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Background and objectivesTo compare the performance of the 2017 revisions to the McDonald criteria with the 2010 McDonald criteria in establishing multiple sclerosis (MS) diagnosis and predicting prognosis in patients with clinically isolated syndrome (CIS) suggestive of MS.MethodsCSF examination and brain and spinal cord MRI obtained ≤5 months from CIS onset and a follow-up brain MRI acquired within 15 months from CIS onset were evaluated in 785 patients with CIS from 9 European centers. Date of second clinical attack and of reaching Expanded Disability Status Scale score (EDSS) ≥3.0, if they occurred, were also collected. Performance of the 2017 and 2010 McDonald criteria for dissemination in space (DIS), dissemination in time (DIT) (including oligoclonal bands assessment), and DIS plus DIT for predicting a second clinical attack (clinically definite MS [CDMS]) and EDSS ≥3.0 at follow-up was evaluated. Time to MS diagnosis for the different criteria was also estimated.ResultsAt follow-up (median 69.1 months), 406/785 patients with CIS developed CDMS. At 36 months, the 2017 DIS plus DIT criteria had higher sensitivity (0.83 vs 0.66), lower specificity (0.39 vs 0.60), and similar area under the curve values (0.61 vs 0.63). Median time to MS diagnosis was shorter with the 2017 vs the 2010 or CDMS criteria (2017 revision, 3.2; 2010 revision, 13.0; CDMS, 58.5 months). The 2 sets of criteria similarly predicted EDSS ≥3.0 milestone. Three periventricular lesions improved specificity in patients ≥45 years.DiscussionThe 2017 McDonald criteria showed higher sensitivity, lower specificity, and similar accuracy in predicting CDMS compared to 2010 McDonald criteria, while shortening time to diagnosis of MS.Classification of evidenceThis study provides Class II evidence that the 2017 McDonald Criteria more accurately distinguish CDMS in patients early after a CIS when compared to the 2010 McDonald criteria.

Original publication




Journal article



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e1 - e14


From the Neuroimaging Research Unit, Division of Neuroscience (M.F., P.P., A.M., M.A.R.), Neurology Unit (M.F., P.P., M.A.R., V.M.), Neurorehabilitation Unit (M.F., G.D.C.), and Neurophysiology Service (M.F.), IRCCS San Raffaele Scientific Institute; Vita-Salute San Raffaele University (M.F., G.D.C., G.C., M.A.R.), Milan, Italy; Clinic of Neurology, Faculty of Medicine (S.M., J.D., J.I.), University of Belgrade, Serbia; Section of Neuroradiology, Department of Radiology (A.R.), and Department of Neurology/Neuroimmunology, Multiple Sclerosis Center of Catalonia (M.T., X.M.), Hospital Universitari Vall d'Hebron, Barcelona, Spain; NMR Research Unit, Queen Square MS Centre, Department of Neuroinflammation (O.C., W.B., K.M.), UCL Institute of Neurology, London, UK; Department of Neurology (C.E., M.K.), Medical University of Graz, Austria; Departments of Radiology and Nuclear Medicine (F.B.) and Neurology (E.M.M.S.), MS Center Amsterdam, Amsterdam Neuroscience Amsterdam UMC, location VUmc, the Netherlands; Institutes of Neurology and Healthcare Engineering (F.B.), University College London, UK; Clinic of Optic Neuritis and Clinic of Multiple Sclerosis, Department of Neurology (J.L.F.), and Department of Clinical Physiology, Nuclear Medicine and PET, FIU Unit (S.P.C.), Rigshospitalet Glostrup, University of Copenhagen; Department of Clinical Physiology and Nuclear Medicine, Centre for Functional and Diagnostic Imaging and Research (S.P.C.), Hvidovre Hospital, Denmark; Neuroradiology Unit, Department of Experimental and Clinical Biomedical Sciences "Mario Serio" (E.F.), and Department of Neurofarba (M.P.A.), University of Florence; IRCCS Fondazione Don Carlo Gnocchi (M.P.A.), Florence, Italy; and Department of Neurosciences (C.G., S.R.), San Camillo Forlanini Hospital, Rome, Italy.


MAGNIMS Study Group, Brain, Humans, Multiple Sclerosis, Demyelinating Diseases, Disease Progression, Oligoclonal Bands, Magnetic Resonance Imaging