Announcer:
Welcome to CME on ReachMD. This episode is part of our MinuteCE curriculum.
Prior to beginning the activity, please be sure to review the faculty and commercial support disclosure statements as well as the learning objectives.
Dr. Freedman:
This is CME on ReachMD, and I'm Dr. Mark Freedman from Ottawa, Ontario, Canada. And joining me today is my colleague, Dr. Ahmed Obeidat.
Ahmed, we are reaching our ceiling in terms of outcome measures in trials looking at relapses and MRI. And now agencies like the FDA are asking us what is the meaning of some of these changes of a 20% reduction in relapse rate? How is that impacting the patient, and how is it changing their life? And so the introduction of the so-called patient-related outcomes, or PROs, have become very important. What can you tell us about these?
Dr. Obeidat:
Yeah, great question, Mark. So patient-reported outcomes or measure, or some people say PROs or PROMs, right? These are things that are definitely coming into clinical trials. They’re already collected in clinical trials, but they haven't been over time, kind of affecting decisions on treatments because it's thought to have some subjective component to it. When a person living with a disease can report their symptoms, maybe it's not as objective a measure as people think as a measure you do in clinic as a neurologist. Right? So it's an interesting concept because, to me, when I talk to my patients, I think that the patient’s story is the most important, and that’s the most important patient-reported outcome measure is what’s their story, how the disease is impacting their function, how they are living with this disease.
So that's one thing. But now, we try to put more even, I would say, objectivity to the subjectivity where we actually design scales. And say, okay, here are the scales, several questions. A patient will answer these questions, how, and then we will look and score them and know how this disease is impacting their lives. For example, there are some used in MS, like the MS quality of life, SF-36. Right? Or fatigue severity scale or modified fatigue impact scale, or we use a lot of screening, sometimes, for depression or anxiety, like the Beck Depression Inventory, or like, we use a multiple sclerosis impact scale 29, MSIS-29. So, so many of them. But how can we integrate them in practice? It's going to be something where the patient can fill some of those ahead of time of the clinic visit, because a lot of them are time-consuming. Patient has to have a right atmosphere to be able to have the time and focus to be able to fill those. And that’s where maybe technology, web-based approaches, can help us.
There is a movement now, a global movement, actually, to integrate patient-reported outcome measures into clinical trials and routine care for people with MS. And the focus is on web-based PROs or PROMs. And that’s where patients can fill those via portal somehow, and then the results can be automated and come to us as a clinician to be able to integrate them in clinical care and in clinical trials. And I think that maybe where the future is heading is can we use technology again to be able to get some information from our patients before they come to us or even in between the visits? And I think this is a way to use those patient-reported outcomes. But to me, I always like to talk to the patient. I like to hear their stories, and that to me is the most powerful PROs.
Dr. Freedman:
Well, I think that these are all important, and the way in which these PROs are collected is important. They get at an aspect that we can't measure. And as you say, if there are web-based approaches to this, that they could then inform us on a consistent way that this is a patient maybe whose walking has gotten slower because their PROs tell us this. And I should remind our audience, many of these PROs have been validated, and they’ve gone through the validation with agencies like the FDA. So these are proven to be useful not only in clinical trials for looking at efficacy of drugs, but possibly integrating it into clinical care.
Yeah. And with that, our time is up, and we hope you found our perspectives useful, and thank you for tuning in and listening to us.
Dr. Obeidat:
Thank you so much. This was a great discussion. Thank you.
Announcer:
You have been listening to CME on ReachMD. This activity is provided by AGILE and is part of our MinuteCE curriculum.
To receive your free CME credit, or to download this activity, go to ReachMD.com/AGILE. Thank you for listening.