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.

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This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.

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.

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.

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.

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.

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.

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.

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

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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.

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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.

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.

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.