An international panel of multiple sclerosis (MS) experts has proposed revising the McDonald criteria guidelines to improve and expedite the diagnosis of this disease.
Co-chaired by Dr. Jeffrey Cohen of the Cleveland Clinic and Dr. Alan Thompson of the University College London, the 30-member panel reviewed newly available research and evolving knowledge to seek an update of the current criteria, in use since 2010.
The study, “Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria,” appeared in The Lancet Neurology. It was supported by the International Advisory Committee on Clinical Trials in MS, and sponsored by the New York-based National MS Society and the European Committee for Treatment and Research in Multiple Sclerosis.
“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,” Bruce Bebo, executive vice president of research at the NMSS, said in a news release. “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.”
Diagnostic criteria for MS combines clinical examination, medical history, brain and sometimes spinal cord imaging, and laboratory data. Scientific and technological advances have improved clinical practice, with earlier, more sensitive and more specific diagnosis. This natural evolution underscores the need to periodically re-examine diagnostic criteria and their usefulness, researchers said.
Diagnosis guidelines are intended to gather evidence that can identify lesions in the central nervous system (CNS) linked to MS development and progression. Due to the complexity of the data, experts believe multiple sclerosis is best diagnosed by a clinician with MS-related expertise, and supported by imaging and other tests.
Following the previous version of McDonald criteria, the proposed updates continue to apply primarily to patients experiencing a typical clinically isolated syndrome, which is based on the detection of CNS lesions in more than one place, and of damage that has occurred more than once.
Clinically isolated syndrome is a first clinical presentation of neurologic symptoms that typically lasts at least 24 hours. It might indicate a MS relapse in someone who has not been diagnosed with MS.
Supported by new research and clinical evidence, the panel proposed analyzing specific oligoclonal bands (or bands of immunoglobulins) in the spinal fluid as a surrogate strategy to detect inflammation in the CNS and lesion dissemination.
In addition, experts believe that both asymptomatic and symptomatic MRI lesions — except for lesions in the optic nerve — can be considered when determining dissemination in space or time, whereas lesions in the cortical and juxtacortical areas of the brain can help discriminate dissemination in space.
Taking these recommendations into consideration may help improve MS diagnosis accuracy, especially in patients with atypical clinically isolated syndrome, or in children, older individuals, non-white people or other groups in which MS is less common.
“None of these changes is anticipated to invalidate the diagnosis of multiple sclerosis according to previous versions of the McDonald criteria, or affect the regulatory-approved indications of disease-modifying therapies for multiple sclerosis” the team emphasized.
More studies are needed, however, to further refine and validate the proposed 2017 McDonald criteria, particularly in regard to optic nerve involvement, validation in diverse populations, and incorporation of advanced imaging, neurophysiological and body fluid markers.
“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,” said Dr. Bruce Cohen, chair of the NMSS National Medical Advisory Committee.