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Q&A With Dr Thomas LeBlanc: The Value of ePROs in Oncology

Surabhi Dangi-Garimella, PhD
The FDA has recognized the need to include the patient's voice in the drug development process. The question is: what is the best way to do this?
PATIENT-REPORTED OUTCOMES (PROs) are finding a significant place in healthcare quality metrics, and PROs are sometimes thought to be more reliable than clinician-reported data. The challenge continues to be adopting service workflows to collect this information from patients, and electronic PROs (ePROs) have definitely enhanced this process.

Evidence-Based OncologyTM (EBOTM) spoke with Thomas W. LeBlanc, MD, medical oncologist, Duke University School of medicine, Durham, North Carolina, about the real-world influence of PROs.

EBOTM: Could you provide a brief introduction to PROs, their influence on the cancer drug development process, and the subsequent influence on cancer care overall?

LeBlanc: PROs are validated tools that help provide additional information about what patients are going through and how they are feeling. Until relatively recently, these were mostly just tools used in research studies. Patient-reported outcome measures of things like health-related quality of life include different domains about how a person is functioning physically, about what symptoms they’re going through, their emotional state, their social well-being, and so on.

The FDA, too, has recognized that this aspect of measuring the patient experience was missing from the drug development process. They have increasingly been saying that PROs need to be part of what we measure when we test new drugs or compare drugs, and it’s an important part of what should be in the repertoire of clinical trial end points. While traditional clinical trial end points— remission rate, complete response to chemotherapy, overall survival [OS], and event-free survival—are all very important, other kinds of end points, such as what happens to someone’s overall health-related quality of life when they get treatment A versus the standard treatment, are important as well. If all things are equal, if people live about the same length of time, what is that time like? Is the time potentially better? Is it worse because of side effects?

PROs are an important way to amplify the patient voice as part of what’s going on in clinical trials.

EBOTM: Are PROs usually secondary or tertiary end points in a clinical trial? What is their influence on the outcome of a trial?

LeBlanc: There are several recent examples of PRO measures being important in the drug approval process, and [they are among] the things we review in our paper.1 There is a drug called ruxolitinib, indicated for the rare blood cancer myelo brosis, that was approved in large part because it dramatically improved a PRO measure called the total symptom score scale [TSS]. Patients with myelofibrosis have really debilitating symptoms: They have spleen enlargement that pushes on their stomach, so they feel full all the time; as a result they don’t eat well, they lose a lot of weight, and they experience other constitutional symptoms such as fever and dramatic fatigue. A lot of these things were improved with this new medication. So, although ruxolitinib met some traditional end points too, such as improved OS, some of the earlier, more exciting, and interesting findings really had to with TSS, and that was a big part of the story around the drug getting approved.

Similarly, another story we mention in the paper is the approval of a chemotherapy for pancreatic cancer, gemcitabine, which was compared with the standard treatment at that time, 5-fluorouracil. While gemcitabine improved overall survival, it also improved a composite measure that evaluated patients’ experiences, including pain, maintenance of physical function, and weight loss, among other things—our paper describes this in detail. These are just a couple of examples where in the last few decades the patient voice, through PROs, has become so much more important in how we count what is a meaningful di erence with a new treatment.

EBOTM: In your paper, you discuss how ePROs could make it easier for patients or their family caregivers to participate in the process of reporting the patient experience. Can you tell us more?

LeBlanc: Electronic PROs are the next frontier in the field. The big distinction here is what happens on research studies and clinical trials versus what can just happen in how we take care of people. For me, what’s most exciting about ePROs is that they can be a part of good cancer care, or medical care, and not simply a clinical trial tool.

A few recent examples have shown that using ePRO methods for people with advanced cancer enhances our ability to take care of them. One such landmark study, which we refer to in our paper, was done by Dr Ethan Basch and published in the Journal of Clinical Oncology,2 regarding its quality-of-life end points, and then more recently in JAMA, regarding the survival measures from that study.3

What the authors did was electronic symptom monitoring on a weekly basis. So, when people were home, they were filling out a questionnaire about 12 common symptoms; the results were relayed back to the care team and to nurses who could then intervene and not have to wait for the person to call or show up in the emergency department [ED] to get help. It’s almost like an early warning system for people with cancer, whereby reporting their experiences and symptom burden between visits led to improvements in overall quality of life, fewer ED visits, and then eventually about a 5-month survival benefit. In patients with advanced solid tumors, it’s quite remarkable.

That’s about what we expect to see with new therapies for advanced solid tumors—and this wasn’t a treatment, it was just improved monitoring and better care. That’s why I like to say that ePROs really amplify the patient voice and help us to better see the patient experience to incorporate it into what we are doing for that person to provide excellent cancer care to them.

EBOTM: How do you ensure that the most important PROs are being collected but that the patient is not burdened?

LeBlanc: The issue of survey overload is really the big one that we are facing now in this part of the eld. We can measure anything and everything at this point—there is a PRO for so many di erent things—but you can’t ask every patient 250 questions on a weekly basis, daily basis, or every time they come to the clinic, because people quickly get tired of it.

Part of what we wrote about in our paper,1 though, is that the recipe to success with PROs seems to be not so much related to how many questions you ask people, but rather if you make it useful to them to answer those questions. What I mean by that is that we found when the answers to the questions impact the care that people receive, that is a reinforcing experience. So, if patients realize, “My doctor actually looked at this, and cares about the result, and cares about how I am feeling. This is a way for me to communicate things that we didn’t have time to talk about in a short visit; my doctor went over these things with me that I said were really bothering me during the next visit, and I can see that it actually changed the care that I received, it helped me be heard in ways that maybe I wouldn’t have been,” that’s important.

In 1 of our analyses, we evaluated the completeness of questionnaire batteries and people getting PRO assessments as part of routine care, here at Duke, and found a significant correlation, such that people who weren’t likely to come back for a consult were a lot less likely to fill out the questions. On the other hand, among people who filled out the questions and then realized that it changed the care they received, the completion rates were more than 90%. They always filled it out at subsequent visits because they realized it was an important part of coming to the clinic and us being able to take good care of people by knowing what’s going on with them and how they are feeling.

EBOTM: What are some of the challenges of collecting PROs in the clinic?

LeBlanc: One of the major challenges is the work ow. Everyone is really busy in oncology clinics, and if you do something where you create a new app, and the patient has to download and use it, and then the doctor has to use it as they are also trying to do everything else they are supposed to do in a 10-min- ute visit, which is already too much, then it just won’t work. They are struggling with documentation and the electronic health record [EHR]—if the app doesn’t integrate with the electronic record, then nobody is going to use it. It doesn’t matter how much money you spend developing an amazing app; if it doesn’t really make things easier for the clinicians and the patients, then it will not be used, or will not be viewed as being helpful.

The other issue is the EHR itself. Despite the advancements, EHRs are quite problematic in fundamental ways. Each is a bit different, but I have yet to see one that really does a good job of providing an off-the-shelf PRO module, or that does it in a way that works well in real-world practice. For example, with the system that we are using here at Duke, I can send out electronic questionnaires to patients automatically before a visit. However, I can’t necessarily control what the data look like when they come back to me—I can’t control where they go in the chart, and they don’t come back in ways that I find particularly useful for patient care. EHR vendors have not really stepped up to the plate on this issue, which has resulted in the development of homegrown PRO systems in the clinic, which creates other problems with sustainability. I hope to see this change in the coming years.

EBOTM: Is there a challenge in bringing providers on board to be a part of this process?

LeBlanc: It is very much a challenge. There is a lot of activation energy required to change what you do. Anyone who comes in and says, “Now we are going to start collecting this new questionnaire and we want you to use it in clinic,” is perceived as someone who is just telling you to do more work when you are already overworked. That’s a recipe for failure with busy clinicians.

 
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