To hasten diagnosis and reduce the chances of a misdiagnosis, a 30-member international panel of experts in multiple sclerosis (MS) have revised the McDonald Criteria for the Diagnosis of Multiple Sclerosis. Their revisions and recommendations were published online in The Lancet Neurology.

“Treating MS early and effectively is our best current way to limit permanent damage to the nervous system, so speeding the diagnosis of MS with improved accuracy is an important goal,” commented Bruce Cohen, MD, professor, Davee Department of Neurology and Clinical Neurosciences, Northwestern University, and chair of the National MS Society’s National Medical Advisory Committee.

Dr. Cohen and panel members reviewed recent MS diagnostic criteria and evidence that has been published since the previous McDonald Criteria were released in 2010. The results were the basis of their paper “Diagnosis of multiple sclerosis: 2017 revisions of the McDonald Criteria.”

Key changes to the criteria in patients with typical clinically isolated syndrome (CIS) include the following:

• In some settings, positive findings of CSF oligoclonal bands may be substituted for findings of lesion dissemination in time.
• The presence of both asymptomatic and now symptomatic MRI lesions may be considered when determining dissemination in space or time. In patients presenting with optic neuritis, however, this does not include MRI lesions in the optic nerve.
• In determining MRI criteria for lesion dissemination in space, cortical lesions may now be used in addition to juxtacortical lesions.

The following are some of the key points in the criteria that have not changed:

• MS is best diagnosed by a clinician with expertise in MS, using supporting imaging and other tests.
• Although lesion dissemination in the nervous system in space and time are required, the revisions include additional ways to obtain supporting evidence of such dissemination.
• In all patients, the need to make sure that there is no better explanation for their symptoms is essential.
• The McDonald Diagnostic Criteria apply to those patients experiencing a typical clinically isolated syndrome (CIS).

Further recommendations from the panel include the following:

• During the MS diagnostic process, a brain MRI should be obtained. In cases where additional data are needed to confirm the diagnosis, spinal MRI should also be obtained.
• In patients in whom spinal fluid is used as part of the diagnostic process, paired serum and CSF samples should be analyzed to confirm the presence of oligoclonal bands that are unique to the CSF.
• At the time of MS diagnosis, the MS course should be indicated to be either active or not, and progressive or not. The type and course of MS should also be periodically re-evaluated as the disease evolves.

Another important inclusion in the new criteria centres on the misdiagnosis of MS, which happens frequently. In patients who do not have typical CIS or who are members of populations in which MS is less common, including children, older individuals, or non-white persons, additional testing may be helpful in gathering the additional evidence needed to definitively diagnose MS.

Patients who have been diagnosed with MS using previous versions of the McDonald Criteria will also meet the criteria for MS as laid out in the 2017 McDonald Criteria.

Finally, the panel recommended that the 2017 McDonald Criteria be validated in a number of studies and populations, and called for continued research on biomarkers, imaging, and other advances that may help refine the diagnostic process.

“Efforts like the work of this international panel illustrate the National MS Society’s role as a convening force to push forward progress that not only improves clinical care, but also identifies research gaps and opportunities,” noted Bruce Bebo, PhD, executive vice president of research at the National MS Society. “The paper highlights the need for research to identify additional biological markers of MS and its subtypes. This gap impedes progress on several fronts, making it a critical target for the global MS research community,” he concluded.

The panel was co-chaired by Jeffrey Cohen, MD (Cleveland Clinic) and Alan Thompson, MD (University College London), and convened by the International Advisory Committee on Clinical Trials in MS, and sponsored by the National MS Society and the European Committee for Treatment and Research in Multiple Sclerosis.

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