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).
Epub ahead of print: Bosma et al. Clinical scales in progressive MS: predicting long-term disability. Mult Scler. 2011 Aug 25.
“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.”