Application of the 2017 Revised McDonald Criteria for Multiple Sclerosis to Patients With a Typical Clinically Isolated Syndrome

Abstract

IMPORTANCE In 2017, the International Panel on Diagnosis of Multiple Sclerosis revised the McDonald 2010 criteria for the diagnosis of multiple sclerosis (MS). The new criteria are easier to apply and could lead to more and earlier diagnoses. It is important to validate these criteria globally for their accuracy in clinical practice. OBJECTIVE To evaluate the diagnostic accuracy of the 2017 criteria vs the 2010 criteria in prediction of clinically definite MS in patients with a typical clinically isolated syndrome (CIS). DESIGN, SETTING AND PATIENTS A total of 251 patients at Erasmus MC, Rotterdam, the Netherlands, in collaboration with several regional hospitals, fulfilled the inclusion criteria. Thirteen patients received another diagnosis early in the diagnostic process and therefore were excluded from the analyses. Nine patients with CIS declined to participate in the study. This left 229 patients who were included between March 2006 and August 2016 in this prospective CIS cohort. Patients underwent a baseline magnetic resonance imaging scan within 3 months after onset of symptoms and, if clinically required, a lumbar puncture was performed. Data were analyzed between December 2017 and January 2018. MAIN OUTCOMES AND MEASURES Sensitivity, specificity, accuracy, and positive and negative predictive value were calculated after 1, 3, and 5 years for the 2017 vs the 2010 criteria. RESULTS Among the 229 patients with CIS, 167 were women (73%), and the mean (SD) age was 33.5 (8.2) years. One hundred thirteen patients (49%) were diagnosed as having CDMS during a mean (SD) follow-up time of 65.3 (30.9) months. Sensitivity for the 2017 criteria was higher than for the 2010 criteria (68%; 95% CI, 57%-77% vs 36%; 95% CI, 27%-47%; P < .001), but specificity was lower (61%; 95% CI, 50%-71% vs 85%; 95% CI, 76%-92%; P < .001). Using the 2017 criteria, more MS diagnoses could be made at baseline (n = 97 [54%]; 95% CI, 47%-61% vs n = 46 [26%]; 95% CI, 20%-32%; P < .001). In the group with at least 5 years of follow-up, 33% of patients who were diagnosed as having MS using the 2017 criteria did not experience a second attack during follow-up vs 23% when using the 2010 criteria. CONCLUSIONS AND RELEVANCE The 2017 revised McDonald criteria are associated with greater sensitivity but less specificity for a second attack than the previous 2010 criteria. The tradeoff is that it leads to a higher number of MS diagnoses in patients with a less active disease course.

Expert consensus from the Arabian Gulf on selecting disease-modifying treatment for people with multiple sclerosis according to disease activity

“…Criteria for the diagnosis of CIS have been updated recently [54], and a substantial proportion of patients previously considered to have had CIS would be diagnosed with MS under these current criteria [55]. Randomized trials have demonstrated that treatment with one of several DMDs delayed to a statistically significant extent the conversion of CIS (as diagnosed using contemporaneous criteria) to clinically definite MS (reviewed elsewhere [56]).…”

Instead of tweaking the diagnostic criteria for MS in those with CIS, we should develop diagnostic criteria that distinguish MS from other conditions – Commentary

“…Admittedly, it is also unlikely that further modifications of the McDonald criteria will make a major difference given the overall small gains achieved with the recent revision. 9,10 Thus, increased efforts should go into education and teaching of the appropriate diagnostic workup for MS and how to apply the current criteria to the right patient and in the right setting. 2 We should also not risk a potentially false diagnosis of MS just because we would like to somehow label a patient's symptoms (which is often requested) or to offer treatment.…”

Clinically isolated syndrome, oligoclonal bands and multiple sclerosis

“…6 Therefore, a recent study showed that the 2017 revisions of the McDonald criteria have higher sensitivity, but lower specificity in comparison with the 2010 revisions, and pointed to inclusion of OCBs as the main contributor to the lower specificity. 8 Research on clinical and laboratory predictors of the long-term course of the disease at the moment of CIS is of crucial importance.…”