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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. -
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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.
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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.
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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.
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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. -
Dr. Nathan Pennell and Dr. Jennifer Ligibel discuss weight management and physical activity programs for patients with cancer.
TRANSCRIPT:
Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. I'm sure everyone who listens to this podcast is aware that obesity and lack of physical activity are major health problems in the USA, and they contribute to multiple medical conditions such as heart disease, diabetes. But how much do patients and oncologists know about how obesity and lack of physical activity impact cancer incidence or treatment or outcomes? And how do physicians manage these issues in their practice?
With me today to discuss this issue is Dr. Jennifer Ligibel, associate professor at Harvard Medical School and medical oncologist at the Dana-Farber Cancer Institute, where she also serves as director of the Leonard P. Zakim Center for Integrative Therapies and Healthy Living. We'll be discussing her paper, "Oncologists' Attitudes and Practice of Addressing Diet, Physical Activity and Weight Management with Cancer Patients, Findings of an American Society of Clinical Oncology Survey of the Oncology Workforce." Welcome, Dr. Ligibel, and thanks for joining me today.
Thank you so much for having me.
So just to set the stage for our listeners, how big of a problem is obesity and physical inactivity among cancer patients? Is this something that is generally mirroring the larger problem we see in America, or is there anything different about our cancer patients?
Well, we know that obesity and inactivity are risk factors for developing a number of different malignancies. The International Agency for Research in Cancer and the World Cancer Research Fund have both analyzed observational data linking obesity, inactivity, poor dietary quality to the risk of developing malignancy, and have demonstrated really consistent evidence that there is at least 13 different malignancies where obesity, in particular, increases the risk of developing the malignancy. So if you think about the fact that obesity and inactivity are pretty prevalent in the United States, in general, and that these factors also increase the risk of developing malignancy, we find that an even higher proportion of cancer survivors are obese and inactive as compared to the general US population. We also know that treatment that patients get for some malignancies can contribute to weight gain, and also can contribute to inactivity. So you put all of these factors together, and a very large proportion of cancer survivors are at risk for obesity, inactivity, poor dietary quality, or all of those factors together.
I mean, the number that you and your co-authors mention is that almost 1/3 of cancer survivors are obese. That seems like a huge number. So clearly a major problem.
Yes, that's true. And that number has increased significantly over the last decade.
So I know that obesity contributes to cancer risk. But is there data that even treatment of cancer can be impacted by these issues?
Yes. So we know that obesity has an impact on treatment-related outcomes and, likely, on the risk of recurrence and mortality in many different diseases. Breast cancer has been the best studied, where we know that women who are obese when they're diagnosed with breast cancer actually have a 35% higher risk of dying from breast cancer compared to women who are of normal weight when they were diagnosed with breast cancer.
Similar data are emerging in other malignancies. Colorectal cancer, there has been a strong link with obesity and cancer outcomes. Prostate cancer, gynecologic cancers, there's emerging data as well. So we know that these factors can impact the risk of recurrence and mortality. But there's also evidence that suggests that people who have excess adiposity, have metabolic complications of obesity, are at higher risk of complications like poor wound healing after surgery. They're at higher risk of lymphedema and some malignancies. They may be at higher risk of things like peripheral neuropathy related to chemotherapy. So there are a lot of poor outcomes associated with body weight in cancer patients.
Now, I know even dosing of chemotherapy, I believe, obese patients are at risk for under-dosing because people are afraid to give them proper weight-based dosing. So lots of reasons to pay attention to this issue. Is there data, though, that changing that-- intervening with helping patients lose weight or patients at risk losing weight, or increasing their physical activity-- mitigates these risks?
That is a great question, and one that will hopefully be answered within the next few years through a number of large-scale, ongoing phase III trials that are looking at the impact of weight loss, increased physical activity, better dietary quality on cancer recurrence and mortality. We don't have data from randomized trials, at this point, looking at the impact of lifestyle change after diagnosis on outcomes. But we do have a lot of observational data that suggest that individuals who are physically active are at lower risk of recurrence in malignancies like breast cancer, colon, and prostate cancer. And we do also have a lot of information from randomized trials that are smaller in scale that demonstrate that losing weight, exercising more has an impact on shorter-term outcomes, like quality of life, cancer-related and treatment-related side effects like fatigue, neuropathy, joint pain. So we know there are benefits of lifestyle change after cancer diagnosis, but we're still awaiting these large-scale trials that will show us whether changing these behaviors actually reduces the risk of recurrence and mortality.
So already enough evidence that it's important that we address it, but hopefully, we'll have more convincing evidence soon. Can you take us through the ASCO survey? What was the background to doing the survey, and what did it try to assess?
So in 2014, ASCO launched an obesity initiative that really sought to educate the oncology workforce about the connections between obesity and related factors in both cancer risk and outcomes, and to provide tools and resources to help oncologists talk to their patients about physical activity, weight management during and after cancer treatment. There was also a part of the initiative that focused on research and advocacy.
We were interested, given that 2014 was a number of years ago, to look at what were the current attitudes of oncology providers toward these topics? What was their practice? Were they talking about weight? Were they talking about physical activity and diet with their patients?
And what did they perceive as barriers to really implementing behavior change after cancer diagnosis? And so we designed a survey that would be delivered to individuals that were currently seeing oncology patients. And they could be physicians, they could be nurse practitioners, they could be dietitians or anyone that was currently working with oncology patients and was an ASCO member. And then we asked them questions about their practice, about the attention that they paid to these topics, about what they felt got in the way. And then thinking more broadly about how important did oncology providers think that these topics were in the scope of their practice.
Why don't we just jump right into the results? So what were the results from the survey?
So first of all, we found that the people that filled out our survey were pretty typical for the general ASCO membership. So about 2/3 of the people that filled out the survey were based in the US. The other 1/3 were international. We did have a higher proportion of medical oncologists, partly because this was limited to people that were actively seeing patients. We had a nice balance of private practice and academic centers, and we had individuals that were treating all different kinds of cancer. So we were happy with the population that filled the survey out as being fairly representative of oncology providers in the US and more broadly.
We found, when we asked the providers what were their perspectives on issues related to obesity and cancer, that there was a very strong agreement that obesity impacts treatment outcomes in cancer patients. And in fact, more than 90% of the survey respondents strongly agreed or agreed with that statement, which we were very excited to see. There was also high agreement with addressing a patient's weight should be a standard part of cancer care. And most of their respondents felt that it was the responsibility of the treating physician to recommend healthy diet, regular activity, weight management for patients in whom that was relevant.
But there was much less agreement that the oncology workforce felt that they were prepared to be either delivering those interventions or that they had enough information or enough training to really feel comfortable in their skills to help patients start to make these changes. So I thought that was very important that there was high agreement that these things were important, but also a feeling of there needed to be other parts of the health care team that could help patients once these issues were identified in really helping them to make the changes that needed to after diagnosis.
We then asked providers about what they were doing now, and we found that the vast majority of providers that completed the survey indicated that they were asking patients about their physical activity patterns, about their diets. They were assessing patients' weights. And this was both during and after cancer treatment. There was a much lower proportion of survey respondents that were actually making referrals to dietitians, to weight management services for their patients. So although there was a lot of discussion and there was an assessment, there wasn't necessarily the next step, which was helping patients actually incorporate these changes through a referral to a skilled provider.
And then, the last piece was looking at barriers. And I think that this was something that we were actually a little bit surprised about some of the responses. The last part of the survey focused on looking at the respondents' perceptions of barriers. What did oncology providers feel like was getting in the way of patients changing their diets, exercising more, losing weight when it was relevant?
We found that, not surprisingly, lack of time for counseling was something that many providers noted, lack of available resources. So even if you identified that a patient wanted to lose weight or meet with a dietitian, there wasn't necessarily someone that was available. Lack of training or expertise on the part of the oncology provider was also noted. We also found that the majority of participants felt that patients' resistance to behavioral interventions was also a large barrier to helping people make these changes. And this really led us to think start thinking about, well, what is the patient's perception?
And I think that's something that we did not cover in this survey, but that is really critical. Because if we find that oncologists are talking about these topics and are trying to reinforce the importance, but patients aren't hearing that or aren't making these changes, then we're really not accomplishing what we want to. So I think from this survey, we now can see what oncologists feel is important and what they're doing in their practices. And we need to figure out, what are the patients hearing and what is the result of the advice that the providers are giving to patients?
Yeah, that really is an interesting and kind of a surprising piece. So the first part resonates with me. So I certainly address, you know, in my patients that are in follow-up and survivorship, exercise and trying to maintain a healthy weight. And I also feel that I'm not super comfortable with trying to intervene in that myself, but rather try to suggest that they look for SilverSneakers or some sort of local exercise gym or other opportunities or, perhaps, refer them to a dietitian.
But I don't know that I have a perception that the patients wouldn't welcome that advice or that they might be resistant. Is there any plan to try to get an assessment of cancer patients' attitudes on this?
So this is something that we are planning at this time. We are trying to develop a survey and partner with some patient advocacy groups to really better understand what the patients' perceptions of these topics are. There is not much currently in the literature, but there have been some assessments. There was a large study that was done in the UK that looked at patients with colorectal cancer and the attention that was paid on the part of their provider to exercise. And if patients remembered hearing about exercise, they were much more likely to do it.
So I think that something that we really need to better tease out is, what is the patients' receptivity to this type of information? And are the suggestions that oncologists are making enough to get patients, on their own, to seek out a program? Or do we really need to try to educate providers about effective ways of making referrals?
I think the reality is that we also need more programs that patients can be referred to. And something that I think is a real need within the oncology space is programs that help people lose weight that are able to help people become more active, and recognizing some of the limitations that many patients have as a result of their therapy. Things like lymphedema, things like neuropathy, that can be barriers. How can we manage those in oncology patients to help them successfully achieve these behavior changes?
And this is, I think, such a great topic because patients really care about interventions that they can do themselves to help their cancer care and their health. And there's so much out there, in terms of complementary therapies and whatnot. But we have real data on things like diet and exercise, and I think more attention being paid to this within cancer centers would really be welcomed by patients.
I think so too. You know, we, right now here at Dana-Farber, are leading a trial called the Breast Cancer Weight Loss Trial that's a phase III study looking at the impact of a weight loss intervention on recurrence in women who are overweight or obese when they're diagnosed with breast cancer. And when we started this study, we weren't sure what the uptake would be. It's a very different type of model. But we've enrolled now more than 2,000 patients in less than three years. So there's definitely a very, very significant interest in this topic amongst patients.
There's a similar trial going on in ovarian cancer that just enrolled 1,000 patients with a disease that's much less common than breast cancer over just a few years. So I think that the interest on the part of patients in this topic is large and we want to be able to provide them with evidence-based recommendations. There's a lot of stuff out there that's not so evidence-based, especially about diet, and I think that, as oncology providers, we really owe it to our patients to get them the best information that we have about things that they can do to help improve their outcomes and to make themselves feel better during and after their cancer treatment.
And we're very lucky to work at institutions like the Dana-Farber Cancer Institute or here at the Cleveland Clinic, where we've actually got a lot of resources devoted to these efforts. But what can people who work at smaller institutions, or really don't have a lot of infrastructure for this, where can they access data or suggestions on how they can counsel patients or help their patients address problems with obesity and lack of physical activity? Is this something that ASCO can help with?
So as part of the ASCO Obesity Initiative, we developed toolkits for oncology providers and for patients about the role of weight management and physical activity in cancer. And so those are available at cancer.net. They can be downloaded. You can give them to your patients to start a conversation about the importance of these topics in oncology care.
The American Cancer Society also has diet and exercise guidelines for cancer survivors that oncologists can use as a guideline. The American College of Sports Medicine also has a website where they have oncology-trained exercise professionals in different communities. So if a patient wants to work with a trainer that has an understanding of the complications of cancer treatment and the side effects that patients have, that's another good resource.
The other thing that is available in many communities is the Livestrong at the YMCA program, which is a free exercise program that's offered for cancer survivors. This is offered now in more than 700 YMCAs across the country. It's a 12-week program that includes both aerobic exercise and strength training. And this is a resource that I send a lot of patients to, and that is available to people not everywhere, but increasingly more places. So that's another good resource for oncologists and for patients across the US.
Well, that's fantastic. So good, I'm glad we got to plug that on the podcast. And Dr. Ligibel, thanks so much for talking to me today.
Thank you.
And I also want to thank all of our listeners out there who joined us for this podcast. The full text of the paper will be available online at ASCOpubs.org/journal/JOP in June 2019. This is Dr. Nate Pennell, for the Journal of Oncology Practice, signing off. -
Dr. Pennell talks with Dr. Patrick Conner Johnson, hematology oncology fellow at the Dana Farber Cancer Institute Massachusetts General Hospital fellowship program about his and his co-authors' new study titled "Potentially avoidable hospital readmissions in patients with advanced cancer."
Hello and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Potentially avoidable hospital readmissions are a major target for reducing costs in the health care system. However, for cancer patients, the issue goes way beyond cost.
Many of our advanced cancer patients have a limited lifespan. And every unnecessary day they spend in the hospital is one less day they spend at home with their loved ones. The reasons behind cancer patient readmissions may differ from other types of patients. And so broad efforts to reduce hospital readmissions may not apply quite as well to this population unless we understand the specific reasons behind readmissions for our vulnerable population.
Today we're going to be talking about this topic with Dr. Patrick Conner Johnson, hematology oncology fellow at the Dana Farber Cancer Institute Massachusetts General Hospital fellowship program about his and his co-authors' new study titled "Potentially avoidable hospital readmissions in patients with advanced cancer," which was published in the May 2019 JOP. Welcome, Conner, and thank you for joining me today.
Nate, it's truly an honor to be on the podcast. I appreciate your time and [INAUDIBLE].
So first of all, can you give us a little bit of background on why hospital readmissions are a topic that people are talking about? How big of a problem is this and what's the scope of the issue?
To start with, just hospital admissions period are a major topic within cancer care and all of medicine. If you go back to the health care cost and utilization project report since 2009, more than 4.5 million cancer related hospitalizations amongst adults. So that's hospitalizations.
Some percentage of these are potentially avoidable both in the general medicine literature and in the oncology literature. and both from a cost and value standpoint and from quality of cancer patients' lives, I think these are important issues to think about in terms of addressing.
And then when we looked, particularly in our study, we focused on readmissions by which we define having a panel of patients who already had admission once and then looking at subsequent admissions after that.
There is a fair amount of literature out there looking at causes of hospital readmissions as a target for improving value based care. What do you think is different about cancer patients that makes this something we need to study uniquely in them?
I think, in general, amongst a variety of different subspecialties, there's an importance in focusing on targeting each individual population to understand the nuances of that population, whether that's a literature on COPD or heart failure. And oncology in particular is still a wealth of drugs with a wealth of potential consequences and with a sub-population within oncology of advanced cancer patients who have defined limited lifespans.
There's a whole host of factors and different unique circumstances that could potentially affect their readmission profile a little bit different than other general medicine populations. And I think the greater understanding we have of each subset of patients within a number of disciplines is probably going to target our interventions to be more likely to be successful.
And I think that makes perfect sense. One of the other things you mentioned in the background section of your paper is that many of the studies looking at potentially avoidable readmissions have not incorporated patient reported outcomes. And why do you think that would be an important thing to include in the study?
I think looking across oncology care, the study by Dr. Schrag and Dr. [? Basch ?] and colleagues comes to mind. There's been an increasing interest in incorporating patient reported outcomes in order to better pair these with our other outcomes.
And I think that our hope with this was to gain a greater understanding of what kinds of symptoms and other things patients report and trying to identify if there is any correlation with admissions. And the same thing's being done across a number of different facets of oncology care.
Yeah. I'm not sure people outside of oncology understand that there's a significant percentage of our inpatients are admitted for symptom control specifically as opposed to general medicine problems like pneumonia or blood clots.
And so definitely in that case being able to assess their symptom burden makes perfect sense when you're trying to do the kind of study that you're doing. So speaking of your study, can you walk us through the design? How did you put this together?
So this was a longitudinal cohort study of consecutive patients that were admitted to the hospital. And patients were enrolled. And as part of their enrollment, their symptoms were assessed at the time of their enrollment.
So this was a one time symptom assessment within two to five days of their hospitalization when they completed a symptom burden questionnaire essentially. We took available data that we had.
And we had two coders go back, review the medical record with a focus on the discharge summary to try and understand the reason for hospital admission. And then we had a peer review system to try and identify which readmissions were potentially avoidable.
And we used some adaptive criteria, which has been utilized in some other studies in leukemia an GI cancer. And that process was essentially two physicians doing an initial coding review using these criteria. And then anything that was considered potentially avoidable by either of those physicians went to a panel that included two board certified oncologists.
Yeah. I'm curious about this. I know that there are published methods for how they do this. But can you give us an example? How do you determine if a patient had an a potentially avoidable readmission? What's an example of something they might find.
There's no question that it's a challenge. And it's rife with some subjectivity at times. In order to try and minimize that, we have defined criteria. For an example, one of those is premature hospital discharge, which in this study was defined as being readmitted within seven days of discharge with identical symptoms to the prior admission. And that's by a review of the hospital discharge summary.
OK. That makes perfect sense. And you would think that that would be a significant risk for patients since the length of stay is such a big target for hospitals to try to reduce costs. And also our patients typically want to go home.
You know, we have to sometimes convince them to stay when we think they need to stay. OK. So if they were readmitted within seven days with the same symptoms that's how you determine that. So tell us some of what you found.
Thanks, again. Major points from our paper are, first, similar to some other studies that try and look at potentially avoidable hospitalizations at large. More than 30% of the admissions were qualified as potentially avoidable readmissions, which I don't think is anything that has ever been described.
Again, that's fairly consistent with actually the general medicine and with some other oncology literature, but it speaks to the importance of the topic and the sizable possibility of interventions down the road. And the two major important risks that we identified in a multivariable model were marital status, and which we think is a proxy for social support and was protective against potentially avoidable readmissions, and higher physical symptom burden.
And those with higher physical symptom burden were more likely to have potentially avoidable readmissions. And finally, when we looked at the most common reasons as using our criteria for potentially avoidable readmissions, those were premature discharge from a prior hospitalization and also not having what's called a timely follow up, which was a seven day follow up. And so that speaks in our mind to the hazardous time period that is the discharge is fraught with a lot of possibilities of difficulty in terms of making that transition.
Yeah. I think that makes perfect sense. I know our institution in particular has instituted a mandatory call from the outpatient team to a patient the day after they're discharged to just check and see how they're doing. And then we try to get everybody an appointment within seven days although that's not always possible. Are there any other interventions that you think would come out of what you found that might help reduce potentially avoidable readmissions?
I think from the social support side of things, given that social support can be challenging, there is an idea that if we identify patients with that limited social support that that might be the patients that we target for patient navigation programs, more intensive social work involvement programs, or a specially designed care transition programs at hospital discharge as well as potentially patients who have a higher physical symptoms.
And the association with higher physical symptoms also makes perfect sense, although that's always a challenge to address appropriately. I know that there's a lot of focus certainly in solid tumors about integrating palliative medicine and [INAUDIBLE] of medicine support for patients with solid tumors to control that. Is that something that you think could be helpful in this setting as well to help reduce readmissions?
Absolutely, Nate. I think that the hope would be that this also raises a possibility of identifying a patient population that may already be plugged in with palliative care. But if they're not, this could help identify another group of patients that can benefit from integrated palliative care with the hope being that we can identify interventions that can reduce their hospitalization burden.
And where do you think we're going to go here in terms of research. So you've identified some nice potential associations. And there's some low hanging fruit in terms of arranging fast follow up. But what's the next steps in terms of trying to reduce potentially avoidable readmissions for our patients?
I think an integrative palliative care interventions for those with high physical symptom burden. And I think that targeted interventions such as more intensive social work involvement or care transition programs for those with limited social support would be potentially good intervention based studies to start with.
I also think that, as you mentioned, you raised good points about there's still a good bit of research to having a greater understanding within the world of oncology. What is the ideal follow up after discharge for each sub-population even within oncology? And there's probably a great deal more research into understanding that as well as more about the physical symptom burden of hospitalized patients in oncology.
I don't know what your opinion is. Do you think we'll ever be able to avoid almost or all potentially avoidable readmissions?
No. I don't think so. I think that it's a patient population that has a high symptom burden and has a high complexity of care. But I do think that any interventions to reduce the burden of hospitalizations could potentially have far reaching consequences.
I know. I agree with you. I mean there's no way we'll ever be able to avoid this completely. And we all have experience with patients who we can tell when we're getting ready to discharge them that they're at high risk of not successfully transitioning home and yet they want to try.
Perhaps they might be better off in a facility where they could have a higher level of care. But they really want to try to get home. And we want to give them the chance to succeed. And it's just not always successful. So giving them every resource that we can sounds like the right thing to do.
[INAUDIBLE] I agree with you totally. I think the other point to mention is just that the care transition time is a very fragile one. And other interventions to try and improve that transition period as well are something that would be of interest for us or other folks to explore around this topic.
Yeah. It sounds like that would be ripe for a quality of care study to look and see if really intensive interventions in that first few days or a week after discharge can reduce this. I know that we've moved forward with doing that, but I'm not sure if we have any data that it's effective. But it certainly makes sense that it would be helpful. Connor, thank you so much for talking with me today.
Thank you so much for having me.
And I also want to thank all the listeners out there who joined us for this podcast. The full text of Dr. Johnson's paper is available online at ASCOpubs.org/journal/JOP in the May 2019 issue of the JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.
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Dr. Pennell talks with Dr. Ray Page about efforts to address the opioid crisis impact onthe care of patients, and what role oncologists can play on this issue.
Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP.
The opioid crisis continues to be a major public health issue, with increasing attention at both the state and national level. Efforts to address this issue are highly relevant to oncologists, because we treat a unique population of cancer patients for which opioid prescriptions are an established standard of care.
So how will these efforts to address the opioid crisis impact the care of our patients? And what role can oncologists play on this issue?
Today, we're going to be talking about this topic with Dr. Ray Page medical oncologist and hematologist at the Center for Cancer and Blood Disorders in Fort Worth, Texas, who currently serves as chair of ASCO's Clinical Practice Committee, is on the ASCO Government Relations Committee, and is the current ASCO delegate to the AMA House of Delegates, about his new editorial titled, "Opioids and Cancer Pain, Patients' Needs and Access Challenges," which will be published in the April 2019 JOP.
Ray, thanks for joining me today.
Thank you.
So can you start out by giving our listeners a little background on the magnitude of the opioid problem in the US.
Sure, Nate. Let me just first say, the opioid epidemic is real and is startling. The CBC reported that in 2017 that over 72,000 in the United States died from drug overdoses. And this included over 47,000 people who involved in drug overdoses of opioids.
And most of us have heard from the media that the biggest increase in use is through that synthetic opioid fentanyl. And it's often laced with heroin. And the recent volumes that have confiscated at the US border are enough to kill ever single US citizen.
And the escalation of opioid abuse is really complex societal issue. And it includes contribution from all of those social determinants of health and mental illness. And when policymakers sometimes they like to look at a one size fits all kind of solution, which means they oftentimes want to largely focus on physician prescribing habits and just regulating patient access to opioids.
Is there evidence that this kind of solution of targeting opioid prescriptions is impacting opioid prescribing in cancer patients?
There is a negative impact there. But let me just say that cancer pain is very real and it's very frightening. And we know that cancer pain is historically undertreated. 8 out of 10 advanced cancer patients experience moderate to severe pain. And about 55% of cancer patients and 40% of cancer survivors experience chronic cancer related pain. So upwards of 43% of cancer patients and 10% of survivors use opioids to manage chronic cancer pain.
Because of the heightened media awareness about the opioid epidemic, cancer patients are really experiences a lot of fear firsthand. Many of my patients have expressed to me that they actually have a fear of dying from taking opioids. And there's also of addition. And then on the other hand, they also have a fear that they may not even be able to get their hands on pain medicines at all.
That actually is a really interesting topic that I hadn't thought of because I have the same problem with my patients worrying about taking opioids. You think that this being so much in the public eye is really influencing cancer patients' ideas about whether they should be taking opioids or not. They feel like they're at risk for addiction and contributing to the problem.
Our cancer patients I think do have those real concerns and they have fear over it. And we're actually seeing that about a 1/3 of cancer patients and survivors are actually having difficulty to getting access to their prescribed opioid medications. And that has continued to increase markedly since just a few years ago in 2016. And the vast US oncology practices are concerned that restrictions on opioid prescribing is going to ultimately result in undertreatment of cancer pain.
So it's these kind of dynamics what makes it difficult for physicians to treat pain, particularly cancer and cancer survivors. And while judicious prescribing is important, patients with cancer and cancer related pain, they need to have consistent access to pain control.
Well, I think we can all agree on that. Before we talk about how we can protect cancer patients' access to these drugs, can you talk a little bit about what is being done sort of at the state and national level to address the opioid crisis and sort of how that's impacting our cancer patients?
Yeah, absolutely. The opioid epidemic will continue to be a bipartisan priority for both state and federal governments with currently over 100 state bills that are out there that are identified. In a lot of upcoming state legislative sessions, there will be consideration of bills that are related to such things prescription fill limits and prescription drug monitoring programs and opioid prescribing guidelines.
And we're all expecting to see bills that are going to be related to the identification of outlier prescribers and bills that are promoting the utilization of opioid alternative therapies in the cases of both acute and chronic pain.
Just on the federal level, you know in 2016, President Obama, he signed the first major federal addiction law in 40 years. And that was the Comprehensive Addiction Recovery Act. And that bipartisan legislation authorized evidence-based prevention and treatment programs and recovery programs and law enforcement initiatives to help prevent overdose death and proper prescriptions.
And as you had asked, in 2017 when President Trump came into office, he announced that his administration was declaring an opioid crisis and made a national public health emergency under federal law. And as a result, the White House office of the national drug control policy directed numerous federal agencies to address the opioid problem. But that was largely within their current budgetary confinements. But I think actions by both administrations had positive impacts on the opioid problem primarily just by initiating activity in our government agencies.
So when the various laws and policies are passed, do they have built in protections for vulnerable populations that need access to opioids, like cancer patients?
Yeah, that's one thing that we've pushed a lot for. And in general, most of them do. And so President Trump signed a sweeping legislation in 2018 that was touted as the single largest bill to combat the drug crisis in our countries history. And there was a lot of efforts to do things like expanding access to treatment for substance abuse disorders and those kind of things.
But, for example, January 1st of this year, as part of that law, it included new opioid prescribing policies that will impact Part D beneficiaries and the prescribers. And this includes such things as real-time safety alerts on pharmacy dispensing of opioids and drug management and utilization tools and the improvement of communications between the pharmacists and the physicians.
But as you asked, one important note about this legislation that was passed is that residents of long-term care facilities and those that are in hospice care and patients receiving palliative care or end of life care, and patients being treated for active cancer related pain, they are exempt from a lot of these interventions.
Well, it's good that at least someone is considering our patients in this. But I know that certainly-- I believe ASCO has quite a bit of concern about maintaining access to patients. So what role is ASCO playing in this issue?
You know, Nate, ASCO is very sensitive to the needs, to address the opioid crisis and to support thoughtful and evidence-based interventions aimed at decreasing substance misuse and abuse and overdose death. However, ASCO really continues to advocate for appropriate access to pain medications for cancer patients, recognizing that that typical one size fits all solution risks oftentimes marginalizing our cancer patients and their needs.
And so in 2016, ASCO released an ASCO policy statement on opioid therapy which emphasizes the unique pain management needs of patients with cancer and especially those with advanced disease. And in this policy statement, ASCO points out a lot of core principles to balance public health concerns and cancer patients' needs.
Well, I really like the fact that ASCO is focusing not so much on specific individual needs, but rather making sure everyone recognizes that there is no one size fits all solution here and also you know acknowledging that there is a real problem with opioid misuse in the United States, but that our patients need to be considered carefully in this.
One of the things I liked about your editorial was focusing on how physicians might actually be able to learn about managing pain in cancer patients and not necessarily just focusing on the use of opioids. Can you talk a little bit about that?
Yes, sure. You know, just in general, as we all know, as oncologists, we rely heavily on the use of opioids. But we should never rely solely on the use of opioids. And we need to determine if opioids are indeed the right drug for particular type of cancer-related pain.
And so ASCO published recent clinical practice guidelines for chronic pain management in cancer survivors that gives advice on careful assessment of pain and its effects on function and of the possible risk associated with an opioid. And so I generally recommend that clinicians review some of these practice guidelines because many of these recommendations can help reduce opioid prescribing and actually consider other good, viable non-opioid alternatives, such as using pain specialists and other interventional procedures.
Yeah, I think everyone would benefit from being aware of the problem and making sure that they are using opioids appropriately. I guess I'm just a little concerned about how all this attention is impacting our patients and their access to drugs. We did a JOP podcast, oh, I think a year or so ago with Dr. Bruera, who is a palliative care specialist at MD Anderson, who published a study showing that palliative care physicians were actually prescribing significantly less morphine equivalents for cancer patients. And there was a lot of alternative treatments, such as tramadol, that were being used. And we had a nice discussion about how perhaps some of that was a good idea. But they're also putting sometimes patients at risk of being under treated.
Yeah, that dynamic is very complex, because I think we all realize that are certain types of pain that do get effectiveness with opioids to get appropriate pain relief. But the palliative doctors are usually very good and many oncologists also about entertaining those alternatives. And so oftentimes there are many kinds of cancer pain syndromes, both acute and chronic that can be managed with non-opioid alternatives.
We as oncologists, we realize that this is a really vulnerable patient population. And we'll continue to develop and utilize all the latest advances in the comprehensive management of cancer in accordance with published evidence-based physician developed guidelines. However, we also want to design the statutory and regulatory requirements do not unduly restrict access to opioids and acknowledge the need to exempt cancer-related pain in our opioid policies.
And I think that's absolutely critically important. And you know this is exactly the kind of function that societies like ASCO and the AMA really exist for, to protect our patients and the physicians who are prescribing these necessary medications to our patients.
Well, it's been my pleasure to share this publication with you. And I hope it will be an important educational tool for the oncologists to work on to deal the opioid access problem for our patients.
Thank you so much for joining me. I also want to thank all of our listeners out there who joined us for this podcast. The full text of the paper will be available online at ascopubs.org/Journal/JOP in April 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. -
Dr. Pennell talks with Dr. Genevieve Digby about the importance of timely care for cancer patients, and more specifically, lung cancer patients.
Hello, and welcome to the ASCO Journal of Oncology Practice Podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. On this month's podcast, we're going to be talking about a new study from the JOP Quality and Action series, titled Improving Timeliness of Oncology Assessment and Cancer Treatment Through Implementation of a Multidisciplinary Lung Cancer Clinic, published online in the JOP, January, 2019.
Joining me today on this podcast is the author, Dr. Genevieve Digby, assistant professor in the division of respirology at Queen's University School of Medicine, where she's also the clinical lead for the lung diagnostic assessment program. She has an active interest in quality improvement projects, which is what led to this paper that we're going to be discussing today. Dr. Digby, thank you for joining me.
Thank you so much for the invitation.
Obviously, everyone likes to be seen as quickly as possible when they're trying to get into the doctor, but can you give us just a little bit of background into what led you to do this particular quality project? Why is the timeliness of care more important for cancer patients or, specifically, lung cancer patients?
So great questions, Nate. Timely care is very important for patients, as you pointed out. In fact, the Institute of Medicine has timeliness as one of the six dimensions of quality. And for lung cancer patients this is particularly important, as we know that there's evidence to show that patients who have delays in their diagnosis or delays in treatment, that this is associated with progression of disease, and there's evidence to show that more advanced disease is associated with worse outcomes. And as we know from the lung cancer screening trials, earlier detection of disease is associated with better outcomes.
Not only is timeliness of care important for patients from the point of view of getting their treatment underway, but it also is important in terms of the anxiety and distress that patients have. So we know that the longer delays are associated with more distress, and lung cancer patients to begin with are some of the patients who have the highest levels of anxiety and distress amongst oncology patients. So for us, the study arose because of an identification locally that there were delays in our care processes in regards to transitioning patients from the diagnostic phase of the lung cancer pathway to the treatment phase and a desire to improve those care processes.
I think that that really resonates with me. I know at my institution we've been paying attention to the time to initiate treatment for a while, and it's not like going to see the dermatologist. When you're diagnosed with cancer, you really have a lot of anxiety, and you want to get in to get treatment as quickly as possible. And of course, as you've mentioned, especially for early stage lung cancer, there's pretty good data suggesting that the longer someone waits to make a diagnosis, the more likely they are to have their potentially earlier stage cancer turn into a later stage cancer with worse outcomes. So I applaud you for addressing this.
And in your particular project, you focused on the establishment of a multidisciplinary clinic. And this is something where I think a lot of the literature out there on looking at processes and time to treatment has focused on that. So is there data suggesting that multidisciplinary clinics specifically are a good intervention for improving timeliness of care?
So that's a good question. And the literature varies in terms of its robustness based on the type of cancer that we look at. So my group published a systematic review looking at multidisciplinary clinic models in lung cancer specifically. And we were surprised, actually, by the relative paucity of data in terms of what the optimal catalytic characteristics are, even just in terms of the number of studies that's actually evaluated a multidisciplinary clinic, per se.
In other cancer types, there is evidence that multidisciplinary clinics lead to better collaboration between specialists. There is some evidence, even in lung cancer, that perhaps there's better compliance with staging guidelines and guideline-based care when care is delivered in a multidisciplinary clinic. And there's also some evidence, though limited again, especially for lung cancer, surrounding the patient experience and patient satisfaction with their care when it's delivered in a multidisciplinary clinic model.
Yeah. Honestly, I don't think I've ever heard anyone argue that there's a downside to a multidisciplinary clinic. But I do appreciate studying measurable metrics that may demonstrate benefits because, of course, you have to get support for these sorts of things. So why don't you take me through your project's design, and what were the goals that you tried to achieve?
So this is a quality improvement study. We started by identifying what our overall goals and outcome measures were and how we would go about achieving those goals. For us, the focus was to improve our transitions from the point of care of receiving a diagnosis of lung cancer through to starting treatment with an oncologist. So this particular setup was due to the fact that in our center we have a separate thoracic surgery program where patients with suspected early stage disease directly go to a thoracic surgery program and those with more advanced disease or suspected non-operable disease are initially managed by a respirologist, and then are seen through with the appropriate thoracic oncology specialist subsequently.
So for us, we looked at our data, and we actually identified that that time from transition, where a patient receives a diagnosis of lung cancer, to when they're first assessed by an oncologist was upwards of about two weeks. The time then to go on and start their first treatment for cancer was in the range of 40 to 45 days. And we identified that there was room to improve and set a target of reducing both of these individual time frames by about 10 days.
We hypothesized that if it could improve timeliness to seeing an oncologist from about 14 days to closer to 4 days-- 3 to 4 days-- that we would similarly lead to maybe about a 10-day improvement in time to treatment on the other end. So our improvement plan was to launch this multidisciplinary clinic. And we used a quality improvement called plan, do, study, act cycles, or PDSA cycles, to help facilitate that and fine-tune our multidisciplinary clinic along the way to make it even more efficient.
That sounds great. It sounds like a very worthy project. So what did you find?
We found that by implementing a multidisciplinary clinic, even within a very short time of implementing it, that we were able to significantly reduce the time from a patient's lung cancer diagnosis to when they were first assessed by an oncologist. In fact, just with the implementation of the clinic, we led to about a 10-day improvement. We fine-tuned our processes to help create sustainability of the teams. Initially, there was still some variability. And we were able to maintain about a 10-day improvement overall over time.
What we found though, and what was really interesting, was that as we went about our change processes, we had ongoing improvement in time to treatment, so that time from lung cancer diagnosis to time to first treatment. With our initial clinic implementation, we had about a 10-day improvement in time to treatment as well. But as we noticed, as we fine-tuned our processes, that improvement actually increased such that we overall reduced time to treatment from about 40 days at baseline to 15 to 20 days by the end of our quality improvement initiative.
And that is incredible. I think, to me, was the most impressive thing is not so much that you, by moving up your evaluation by 10 days, you improved time to treat by 10 days, which makes perfect sense, but that somehow implementing this entire project, you greatly exceeded your expected improvement in time to treat. And so, did you look at what specific interventions might have led to that even better improvement than you expected?
So that's a great question. And as you said, what surprised us was the extent to which timeliness, in terms of receiving first treatment improved, even beyond just time to seeing an oncologist. And when we considered the data, some of the things that came out were likely the increase in collaboration that we were seeing amongst specialists, particularly medical and radiation oncologists in terms of being able to decide on a treatment plan a bit sooner and get that plan up and running.
In fact, when we looked at the data, the patients that had the greatest improvement in time to treatment were those with stage 2 and 3 lung cancer, and also including patients with stage 4 lung cancer. And those are often-- especially stage 2 and 3-- where patients are most likely to need a concurrent chemoradiation, where the treatment plans are often decided together amongst the radiation oncologist and the medical oncologist. And so having that ability to discuss the treatment plans and come up with a clear plan sooner is what we hypothesized is leading to be faster kind of treatment.
To evaluate this further, we actually also have recently completed a qualitative study, where we interviewed physicians, and including patients and caregivers, about the impact of a multidisciplinary clinic. And while I don't want to give away all the results yet before it's published, one of the themes that comes up certainly for the physicians and particularly oncologists is just the overall ability to collaborate and have real-time discussions with each other and with the patients about what their treatment plans would be, leading to a faster implementation of that plan.
Well there you go, listeners. You're getting a sneak peek of a future study going to be coming out of this group. But I think that makes perfect sense. So again, as a group that has, at least internally, been focusing on improving our time to getting patients to treatment, I think just having an emphasis on studying how long it takes to treat and that everyone understanding that it's a priority to try to make that as short as possible seems to just lead to improvements because everyone's aware that it's an important aspect of treatment. And things tend to show improvements without any real specific interventions taking place.
And then, of course, the multidisciplinary clinic. It makes perfect sense that multidisciplinary care would be better coordinated. So I think that that's a really nice validation of what you were trying to do. So how would other centers that maybe are starting to look at this, how would they take what you've done and apply it to their own programs?
So that's a great question. I think there's a few things to consider. Firstly, quality improvement processes can be instituted in any organization. And part of quality improvement is identifying what the main barriers are to achieving the timeliness of care goals that an individual center has and just implementing the PDSA cycles at their own institution to help achieve those targets because the barriers can be different between different organizations. So where possible, I think eliminating the silos that exist in our care models of the traditional model of seeing one person at a time and really trying to get people to work together, that can be challenging administratively. But once those barriers are overcome, it's actually more convenient for people to really work collaboratively to improve patient care as a whole.
That's great. And this really fits in nicely with both the US National Cancer Institute and ASCO, in particular, have really paid a lot of attention in recent years to teamwork and building team science to help improve outcomes. And I think that your study is a wonderful example of how that can lead to direct and measurable improvements in care.
Well, thank you. We certainly think that we've led to some improvement locally and hope that other centers can learn from what we've learned to help drive change.
Dr. Digby, thank you so much for talking with me today about your study. And I really want to thank you for sharing the results of your project because I think high quality quality improvement projects that are going on all over the world, really, but oftentimes don't get shared outside of the individual team or institution where they're doing them. And this is going to allow, hopefully, a lot of people to see how investments in teamwork and trying to improve on these metrics can lead to really important results for our patients.
I completely agree. It's important to share the knowledge that's learned, particularly with quality improvement. We're all working towards common goals for delivering better patient care, and it's great to be able to share those learned experiences with others.
And I also want to thank our listeners out there who joined us for this podcast. The full text of the paper was published online at ascopubs.org/journal/jop on January 7, 2019. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. -
Dr. Pennell talks with Dr. Sushil Beriwal about guideline variability and how care pathways might play a role even in situations where the best practice seems clear.
Hello, and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the Journal. The best available evidence for cancer treatment seems to change at just a staggering pace. And yet, as physicians, we're expected to keep up with these changes and always give the most evidence-based treatment, which is obviously an incredible ongoing challenge.
Guidelines from major organizations can play a role in helping us stay up to date. However, considerable variability exists, even in situations where the best practice seems to be clear. This creates an opportunity where things like care pathways might play a role.
Today, we're going to be talking about this topic and about a new paper titled "Lag time between evidence and guidelines-- can clinical pathways bridge the gap?" which will be published in the March 2019 JOP.
Joining me today for the podcast is the senior author of the paper Dr. Sushil Beriwal, professor of radiation oncology at the University of Pittsburgh and deputy director of radiation services at UPMC Hillman Cancer Center. Dr. Beriwal, thank you for joining me today.
It's my pleasure. Thanks for having me.
So why do you think there is so much variability in care, especially around things where a lot of people have broad agreement? So the example in your paper that you use is hypofractionated whole-breast radiation, which has been part of a major guideline since 2011. And yet, it seems as though many people don't use it.
So we do see variability in the cancer care. And hypofractionated radiation therapy is one of a good example. What is exactly? It's hard to pinpoint. But I think it's for multiple reasons. Could be a physician is used to practicing a certain why. They don't want to change the practice. They're not aware of the newer data and guidelines.
Or it could be the fact that they're concerned about increased side effects and toxicities with this newer approach. They may not have technology or resources to do it. And last, but not the least, sometimes the fee-for-service model may have a detrimental effect in accepting a shorter course of treatment.
Oh, I hadn't even thought of that, but that's a good point. So can you take me a little bit through your study? What was the problem that you were trying to solve?
As you know, there have been various studies which have come out in the last 5 or 10 years, looking at adoption of hypofractionation for breast cancer care, even though the randomized data suggests that hypofractionation is similar for cancer outcome and possible less side effects, [? with ?] the adoption rate based on the National Cancer Database analysis, or some keyword industries, or some state data, it's somewhere within 10% to 50%.
So there is wide variation and acceptance and adoption. And we were trying to figure out a way to make it more uniform so the patient get similar kind of care based on the best available evidence for that patient.
Is care pathways or clinical pathways something that you've had experience with working with before? And I guess, maybe just for our listeners, kind of explain to us what a clinical pathway is.
Clinical pathways are like additional [? aid ?] tool which basically guides the physician to decide about the care of the patient based on the stage, grade, and other factors associated with that patient. So we at UPMC Hillman Cancer Center started the clinical pathway in a very rudimentary form about 14, 15 years ago. It has come a long way from being a paper trail to an electronic format.
The way it works out is anybody who sees a patient in our network of 25 sites has to enter a decision to-- in the care pathway model created by this company called Via Oncology, which was initially part of UPMC, but this year, it was bought by somebody. Well, it was an outside company called [INAUDIBLE].
So say, for example, if I see a patient in my clinic, I go to care pathway website. And automatically, it will ask me for stage, grade, and what needs to be done. And then it gives me the option of what to do. So if the option for that patient is hypofractionated radiation therapy, that's what I have to choose.
I see. And how do you decide what goes into these care pathways? Is this determined by an outside group? Is this something that you get to determine within your own institution?
When we started, it was within our own institution. But now we have oncologists from all over the country who participate, who are part of the same care pathway module. We have chair and co-chair for each site. And we have committee members for each site.
So we meet every six months on a regular conference call. And whatever evidence has come out in the last six months, we try to incorporate that in our discussion and make changes accordingly. So initially, the agenda is discussed. The committee decides and discusses. It goes back and forth.
And once the committee agrees, then it's sent out to all the members for voting. And once everybody agrees in the voting, then it is implemented. And that becomes the care pathway for that disease and stage.
And so what were the results of your intervention?
So we went by a very stepwise manner. So initially, the 10-year data for hypofractionation from the UK group came out in 2013. So when that came out, we as a group decided to mandate hypofractionation for somebody who is 50 and above, like postmenopausal women with early-stage breast cancer. When you're trying to keep breast or just [INAUDIBLE] level to use.
And we found when we assessed the outcome that there was a very high acceptance rate of hypofractionation. But one of the concerns we found that the physician had in accepting hypofractionation was how best to do it, because those papers and the data did not define fully the best way to deliver the dose, how best to achieve dose homogeneity, what should be the [INAUDIBLE] and the hard dose.
So within our own network, we came up with a very good guideline of how best to achieve dose homogeneity to deliver this dose safely and make it better for the patient. Once we got success with that, then we took the next step of implementing this for younger women.
And since we already had the track record, we found that the resistance to the acceptance of hypofractionation was much-- there was much wider acceptance, because people knew how to do it from the previous experience. And the acceptance was much more wider and much more-- the numbers were close to 95% to 100%, which was very reassuring and which was very gratifying to see that patients across our network were getting similar kind of care.
No, actually, the numbers are staggering. I mean, in 2015, the number was only 4.2%. But by the second intervention, you said it was 96.5%. So were the doctors actually mandated to use this? Did they have the option of changing it if they wanted to?
So the way our system works is the only option we had was to do hypofractionation, but they can change it. But they need to have an evidence-based discussion of why they want to change it.
And see, I'm department director for the breast. So anybody who wants to do something different, then he will send an email to me, that he doesn't agree with the pathway recommendation. And these are the reasons why he wants to do it. If the evidence-based discussion is consistent, then we say, go ahead and do the conventional fractionation.
Well, it clearly was very effective. I'm curious if you saw pushback from the doctors in making this change? Did people have a problem with being directed towards this particular treatment?
Initially, I did. Initially, when we did it for the first time, there was a lot of communication back and forth. And people made different kind of arguments, like we only have 10 years' data. We don't have 20 years' data. And we don't know whether it is safe or not.
Or [? they could ?] quote previously have done studies which have shown poor outcome. But they were done with different techniques and different philosophy. So there were a lot of discussions back and forth. And to alleviate some of the concern, I did a [INAUDIBLE] conference in our network, where we mandated all of our physicians to participate and listen to the [INAUDIBLE] conference, where we defined how best to do hypofractionation in terms of dose homogeneity, in terms of heart and lung dose.
The most important factor was dose homogeneity. And once physicians understood that the dose homogeneity is the more important component than the fractionation, and they could see the results from the patient's perspective and from physician's perspective, the adoption became like a no-brainer.
The other thing that is remarkable to me about the pathways at the University of Pittsburgh and the people who use the Via Oncology Pathways, so my own institution at the Cleveland Clinic, we also come up with our own evidence-based care paths. And we try to educate people about them. But there isn't really a good way to track how well people adhere to them.
How important do you think having the web-based monitoring, where people actually have to track what they're doing, is to adherence to these care pathways?
Well, it definitely helps us, because there are two ways we monitor it. One is like the [INAUDIBLE] tool. Then anytime you go off pathway, it comes to the pathway director as an email for him to respond to the rationale behind our pathway and whether he or she agrees with it. And if he agrees with it, then it goes into the system as "On Pathway," even though the track was not on pathway.
And the second thing is you may say you're doing something, but you may not be doing it. So we have an audit system built in where we have one of our staff members audit the charts randomly across our network and match what has been done to the patient to what has been entered into the clinical pathway, to make sure they match.
If other centers wanted to start adopting clinical pathways in order to help improve the quality of their care, what are some of the take-home lessons you learned during this process that you can pass on to them?
I think it's important that you have the buy-in from the providers. So in our pathway, it's not like the total is 1% of [INAUDIBLE]. It's a committee, it's a member, and it's an open discussion. If you don't have the buy-in from the people, then it's hard to implement it. You need to explain to the patients it's not taking over their autonomy. The physicians still have the autonomy. It's just helping them guide better to have uniformity of care.
And having some-- there are system guidelines. And there are other guidance available. But they try to keep it very lighter in terms of options. The difference between the guidelines of the pathways is there's much more [INAUDIBLE].
Like, for example, we call it the philosophy of efficacy, toxicity, and the cost. All things being equal, the one which is most efficacious gets number one ranking. If it is equally efficacious, then the toxicity gets the high ranking. And if it is equally efficacious and toxic, then the cost gets the high ranking.
So the hypofractionation for the breast, it's similarly in approximation to efficacy to [INAUDIBLE] fraction. The toxicity is somewhat better with hypofractionation. And the cost is much better.
I think that's a critical point to illustrate, that the first and most important thing is that we make sure that it's just as effective and also at least as tolerable, if not better. We want to make sure people understand that the clinical pathways such as this are not designed just to save money but also to improve actual patient care. And what are the next steps? Where are going from here?
So just to take this concept to the next step, like we have recently adopted hypofractionation for prostate cancer. And we have implemented in our data our guidelines how best to do it. So our next step is to look at the adoption of hypofractionation for prostate cancer, which is like nine weeks treatment versus six weeks treatment, with the guidance of how best to do it.
And the next thing we'll be executing is whether we are able to successfully do that or not for prostate cancer too. I think this has given us a benchmark and a platform to take it to the next level for other disease sites, and to make sure that we are following the data and evidence to the best of what we can do.
Thank you for agreeing to talk to me today. I think this is going to be really of interest to the listeners of the podcast.
Thanks for having us. And it was a pleasure talking to you. And I hope that this can send the right message to the audience for them to take these steps in their own practices.
I also want to thank our listeners out there who joined us for this podcast. The full text of the paper was published online at ascopubs.org/journal/jop on December 7, 2018, and will be in the March 2019 JOP. This is Dr. Nate Pennell for the Journal of Oncology Practice, signing off. -
With the care of patients with cancer strewn across numerous settings, are electronic health records (EHRs) meeting the definition of interoperability according to the 21st Century Cures Act? Dr. Pennell speaks with author Wendy Rubinstein.
Read the related article "CancerLinQ: Cutting the Gordian Knot of Interoperability" on JCO OP.
Hello and welcome to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Most oncologists in America today use an electronic medical record, or EMR. But for a number of reasons, few of us are able to access records for patients outside of our own practice, a concept that's known as interoperability.
Today we're going to be talking about a new editorial published as part of a series called "The State of Cancer Care in America." This editorial is titled "CancerLinQ-- Cutting the Gordian Knot of Interoperability," published in the January 2019 issue of the JOP. Joining me on this podcast is the author Dr. Wendy Rubinstein medical geneticist and Deputy Medical Director at CancerLinQ, LLC. Dr. Rubinstein, thank you for joining me today.
Thanks for having me.
So I know that this is not going to be a surprise to any of our listeners, but would you mind just kind of giving us a little background on the issue of EHR interoperability, and how did we end up with the scenario that we have today?
Well, sure. Of course, electronic health records systems weren't built with interoperability in mind. The overarching goal for hospitals was documentation to support billing, and it hasn't been a priority for hospitals to make it easy for their patients to interact with other health systems. But to be fair, people didn't talk much about interoperability 10 to 15 years ago. And I'm not even sure an official definition existed.
So now the 21st Century Cures Act provides a definition. So basically, electronic health information should be able to be securely exchanged with other health information technology. And there should be no special effort required by the user, especially and including patients. And the data exchange for the authorized use, it needs to be completely enabled under applicable laws, and any information blocking is prohibited.
So what this comes down to, basically, is that a patient should be able to have care at one medical office, and then go to a separate system across town, without having to fill out another paper form with their complete medical history, medication list, and review of systems all over again. So part of the article talks about, and you mentioned, the ASCO Oncology Practice Census. And in 2017, the practice census found that 40% of practices were unable to accept any patient information from other practices.
And you might think that the problem is getting better with attention to it, but actually, it's getting worse. In the 2016 practice census, 34% of oncology practices said that their EHR was interoperable with hospitals in their region. But in 2017, only 10% were interoperable with regional hospitals. So in oncology, this is especially important because cancer patients typically have their care strewn across multiple specialists, surgery, radiation oncology, medical oncology, and more. So with their care being decentralized and being complex, how can we really subject our patients to recounting their entire history every time they come to a new specialist?
And we're relying on them to be savvy about their cancer history and to be accurate about it. And this is often the worst time of their life. So without quite saying it to them, we're basically letting them know that we don't communicate with our other doctors. And I have to say, sometimes my own medical profession embarrasses me.
Yeah, it's interesting. I mean, it's a couple of different issues, the first being of just simple interoperability and having access to your patients' records when they're not within your system. The traditional way of doing this is you've typed up a letter or a note from what you've done, and then you mail it to the other physicians who are either the primary care doctor or the person who referred to you the patient. And strangely enough, that's still mostly how this happens.
I have a sophisticated electronic medical record that puts together a sophisticated note filled with all kinds of important information, which gets printed out and put it in an envelope and mailed to someone, rather than sending that electronically and having it available whenever they need it. They have to somehow come up with a way to scan that into their system so that they can read it. So it's really remarkable that we're still in that system. And I now have limited interoperability with other people through my own EMR, and it's just astonishing how much easier it is to keep track of people with that. Once you start to get a taste of the potential of that, it's really hard to go back and not be able to access patient's records anymore.
Everyone I think is a little bit aware of this issue and becoming increasingly aware of this issue. What are the barriers out there to making EHRs interoperable? It just seems like such an obvious thing to do, and yet it somehow is a difficult process.
To attempt to maybe take something complex and bring it to some basic issues, I can call out a couple of issues. One is extreme customization, and the other is that we need a common language that can speak across different implementations of electronic health records. So with extreme customization, and this is how I would characterize it. So customization is very effective at locking up health information and preventing it from being exchanged. And for any EHR vendor, offering a way for clinicians to customize their reports, their documentation, it really is a great way to satisfy them.
And in fact in my own experience, my cancer genetics practice became very efficient by creating templates for notes and letters about genetic testing and managing patients at high risk of cancer. But if you think about it, when I recorded a diagnosis of colon cancer in a letter to the patient or the clinician, it wasn't mapped to any standard vocabulary or code. It can't be shared other than as a TXT file.
When you talked about bringing in scanned documents, yes, you can look at them, but they're not machine computable. In fact, if you like to know how many ways you can say total neutrophil count in an electronic health record, CancerLinQ was in the unfortunate position of figuring this out. So in the first 30 oncology practices that CancerLinQ received data from, there were 76 distinct ways to say total neutrophil count, like white blood cell count or WBC. And that means that there were more than two names per organization on average, even within an organization. There's no agreement on what to call this.
So it's certainly true. We, as human beings, we can all semantically process different terms for total neutrophil count, but a computer can't. It can't do that, unless we provide a mapping or we create it. So this basically locks up the data and reduces its value. So to extract the value, we apply natural language processing and human observation using interfaces. But that's expensive, and the problem is it doesn't help at the source. You still have the EHR, it's not really aggregated together yet, and in the day to day workings, you're not really doing anything to solve the problem.
So the other problem which is very much related is we need a lingua franca. We need a common language to make the proper use of the data that we have in EHRs. And so on a higher level, ASCO and CancerLinQ have convened a volunteer stakeholder group, and this represents diverse perspectives in oncology, different specialties coming to the table. And the purpose is to create a core set of data elements from oncology called mCODE.
So mCODE stands for Minimal Common Oncology Data Elements. And ASCO is aligned with other medical organizations, as well, and the Biden Cancer Initiative, so that together we can inform oncology EHR vendor design. We can inform their decisions and, hopefully, prompt interoperability to improve cancer care.
One of the things that's-- of course, you now work with CancerLinQ. Can you tell us just a little bit about CancerLinQ and how CancerLinQ can work to overcome some of these issues?
Sure, I'd love to. So CancerLinQ is a major initiative at ASCO. And the goal was to create a learning health system for oncology. So first and foremost, CancerLinQ is a quality measurement and reporting system. We have over 100 health care organizations. These are large and small, they're community and academic, that are participating in CancerLinQ.
And so far, we've established data flows with 47 organizations, and we've integrated data for over a million patients with cancer. And that reflects their comprehensive longitudinal record of health. So by doing this, the reason to do this is we're enabling practicing oncologists to measure, and report, and improve the quality in patient care.
So when you look at, for example, the 2017 ASCO Oncology Practice Census, about 25% to 30% of practices, they called out quality measurement and reporting activities as a top burden for them. In order for them to do this, they have to actually do manual extraction from electronic health records, if you can wrap your mind around that. You have to pay to do that. So the CancerLinQ platform reduces the reporting burden by displaying the quality measures for MIPS, MACRA reporting and also supports ASCO's QOPI certification.
And what this means is that clinicians can actually see the time window they have left to take specific actions to meet the quality benchmarks. The other part of CancerLinQ is that we provide statistically de-identified data sets from the cohort to researchers and to FDA. And in that way, we're trying to accelerate discovery and scientific improvements to cancer care.
Yeah, it's a fantastic initiative, and I'm glad to see that it seems to be growing and doing well. The next question would be, how can CancerLinQ, aside from individual practices being able to use the data for quality metrics and, of course, the anonymized pool data for research, how is this working to overcome problems of interoperability?
So CancerLinQ is somewhat unique in that we've integrated data from practices, so far using seven different electronic health records. So we don't limit, we feel we can't limit the data aggregation to a single EHR type because the overall goal is to learn from all patients. But there are some common problems that we share with other big data providers. So any entity that's performing data aggregation, they're also coming up against the same problem we have, as needing a common language for oncology, such as mCODE.
And as I mentioned, ASCO is looking to engage everyone who has this common problem to solve it together. One barrier I can't resist talking about as a geneticist is the way genomic data is handled. The one disturbing practice is that really the way DNA sequencing data exists is it's completely structured in machine computable when it comes off the sequencer. I mean, almost by definition.
And then the results get reported by paper, and even if there is an electronic file sent to the practitioner with the report, there's nowhere in the electronic health record to store the genetic test data in its rich detail. So the report might get scanned or copied someplace, and it'll get attended somewhere where you can go visualize it. If it's scanned in, it loses all of its structure, and then it requires optical character recognition and very messed up tables to try to make sense.
So if you think about it, like what we want to do with that data, how can we automatically run clinical quality measures for colon cancer without having a place for KRAS gene test results? That's already in all the quality measures. If an oncology practice is running Molecular Tumor Board, how can they do that with reading off of this piece of paper? They need the files to really run that activity. And the same thing is true for identifying patients who are eligible for a clinical trial, increasingly based on a molecular variant result.
So we can do that to some extent. We can do all these things, but we really can't scale precision oncology with these kinds of limitations. So I think a common theme across CancerLinQ and other entities that are trying to aggregate data and especially to combine it with the rich phenotypic data in electronic health records, the molecular diagnostics laboratory should routinely make these results available to the ordering clinicians as structured data files. It may be difficult for them to maintain it themselves. The electronic health record really should have a place for this, which with mCODE, that will definitely be a part of mCODE.
Where do we go from here? How do we get from where we are today to the world where all this information is easily shareable across EHRs?
The technical challenges there, but really it's about collaboration and having a will to solve this across the entire ecosystem. So we have created an organization called the Oncology Leadership Council. So CancerLinQ's Oncology Leadership Council includes corporate nonprofit and government collaborators and, for example, the American Society for Radiation Oncology, National Cancer Institute, FDA, the Cancer Informatics for Cancer Centers, Ci4CC, AstraZeneca, College American Pathologists, American College of Medical Genetics and Genomics, and many others.
Now ASCO doesn't think that this is something that we could or should solve alone. This really means helping the entire oncology community to improve care by solving the problem at the source. And that means capture all of the important oncology data as structured, computable information. And we have to do this without imposing any more documentation burdens on physicians. And frankly, we shouldn't really be hiring an army of data entry clerks to do this either.
I like to think about call to action. What can people do, given the situation? So I would like the listeners to know that the Office for the National Coordinator for Health IT is right now soliciting comments on what they call the strategy on reducing regulatory and administrative burden relating to the use of health IT and EHRs. So ASCO is currently preparing comments, and you'll have a chance to review and provide feedback. And I also wanted to let listeners know that you can also participate in the writing of comments, which is going on by the American Medical Informatics Association, AMIA. The comments are due soon, on January 28, 2019, but input would be very valuable.
I'd also like to mention that CancerLinQ is concerned about information blocking. And as I mentioned before, information blocking is prohibited by ONC. And lastly, I can't resist inviting people, that if you're interested in joining CancerLinQ, please contact us.
Excellent. I think that was a good idea to put that message out there. And I will also put the plug in that joining CancerLinQ is actually free of cost to get this wonderful resource.
You bet.
Dr. Rubinstein, thank you so much for talking with me today.
Thank you, it's a great opportunity and a real pleasure.
And I also want to thank our listeners out there who joined us for this podcast. The full text of Dr. Rubinstein's paper, "CancerLinQ-- Cutting the Gordian Knot of Interoperability," is available online now at ASCOpubs.org, backslash journal, backslash JOP in the January 2019 issue. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. -
Dr. Thomas Knight talks to Dr. Pennell about a major issue in cancer care: financial toxicity.
Read the related article.
Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. The rising costs of medical care is on everyone's mind these days. But while policymakers or physicians tend to discuss this more of as a societal or economic problem, the real consequences of the high costs of cancer care are ultimately being felt by our patients.
But how do we measure the financial burdens of cancer care? And how does this impact our patients' lives and ultimately their outcomes from treatment? Today, we're going to be talking about a new paper titled, Financial Toxicity in Adults With Cancer Adverse Outcomes in Noncompliance, published in the November 2018 JOP.
Joining me for this podcast is Dr. Greg Knight, medical oncologist at the Levine Cancer Institute in Charlotte, North Carolina. Greg, thanks so much for joining me today.
Thank you so much for having me.
So I thought this was a really interesting paper. Can we just start with a little bit of terminology? So what do you mean when you're talking about financial toxicity? I've heard people use this term bandied about. I think it's a term that oncologists are used to dealing with. And obviously, we know that health care is expensive. But this implies that there is a harmful element to this.
Yeah, sure. The term financial toxicity is still a relatively new term. We first started to use it probably around 2013. Dr. Zafar at Duke published a paper first looking at this in terms of the costs and the harm to patients. And the idea behind it is we want to be able to quantify what we're doing in terms of harm to the patient with the costs of treatment.
As oncologists, one of the things that we're really good at is grading toxicities. So we worry about nausea. We worry about neuropathy. We worry about hair loss. But one of the things that we weren't very good at was also looking at the harm we were doing to patients with the costs of our treatment.
And when I refer to cost of treatment, this term actually encompasses a lot, in terms of not just what we usually think of, which is offices, it's medications, hospitalizations, all those bills that they get from us, but there's other costs that go along with having a cancer diagnosis. Those are things like transportation, clothing, lost wages, child care. All of these things are impacting our patients. And we need to quantify this because it does have implications on their treatment and how they're going to do.
Well, that makes perfect sense. And I think that's something relatable to everyone who's treating cancer patients today. Can you give us a little bit of an idea of the magnitude of this issue in the United States? Is there existing data before your particular study came out?
There were some both small scale papers and some large database looking papers. And the general consensus was, at the time when we started this study was about 1/3 of patients are going to have severe or catastrophic financial difficulties associated with their treatment.
Wow. That's a huge number. So why don't you tell me a little bit about your study and what was the intention of the study and how did you go about it.
One of the things we really wanted to do with this study, which was part of a much larger study we had at the University of North Carolina, was we wanted to evaluate both prevalence of this financial toxicity. Because again, there had been some database studies. There had been some smaller scale studies. But we wanted to get actual patient reported data on the prevalence of this financial toxicity and in a wide variety of cancers.
But we also really wanted to look and see other things. How did it impact health services? Basically what are targets that we could intervene on to try to improve this? And so really with this study, what we did was we went into the clinics of all of the oncology clinics at UNC, and we embedded researchers in there and approached pretty much any patient that came to the clinic. Wildly successful actually, we had over 52% of our approached individuals actually enrolled in our study. And then within two weeks of that enrollment, we had interviews conducted by our staff using basically a computer assisted telephone interview.
Now as I said, this was part of a much larger project. And what we were trying to do was basically get this comprehensive database of both clinical and interview data. And then we paired that with biologic specimens and tumor tissue. However, our piece of it was we were really trying to delve down on this financial question and then look at quality of life and how it impacted their care.
Are their existing instruments that look at financial toxicity? Or is this built into existing PRO surveys?
At the time when we started this, there actually was not. Dr. De Souza at the University of Chicago actually developed the cost measure, basically posted that after we had started with us. Having said that, and I love the cost measure. I think it's a fantastic. It's a nine question survey basically looking at grading financial toxicity.
One of the things that we really were hoping to do with our primitive attempts at this was to find maybe one question things we can do in a busy clinic to try to identify high risk populations. And so with this one what we used was actually a statement from the PSUA team, which was, you have to pay for more medical care than you can afford. And then patients were asked to respond to the statement basically strongly agree, agree, uncertain, disagree, or strongly disagree. And we dichotomized them as basically exhibiting financial toxicity if you strongly or agreed with that statement, or not exhibiting financial toxicity with any other response.
That sounds like a pretty clear and straightforward question. Was there like a free form portion where they could talk about, did this affect their ability to take their medicines, or go to doctor visits, things like that?
There was. And we actually did a couple of different things. So we both did standardized questionnaires, so we did things like the fact GP, which is looking at multiple facets of patient well-being. We also looked at other health related quality of life issues. We also had developed our own access to health care questionnaire, which was looking at certain things like, were you having problems getting to your appointments? Are you being able to pay for your medications?
We did several questions about paying for lab tests, paying for office visits. And then also, we really wanted to make sure that we knew if the reason you were missing these things was because of cost, or if there were other reasons. Because obviously, we don't want to attribute this all to cost if that's not what's causing the harm.
OK, yeah. So it sounds like a lot of information gathered. So what did you find?
In our study, we had almost 2,000 participants. And we had over a quarter, so 26% agreed or strongly agreed that they had to pay more for medical care than they could afford, which is in line with other studies.
I would have thought it might have been higher than that. But it sounds like this is a nice validation that your survey was a pretty accurate instrument, even with such a simple question.
Unfortunately, what we found is that when you take this population, the population that tells us that they are having financial toxicity by our definition, what we were finding was much higher rates of noncompliance. And that was a very scary thing when you're talking about cancer patients. Our patients who had reported financial toxicity were much more likely to report needing but unable to afford prescriptions, over-the-counter medications. They were also reporting noncompliance due to cost concerns for medical care like doctor's visits, medical tests, mental health care. All these things for the majority of patients undergoing active chemo is a really scary thing.
And there's been some really good research in this area recently. There was a recent study where they were looking at imatinib and CML, and it found that individuals who had copayments greater than $53 a month were 70% more likely to discontinue within six months. So it's real world implications of this concept.
Absolutely. And were there any other factors that were associated with financial toxicity, things that you might be able to use to screen or predict for this?
In terms of the predictor, we basically validated what it had been thought of before, which is that there were certain factors that seem to be more predictive for exhibiting financial toxicity. The ones that we really know of are age less than 65 years, being non-white race, less education. All of those things had been previously described. It was nice to see with a large population model that we could validate those findings that would have been found in smaller studies. But it does seem that those patients are at much higher risk for financial difficulties.
Yeah, and the less than 65 is interesting to me. So I assume that that's probably related to Medicare coverage, that that somehow makes it less of a financial burden.
That's what it looks like. And I think that, obviously, Medicare is a nice protection for a lot of our patients over the age of 65, in that they don't see a lot of some of the costs our younger patients, especially our underinsured patients see. However, there was a recent study where individuals with cancer that were insured by Medicare alone were incurring mean out-of-pocket costs that were 1/4 of their household income. So I would say even though they have probably less bills for a lot of those patients, they're on fixed income. There is not other income coming in. So a lot of the folks over the age of 65 are still having financial toxicity even with the better insurance coverage.
Did you look at insurance coverage in this? Was that a variable in the analysis?
It was not. It was one of those things that when you go back and you wish you would have done it at the time. We felt like we had covered every single base. And it actually was a thing where we thought we were going to be able to pull that data from a database. But ultimately, we were unable to do it. It's now built into every model going forward. But we unfortunately did not have that data.
So you did a great job of identifying these patients and all the consequences of the financial toxicity. So what are we to take from this? Presumably, the idea would be to try to figure out a way to intervene on these patients. So what can we do?
Yeah, I think that, I mean, obviously, the first step is to identify the problem. And I think that that's always an issue. There's been multiple surveys of oncologists who feel it feels very wrong to discuss costs with patients. I think that we get very wrapped up in the science. And we have the latest and greatest drug that we just know is going to work. But obviously, drugs are getting more expensive plus all the treatment time and coming to and from the hospital, and basically outpatient versus inpatient chemotherapy. All these things need to be thought of when you're thinking about your treatment plans.
Having said that, once identified, if you're screening your patients for this, there are specific areas it seems like we can intervene. In our study, what we found was there were pretty interveneable reasons people were saying that they were having problems with their care. They include things like not having transportation, a lack of insurance, the inability to pay for travel. They can't take time off work. They don't have child care.
These are things that are specific issues that they're having, that with foundational support, with local and community support, you can usually intervene on. But you really do need to identify them. I know our group and the group out in Washington has done some research in the use of trained financial navigators to help patients. And that group in Washington has shown fantastic results saving a lot of money annually for these patients.
And in our group, we've also done things like treatment plans based on where you live. So can we get you treatment close to home? And if not, how can we get ride share? How can we get gas cards? Can we do things to help you?
And then also, I mean, again, there are actually a decent amount of foundational money out there if you're looking for it. There are groups out there that are there to help. But again, like I said, a lot of times, we just miss the problem.
Yeah. I mean, I know that I feel vastly unqualified to discuss costs of care with my patients. Oftentimes, I really don't even have a good idea of how much things cost. But it sounds like there ought to be a way to screen patients right up front beyond simply what their level of insurance is to see if they might benefit from these extra services. And then it's important for cancer centers to have these kind of interventions to be able to help provide with transport and identify patients who would benefit from that foundational help.
So I don't know how broadly available those kinds of services. I know we have them there. And your cancer center is actually run by our old boss, who used to run our cancer center, Dr. Raghavan. So I'm not surprised that you might have those as well. Is this something that is broadly available in oncology offices throughout the country?
It's not. I mean, honestly, it is not. And one of the things that I'm kind of one of my big pushes in terms of the research is that I think that everyone has their own issue that they're very passionate about. And I think that we could survey patients until the cows come home about different issues and try to identify patients at risk. And so one of things we've really tried to do is a couple of things.
Number one is to identify specific questions, especially in this case and some of our other studies, one or two question surveys where we can identify patients that are at very high risk for having these difficulties and identify that subset of population. And then one of the things that we're actually also working on in association with a couple other foundations and a couple of national organizations is we are actually hoping at some point to be able to start to roll out telemedicine, tele financial counseling basically and internet and other programs.
There's a pilot going on in Boston right now. There's another program we're going to be rolling out here in January, where we are trying to intervene on the problem even just from financial planning standpoint. There's a large amount of patients who it doesn't matter where you are in terms of your financial situation, financial planning is incredibly important. You could have a lot of money in the bank and good insurance, and then you get hit with a cancer diagnosis. And you're trying to figure out what you're going to do with your assets, versus a lot of our patients, which are you now can't work. And there's no money coming in. How are the bills going to be paid? How are you going to basic budget?
Again, I think this is going to resonate with everyone who treats cancer, no matter where you are. Because a big segment of our patients really struggle with this. And while it might not be immediately visible, if you dig down a little bit, it's not hard to find. Well, Greg, thanks so much for talking to me today.
Thank you.
And I also want to thank all our listeners out there who joined us for this podcast. The full text of the paper is available online now at ASCOpubs.org/journal/jop in the November 2018 issue. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. -
Dr. Pennell and Dr. Schapira discuss the risks and benefits of online communities and provide recommendations for improving communication between clinicians and patients about the use of online resources.
Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic and Consultant Editor for the JOP. So it won't be news to any of the listeners of this podcast that living with cancer and dealing with the sequelae of cancer treatment is a terribly stressful proposition and that cancer patients and their caregivers benefit from support services and survivorship programs. Most of us, however, think of providing these support services for cancer patients in terms of in-person interventions, but increasingly, people are looking online for these kinds of support.
I suppose that's probably true for many other aspects of our lives as well. Online communities have been forming in an effort to improve access to support for cancer survivors. But how much do we really know about these communities, and what evidence is there that they are genuinely helpful?
Joining me today to talk about this fascinating topic is Dr. Lidia Schapira, Associate Professor of Medicine at the Stanford University Medical Center and Director of Cancer Survivorship at the Stanford Comprehensive Cancer Institute. Dr. Schapira is also the Editor in Chief of ASCO's patient information website, cancer.net, and is a fellow of ASCO. Today we'll be discussing her paper titled Online Communities as Sources of Peer Support for People Living With Cancer-- A Commentary.
Lidia, thanks so much for joining me today.
Thank you so much for the invitation.
So first, this is obviously too big a topic for this podcast, but explain a little bit about why cancer support services in survivorship is important for cancer survivors. And I guess more importantly, where is there an unmet need, that people might need to seek that somewhere else, such as online?
Sure. So we think of support as something that is delivered in person. And certainly in traditional medical settings, we offer support, I hope, through empathic communication, through referrals to social services, through programs. We are very much aware that going through cancer alone is much harder and that support is both important just strategically to get through it but also emotionally.
I think that increasingly we also realize that people are seeking support in other ways that are not traditional and have been less well studied, and that's where the online services and supports really are playing a very important, an increasingly important, role for many patients and caregivers as well.
This is coming up actually a lot among patients of mine, especially younger patients. So can you just tell us a little bit, when we talk about an online community, what exactly is that?
So there are two words and each one is really important here. Community means, really, a group, so it's not just a one time exchange, but belonging to something, a sense of belonging to a group. And the group shares a common interest. In this case it's something related to cancer.
And online refers to where this group, or this community, meets. It could be through instant messaging. It could be through other new media or platforms. It could be through email. It could be through a website. And that is going to change as technologies change.
What we're basically saying as a way of meeting people not in person but meeting over time and through a shared expressed common interest.
And there's lots of different examples of kinds of online communities that you described in your paper. Can you tell us a little bit about them? I know that there's some that are a little bit more formal and structured and others that are really kind of left up to the patients to moderate themselves.
Exactly. And to somebody who is not a digital native, like myself, this has been a real interesting process of discovery. We tend to think, perhaps incorrectly, that online means improvised, and it's anything but improvised. A good online community that is mature, that keeps the interest of its members over time, requires some management, requires some decision, requires some effort on the part of the people who are starting the community. And so we learned that there are different types. There are different media.
Some have actually some formal facilitation with social workers and really function similarly to the way an in-person support group functions. And some are much more informal, people sort of coming together. So there are some online communities that are sort of offered through large advocacy organizations like the American Cancer Society or CancerCare. And there are others that are not, and those typically occur in spaces like Twitter or Facebook.
And now there are even some privately sponsored online communities such as Smart Patients. And we reference Smart Patients because their headquarters are in Mountain View, California, and we got to do a visit and really learn a lot about them just, again, to get a better understanding of what's available for our patients.
Well it's nice that there's so many different options. How do patients even find these? Do you know?
I think patients just find information in ways that come naturally to them. There are lots of groups for young cancer patients and survivors that have fun names, Stupid Cancer and so on, that are terrific. And there are some that are more formal through other societies. Facebook and Twitter are probably places that people go to, and they're just basically looking for others with a shared diagnosis. And so it's hard for me to answer that. It depends a little bit on how familiar people are searching for things and then what pops up when they are actually looking for something.
And one of the things that, as an experienced oncologist, I always worry about is how safe they are. I think what first comes to mind is, oh my goodness, people may be misinformed, or they may have exaggerated ideas about one treatment or so on just by asking these questions without really doing some formal research. But it's amazing actually how much good information is also transmitted through these very informal groups, some of which are absolutely not monitored. But people just really push each other to learn and to look for information in addition to giving each other support.
When we started this, the driving question that I had-- and my co-author was then a chief resident at Stanford and is now an oncology fellow. The question we had was really, are people looking for information about cancer and cancer treatment, or are people really looking to connect with each other and help each other through a difficult experience? And what we found actually is that it's both, and it was very difficult to tease out where the good information becomes also a source of support.
I would say that this sounds wonderful, and taking it at face value is probably fine. But because we are academics, we always look for data. And so is there actual data? Are there studies on the benefits and risks of patients participating in these online communities?
Unfortunately, I would say there is little rigorous data. We looked for it, and we were hoping to be able to find sufficient numbers of well-designed randomized controlled trials or other good trial designs where we could actually study this. And one of the things we are interested in is, of course, is it safe? And also, if it is helpful, in what way is it helpful?
I mean, do people cope better? Do people feel that they're better able to handle their illness, in other words? Could we find measures of self-efficacy or coping or information or something that was measurable? And we found many studies done but, unfortunately, few that were of high quality and few that were high quality and relevant to cancer. So what we found was actually not sufficient to come up with either a sound recommendation or to go a little deeper and do a systematic review or some more rigorous review of evidence.
Yeah, it's interesting. You cite in your paper a few studies that have shown some improvement, at least in things like self-efficacy and decreasing anxiety or at least perceived improvements in these, and then some that are worse and many that really don't seem to show a significant difference. Is that something that you think can change? Are there plans to do more rigorous research?
Our group has actually been very interested in trying to find the proper design for a study. And we've brought together social scientists, mental health scientists, and oncologists, and people who really understand the technologies, and we're trying to figure out how one could possibly study it. We think it needs to be done, and I'd be delighted to collaborate with others who are looking into this.
I mean, we know social media can help patients find each other or find, perhaps, centers where they're doing research. Certainly, patients with rare diseases find that it's a very useful way of connecting with others. But what we were really interested also in trying to identify how much-- what is the dose of social media? What is the best venue? Is there a way of matching a patient to group so that he or she may find what they're looking for, and when is this benefit transmitted?
Our hunch is that it's probably early on in the cancer experience that people derive the greatest benefit from feeling connected and that what actually happens is that they feel some validation. They feel better able to handle it. They actually learn how to ask better questions. But it would be wonderful if we could actually find a way of studying it. As you may well imagine, it's hard to study something that people are already doing, so finding the proper study design and population is what I think is keeping us still from being able to answer these questions.
Sure. So when you see a patient who's, let's say, just gone through surgery for breast cancer and is just embarking on her long adjuvant therapy, how do you talk to them about these resources online? How do you-- or really to all of us oncologists out there, how do we guide our patients to wade into this brave new world in a responsible and helpful way?
So for me the first step was to just recommend in my after visit summary that patients visit cancer.net as a way of getting informed. That to me was already sort of an important step. And the next step, and I'm still thinking through this, is to try to have this conversation with as many patients as I can, those were receptive to this. And as I ask them, do you feel supported, do you need a referral, I should also say, there are some online groups. Some of the times I do. It's still not part of my routine, but I bet you in a couple of years it will be.
No, that makes sense. I actually for a while was handing out to people a little card which had some responsible, what I thought were good websites, but mostly, again, for information as opposed to actual communities where they could meet other patients. So that's definitely worth some thought.
Well, Lidia, thank you so much for agreeing to speak with me today. I'm sure our listeners got a lot out of this.
Thank you so much for the opportunity, Nate.
And I also want to thank our listeners out there who joined us today for this podcast. The full text of the paper is available at asacopubs.org/journal/jop, published online in September 2018. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. -
Dr. Pennell and Dr. Nancy Lin discuss whether prior authorizations reduce overall health expenditures.
Read the related article "Increasing Burden of Prior Authorizations in the Delivery of Oncology Care in the United States" on JOP.
Hello, and welcome back to the ASCO Journal of Oncology Practice podcast. This is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, we're going to talk about a topic that I think is going to resonate with just about every clinical oncologist in America-- prior authorizations.
Although these have been around for longer than I've been practicing, it really seemed to me over the last couple of years that more and more claims have been denied by insurance companies, more requirements for prior authorizations, and often for things that really didn't seem like they used to need prior authorizations, such as inexpensive medications. And now, based on data from the 2017 ASCO Oncology Practice Survey, we have some hard data that isn't just my imagination. This is a real phenomenon that is putting stress on an already stressed health system.
Joining me today to talk about this topic is Dr. Nancy Lin, associate professor of medicine at Harvard Medical School and director of the Metastatic Breast Cancer Program at the Dana-Farber Cancer Institute in Boston. She's going to discuss her and her co-author's editorial titled "The Increasing Burden of Prior Authorizations in the Delivery of Oncology Care in the United States." For 2018, the JOP is publishing a series of papers on the state of cancer care in America, and this is part of that series. Welcome, Nancy. Thanks for joining me.
Thank you.
I know probably most people listening to this are familiar with prior authorizations. But can you talk just a little bit about, what is the intended purpose of prior authorizations? And is this something that ever made sense before the current craziness?
Sure. Before I start, I would just like to acknowledge my co-authors on this editorial, Harvey Bichkoff, the CEO of Marin Cancer Care, and Dr. Michael Hassett, a medical oncologist at Dana-Farber. So together, we run the spectrum between academic oncologists, community practices, as well as Dr. Hassett has an interest in health policy-- so kind of running the gamut of interests here.
You know, I think we can all agree that the cost of cancer care continues to increase-- I don't think that's a controversy at all-- and that continuation along this trajectory is not sustainable in the long term. So insurers, whether they are public or private, are struggling to keep premiums down while keeping up with all the new advances in diagnostics and treatments, and many of these are quite expensive.
So, you think prior authorizations came out of this, which is that an attempt to try to maintain some cost containment in a way that, at least at the outset, the hope was that this would be in a fashion that would lead to the use of treatments in a medically indicated fashion and reduce the use of non-indicated treatments.
That sort of makes sense, doesn't it? If people are doing things that don't have a lot of data behind them or are using the most trendy, expensive test or medication, it might actually make sense to have some control to make sure that they're following some reasonable practice or guideline.
Yeah, I don't think that what is most upsetting oncologists, or oncology nurses, or front-line staff is denial of unproven or unuseful treatments. I think it's really the many and what seems to be increasing hoops that one needs to jump through in order to get testing or treatments that are really the right thing to do for patients that are really well within the standard of care.
So while the PA system might have started with good intentions, I think as it is often currently constituted-- I don't want to lump all the systems together in one. But I think it contributes in a way to sort of a siege mentality. So I think if you talk to any practicing oncologist, you will hear stories of the kinds of struggles they have had getting very standard treatments approved in a timely fashion. And while in the short term, most of us make these heroic efforts to get things approved, I think that process really as set up is really counterproductive in terms of the long-term health of our health care system.
So at the institution I work with at Dana-Farber, we tried to actually do a project where we quantified some of these kind of gestalt feelings. And so what we did is we actually looked at all prior authorizations for outpatient medications originating from the breast medical oncology practice over a six-month period of time. And we focused only on outpatient medication. So we're not talking about scan authorizations or IV chemotherapy but just outpatient oral medications, whether antineoplastic or not.
And we found that we had to process over 300 PAs over a six-month period of time and that 97% of the PAs that were requested were approved on the very first try. We went back, and we coded whether the medications were being prescribed in accordance to NCCN guidelines. And yes, most of the time they were.
And strikingly, we actually found that 15% of our PA requests were for generic medicines, like tamoxifen, aromatase inhibitors. These are medicines where there's just absolutely no debate about the efficacy or importance of the treatments. They've been around forever-- maybe not forever, but for many, many years. They're available in generic form. They're inexpensive.
And then seemingly random treatments, no matter how much we appealed, we couldn't get through the PA process. And this includes a scopolamine patch for refractory chemotherapy-induced nausea or Lupron for the purpose of ovarian suppression. And I think that when clinicians deal with this on a daily basis, they see that almost 98% of their prior auths go through the first time, that you get these sort of bizarre requests for all sorts of paperwork for tamoxifen, for goodness sakes. It really gives a sense of being besieged by paperwork and process and not really being able to see a clear benefit of the PA system. And I think that really is what contributes to this burnout and the sense that the prior authorization process is broken.
And it's not just your colleagues in Boston. I know, certainly, I've had that sensation here. But now we have some national data suggesting this is a problem being felt everywhere. I know that the most recent ASCO practice census, and maybe you could give us a little background on what that is, seems to show that this is a burden everywhere.
ASCO actually conducted an oncology practice survey. So they've surveyed about 395 practices in 2017. This actually represented about almost 60% of the US hematology-oncology workforce. So was is a pretty big survey. There were 7,200-or-so respondents.
And what was found, the key point was that payer pressures were actually the most important pressure that was felt by practices. And this was felt across all types of practices-- academic, physician-owned, rural, urban-- and that prior authorizations were actually the most commonly cited pain point, and they were cited by 78% of the respondents. So this is really something that people are feeling, truly, on a daily basis.
And this is not limited just to oncology. There was a related survey by the American Medical Association. This covered not only medical oncology but primary care and other specialties and, basically, found very similar findings. Prior authorizations are a huge burden on practices. In fact, in the AMA survey, 90% of practices reported delays in care because of PAs. Almost 80% abandoned treatment plans at least some of the time because the PA is too burdensome. So these are things that have direct effects on patients.
Oh, absolutely. And I think what was striking to me about the practice censuses, you may think this has always been a major issue, but this is a real change in the most recent year's survey. It was, I think, the third or fourth top concern of practices until this survey where, suddenly, it's now far and away the top burden on practices. And there is also some data I see here looking at quantifying the amount of time that it's taking staff and money, that practices are having to invest in trying to work around this pretty significant burden.
There are some studies that suggest that US practices spend nearly four times as much money interacting with payers than do practices, for example, in Canada, which has obviously a very different health care model. In some studies, the costs have been estimated somewhere in the $80,000 to $90,000 per 1.0 full-time FTE physician per year just to deal with prior authorization. And in the ASCO survey, the 2017 survey, the [? hema ?] practices that were surveyed reported a requirement for an average of 6.1 FTE staff to manage prior authorization. So that's a huge burden.
And I think what's important is that, more importantly than sort of the-- obviously, there's a bottom line to practices. You have to pay for these FTE. But the reality is that leaves practices to have to make decisions about how they're going to allocate their money, right? So how much are you going to support a social worker, a program nurse, a practice coordinator? How much are you going to support all of the staff required for PAs?
And what proportion of the front-line physician staff, nurse practitioner staff, PA staff will be spent during office hours-- because, often, that's when one needs to do these-- interacting with payers versus providing direct patient care? So I think that this doesn't all happen in a vacuum, and that's also very important. And when you spend money in one place, you're making trade-offs in other places.
Oh, absolutely. It's something that no one can ignore now. Do you know, is their actual data showing that all of these denials and prior auths, does that actually save money in health care?
You know, there's not a lot of information specifically looking at oncology. That's really looking at the global picture. Because if you think about it, if you don't pay for an antiemetic, you might save money on the antiemetic, but the person may end up in the hospital with need for IV fluids. And so I haven't seen very large kind of studies that are comprehensive in that way to look at the full cost of cancer care with and without various types of prior authorization processes.
That has been done in some other disease types. And in those disease types, there have been sort of mixed data as far as whether there are differences in the overall costs, for example, in the mental health area where requirements by insurers to switch from one antidepressant to another may then lead to a, for example, psychiatric hospitalization.
So there, there's been a little bit more study for that. And it does seem, at least in some studies, that the overall cost of care may go up. That's not been seen in all studies. I'm not aware of really well-done studies in oncology-- they may be out there, I'm just not aware of them-- looking at the sort of overall picture, which, I think, is what we worry about.
And we also worry about the other part-- is that what we can't really measure is what happens to the vulnerable patient who goes to a practice that just isn't as well resourced, and we just can't get or the practice just can't get something through that's really medically indicated, and the patient has a adverse oncology outcome as a result.
And that's not really something that we, at least to date, have been able to really appropriately measure in terms of what potential impacts might be of not only prior authorizations but all the sort of different types of barriers that are present to affect care of vulnerable populations.
To some extent, you have to conclude that it must be saving at least the insurance companies some money since it seems like they're doing it more and more. And that almost has to be driven by a certain percentage of claims that are people just sort of drop it because they don't want to go through all of the time that it takes to do that. That certainly doesn't seem like a very good system for patient care.
I know, certainly, when I'm called to do a peer-to-peer, I always have a moment where I sort of put my head in my hands and wonder how badly I really want to do this. But obviously, if it matters, you have to push it through. And as you pointed out, when you finally get to the peer-to-peer, almost always they approve reasonable requests based on the exact same information they had when you submitted it the first time. It's not like you had to give some special, secret information to the reviewer to get it approved.
That's exactly right. And I think the arbitrariness of the program or the process is part of what oncologists are responding to, those sort of lack of transparency, the sense that one could easily talk to a computer and just punch in the key for the response and get the same results. I mean, I think there is this anecdotal sense of that. And how much of that is true it's hard to know without a definitive study. But I think that is a sense that people have out in the front lines, and that's part of the frustration.
Yeah. Well, so you state unequivocally that the system is broken. And I'm going to go out on a limb and say that I think you may be on to something. So what can we do? Or what are some possible solutions to this?
So, I mean, I think we can all agree that a shared goal is to deliver timely, high-quality care to patients with cancer. And I really emphasize both the timely part and the high-quality part because they really go hand in hand. And so whatever we do to try to constrain costs, we really want to make sure that we're not affecting the timeliness and the quality of the care that we provide to patients with cancer.
We make a number of recommendations in our editorial. But I think one key point is that we believe there is a role for some cost-containment strategies from payers. I mean, we recognize the need for it. But we think that payer-based coverage guidelines, prior authorizations, whatever sort of mechanism is there really should be the exception rather than the rule. And when they are in place, they should reflect the best and most up-to-date evidence. We shouldn't be arguing for something that was approved three years ago.
And I don't know that it's really the goal or the role of insurers to micromanage every aspect of a patient's cancer care. And so I think some possibilities, like insurers have these really large [? beta ?] databases, so trying to understand and focus on which expensive medications are frequently not used according to guidelines, having two-way conversations with oncology and patient advocacy organizations in areas of controversy to try to come up to some consensus of where these somewhat more soft indications might be covered, demonstration projects to look at alternatives to prior authorizations.
And I think all of these would be welcomed by the oncology community. I don't think the oncology community is unaware or doesn't care about this big elephant in the room, which is the high cost, right? But I think the pushback is really just the implementation in a way that just doesn't feel like it-- it feels like it's actually getting us away from timely, high-quality care. I think that's where the dissatisfaction comes from.
And when prior authorizations, or pathways, or whatever cost-containment tool was implemented, I think listening to the oncology community is really important. So are there processes that can be simplified so that you can achieve similar results with less pain? Are there ways to make the processes or forms more uniform?
So between the myriad of insurers that every provider deals with on a daily basis, every form is different. Every check box is different. Everything is different. It's a pathway. If there are pathways, you don't want to be navigating 20 different pathways, and the person on one insurance gets one chemotherapy in the third line. Maybe another on the other insurance gets this. I mean, it's just this is-- you don't want that to be how we practice medicine.
And when PAs are denied, I think we want to have a streamlined appeal process. I mean, we want to ensure that the person on the other end is qualified as a peer reviewer-- which, I think, there is a sense that that's not always the case-- and also empowered to use their clinical judgment.
So even when there is a clearly qualified peer reviewer, sometimes they just don't have the latitude to make clinical judgments. They're constrained in internal ways. And so I think that also gives the sense that the patient isn't the priority. And I think we just can't forget, right, the patient is the priority.
Yeah, I mean, I think giving everyone the benefit of the doubt here, I think everyone's goal is to deliver the best value care, the best quality of care to the patients, and to try to keep in mind the incredible problem of the rising costs of care. And the insurance companies have been placed in a difficult position where they really have had to take something into their own hands, which means we need to get everyone to the table to try to solve this. All right, well, thanks so much for joining us.
Thank you for inviting me.
And I also want to thank all of you out there who joined us for the podcast. The full text of the paper is available at ascopubs.org/journal/jop, published online in August 2018. This is Dr. Nate Pennell for the Journal of Oncology Practice signing off. - Mostrar más
