I’m Aware That I’m Rare: Charles Burger, MD (481)
the phaware® interview
In this episode, Dr. Charles Burger, the medical director of the Pulmonary Vascular Center at Mayo Clinic in Jacksonville, Florida, discusses the importance of patient registries, specifically the Pulmonary Hypertension Association’s PHA Registry (PHAR) for pulmonary hypertension. This registry collects clinical information and surveys from patients to understand their characteristics, treatment options, and outcomes. The PHAR registry also provides opportunities for research on topics like social determinants of health and newly diagnosed patients.
My name is Dr. Charles Burger. I work at Mayo Clinic in Jacksonville, Florida. Approximately, 32 years ago when I first started my career, I encountered patients that had pulmonary hypertension with not a lot of therapies to offer. From that very beginning, I developed an interest in how to change that. Over the course of -three decades, I’ve become the medical director of the Pulmonary Vascular Center practice at Mayo Clinic in Jacksonville, Florida, which is a fully accredited center with the full offerings of currently available treatments, which is very exciting for our patients. It’s really been a fun ride.
Today I’d like to talk to you a little bit about patient registries, particularly pulmonary hypertension registries, and more specifically the PHAR Registry.
The PHAR Registry is sponsored by the Pulmonary Hypertension Association, so P-H-A-R, PHAR. It’s an endeavor on the part of accredited pulmonary hypertension centers and the patients to be willing to provide their clinical information and to have surveys on a regular cadence. so that we understand if they’re improving with the treatment that’s been provided for the pulmonary hypertension. Over the course of approximately three years, there have been about 70 accredited centers that have participated to the extent of enrolling participants that are their patients into the registry, generating a total of 2,743 participants overall.
It really provides us a beautiful opportunity to understand characteristics of the patients and the current treatment opportunities, activities of the center to make an accurate diagnosis and get patients on the most appropriate treatment. Most importantly, how they do over time with these interventions. I think at this point, what is an additional opportunity is that each of the participating centers that enroll patients have an opportunity to look at that information with a research question. If they make a proposal in that regard and it’s reviewed and not redundant to something that we’ve already done and it sounds like it’s feasible, then we support that center with providing them data to answer their research question.
Many of those have been around the social determinants of health. What are the patient’s capabilities in terms of education, socioeconomic class, access to these centers, access to experts, access to all the various treatment options, and how does that impact their outcome? Many times, a patient with lower education or lower socioeconomic status only has the emergency department as an outlet for their care. They may or may not have access to a center. That’s clearly an access issue that we need to address from the standpoint of getting the patients to outpatient appointments, where their symptoms can be addressed without waiting hours in an emergency room that’s costly to them, costly to the healthcare organizations. When we’ve analyzed the data with certain of these studies, it’s very clear that that puts the patient at a disadvantage.
They’re less likely to have a full complement of therapies. They may have one or two medications when perhaps they need three medications. It increases their risk for hospitalization, which of course takes them out of their job, takes them away from their families, creates a huge hospital bill at the end of that stay that they may or may not have capacity to pay. It really has opened our eyes looking at data that’s been generated with this registry to understand that there are gaps that provide opportunities for us to think about how do we do things differently? How do we measure these limitations in our patients in a meaningful way and then address them once we’ve identified them at a higher risk of not having this access? Do we connect them with organizations that currently exist that are patient focused that might provide some additional means of supporting their travel to appointments? Do we connect them to drug assistance programs that might give them an opportunity to be on the therapy that they need?
Do we get them into a research trial where they would have full support of all of the testing that they would need to monitor the pulmonary hypertension and access to a potentially new effective therapy free of charge, from the standpoint of being billed to them personally or to their insurance carrier? At this point, I feel like it’s a wide open landscape for us to begin to explore more and more topics that are germane to many of the issues that we know are actively limiting our patient’s ability to get the type of care that we all feel that they should have.
We’re really trying to focus on newly diagnosed patients and how quickly they’re diagnosed, how quickly they’re on most appropriate therapy, because we know any lag in that regard can be negatively correlated to good outcome, i.e., they would have poor outcome. We’re trying to get newly diagnosed patients into this registry to better understand that across the board. For the most part, that’s the focus of all of the centers that are participating.
In many instances, patients are proactive. They’ve been referred to you with a very threatening diagnosis. As an expert in the area, they’re obviously very interested in making sure that they’re getting the best treatment possible and that they have the most accurate diagnosis possible. But because of the rarity of it that they already appreciate it from perhaps doing their own personal searches on the internet, they will ask about research opportunities from two perspectives. One is, access to newer, better agents that may provide a cure. That’s one of our long-term objectives, of course. Until we study a new medication that might have that potential, we will never know. Secondly, they almost universally, when you broach the subject of research, say, “I will do anything to help anybody else who’s faced with the same condition, because of the stress that it’s put on me personally, both psychologically and physically. Whatever I can do can inform future decision-making to make that less burdensome for patients coming down the pike.” It’s very unusual that a patient’s not interested in doing that.
To the point around a registry, basically you’re saying we would take your clinical information, de-identify it, put it in a data repository that we could answer some research questions and you’ll be required to do some follow-up questions about how you feel day in and day out, i.e., a quality of life questionnaire. They don’t view that as very burdensome at all. I’ve maybe had one patient not want to do this. In retrospect, I think that was my fault. I don’t think I explained it in the way that I just did, because the second time that I brought it up, they agreed.
The one last thing that this registry will offer that I’ve not seen as a potential in previously generated or active past and present registries with pulmonary hypertension, is conversations around how to centralize some of this data collection. Obviously, many patients are electronically connected in a way that wasn’t the case 20 years ago. Secondly, I think that there’s a lot of interest in new pathways of treating it. So the pharmaceutical companies that are generating these potential new medications want to understand what patient groups are their medications most likely to work. They want to target those patient groups, obviously, to show benefit of the medication, which will help us sort of overcome some of these existing barriers, I hope.
That’s not really a broad partnership that many of these registries have had in the past. There’s ongoing conversations, some of that has already happened. But I think there’s more opportunity to come that then could potentially serve as a bit of a source of income to help support the coordinators and the patients with this data entry, particularly longitudinally, as this goes on hopefully year after year.
Their information is not shared with the industry or the pharmaceutical company in a way that it’s identifiable. It’s basically shared in a general sense. Out of these 2,743 patients, the average age is 59. That’s what they would get. Not Mrs. Smith is 52 and has pulmonary hypertension at Mayo Clinic in Jacksonville, Florida in a way that privacy and confidentiality would be violated. Human subjects protection rules apply and their privacy and confidentiality is of utmost importance for us to maintain.
My name is Charles Burger, and I’m aware my patients are rare.
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