Stephen Krieger, MD: I think that’s a perfect segue into the situational dependence to say, how do we know when our treatment strategy has actually been effective for shutting down a relapse? And so let’s turn to the final portion of this, which lines up with the final portion of the optimizing MS relapse management approach presentation that you’re making here. We’ve talked about assessing the relapse. We’ve talked about treating it. How do we assess our outcomes? How do we know, Sam, to your point, whether the patient has made as much of a recovery as we can expect, or if we need to retreat or further treat? This is where the ARMS [Assessing Relapse in Multiple Sclerosis] questionnaire really comes into play, which you already described. Maybe you can tell us a little bit about how the ARMS tool can be used for relapse assessment in the community.
Amy Perrin Ross, APN, MSN, CNRN, MSCN: Again, I think if we start off with the tool assessing the relapse, there’s a place on there for saying after all this, “No, we don’t think this was a relapse.” It turns out it was a pseudo-relapse or whatever. So just because you’re going into this doesn’t mean you’re committing to the fact that, yes, this is a relapse.
You do the assessment, and there are checkboxes for the symptoms you have. But then, about a month later, with our reliability and validity testing, we looked at it about a month afterward. You’re asking people, what changes, if any, have they noticed? Have they been improvements? Have they worsened? What sort of treatments did they get? Did they get IV steroids? Did they get oral steroids? Did they get plasma exchange? What is it that they got and how effective do they feel that that treatment was for this current relapse?
The 2-part ARMS tool has 1 page for the initial assessment, 1 page for the assessment afterward. And the assessment at the end is really meant to be done over the phone. There’s no harm in it, and it’s nothing lost if that’s what you’re going to do with it.
Stephen Krieger, MD: I think that’s an important point: that it’s a self-assessment, it’s a patient-reported outcome, in essence. If we do bring the patient in and examine them, we get additional information that we can use. But the main disability scale we’ve had all these years is the EDSS. The way relapses are defined in trials is typically using a change in EDSS [Expanded Disability Status Scale], so a measurable change on 1 of the functional systems, as you described: the vision motor, pyramidals, brain stem, etc, a sensory change. Do you use the EDSS in practice at the University of Pennsylvania to assess the level of disability that a patient has from a relapse and the extent of their recovery?
Joseph R. Berger, MD: We do, but not with the consistency we would like to.
Stephen Krieger, MD: Sure.
Joseph R. Berger, MD: And in large measure it has to do with the time allotted for patient assessment, because it takes time to do an EDSS. The EDSS was developed by John Kerstin back in 1983, and it’s still with us. Unfortunately, it’s not a linear scale. Even though the numbers go from 0 to 10 with 0.5 increments between them, assessed on the basis of these functional systems that Steve just mentioned—the pyramidal, cerebellar, the brain stem, the sensory, the bowel and bladder, the visual and the cerebral, each being graded from 0, having no disability, to 5 or 6, having severe disability, and then calculating the score of the 0 to 10 on that basis—this is a scale that is heavily weighted to gait. And once you get to 4.5 on this scale, you’re using a cane, and you’re using some assistive device in order to walk.
It doesn’t as effectively encompass all the systems as we’d like it to. It’s the best we have for now. There have been other iterations, and in part, we don’t use it as consistently as we’d like to because really of the time allotted to see each of our patients. Though we do find that it’s quite helpful.
I will say though that there’s a variability in the EDSS. And even in clinical trials, when 1 does EDSS and looks at EDSS at 3 months and 6 months and looks for a change of 1 between each of them, it’s not necessarily a persistent change. Some people revert back to where they were before. It’s the best we have, but still probably not 100%.