because otherwise, the patients wouldn't be there, if they didn't value the screen. Mm-hmm. I guess that makes sense. They knew why they were there. Is there a next planned follow-up study for this? Good, I'm glad you asked that. So using this data, we're testing this more centralized model and using it in a different setting. So now, we're taking this into a quit line setting. So we have a Cancer Prevention Research Institute of Texas, or CPRIT, grant that's looking at the decision coaching being delivered by tobacco treatment specialists via phone. So a primary care provider identifies patients with upcoming appointments that might be eligible based upon age and being a current smoker. And then they get contacted with our quit line folks, here at Anderson, and we deliver the counseling and share decision-making visit, in addition to the cessation, and we give a report back to the BCP. And well, we're hoping that increases individuals to get screened and also have proper follow up, if there is something abnormal on the scan. So I'm curious if you have any other suggestions outside of your program of ways we might improve the uptake of lung cancer screening in the US. Oh, I think we could do a number of things. So I think we have to think about each step of the pathway. Right? So one, we have to increase awareness of it. So that's through social media, social marketing, that kind of stuff for both patients and providers and caregivers. Then, two, we need multiple avenues, where we talk about lung cancer screening, like how we do with breast cancer and colon cancer. Like at church, at your beauty parlor, at your grocery store, and have those kind of public health interventions to get out the information. And three, we really need to train up our health care workforce and help programs. Where it's possible to either have the PCP do it in a robust manner or have a more linked program, where they can refer to a centralized program. Where the counseling and shared decision-making visit can be delivered by their pulmonology or in the radiology scan, and the patient can get scanned that day. So I think there's a lot of different questions and different delivery models that can be asked, and this is a great area to be working in right now. Because with the release of the Nelson study, it's even more exciting to show that lung cancer screening can be very beneficial, and with using the lung rads, the false positives are much lower. So I'm pretty excited, and I think there's so much opportunity, and we can learn so much from what we're doing in breast cancer and colorectal cancer screening. No, I completely agree with you. I think it's very exciting that the Nelson study was finally just published, and so hopefully, this will overcome any residual skepticism about the benefits of lung cancer screening. And obviously, continuing to improve on the screening tools themselves, maybe using some kind of companion diagnostic, maybe blood or breath-related, that might improve the-- or using artificial intelligence to better tell benign from malignant nodules. Ways that you can reduce the false positive rates would be very helpful. Well, Dr. Lowenstein, thank you so much for joining me on the podcast today. Thank you. It's a pleasure. Until next time, thank you all for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts, Google Play, or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode. JCO OP's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper will be available online at ascopubs.org/journal/op, in February, 2020. This is Dr. Nate Pennell for JCO Oncology Practice signing off.…

1
Improving the Time to Activation of New Clinical Trials at a National Cancer Institute–Designated Comprehensive Cancer Center 19:28

5 years temu19:28

19:28

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, internally. It makes it more useful to the outside companies or organizations that you're working with. And, you know, even the non-value added time that's not in your control can sometimes-- you can intervene in that. You could potentially escalate things if you haven't heard from a company in a certain period of time. So I completely agree. That makes perfect sense. DR. PENNELL: So, well, why don't we dig into your results? So what did you find through the mapping process? DR. BEG: I think one of the issues was how we can move some of the steps that happened in parallel or that happened sequentially to try and make them work in parallel. And like Erin mentioned earlier, just mapping out the process and having the different offices represented on campus that are a couple blocks away from each other really think about how they-- when they start their clocks and why they wait for specific milestones to start a review process was very helpful. So one of the steps was to really move from a sequential process of scientific review followed by an institution review board review into a process where we move that in parallel to each other. And different centers have grappled with this question in different ways. The way we decided to address this, we didn't want the IRB to be bogged down by a study that wasn't scientifically valid, that may have concerns, or is not novel enough. But we have internal data that our scientific review committee-- and this is published data-- that our scientific review committee very rarely changes the design or the structure of an industry-sponsored clinical trial, for example. So we decided that we would come up with a process where the IRB will physically review the study at a time after the scientific committee has reviewed the study. If the study is disproved, then it falls off the IRB's docket. But if it's approved, then they will be ready to review it. And we were able to shrink that time from scientific review to IRB quite significantly by modifying that process. We talked about institutional studies, so studies that our own investigators are developing. Those studies do tend to get more criticism at the scientific review committee. Our committees review them much more closely and have much more impact on those. And we decided to move them forward on a case-by-case basis. So it really required some restructuring. MS. WILLIAMS: One of the other things that we outlined in the paper, one of the other outcomes, was that our hospital review committee agreed to review the study in parallel with the IRB and in the PRMC review process and just hold their approval until those approvals had been received. And that happened. And if you looked at the individual time to getting that hospital review committee approval immediately following the intervention, it went down significantly. As with anything, it takes consent kind of massaging and working with those groups. And some of the offices and the infrastructure around clinical trial changed subsequent after we had our time to activation. And so with any of that change, processes start over, people start looking at things over again, and they decide, well, wait, why are we reviewing this in parallel? Or these other groups of people need to be reviewing this in more detail. Having said that, as those processes have changed, what we've heard and what we've experienced with those stakeholders in the institution is that their eye is always on the activation timeline. And that if we report to them, hey, this time to review committee approval has kind of gone back up, it's creeped back, and we really need to look at this again, you can see their immediate response is, oh, absolutely, we understand, these are kind of some shifts that we made, but let's get together, let's look at it, we really are hoping to push it back down. DR. PENNELL: Well, I think that's a great point to point out, that this is not a one-time thing. And whatever changes you institute, you can't just do it once and then expect it to be a permanent change if you don't follow up and ensure that it's still working. DR. BEG: One of the other things which came up when we were looking at our numbers was to figure out how to staff different positions. And there are some steps of the activation process that are very nuanced, really require special expertise. And an example for that is the coverage analysis evaluation, where a third party independent of the investigator's team decides whether every procedure or blood test or scan gets billed to insurance or is that something that gets billed to the study. So is it a research procedure or is it a standard of care procedure? And in oncology, where philosophically we view research as embedded within standard of care, that can be a pretty tricky determination to make. So the people who do this come in with a really unique set of expertise from their clinical-- that have clinical expertise and research expertise. And one of the things we noticed was for positions like those and for positions other than that, it's really important to have redundancies in those positions, so if there is staff turnover of any kind, that that process can keep moving forward. Because those are steps that-- it's hard for a consultant to come in and fill in and those people don't really just hang out on campus for us to be able to tap their time and to start processing those studies. So other than looking at our processes, it did come down to staffing those positions and making sure that we create some redundancies in those positions so that we're not completely dependent on, for example, one person for a task like that. DR. PENNELL: And that is such an obvious issue that I think maybe a lot of people may be shocked to hear that institution's administrations don't always agree that you need more than one person to do a task. But again, this is really resonating with me personally, because we went through this same issue. And there are so many important things that for some reason there's always just one person who can do it. And if they're out for whatever reason, or they leave and there's staff turnover, things just grind completely to a halt. And so I think that that's a wonderful illustration that hopefully will be convincing. Did all of this work end up making a difference in your time to opening trials? MS. WILLIAMS: It is making a difference. We are seeing improvements in certain steps of the process. We've definitely seen an improvement in our time to both scientific committee review approval, our time to IRB approval. Our coverage analysis timeline has been very steady. Our time to activation for our national cooperative group studies has been very stable at around 90 to 100 days, since instituting just kind of these simple-- well, not so simple-- but since instituting this whole process. Where we still have challenges is in our budgeting and contracting process. However, again, since we've got that institutional buy-in, it was actually our sponsored programs administration office contract director who approached me about two or three months ago and said, you know what, we really need to talk about the workflows between covered analysis, budget negotiation, and contract, because I see things kind of being an issue for us, as far as getting expedited approval and execution of contracts. So we had another about 2 and 1/2 hour meeting just about a month ago to sit down and go through that workflow and identified, again, a couple of key places where we can bring previously sequential steps into a parallel-step process. And so once again, I think the take-home of the exercise that we performed is that we have institutional stakeholders who aren't necessarily just waiting to hear from us to figure out how we can do better, but are coming to us and identifying timelines and being able to work together to continue to make those happen. DR. PENNELL: And it sounds like this has worked very well for your institution. But you point out in your manuscript that a lot of the processes are so unique to individual institutions that it's hard to make blanket recommendations that apply everywhere. So what can other sites who are also worried about their time to activation take from your process? DR. BEG: I think one message is to know what your internal process is. And I think a lot of folks who are listening to this podcast will admit that at their centers there's no one document that really maps out the entire process. So for us, the process of mapping out the trial activation process was probably the most transformative bit, the rest sort of just fell into place. DR. PENNELL: Shaalan and Erin, thank you so much for joining me on the podcast today. DR. BEG: Thank you very much. MS. WILLIAMS: Thank you. DR. PENNELL: Until next time, thank you for listening to this Journal of Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode. JOP's podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org . The full text of this paper will be available online at ascopubs.org/journal/jop in November 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. [PIANO MUSIC PLAYING]…

1
Coverage, Financial Burden, and the Affordable Care Act for Cancer Patients 15:17

5 years temu15:17

15:17

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 well as an increase in the high deductible health plans. So people seem to be enrolling in either Medicaid or private coverage, and that tends to be with some of the higher deductible health care plans. We see similar changes for individuals who what we'll call current cancer, and those are the ones who not only have been diagnosed with cancer, but show some utilization in the current year. And then, I guess, in addition, what we find, we find something slightly different in the higher income cancer sample, and that's that they also experience an increase in the enrollment in high deductible health plans, but they also see a significant increase in their out of pocket premiums as well as the fraction of family income spent on health care. And so that's what we see in terms of just comparing pre and post. But we also do a number of comparison to some different groups to try to tease out sort of what might be driving, and sort of how similar the cancer population might look in terms of their improvements to some of the other population. You mentioned that a lot of this had to do with the expansion of Medicaid, but of course, that that was rather sporadic because not every state expanded Medicaid. Did you look regionally at these numbers or is this basically nationwide? So it's nationwide. In some of our adjusted analyses, we're able to control for region. But actually, one of the limitations of our study is that in the data that we have available, we can't identify an individual's state. So we don't know whether or not they're necessarily in an expansion state or a non-expansion state. Yeah, because one of the first things that occurs to me is that if everyone had expanded, would the number be larger? And is there any evidence of the Affordable Care Act improving coverage and financial burdens specifically in states that didn't expand Medicaid? But I think that would be an interesting thing to look at maybe in the future. Absolutely, and there's certainly some evidence to suggest that within cancer populations, generally, there does seem to be improved health insurance coverage, in particular, in some of the Medicaid Expansion states precisely for the reasons that, I think, you're mentioning. One of the other things you looked at is you looked at a comparison group with a higher income level, what did you find in that group sure so one of the comparisons we make is that some changes in our outcomes between the lower income cancer sample and the higher income cancer sample what we see is maybe not surprisingly there's less of a change in health insurance coverage among the higher income cancer sample part of that is that they've had they had higher coverage rates to begin with. But what we also see is an increase in the out-of-pocket premium of about $800 per year for the higher income sample relative to the lower income sample. And we also see it relative to lower income sample that day they experience about a two to three percentage point increase in the fraction of their income spent on health care costs. What we find seems to be driving that is actually more of a modest increase in the fraction spent among the higher income cancer sample along with sort of a very modest decrease in the lower income sample where are you going to go from here with these data what future studies do you have planned and what ideas can you pull from this to try to help reduce future financial burdens on cancer patients. So part of it is trying to get access to some of the restricted data where we would actually be able to identify what state people are and so we could get a much better sense of whether we're seeing some of these changes differentially in expansion states versus non-expansion states. Also, with some additional restricted data, we'd able to get a better sense of how these patients might be transitioning across different types of health insurance plans once they're diagnosed with cancer. So right now, we've got a mix in terms of patients who are in active treatment and more recently diagnosed, along with patients who may have been diagnosed further back. I mean, unfortunately, in the data we currently had, we're not able to accurately distinguish exactly when they were diagnosed. But again, we'd be able to better tease out some of those differences between people who had maybe been diagnosed longer ago versus more recently. So one of the things that everyone is worried about today, of course, is the rapidly rising cost of medical care, especially drugs in patients with cancer. That probably poses a challenge to doing this kind of research showing pre and post expenses when the actual cost of care is going up during the study period. It's certainly an important thing to consider. Obviously, during this time period, the cost of, in particular, some of the cancer therapies has gone up significantly. We try to account for it, I guess, in a couple of different ways. One was going to be we're comparing some of the higher income and the lower income populations to get a sense of whether they differentially experience some of the financial burden. So to the extent that both lower income and higher income cancer patients are facing the same increase in drug prices, we would control for that to some extent. I guess the other comparison we made was to compare, in particular, the lower income cancer sample to a lower income sample that did not have cancer. And actually, interestingly, what we find is we don't really find much of a significant difference between those two samples. So what that suggests is that the Affordable Care Act improves coverage and may help to mitigate some of the financial burden, but it does similarly for both cancer and non-cancer patients who are low income. And that makes sense. As much as we pay attention to cancer because that's our field, it's only one of major health issues. Especially in a non-Medicare age population, I would think there'd be a lot of other competing risks. But still, it sounds like that is a good control over the overall rising costs of health care. Well, Dr. Segel, thanks so much for joining me for the podcast today. Thank you for having me. Until next time, thank our listeners as well for listening to the Journal of Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode. JOP 's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org . The full text of the paper will be available online at ascopubs.org/journal/jop in October 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.…

1
Determining If a Somatic Tumor Mutation Is Targetable and Options for Accessing Targeted Therapies 23:29

6 years temu23:29

23:29

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 that supports the use in a different cancer type, then, you might be in a situation where Medicare or private payers might provide coverage for that off-label use. So in those situations, contacting the insurance companies is what we reference in the article to obtain authorization to prescribe the medication and get coverage. In situations where there isn't published data, there might be clinical trials that are under way. And in those situations, obviously, the clinical trial-- you'd have to look at the eligibility criteria for the clinical trial. Is it something that's available at your clinic? If it's not available at your clinic, is it something that the patient could travel to obtain enrollment in the clinical trial? So that's really on all along that left side of the figure related to whether the cancer type is mentioned on the drug label, whether there's published data. And the payer might cover it off-label, or if the patient would qualify for a clinical trial. If none of those are a possibility, then there still might be an occasion in which the patient would still be interested in accessing the therapy. And then you might want to look into financial assistance options for the patient. And in the manuscript, we talk about, there's recently been a compilation of patient assistance programs. And we include the website in our manuscript. And that does allow a clinician and a patient to look across multiple pharmaceutical companies to see if there might be patient assistance options available if it's already an FDA-approved approved drug. [DR. NATHAN PENNELL] Oh, that's great. So what about for patients who want to access drugs, but for whatever reason, don't have either an approval for off-label use, or there's no trial available? How would patients access drugs in that setting? [SUANNA BRUINOOGE] In that setting, you're probably thinking about a drug that's an investigational use if it does not have an FDA approval. And in this situation, there certainly may be circumstances in which a clinical trial isn't available. Or maybe your patient is not available at your site. Or maybe your patient doesn't qualify and meet the eligibility criteria or isn't able to travel for the clinical trial. And in those situations, there may be options that you and your patient could explore through something called expanded access program. And there's really three options that are sort of broadly described as expanded access program. A company might offer a large or mid-sized expanded access program. It's essentially like a clinical trial, although it may be collecting less data in the course of the clinical trial. It might be for a broader patient population who might not otherwise qualify for the clinical trial. And typically the company might conduct this as a broader access for patients who don't qualify for a clinical trial. Or perhaps in the interim period between which a company submits its application to the FDA, and they're waiting to hear about the FDA review of the drugs. So these are often sort of in that interim time period before a drug might be approved. The third type of expanded access program is an individual patient use. And this is something that is there's actually new resources that are available on a couple of different locations. There's an organization called the Reagan Udall Foundation. So that's Reagan as in the former president. And Udall-- U-D-A-L-L. This is a foundation that supports the work of the FDA in a broad sense. And they have something that's called the Expanded Access Navigator Program that's available on their website. You are a patient Google Expanded Access Navigator. The Reagan Udall website will certainly become available in the listing. And what this does is list all the companies that provide expanded access program. So this is a good starting point to see if a company might be offering either a large or midsize expanded access programs and also list the company context at the company so you can also figure out how to contact the company to find out if your patient qualifies. If there isn't a program. Then fortunately, in oncology, we also have another option that clinicians can explore. The FDA Oncology Center of Excellence recently launched a program that's called Project Facilitate. And this provides both web-based resources, as well as a phone line that is available during business hours which are largely East Coast business hours. And it's a resource for clinicians to contact related to individual patient access requests. And the FDA has staff who are very knowledgeable about the individual patient access pathway. They can help with contacting companies and sort of serve as an intermediary to help navigate those situations. And the FDA role is actually in any of these three expanded access programs. The FDA plays a very important role in reviewing requests from clinicians. And they provide sort of a third-party review of the circumstances. And they're very quick to respond to inquiries in this regard and really do approve virtually all of the requests for access that they receive. And so long as the company provides access to the drug, ultimately, the decision about whether to provide access to the drug is up to the company. There is another avenue, which is described in our manuscript as well. Some states have also passed right-to-try laws. In these circumstances, these laws are at the state level. So not all states have passed them. But they provide a pathway that bypasses FDA review and assessment. They do not require that a company provide the investigational drug. So that circumstance is really still up to the individual company, whether they want to make the drug available outside of clinical trials. [DR. NATHAN PENNELL] I think a couple incredibly important things that I want to make sure everybody got out of this. One is that all of this relies on the pharmaceutical company actually being willing to provide these drugs. So even the right-to-try laws on the state and federal level don't require that the companies give access to the drugs to the patient. So both of those are necessary. And second of all, that the FDA is incredibly helpful in providing access to these drugs. I've personally gone several times through compassionate use single patient's drug access through the FDA. And they've been tremendously helpful and never were in any way a barrier to getting access to the drug. They're fast and responsive. And so I actually haven't personally heard much in terms of the use of the right-to-try laws to access drugs. I don't know if that's something that there was a lot of attention, of course, when the federal government passed the law. But I haven't heard much about it since then. [DR. RICHARD SCHILSKY] Nor have we. I don't think we're aware of any circumstances in oncology where patients have access to investigational drugs through the right-to-try pathway. That may be because the companies are reluctant to make drugs available. Or it may be because appropriate drugs just haven't been on the radar screen. I think all of us, though, would agree that a much better way of providing access to drugs would be to do it in a way where you're actually collecting the information on the efficacy of the drugs and the toxicity of the drugs where you can learn about that process and help lead to an eventual approval. So what is ASCO doing that can help provide access to promising drugs, perhaps, an off-label setting for patients? Many people know the TAPUR is an acronym that stands for Targeted Agents and Profiling Utilization Registry. So it's a quite a mouthful. And so we like to call it TAPUR. So TAPUR is a prospective multi-arm phase II basket trial, which is matching commercially available targeted drugs used to off-label against a genomic alteration in a patient's tumor. So, in essence, we set up TAPUR to be able to learn from the off-label prescribing of targeted drugs to patients who have advanced cancers. And the study has been ongoing now since March of 2016. There are about 1,600 patients who have been enrolled at about 120 sites around the country. We've started to report out both negative and positive results. And we think that negative and positive results are equally important in this setting, because, for example, if a doctor could prescribe a drug off-label, but there's no evidence that the drug actually is beneficial, then those patients are better served by being directed to other clinical trials. So for example, last year, we reported that palbociclib is not effective in either pancreatic or biliary tract cancers that have a CDKN2A alteration. So the implication being, of course, that the next time a doctor sees that alteration showing up on a tumor genomic test report for a patient with one of those cancers, they probably should look for something other than palbociclib. Now, alternatively, we've also begun to identify signals of activity that either have been already reported in more formal clinical trials. And we're just able to affirm that the therapy works in a more real world population or in some cases haven't really yet been identified. So, for example, at this year's ASCO annual meeting, the 2019 meeting, we reported that pembrolizumab has activity in patients with breast cancer that have a high tumor mutational burden. And we think that's an exciting observation. Some of those patients actually had quite prolonged disease control and that the abstract has been presented. The poster is available on the TAPUR website, tapur.org , for anyone who wants to look at the details. And there are some manuscripts of preparation. So TAPUR we hope over time we'll continue to report out both positive and negative results. They can't really help to guide the use of these well-sampled therapies. And, of course, it's also a mechanism, whereby the drugs can be provided to patients at no cost to them, because all the drugs in the study are being provided by the participating pharmaceutical companies. [DR. NATHAN PENNELL] Yeah, it really is a win-win situation. The patients get access to the drugs without having to worry about whether their insurance will cover the off-label use. And the companies learn whether their drugs may have expanded indications outside of where they're currently used. Well, Suanna and Rich, thanks so much for joining me on the podcast today. [DR. SCHILSKY AND MS. BRUINOOGE] Thank you. [DR. NATHAN PENNELL] And until next time, thank you for listening to this Journal of Oncology Practice Podcast. I hope you enjoyed what you heard today. And if you did, don't forget to give us a rating or review on Apple podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode. JOP 's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org . The full text of the paper will be online at ascopubs.org/journal/jop in August 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.…

1
The Opaque Results of Federal Price Transparency Rules and State-Based Alternatives 19:24

6 years temu19:24

19:24

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 first mandated to exist in the actually the Affordable Care Act. And the Trump Administration has really built upon this and said, why make patients ask for the charge master. How about we just require the hospitals to publicly display these? So that's where this kind of mandate came through. It's interesting because as we went through this exercise in the publication, and the codes they use, the abbreviations, even with a medical degree, I had a hard time deciphering what they said. Yeah, it does seem as though a lot of hospitals did not take this as a mandate to try to make this a transparent and useful thing. They said, well, the requirement is we're going to put it up. And here's our Excel spreadsheet or our PDF with all of the jargonese there. And you can do with it what you will. Absolutely. And I wasn't surprised when we saw that even within four months of this being mandated, 88% of the hospitals we looked at in Chicago had it published. They were right on it. They had published it. And it was on their website. Because the ACA had already required that they have it. So really, they just took it out of the file folder and put it on the website without much thought that they were trying to make it helpful for patients. A lot of disclaimer that a lot of, I think, hospitals overall did a really good job of putting kind of the fine print on there and saying that please speak to your doctor and facility to actually get the real cost. So I think the hospitals overall did a pretty good job of that. As you and your authors point out, if someone actually did try to use that information to comparison shop, or what I would think perhaps would be more common, they would look it up just to see what the price is going to be forwardly placed they've been told they're supposed to go. They might see a $3,000 charge for their CT, which might have been completely covered by their insurance with no out-of-pocket expense to them at all and decide not to get it because they're afraid they're going to be charged $3,000. Right. So in the hopes of having this transparent playing field, my major concern is even I, if I saw that amount of money, maybe that would make me pause a little bit actually. And I think the last thing we need to do, especially in these screening tests that there is no shortage of data saying that they improve survival. I want my patients to get them. There's enough barriers, I think, to getting someone a colonoscopy, that I would hate for that to be an unintended consequence of showing people the cost, especially in this inaccurate kind of forum. So what can we do about this? What do you and your co-authors recommend to try to address cost transparency moving forward? I think it's exciting that there is momentum here. I mean, I think price transparency, although has become a buzz word, it is going to continue to be an active issue at the state and federal levels. What makes this exciting to me is that it is bipartisan. So we all care about health care, to a different degree, and we all have different strategies. But I do feel that this is a bigger discussion about transparency, not only here at the patient level, provider level, hospital level even. I really think I hope we're moving to a place where there is a bigger discussion of transparency at all levels. I'm talking even starting up at the manufacturer level. But from a very practical patient level standpoint, we all encourage people to develop APCDs. There's interesting results that have been shown in some states that there is a good way to show people cost. And by doing so, programs, such as California's program, has actually shown that utilization of lower priced facilities has increased. And most importantly is that when patients are shown a cost and have some sort of way to impact or influence the amount of cost sharing that they will have based on their decision making, there is an opportunity perhaps for patients to choose lower cost facilities. Now, even as I'm saying this out loud, my first concern and worry is making sure that outcomes are the same. And so I, first and foremost, care about complication rates for surgery and things of that nature. But there are state level programs that have shown that we can have both. It can be a dominant solution. So I encourage states to especially have the flexibility to accommodate variations in state level health care markets, the states is really where these databases belong. And they should take it the next step further to make them interpretable, inclusive of all cost. And I encourage states and federally to work together to say if we're getting a colonoscopy, that includes services A, B, C, and D. So when patients are comparing, they're actually comparing apples to apples. Evidence-based standardized quality metrics incorporated into these cost models will help us at least keep thinking about getting to this ultimate goal of value. And it's like hard not to plug when we're talking about cost and everything is this concept of value. And making sure that no matter what structure we choose to show people cost to have it impact their out-of-pocket cost sharing, those services as we have deemed in the evidence to be high value, the screening lung CT, the colonoscopy, really should be at a minimal cost sharing for patients, no matter what sort of structure that we have. No, that makes perfect sense. One of the things that jumped out here, if you actually have data that using an APCD increase the number of patients moving to lower priced facilities from here, you mentioned from 68% up to 90%, the first thing that would occur to me is that that might actually end up driving down prices from competition, which is something that has never been a successful strategy in medical care for some reason. Absolutely. The specific program I'm talking about from California is called CalPERS. And it's the government 1.3 million state employee programs. And really, the premise of that program is so interesting because it's the assumption that we can never really decrease the cost of care unless individual consumers are aware of the prices and have some sort of input into their cost sharing and decision making. Oh, yeah. This is everybody is looking for ways to reduce costs. And when you see success like this, you'd think people would jump all over this. You'd think even hospitals and health systems would want to market that they have lower costs procedures to get more business. It's just very interesting that this is flying so under the radar. Absolutely. And I do think, though, that there are more and more states actually jumping on board. So I'm hopeful in the next five, 10 years that as the real discussion of the value and value based care continue, this will really, I hope, will become more common. And Dr. Kircher, thanks so much for joining me on the podcast. Thank you for allowing me to discuss the paper. Until next time, thank you for listening to this Journal of Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode. JOP's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. And you can also find the full text of Dr. Kircher's paper online at ascopubs.org/journal/jop in August, 2019. This is Dr. Nathan Pennell for the Journal of Oncology Practice signing off.…

1
Oncologists’ Attitudes and Practice of Addressing Diet, Physical Activity, and Weight Management With Patients With Cancer: Findings of an ASCO Survey of the Oncology Workforce 18:21

6 years temu18:21

18:21

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 incorporate these changes through a referral to a skilled provider. And then, the last piece was looking at barriers. And I think that this was something that we were actually a little bit surprised about some of the responses. The last part of the survey focused on looking at the respondents' perceptions of barriers. What did oncology providers feel like was getting in the way of patients changing their diets, exercising more, losing weight when it was relevant? We found that, not surprisingly, lack of time for counseling was something that many providers noted, lack of available resources. So even if you identified that a patient wanted to lose weight or meet with a dietitian, there wasn't necessarily someone that was available. Lack of training or expertise on the part of the oncology provider was also noted. We also found that the majority of participants felt that patients' resistance to behavioral interventions was also a large barrier to helping people make these changes. And this really led us to think start thinking about, well, what is the patient's perception? And I think that's something that we did not cover in this survey, but that is really critical. Because if we find that oncologists are talking about these topics and are trying to reinforce the importance, but patients aren't hearing that or aren't making these changes, then we're really not accomplishing what we want to. So I think from this survey, we now can see what oncologists feel is important and what they're doing in their practices. And we need to figure out, what are the patients hearing and what is the result of the advice that the providers are giving to patients? Yeah, that really is an interesting and kind of a surprising piece. So the first part resonates with me. So I certainly address, you know, in my patients that are in follow-up and survivorship, exercise and trying to maintain a healthy weight. And I also feel that I'm not super comfortable with trying to intervene in that myself, but rather try to suggest that they look for SilverSneakers or some sort of local exercise gym or other opportunities or, perhaps, refer them to a dietitian. But I don't know that I have a perception that the patients wouldn't welcome that advice or that they might be resistant. Is there any plan to try to get an assessment of cancer patients' attitudes on this? So this is something that we are planning at this time. We are trying to develop a survey and partner with some patient advocacy groups to really better understand what the patients' perceptions of these topics are. There is not much currently in the literature, but there have been some assessments. There was a large study that was done in the UK that looked at patients with colorectal cancer and the attention that was paid on the part of their provider to exercise. And if patients remembered hearing about exercise, they were much more likely to do it. So I think that something that we really need to better tease out is, what is the patients' receptivity to this type of information? And are the suggestions that oncologists are making enough to get patients, on their own, to seek out a program? Or do we really need to try to educate providers about effective ways of making referrals? I think the reality is that we also need more programs that patients can be referred to. And something that I think is a real need within the oncology space is programs that help people lose weight that are able to help people become more active, and recognizing some of the limitations that many patients have as a result of their therapy. Things like lymphedema, things like neuropathy, that can be barriers. How can we manage those in oncology patients to help them successfully achieve these behavior changes? And this is, I think, such a great topic because patients really care about interventions that they can do themselves to help their cancer care and their health. And there's so much out there, in terms of complementary therapies and whatnot. But we have real data on things like diet and exercise, and I think more attention being paid to this within cancer centers would really be welcomed by patients. I think so too. You know, we, right now here at Dana-Farber, are leading a trial called the Breast Cancer Weight Loss Trial that's a phase III study looking at the impact of a weight loss intervention on recurrence in women who are overweight or obese when they're diagnosed with breast cancer. And when we started this study, we weren't sure what the uptake would be. It's a very different type of model. But we've enrolled now more than 2,000 patients in less than three years. So there's definitely a very, very significant interest in this topic amongst patients. There's a similar trial going on in ovarian cancer that just enrolled 1,000 patients with a disease that's much less common than breast cancer over just a few years. So I think that the interest on the part of patients in this topic is large and we want to be able to provide them with evidence-based recommendations. There's a lot of stuff out there that's not so evidence-based, especially about diet, and I think that, as oncology providers, we really owe it to our patients to get them the best information that we have about things that they can do to help improve their outcomes and to make themselves feel better during and after their cancer treatment. And we're very lucky to work at institutions like the Dana-Farber Cancer Institute or here at the Cleveland Clinic, where we've actually got a lot of resources devoted to these efforts. But what can people who work at smaller institutions, or really don't have a lot of infrastructure for this, where can they access data or suggestions on how they can counsel patients or help their patients address problems with obesity and lack of physical activity? Is this something that ASCO can help with? So as part of the ASCO Obesity Initiative, we developed toolkits for oncology providers and for patients about the role of weight management and physical activity in cancer. And so those are available at cancer.net. They can be downloaded. You can give them to your patients to start a conversation about the importance of these topics in oncology care. The American Cancer Society also has diet and exercise guidelines for cancer survivors that oncologists can use as a guideline. The American College of Sports Medicine also has a website where they have oncology-trained exercise professionals in different communities. So if a patient wants to work with a trainer that has an understanding of the complications of cancer treatment and the side effects that patients have, that's another good resource. The other thing that is available in many communities is the Livestrong at the YMCA program, which is a free exercise program that's offered for cancer survivors. This is offered now in more than 700 YMCAs across the country. It's a 12-week program that includes both aerobic exercise and strength training. And this is a resource that I send a lot of patients to, and that is available to people not everywhere, but increasingly more places. So that's another good resource for oncologists and for patients across the US. Well, that's fantastic. So good, I'm glad we got to plug that on the podcast. And Dr. Ligibel, thanks so much for talking to me today. Thank you. And I also want to thank all of our listeners out there who joined us for this podcast. The full text of the paper will be available online at ASCOpubs.org/journal/JOP in June 2019. This is Dr. Nate Pennell, for the Journal of Oncology Practice, signing off.…

Zapraszamy w Player FM

Odtwarzacz FM skanuje sieć w poszukiwaniu wysokiej jakości podcastów, abyś mógł się nią cieszyć już teraz. To najlepsza aplikacja do podcastów, działająca na Androidzie, iPhonie i Internecie. Zarejestruj się, aby zsynchronizować subskrypcje na różnych urządzeniach.