Diagnostic performance of the 2010, 2017, and 2024 McDonald criteria: clinical implications in multiple sclerosis

To compare the sensitivity, specificity, predictive value, and accuracy of the 2010, 2017, and 2024 revisions of the McDonald criteria in a cohort of patients who have experienced their first demyelinating event suggestive of MS.

We included 118 participants (mean age 32.21 years, 71.2% female) with an average follow-up of 7.89 ± 2.65 years. The primary outcomes were to assess the sensitivity, specificity, predictive value, and accuracy of the 2010, 2017, and 2024 revisions of the McDonald criteria and to compare the effectiveness of these three sets of criteria in diagnosing MS.

The 2024 revision demonstrated higher sensitivity (90% vs. 86% vs 32% and 87% vs. 79% vs. 37%) and lower specificity (35% vs. 47% vs. 69% and 54% vs. 63% vs 92%) when compared to the 2017 and 2010 revisions, for the development of a relapse and new MRI lesion, respectively. The hazard of relapse and EDSS worsening for participants meeting the 2024 McDonald criteria was 3.464 times (95% CI 1.492-8.046), p = 0.004, and 3.395 times (95% CI 1.043-11.049), p = 0.042, higher compared to participants who did not meet the criteria. After adjusting for age, sex, and EDSS, the hazard of switching to HET for participants meeting the 2024 McDonald criteria was 4.617 times greater than that of participants not meeting the criteria.

The findings indicate that the 2024 criteria have the highest sensitivity while retaining clinical applicability, especially in identifying disease activity through new MRI lesions.