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Performance of the 2024 McDonald Criteria in Patients Under Evaluation for Suspected Multiple Sclerosis
Open accessAbstract
BACKGROUND AND OBJECTIVES: The 2024 McDonald criteria provide new recommendations for multiple sclerosis (MS) diagnosis, but validation of the criteria is lacking. We wanted to investigate the application and performance of the 2024 McDonald criteria in patients with suspected MS seen in routine clinical practice. METHODS: We retrospectively identified patients referred with clinical and/or radiologic suspicion for MS between January and December 2024. All patients had a minimum diagnostic evaluation with brain and spinal cord MRI. The 2017 McDonald criteria were applied prospectively, and the 2024 McDonald criteria were applied retrospectively after the initial diagnostic workup and at last follow-up. We investigated (1) the number of patients diagnosed with MS using the 2017 McDonald criteria or the 2024 McDonald criteria, and (2) the diagnostic performance of the 2024 McDonald criteria when applied during the initial diagnostic workup, with an MS diagnosis using the 2017 McDonald criteria as the reference-standard. RESULTS: < 0.01), respectively. After initial diagnostic workup, the 2024 McDonald criteria demonstrated high sensitivity (92.6%, 95% CI 88.1%-95.8%) and accuracy (83.6%, 95% CI 78.7%-87.8%), for an MS diagnosis using 2017 McDonald criteria at last follow-up, but moderate specificity (57.8%, 95% CI 45.4%-69.4%). The increased rate of MS diagnosis and the diagnostic performance of the revised criteria was similar in children (<18 years) and older adults (>50 years). DISCUSSION: Use of the 2024 McDonald allows for earlier MS diagnosis, but also more frequent diagnosis including in patients with radiologically isolated syndrome. The revised criteria have similar performance across the lifespan. Limitations include the lack of data on central vein sign and kappa free light chains, and missing optic nerve assessment in some patients.
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“Recent studies have provided initial evidence for the diagnostic performance of individual components of the revised criteria, suggesting high sensitivity and accuracy of certain approaches.14”
From Applying the 2024-revised McDonald criteria for multiple sclerosis using conventional diagnostic tools: a single-centre prospective cohort study in Germany (2026) · cites this paper as [14]
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“However, overall evidence remains limited and the relative importance of different diagnostic tools within the revised framework has not yet been systematically evaluated.14”
From Applying the 2024-revised McDonald criteria for multiple sclerosis using conventional diagnostic tools: a single-centre prospective cohort study in Germany (2026) · cites this paper as [14]
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Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria
Thompson, A. J., Banwell, B. L., Barkhof, F., Carroll, W. M., Coetzee, T., Comi, G., Correale, J., Fazekas, F., Filippi, M., Freedman, M. S., et al. (2018) · The Lancet Neurology · doi:10.1016/s1474-4422(17)30470-2 · Cited by 8,167
Self-citationDiagnosis of multiple sclerosis: progress and challenges
Brownlee, W. J., Hardy, T. A., Fazekas, F., & Miller, D. H. (2017) · The Lancet · doi:10.1016/s0140-6736(16)30959-x · Cited by 701
Self-citationVidal-Jordana, A., Rovira, A., Calderon, W., Arrambide, G., Castilló, J., Moncho, D., Rahnama, K., Collorone, S., Toosy, A. T., Ciccarelli, O., et al. (2024) · Neurology · doi:10.1212/wnl.0000000000207805 · Cited by 88
Self-citationSaidha, S., Green, A. J., Leocani, L., Vidal-Jordana, A., Kenney, R. C., Bsteh, G., Outteryck, O., Thompson, A., Montalban, X., Coetzee, T., et al. (2025) · The Lancet Neurology · doi:10.1016/s1474-4422(25)00275-3 · Cited by 66
Self-citationPositive cerebrospinal fluid in the 2024 McDonald criteria for multiple sclerosis
Deisenhammer, F., Hegen, H., Arrambide, G., Banwell, B. L., Coetzee, T., Gnanapavan, S., Montalban, X., Tumani, H., Willrich, M. A., & Freedman, M. S. (2025) · eBioMedicine · doi:10.1016/j.ebiom.2025.105905 · Cited by 46
Prognostic factors for multiple sclerosis symptoms in radiologically isolated syndrome
Fissolo, N., Schaedelin, S., Villar, L. M., Lünemann, J. D., Correale, J., Rejdak, K., Schwab, N., Vilaseca, A., Held, F., García-Merino, A., et al. (2025) · JAMA Neurology · doi:10.1001/jamaneurol.2025.1481 · Cited by 27
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Konen, F. F., Mahmoudi, N., Albers, L. M., Arrambide, G., Streichert, A. L., Haar, M., Soldatov, A., Bucak, E., Jendretzky, K. F., Nay, S., et al. (2026) · eClinicalMedicine · doi:10.1016/j.eclinm.2026.104098
“14 Particularly, the newly introduced MRI biomarkers are today not yet readily available in all centres and their availability will only increase over time.”
Metadata
- Authors
- Brownlee, W. J., Maccarrone, D., Nistri, R., Yam, C., Wilson, H., Wright, S., Mankad, K., Hemingway, C., Thompson, A. J., Hacohen, Y., Toosy, A. T., & Ciccarelli, O.
- Affiliations
- UCL Biomedical Research Centre (GB)
- National Hospital for Neurology and Neurosurgery (GB)
- Great Ormond Street Hospital (GB)
- Dunedin Public Hospital (NZ)
- Corresponding author
- Brownlee, Wallace J.
- ORCID
- Venue
- Neurology
- Published
- 2026-03-24
- Volume
- 106
- Issue
- 6
- Pages
- e214688-e214688
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC12938227
- OpenAlex
- W7128785251
- Cited by
- 17
- References
- 6
- Citations by year
- 2026: 17
- FWCI
- 78.35
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Neurology (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Family Practice › Clinical Reasoning and Diagnostic Skills
- Health Sciences › Medicine › Oncology › Polyomavirus and related diseases
- Keywords
- multiple sclerosis, 2017 McDonald criteria, diagnostic criteria validation, diagnostic performance, radiologically isolated syndrome, central vein sign, kappa free light chains, pediatric multiple sclerosis, early diagnosis
- MeSH terms
- Adolescent, Adult, Aged, Brain, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Retrospective Studies, Sensitivity and Specificity, Spinal Cord, Young Adult
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