Research: clinical scales in progressive MS

Epub ahead of printBosma et al. Clinical scales in progressive MS: predicting long-term disability. Mult Scler. 2011 Aug 25.

Background: The aim of this study was to determine which short-term changes on clinical scales including the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg test (9HPT) and Guy’s Neurological Disability Scale (GNDS) are most predictive of long-term outcome of disability as rated by the EDSS in progressive multiple sclerosis (MS). 

“This is a subject close to my heart; we don’t really have scales that measure disability progression with enough accuracy to use in progressive clinical trials of a practical duration to make phase 2 or exploratory trials feasible.”
Methods: From a longitudinal database, all progressive patients, both primary (PP) and secondary (SP), were selected on the basis of at least two complete examinations being available within a time interval of 1-2 years (short-term change). All patients who fulfilled the selection criteria were invited for a third visit after an interval of at least 3 years (long-term outcome). 
Results: 181 patients fulfilled the selection criteria. Early change on EDSS and T25FW were the best predictors of long-term EDSS. 
Early EDSS change was a slightly stronger single predictor compared with early T25FW change. 
Adding early T25FW change to early EDSS change in a ‘combined predictor’ model improved prediction.
Conclusion: Both early change on EDSS and T25FW predict long-term EDSS with comparable strength. Therefore the investigators recommend the use of early T25FW examinations in future clinical trials in progressive MS.
“By definition this study excludes MS’ers who are already in a wheelchair; this is not good for their psyche. Is my disease too advanced to be included in clinical trials? Not necessarily if you are prepared to volunteer for the trial design with repeated lumbar punctures.”

“The other problem with recommending these scales is that MS’ers are unable to measure their own EDSS; you have to be examined by a trained neurologist to be given an EDSS score. A typical EDSS takes about 20 minutes to perform and sometimes longer. We are trying to address this by evaluating a patient related outcome measure that gives you an estimated EDSS. If this works it will empower MS’ers with data that can then be used to calculate their disease courses using tables, etc.”

One thought on “Research: clinical scales in progressive MS”

  1. I don't grok the EDSS. When I joined the Accelerated Cure Project, I asked for my first EDSS score from the trial I was in to pass on. The trial coordinator sent me both pre-trial forms because they were different. My score went in a few weeks from 3.5 down to 3 even though I would've said I was worse at the second visit. Throughout the trial, my EDSS cycled between 3 and 3.5 for no reason that was discernible to me. On the other hand, from my perspective, I was functionally much worse at the end of the trial than at the beginning, but the EDSS didn't seem to be sensitive enough to pick that up. Plus they used the new neuros to do the trial exams which led to a few instances of what even I could identify as operator error.I am not even sure how you would measure progression in MS in some reasonable way. Objective measures like MRI often have a disconnect from functional impact (one lesion in a bad place ought to be worth more than a bunch of silent lesions, but is it always possible to tell from looking at an MRI result?; it seems like most trials just go with number or volume of lesions). Functional measures are so many apples and oranges. Is paralysis worse than blindness or extreme fatigue? Do people's subjective judgments of what they dread most enter into this? I sometimes imagine trying to measure disability as a kind of poker game where different problems are matched off against each other, i.e., I'll see you an episode of optic neuritis and raise you a spastic leg and an intention tremor.

Leave a Reply

%d bloggers like this: