Application of the 2010 revised criteria for the diagnosis of multiple sclerosis to patients with clinically isolated syndromes

Abstract

Background and purpose: Recently, the McDonald criteria for the diagnosis of multiple sclerosis (MS) have been revised, with the aims to diagnose earlier and to simplify the use of brain MRI. To validate the 2010 revised criteria they were applied to a cohort of patients with clinically isolated syndromes (CIS).

Methods: In all, 178 CIS patients were followed from onset. Test characteristics were calculated after 1, 3 and 5 years and compared between the 2005 and 2010 revised criteria. The time to diagnosis of the 2005 and 2010 criteria was compared using survival analysis and the log-rank test. Clinical evidence for dissemination in space and time was the gold standard for clinically definite MS (CDMS).

Results: During follow-up, 76 patients converted to CDMS (mean time to conversion 23.9 months). At 1 year, the specificity and accuracy of the 2005 criteria were a little higher than those of the 2010 criteria (98.0% and 98.4% vs. 86.3% and 88.5%). However, at 5 years, differences completely disappeared (specificity 85.7% and accuracy 93.3% for both criteria). MS diagnosis could be made significantly faster with the 2010 criteria (P = 0.007). Using the 2010 criteria, in 19% of patients the diagnosis could already be made at baseline.

Conclusions: By applying the 2010 revised criteria a diagnosis of MS can be made earlier, whilst prediction of disease progression is maintained. This validation brings along great advantages, for treatment possibilities as well as patient counselling.

Keywords: MRI; clinically isolated syndrome; diagnostic criteria; diagnostic test assessment; multiple sclerosis.