This is the current release of the guideline.

The guideline was reaffirmed by the developer on October 23, 2005 and most recently on November 15, 2008.

Multiple sclerosis

Magnetic resonance imaging (MRI)

Specificity, sensitivity, positive predictive value, and diagnostic accuracy of magnetic resonance imaging (MRI) in multiple sclerosis (MS)

A search was undertaken using the following terms: clinically isolated syndromes, multiple sclerosis, and magnetic resonance imaging. Guideline developers used the Medline database from 1966 to 2003. In addition, the reference lists of the articles identified were also reviewed to identify articles not found by the computer search. They reviewed the abstracts of these articles and further limited their assessment to English language studies that were prospective and utilized a well-defined gold standard for the development of clinically definite multiple sclerosis (CDMS).

Inclusion/Exclusion

The guideline developers only reviewed articles that studied at least 20 patients. There were 22 such studies identified. All of these articles considered the risk of developing clinically definite multiple sclerosis in patients with clinically isolated syndrome (CIS), based on the presence or absence of magnetic resonance imaging (MRI) lesions within the brain or spinal cord.

Currency Process

The reaffirmation dates of this guideline are November 15, 2008 and October 23, 2005. The principal author conducted a literature search using the same criterion as presented in the original guideline. The committee felt that since the guideline recommendations would not change given the new literature available, the committee voted to reaffirm the guideline, stating that the conclusions and recommendations are still valid.

46 articles were originally identified

22 studies met inclusion criteria

Rating of Diagnostic Article

Class I: Evidence provided by a prospective study in a broad spectrum of persons with the suspected condition, using a "gold standard" for case definition, where test is applied in a blinded evaluation, and enabling the assessment of appropriate tests of diagnostic accuracy. In addition, there must be adequate accounting for dropouts with numbers sufficiently low to have minimal potential for bias.

Class II: Evidence provided by a prospective study of a narrow spectrum of persons with the suspected condition, or a well-designed retrospective study of a broad spectrum of persons with an established condition (by "gold standard") compared to a broad spectrum of controls, where test is applied in a blinded evaluation, and enabling the assessment of appropriate tests of diagnostic accuracy.

Class III: Evidence provided by a retrospective study where either persons with the established condition or controls are of a narrow spectrum, and where test is applied in a blinded evaluation.

Class IV: Any design where test is not applied in blinded evaluation OR evidence provided by expert opinion alone or in descriptive case series (without controls).

Not stated

Translation of Evidence to Recommendations

Level A rating requires at least one convincing Class I study or at least two consistent, convincing Class II studies.

Level B rating requires at least one convincing Class II study or at least three consistent Class III studies.

Level C rating requires at least two convincing and consistent Class III studies.

Rating of Recommendation

A = established as useful/predictive or not useful/predictive for the given condition in the specified population.

B = probably useful/predictive or not useful/predictive for the given condition in the specified population.

C = possibly useful/predictive or not useful/predictive for the given condition in the specified population.

U = data inadequate or conflicting. Given current knowledge, test/predictor is unproven.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Draft guidelines were reviewed for accuracy, quality, and thoroughness by the American Academy of Neurology (AAN) members, topic experts, and pertinent physician organizations.

Final guidelines were approved by the American Academy of Neurology Therapeutics and Technology Assessment Subcommittee on April 16, 2002, the American Academy of Neurology Practice Committee on April 2, 2003, and the American Academy of Neurology Board of Directors on June 22, 2003. They were published in Neurology 2003:61:602-611.

Definitions of the strength of the recommendations (A, B, C, U) and classification of the evidence (Class I through Class IV) are provided at the end of the "Major Recommendations" field.

Recommendations

1. Magnetic resonance imaging (MRI) changes seen in multiple sclerosis (MS) are known to be nonspecific (refer to Table 2, entitled "Diagnostic Consideration in Patients with Suspected MS and/or MRI White Matter Abnormalities" in the original guideline document). Therefore, the information derived from imaging investigations must always be considered in the context of the specific clinical situation presented by an individual patient. As a result, the following recommendations are predicated on the exclusion, at baseline, of appropriate alternative conditions that can mimic MS or can mimic the radiographic findings seen in MS.
2. On the basis of consistent Class I, II, and III evidence, in patients with clinically isolated syndrome (CIS), the finding of three or more white matter lesions on a T2-weighted MRI scan is a very sensitive predictor (>80%) of the subsequent development of clinically definite MS (CDMS) within the next 7 to 10 years (Type A recommendation). It is possible that the presence of even a smaller number of white matter lesions (e.g., one to three) may be equally predictive of future MS although this relationship requires better clarification.
3. The presence of two or more gadolinium (Gd)-enhancing lesions at baseline is highly predictive of the future development of clinically definite MS (Type B recommendation).
4. The appearance of new T2 lesions or new gadolinium enhancement 3 or more months after a clinically isolated demyelinating episode (and after a baseline MRI assessment) is highly predictive of the subsequent development of clinically definite MS in the near term (Type A recommendation).
5. The probability of making a diagnosis other than MS in patients with clinically isolated syndrome with any of the above MRI abnormalities is quite low, once alternative diagnoses that can mimic MS or can mimic the radiographic findings of MS have been excluded (Type A recommendation).
6. The MRI features helpful in the diagnosis of primary progressive MS (PPMS) cannot be determined from the existing evidence (Type U recommendation).

Definitions:

Rating of Recommendation

A = Established as useful/predictive or not useful/predictive for the given condition in the specified population.

B = Probably useful/predictive or not useful/predictive for the given condition in the specified population.

C = Possibly useful/predictive or not useful/predictive for the given condition in the specified population.

U = Data inadequate or conflicting. Given current knowledge, test/predictor is unproven

Rating of Diagnostic Article

Class I: Evidence provided by a prospective study in a broad spectrum of persons with the suspected condition, using a "gold standard" for case definition, where test is applied in a blinded evaluation, and enabling the assessment of appropriate tests of diagnostic accuracy. In addition, there must be adequate accounting for dropouts with numbers sufficiently low to have minimal potential for bias.

Class II: Evidence provided by a prospective study of a narrow spectrum of persons with the suspected condition, or a well-designed retrospective study of a broad spectrum of persons with an established condition (by "gold standard") compared to a broad spectrum of controls, where test is applied in a blinded evaluation, and enabling the assessment of appropriate tests of diagnostic accuracy.

Class III: Evidence provided by a retrospective study where either persons with the established condition or controls are of a narrow spectrum, and where test is applied in a blinded evaluation.

Class IV: Any design where test is not applied in blinded evaluation OR evidence provided by expert opinion alone or in descriptive case series (without controls).

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Not stated

An implementation strategy was not provided.

Not applicable: The guideline was not adapted from another source.

American Academy of Neurology (AAN)

Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology
Practice Committee of the Child Neurology Society

Members of the Therapeutics and Technology Assessment Subcommittee: Douglas S. Goodin, MD (chair); Carmel Armon, MD; Elliot M. Frohman, MD, PhD; Robert S. Goldman, MD; David Hammond, MD; Chung Y. Hsu, MD, PhD; Andres M. Kanner, MD; David S. Lefkowitz, MD; Isaac E. Silverman, MD; Michael A. Sloan, MD; Yuen T. So, MD, PhD; Edgar J. Kenton III, MD; Wendy Edlund, AAN Staff Liaison

Not stated

This is the current release of the guideline.

The guideline was reaffirmed by the developer on October 23, 2005 and most recently on November 15, 2008.

Electronic copies: A list of American Academy of Neurology (AAN) guidelines, along with a link to a Portable Document Format (PDF) file for this guideline, is available at the AAN Web site .

Print copies: Available from the AAN Member Services Center, (800) 879-1960, or from AAN, 201 Chicago Avenue South, Minneapolis, MN 55415.

The following is available:

• American Academy of Neurology (AAN) guideline summary for clinicians: the utility of MRI in suspected MS. St. Paul (MN): American Academy of Neurology, 2003 Sep. Electronic copies: Available from the AAN Web site . See the related QualityTool summary on the Health Care Innovations Exchange Web site .
• AAN guideline development process [online]. St. Paul (MN): American Academy of Neurology. Electronic copies: Available from the American Academy of Neurology Web site .

The following is available:

• AAN guideline summary for patients and their families: diagnosis of MS using magnetic resonance imaging (MRI). St. Paul (MN): American Academy of Neurology, 2003 Sep. Electronic copies: Available from the American Academy of Neurology (AAN) Web site . See the related QualityTool summary on the Health Care Innovations Exchange Web site .

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

This summary was completed by ECRI on February 12, 2004. This summary was updated by ECRI Institute on May 17, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Gadolinium-based contrast agents. This summary was updated by ECRI Institute on June 20, 2007 following the U.S. Food and Drug Administration (FDA) advisory on gadolinium-based contrast agents. The information was reaffirmed by the guideline developer August 2, 2008. This summary was updated by ECRI Institute on March 17, 2010. This summary was updated by ECRI Institute on January 13, 2011 following the U.S. Food and Drug Administration (FDA) advisory on gadolinium-based contrast agents.

This NGC summary is based on the original guideline, which is copyrighted by the American Academy of Neurology.