Dr. Ethan Basch & Patient-Reported Outcomes Research

Falk: Because there is this sense that patients disappear, that everything must be okay, because you haven’t heard from them, and thus all is okay. But in reality, in a lot of conditions, not just in cancer, those assumptions are not valid. UNC and many other institutions try to have that dialogue. UNC has “My UNC Chart.” Why doesn’t that work? Or does it work to a certain extent, or does it really only work in certain populations?

Basch: It does work, to a certain extent. My Chart is essentially a patient-facing part of the electronic health record system. We all as physicians and nurses use an electronic health record system to keep track of information about patients, and there is a component of that that allows patients to see their own laboratory reports, to make appointments, and to send messages. These systems do have some rudimentary questionnaire functions, but they really are very rudimentary. We know that unfortunately, the vast minority of patients actually sign up for what are called patient portals. I think we’re at the beginning – I think they’re getting better, and they will become easier for patients. It will be important to meet patients where they live. For example, if I want to do a transaction from my bank account I can do it through my phone, through the web, over the telephone, so we need that kind of flexibility to meet people where they live and how they live their lives.

The research that I’m engaged with is essentially informing how patient portals like My Chart should work in the future, so that we can reach more people and be more effective.

Falk: Especially in this era where everybody is on some sort of social media, even folks of my generation text and e-mail, some Face Book, but it doesn’t work as well with the medical profession. That translation of those tools to patient care seems to have lagged. Why? It’s a big industry.

Basch: You’re absolutely right. One important point from your statement is that people exchange information about how they’re feeling all the time. They exchange information about the side effects from their medications. They exchange information about the symptoms of their disease. And we miss that. We’re not capturing that. It’s a major loss, because we could use that information to understand the effectiveness of drugs and other treatments, we could use that to help manage patients, we could use that information to understand quality of care. So it’s a major missed opportunity. I think it’s because, in many ways this aspect of medicine, like many aspects of medicine, don’t start with the patient in mind. They start with the provider and the institution in mind. We have built hospitals to the convenience of physicians, right? I have a schedule for my clinic and patients must fit into my schedule, and if patients want to reach me they must call my office. We’re not patient-centered.

Falk: The airline industry has completely revamped that. You can not only get a reservation online, you can pick your seat online. You can’t do that in all places in the health care system. Is that what you’re suggesting, that a patient should, if they want to come to see you, have some sort of ease in getting an appointment, but even more importantly, an ease in actually being able to interact with you? Is that what you’re suggesting?

Basch: Yes, I think that’s right. The ATM is a nice example of this. I remember as a child my father lining up on Friday at the bank. That was a great inconvenience, and a simple change like an automatic teller and interoperability between banks really changed this dramatically. I think we’re seeing this more and more in health care. We’re becoming patient-centered, we’re thinking about the patient’s home context and how they live their lives, and real-time and non-real-time means of communication. But we’re really not there yet. So unfortunately, as we sit here today, we both have patients who are out of sight and out of mind, and they may in fact be suffering. That may have very substantial downstream consequences.

Falk: So for a patient, the ability to interact on their terms, would be tremendously beneficial. It would also be beneficial if there was some rudimentary kinds of measures that you could get in the home. You’re working on some of those measures right now. One could imagine weight and blood pressure are physical characteristics that one could ask for, but your questionnaires are trying to, in a structured fashion, probe how the patient is feeling. Am I getting that right?

Basch: Yes, that’s absolutely right. So I run a research program that has been investigating this area for about fifteen years now. We’ve developed multiple questionnaire systems, several for national organizations like the National Cancer Institute or the main Oncology Professional Society. We’ve developed technology platforms, but most of all we have explored the different kinds of work flows – the ways to integrate these into people’s lives—patients’ lives and the ways to integrate these into busy clinician’s lives. We’ve found a number of things. In early research we found that clinicians miss about half of the symptoms that their patients have.

Falk: Just half?

Basch: Yes, well for some things it’s more. Your statement is telling. We as clinicians recognize this. We know that this is a problem. Much of the early work that I was involved with was actually around clinical research, drug development and oncology. That was because when we developed new drugs in oncology, they’re often very toxic. They have a lot of serious side effects, and because of this phenomenon that we’ve been talking about, the missing of people’s symptoms, missing their functional problems. When we’ve developed drugs we’ve had huge underestimates of the negative impact on people, so that when regulatory authorities like the FDA look at the profiles of these drugs, or devices that are coming through, we underestimate the toxicities or adverse events related to them. Much of our work has been to improve drug development to get a better understanding of the patient experience.

More recently, we’ve turned our attention to delivery of care and figuring out how to integrate this into how we take care of people every day.

Falk: What have you found out about what works, and what doesn’t work as well?

Basch: A few things. The first challenge is engaging people to understand that this is important, this is worth their time, and that this information will be used. We found that generally people will be enthusiastic to provide this information if they know that their doctor or their nurse want the information and that they’ll use the information. If they find that nobody is paying any attention to this, they quickly lose interest. And in fact that’s annoying. I personally would be annoyed by that as well. In general when we have spoken to patients, and we’ve spoken to many, many patients from all different kinds of backgrounds, we have found that people are very enthusiastic. For the most part, these are people who have chronic conditions. They have heart failure, or pulmonary diseases, or cancer—people who have ongoing problems, ongoing symptoms. This doesn’t really apply to people who are well and see the doctor once a year. It’s people who are already very engaged with the health care system and understand that their symptoms are important.

We have found that in clinical research, about ninety-five percent of the time people will provide this information, and in clinical practice about eighty-five percent. Most notably what we found, is that in clinical trials, when we collect this information from patients, we greatly enhance the data that we have, we improve the precision of the data that we have, and the clinical investigators consistently feed back—those are the people doing the research–that this information has actually changed their decision making about how the drug is given, how it’s dosed, and how to recommend the use of the drug. And it’s changed drug labels, the actual way that the FDA is labeling the drugs.

In routine care, what we found, is that, again, patients who were enthusiastic about this, clinicians use and are also very positive about the information. As I alluded to earlier, when we integrate these patient-reported questionnaires into practice, symptom management improves, patient’s quality of life improves, communication with providers improves, patient satisfaction improves, emergency room visits significantly go down, and in the case of people with advanced cancers, they actually live longer, because their symptoms are better controlled.

Falk: How do you as a practicing physician have the time to be able to read or assimilate in one way or the other all of this information? How do you make it so that on days when you’re not actually seeing that patient, you have the opportunity to have captured time to listen to these very important thoughts?

Basch: It’s a great question, because there are many potential criticisms or many criticisms or comments one can receive on this, but one of them is, doctors and nurses are already so busy—how can you burden them further with more information? There will be an onslaught of information and it will be overwhelming. I think I have a couple of answers to that. The first is that, again I come back to this patient-centered piece. In orientation or a filter by which we say, we can’t overburden our doctors and nurses with this information—is a very doctor-nurse-centered way of thinking—it’s not patient-centered, because our patients are at home with symptoms and it’s our job to manage those symptoms. The second answer is that this is already part of what we do. Symptom management is a major part of my job as an oncologist. The third part, is that the research that we have done has actually demonstrated that this is not a major burden. There is actually not a lot of added time for doing this. In fact, it ultimately saves time because we avoid bad downstream consequences that we’ve avoided by catching symptoms earlier.

Falk: You specialize in prostate cancer. How have you applied the things you’ve learned to caring for older males with prostate disease? Prostate cancer in particular?

Basch: In my own practice, I’ve applied some of these principles in a number of ways. The first is that we have actually used some of these tools that we’ve been talking about, and that helps these populations to have a better handle on how people are feeling between visits and are very effective for communication, so that when a patient comes into the clinic and sees one of us, rather than starting at the beginning and screening and talking about all of their symptoms, we can say “Mr. Smith, I see here from your form that since I saw you last you’ve been having worsening pain and worsening nausea. I also see that you’ve been trying the following measures for it. Tell me, how’s that going?” That jumps us far ahead and makes our encounter more efficient.

A second way, and I think myself as a provider, I have tried to focus more on how people are feeling, realizing that we miss so much of how people are feeling, so I really try to engage. A third way is I work closely with a nurse navigator. There’s a lot of interest nationally in nurses who focus on how people are doing at home. The nurse navigator I work with has very close interaction with the patients in my practice both at and between visits, to make sure that they understand the various components of their treatment, and that we understand how they’re doing.

Falk: Translating it, in other words. Translating what you’ve said, or just another set of ears to listen to what the patient is trying to say?

Basch: I think it’s both. For example, sometimes results of tests are mailed to patients at home. Those results are in my language, not in their language. It’s often very difficult to decipher the meaning of that, and simply having somebody available to talk to patients about that can be very useful. But to your point, there’s a translation about how patients are experiencing their home life to us in the clinic, where we wouldn’t otherwise be aware of that.

Falk: In the prostate cancer world, as in many aspects of medicine, there can be a divergence between “You’ve been cured of your disease, but your health has not been restored.” In other words, your cancer is gone, but either therapy or psychological adaptation have not been as effective, and the patient’s health is not back to where it was before the cancer therapy—chemotherapy, or radiation therapy was initiated. What have you learned to help us understand how patients perceive, “I’ve been cured of my prostate cancer, but because of the therapy I no longer can have sex.” How does your research help with that?

Basch: That is a real challenge, and not just in oncology but in other contexts. In oncology there are many patients either who are cured or who are living with their cancer for a very long period of time who have many sequelae or consequences of this treatment. In the case of prostate cancer, following surgery or radiation, men may be left with urinary problems and with sexual function problems their whole life as well as fear of recurrence, and other psychosocial challenges.

One of the benefits of the kind of research I’m describing is simply to understand problems that exist among many men and to acknowledge them. For years in prostate cancer, we didn’t acknowledge this, we sort of brushed it under the carpet and this was a problem for a couple of reasons. One, men who were living with this weren’t acknowledged and they sort of suffered in silence. As a result it wasn’t talked about, and people couldn’t seek help or counseling. There are medical interventions to help people, for example, with erectile problems.

But the second reason is that we were not able to adequately prepare men undergoing these procedures for what they might expect. We weren’t able to say, “For the kind of disease that you have, and the kind of procedure you’re going to have, men like you experience moderate urinary problems about a third of the time,by which I mean they had some staining or dribbling on their underwear, or some incontinence when coughing, etc.” This kind of research just makes us more aware so that we can communicate with patients and try to address their problems better.

Falk: Men have difficulty sometimes being able to be in touch with their emotions, let alone being able to express them. Do these questionnaires, does the ability to self-report, permit men to be more honest with these feelings and thus communicate them to you, rather than respond to a direct question that you may ask?

Basch: That’s a terrific question. In fact, there is research demonstrating that, particularly when it comes to delicate topics like sexual function, men and women both are far more likely to report this information to a questionnaire than they will to a human, including their doctor or nurse. This actually enables us to unroof problems we wouldn’t otherwise know about.

Falk: Do you provide these questionnaires to the patient, and at what point do you provide questionnaires to a significant other who may be accompanying the patient on the visit?

Basch: There are all different ways that this is done, in various contexts. For the most part, the questionnaire does go to the patient. However, we know from much of the research that we and others have done is often times the patient brings a team. We know from observing people and questions in the questionnaire, say a man in the practice would be answering, and his wife or child would be elbowing them, saying “Come on, Dad, that’s not really how it is,” – so there’s a lot of input. In general we haven’t really handed out questionnaires to caregivers on a routine basis. The truth is the caregivers go through an incredibly challenging experience when it’s a patient with a chronic illness, and being more in touch with the caregivers, as they say, providing care to the care giver, is really essential. We could probably achieve that through questionnaires- it’s a great idea for future research.

Falk: Tell me what the questions are that men most typically ask you, men with prostate cancer. What are the top 5 questions that are asked?

Basch: I’m an oncologist, so I often see men who unfortunately have a cancer that has come back or can’t be cured. Men want to know things like, what kind of symptoms can I expect to have? How long can I expect to live? People want to know about the side effects of the medications. They want to understand what they’ll still be able to do. What will their strength be like, and can they continue with their activities? People also want to know if they need to make any behavior modifications, to change their diet, or their exercise, are there any herbs or supplements they can take. Those are the kinds of things that people generally ask about.

Falk: Are there new and exciting therapeutic options for prostate cancer patients?

Basch: There are a number of very effective new therapies in the medical oncology field, among people who have advanced prostate cancers that have come into use very recently. These are advanced hormonal types of therapies. One is called Abiraterone acetate and one is Enzalutamide. What’s exciting about these medicines is first they’re pills, they’re not intravenous, so people can take them at home. The second very exciting component about them is they have very few side effects – which we know, because we have administered patient-reported outcome questionnaires to people, to understand that people can actually live their lives without a lot of toxicity which is pretty different from the traditional chemotherapies that we had, which caused quite a bit of toxicity. This is very exciting. There are also exciting, new radiotherapy types of approaches, in which we give these very small molecules to people and they emit a tiny burst of radiation called Alpha particles, right at the site where the cancer is when it goes to the bone. This is called Radium 223.

Immunotherapies have been very interesting across oncology in general, but unfortunately have not seemed to have the same kind of effect on prostate cancer that we’ve seen in other cancers.

Falk: Fascinating. Thank you once again for spending time with me today, and thanks so much for all you do.

Basch: Thank you very much, and likewise.