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Revised 'McDonald Criteria' expected to speed up the diagnosis of multiple sclerosis

The McDonald Criteria, used for the diagnosis of multiple sclerosis (MS), has been revised by a 30-member international panel of MS experts co-chaired by Jeffrey Cohen, MD (Cleveland Clinic) and Alan Thompson, MD (University College London). The new recommended revisions are expected to speed the diagnostic process and reduce the chance of misdiagnosis.

The panel was convened under the auspices of the International Advisory Committee on Clinical Trials in MS and they published their findings in The Lancet Neurology online on 21 December 2017.

Multiple sclerosis can be difficult to diagnose because there is no single test that can determine that a person has MS. The process of diagnosis involves obtaining evidence from a clinical examination, medical history, lab tests and MRI imaging of the brain and sometimes the spinal cord. These tests are intended to rule out other possible causes of a person's neurological symptoms and to gather data consistent with MS.

The McDonald Criteria was last reviewed in 2010, so the panel looked at prior diagnostic criteria and evidence published since the last review to help inform evidence-based recommendations likely to speed the diagnostic process and reduce the incidence of misdiagnosis.

The panel recommended

  • Brain MRI should be obtained during the MS diagnostic process, unless not possible. Spinal MRI should be obtained when additional data are needed to confirm the diagnosis
  • When spinal fluid is used as part of the diagnostic process, paired serum and CSF (Cerebrospinal fluid) samples are to be analysed to confirm that oligoclonal bands are unique to the CSF
  • At the time of diagnosis, the MS course should be indicated, and whether the course is active or not, and progressive or not; and the type and course of MS should be re-evaluated periodically as the disease evolves

Key things that haven't changed

  • MS is best diagnosed by a clinician with MS-related expertise with support of imaging and other tests
  • Dissemination of lesions in the nervous system in space and time are required, but the revisions provide additional avenues for obtaining supporting evidence of dissemination
  • The need to ensure there is no better explanation for the individual's symptoms remains an essential consideration
  • The McDonald Diagnostic Criteria apply to individuals experiencing a typical clinically isolated syndrome (CIS). CIS is a first episode of neurologic symptoms typical of an MS relapse in a person not known to have MS

Key changes for patients with clinically isolated syndrome (CIS)

  • CSF oligoclonal bands – Positive findings of oligoclonal bands in the spinal fluid can substitute for demonstration of dissemination of lesions in time in some settings
  • Types of lesions – Both asymptomatic and now symptomatic MRI lesions can be considered in determining dissemination in space or time. This does not include MRI lesions in the optic nerve in a person presenting with optic neuritis
  • Site of lesions – Cortical lesions have been added to juxtacortical lesions for use in determining MRI criteria for dissemination of lesions in space

Recent studies suggest misdiagnosis of MS is not uncommon. The paper emphasises that if an individual does not have typical CIS, or is a member of a population in which MS is less common (such as children, older individuals, or non-white populations), additional testing can help gather additional evidence needed to firm up whether the person indeed has MS or something else that may require different treatment and management.

Anyone who was diagnosed using previous versions of the McDonald Criteria will still meet the criteria for MS as laid out in the 2017 McDonald Criteria.

The panel recommended that the 2017 McDonald Criteria be validated in a variety of studies and populations, and that research continue on biomarkers, imaging and other advances that may help refine the diagnostic process in the future.

Bruce Bebo, PhD, Executive Vice President of Research at the National MS Society, said: “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.”

Source: MS-UK

Date: 02/01/18

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