Nielsen JM, Pohl C, Polman CH, Barkhof F, Freedman MS, Edan G, Miller DH, Bauer L, Sandbrink R, Kappos L, Uitdehaag BM Prognostic implications of a carefully performed neurological assessment in patients with a first event suggestive of multiple sclerosis. [JOURNAL ARTICLE] BMC Neurol 2009 May 20; 9(1):19.
ABSTRACT: BACKGROUND: To diagnose multiple sclerosis (MS), evidence for dissemination in space is required. There is no clear definition on how symptoms and signs of a patient indicate clinical dissemination. To provide a uniform approach on this subject, a clinical classification system was described recently differentiating patients with mono- and multifocal clinical presentation. Here we assess the predictive value of clinically defined dissemination in space at first presentation for time to clinically definite MS (CDMS). Trial registration number NCT00185211. METHODS: Four hundred and sixty-eight patients with a first episode suggestive of MS were classified as clinically mono- or multifocal by two neurologists blinded to magnetic resonance imaging (MRI) results. These patients were part of the BENEFIT study in which 292 patients were randomized to interferon beta-1b (IFNB-1b) and 176 to placebo. By using Kaplan-Meier statistics the risk for CDMS was studied in multi- and monofocal patients of the placebo group, both with and without taking into account MRI measures of potential prognostic relevance. RESULTS: Time to CDMS was similar in monofocal and multifocal patients. In monofocal patients, the risk for CDMS over 2 years was significantly higher when [greater than or equal to] 9 T2 lesions or at least one Gd-enhancing lesion were present at the first event or 3 or 6 months after the first event. In patients with multifocal presentation, these MRI measures had no significant added value in predicting time to CDMS. CONCLUSIONS: These data indicate that a carefully performed neurological assessment of symptoms and signs is important for defining the risk of conversion to CDMS.
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