Evaluating the Role of Real-World Evidence Studies

Elizabeth Holt, MD, FACE: One of the powers of real-world evidence studies is the very large number of participants who can be included. But most real-world studies also have limitations related to their design, such as the actions of a control group or the types of data that can be looked at. Can you comment on the pros and cons of real-world evidence studies, and are those pros and cons similar or different for a specialist versus primary care?

Eden Miller, DO: I love real-world evidence because I practice medicine in the real world. Yes, I’m very research minded. I have done clinical research. I’ve developed research on my own. But when it comes to patient care, it’s the real world. For me, real-world data has a lot of applicability to my practice. Yes, if you’re going to bring a product and medication to therapy, you want to prove it does what it does. But for me, the purpose of real-world data is how am I going to see how it works in my practice? What I like about real-world data is, believe it or not, it’s retrospective and everybody’s blinded. The patients didn’t even know they were in a trial. You know what I mean? You actually don’t have the study effect in real world. You eliminate it because the person’s like, I didn’t know I was being watched. It’s not that we’re jeopardizing their data or their identity by any means, but real-world studies are just all the things that impact the real world. I’m more of a real-world favorable list. I would say that there are limitations sometimes in real world studies because you have a selection bias. You’re already studying the people that are engaged in it. They have it. You don’t know if other people who are doing their own thing with outside that as the comparator would have had a similar outcome. When you start looking at that level, you then bias it as well because those individuals are looked at in the lens of being in the placebo group. I know that every group is different - I want to be very respectful to my colleagues and I identify very much so with the primary care. We’re very much pragmatics. We’re simple, real-world kinds of physicians. That is not to say that endocrine specialists are not. I do see that they might approach it differently. They might have their different perspectives, which is amazing that we all look at that. In my opinion, real-world data is more applicable to me. I think that my specialist counterparts, once they see some of these data, they’re going to say it can’t hurt to recommend a particular meter with Bluetooth and an app. It can’t. Let’s see how I do, because what really has impact is how you, as a clinician, see it. How you see the person in front of you is benefitting. That’s the most convincing way you do anything in clinical practice.

Elizabeth Holt, MD, FACE: As a real-world evidence pragmatist, do you think that this particular data set shows evidence that would apply to your patients?

Eden Miller, DO: It’s pretty solid. It would be harder to argue against it than for it by any means. It’s very, very solid.

Elizabeth Holt, MD, FACE: What role does information like this play for you when you’re thinking of your treatment paradigms for your patient populations, especially those patients who have type 2 diabetes?

Eden Miller, DO: I think there’s a lot of diabetes distress. I still have patients that will come in clinic say, "Dr Miller, you’re going to be disappointed with me." I always say, "Really? Do I get disappointed?" There’s this pressure when you have diabetes. Imagine you go to your oncologist. You have cancer, you go to an oncologist. Oh, you’re going to be disappointed with me. There aren’t those conversations, but diabetes is unique. It’s so driven about the patient’s behavior. I think that this is a way to help reduce some of the distress related to diabetes and so for me, it’s that distress buster. Anything I can do to lessen that feeling, increase engagement and success. But understand, here’s where the loop completes. You talked about how we’ve got the patient side of this, and this study was immense with that. We need the healthcare prescribers’ side because then they need to say look at how good you’re doing. Look at what’s changing. How is this impacting you? That’s that shared, individualized plan that we don’t even know that potential when the person is engaging in their data - they’re transferring it to the prescriber, and then they’re each celebrating that. That’s where you take the burden away from diabetes. That’s where you have that good moment, that encouraging moment. What’s unique about diabetes and its marathon stance is anything that improves that adherence, engagement, that “nice job” attitude goes a long way. It’s a building block for other things. This is what we’re looking for. We’re looking for things like this. We’re looking for things that are easy to implement, that will give us this kind of return. Like your cost benefit ratio of time and effort - this is definitely one of them.

Transcript edited for clarity