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15 May 1994 | Volume 120 Issue 10 | Pages 856-871
Purpose: To assess the clinical efficacy of magnetic resonance imaging (MRI) for neuroimaging and to provide guidelines for clinical practice.
Study Selection: After a comprehensive literature search, studies of the diagnostic accuracy of MRI alone or compared with other tests and of any impact on therapeutic choices or patient outcomes were reviewed by independent readers, followed by discussion to reach consensus conclusions.
Data Extraction: Of 3125 citations retrieved, 156 studies with original data could be rated according to methodologic criteria for study design. One article contributed grade A quality information about diagnostic accuracy, 28 were graded B or C, and 113 were graded D. One randomized trial and 2 comparison studies contributed grade B or C information about the impact on therapeutic choices. Only 2 studies surveyed health status before and after magnetic resonance scanning.
Results: For most abnormalities, the sensitivity of MRI is equal to or better than competing technologies. Magnetic resonance imaging shows greater contrast and detail than computed tomography (CT) but also shows more clinically silent abnormalities or incidental findings. A few studies found a modest impact on therapeutic choices but no impact on quality of life or disability. Costs for MRI are high. Computed tomography is sufficient for initial diagnosis of most mass lesions or intracranial hemorrhages requiring immediate intervention. Magnetic resonance imaging is more accurate in the temporal lobes, posterior fossa, brainstem, and spinal cord. For lumbar radiculopathy, MRI and plain spinal CT are as accurate as postmyelographic CT and are less invasive. The role of magnetic resonance angiography for carotid artery stenosis is being studied.
Conclusions: Although suggestions for appropriate use of MRI in clinical practice can be made, the supporting evidence in published studies is weak. Firm guidelines for appropriate use of MRI should be based on further clinical research using more rigorous methods.
1. Magnetic resonance imaging (MRI) has revolutionized neuroimaging. Many internists now are familiar with the technology. However, strong support for a greatly expanded role of MRI for diagnosis and management of neurologic diseases is lacking because the evidence for clinical efficacy in the published literature is incomplete [1-3]. Because many more studies have appeared in the past 6 years, the American College of Physicians decided to update its 1987 report on the clinical efficacy of MRI in neuroimaging [4]. This review provides the basis for the updated assessment and accompanying suggestions for use of MRI in various clinical situations. REVIEW
The Clinical Efficacy of Magnetic Resonance Imaging in Neuroimaging
[Note that sections in this review are numbered so that they can be identified with cross-references as supporting evidence in the article "Magnetic Resonance Imaging of the Brain and Spine: A Revised Statement," published in the Position Paper section of this issue; see pages 872-875.—The Editor]
2. Methods
2.1 Titles and abstracts of 3125 citations from the peer-reviewed medical literature from 1987 through November 1993 were found using MEDLINE and ancillary searches. After screening out reviews, technical reports, case reports, and other publications describing fewer than 30 original case-patients, we identified 285 papers for further review. Two investigators independently read and classified each article according to the disease studied, the applicable level of clinical efficacy, and the methodologic quality of the study design. This three-part classification is summarized in Table 1 and has been described in detail previously [3]. Discrepant ratings were resolved by consensus.
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2.2 Because the imaging capabilities of MRI have been widely discussed in case series, we focused on the 156 articles that addressed diagnostic accuracy or diagnostic impact, therapeutic impact, or patient outcomes. For diagnostic accuracy and effect, methodologic quality was rated as A if the study had more than 35 patients with and more than 35 without the pathologic abnormality in question, drawn from a clinically relevant sample whose clinical symptoms were completely described, whose diagnoses were defined by an appropriate reference standard, and whose magnetic resonance images were technically of high quality and were evaluated independently of the reference diagnosis. Studies were rated D if they had no credible reference standard for diagnosis, or if the test result and determination of final diagnosis were not independent, or if the sample size was smaller than 35 for patients with and without the disease, or if the source of the patient cohort could not be determined or was obviously influenced by the test results (work-up bias).
2.3 Studies of therapeutic impact or changes in patient outcomes were evaluated for methodologic quality according to a similar A through D scale, adapted from Sackett [5]. For example, an A-rated study required a randomized controlled trial using a clinically relevant, well-described sample, with adequate power to detect differences in well-characterized outcomes. The rationale and details for these ratings have been described [3, 6].
2.4 Among 143 articles reporting on diagnostic accuracy or impact, 1 was rated A, 14 were rated B, 14 were rated C, and 113 were rated D for methodologic quality. Deficiencies included small numbers of patients, failure to describe the source of patients and their spectrum of disease, failure to maintain independence between interpretation of the MRI scan and an appropriate reference standard, or obsolescence of the magnetic resonance technology. Estimates of sensitivity and specificity were derived from the A, B, and C studies. Results from receiver-operating characteristic (ROC) curves are discussed in the text when available. Among 21 articles reporting on the therapeutic impact of MRI, none were rated A, 1 randomized trial was rated B, and 2 comparisons with computed tomography (CT) were rated C (Table 2). Five studies comparing treatment plans before and after MRI, but without comparison to an alternative test, were rated D for methodologic quality. Retrospective surveys of anecdotal experiences were not rated. No studies provided data on long-term patient outcomes.
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2.5 Suggestions for practice are given in the companion report from the American College of Physicians [4]. A strong "strength-of-evidence" rating would have been given to a suggestion supported by randomized controlled studies of patient outcomes and by conclusive evidence about diagnostic accuracy. The one suggestion given a moderate rating was supported by studies that used comparison groups to show improved therapeutic choices and a definite impact on diagnoses. Most of the suggestions given weak ratings were supported by fair or good studies of diagnostic accuracy but had no supporting studies of therapeutic impact or patient outcomes. The suggestion given an equivocal rating was based only on prevalent expert opinion and several reports describing a predominance of clinical practice patterns.
3. Safety, Technical Issues, and Costs
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3.2 Paramagnetic contrast agents improve confidence in diagnosis in 45% to 75% of scans and actually change the apparent diagnosis in up to 30% of patients [12, 16-22]. None of these studies could report diagnostic accuracy statistics because the comparisons were done without any independent reference standards. The larger multicenter evaluations of contrast agents probably contain case-selection biases that skew statistical analysis [21]. Paramagnetic contrast agents cross the placenta and typically are contraindicated during pregnancy [9], but all are otherwise safe [23, 24]. Minor adverse reactions to the agents occur in 2% to 3% of patients, and anaphylaxis occurs in about 1 in 100 000 patients [25].
3.3 Diagnostic specificity for MRI has been studied only infrequently [3]. Although "specificity" has been used to mean that an imaging test can determine "specific" tissue composition, specificity as used in this paper is one minus the false-positive rate [26, 27]. Classically, a false-positive result is a positive test result when no disease is present. However, MRI often shows incidental anatomic abnormalities that are real and technically are not false-positive images (examples in Table 3. If any incidental abnormality of the cerebral white matter is called a false-positive result, the apparent diagnostic specificity can be low (0.28 to 0.58 [28-31]). The specificity is much higher if a more stringent test interpretation, such as one requiring multiple abnormalities to indicate disease, is used (0.80 to 0.90 [28]). The reliability of readings about white matter abnormalities is low [32]. No studies have reported investigations into the incidence of therapeutic misadventures caused by overinterpretation of white matter findings or by other asymptomatic abnormalities.
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3.4 Costs of MRI historically have been high compared with competing technologies. Facility and professional charges for MRI are 30% to 100% higher than for CT (Table 4). Some payers reimburse MRI only at a rate equivalent to CT (for example, Medi-Cal). If MRI obviates further tests but CT does not, using MRI as the initial test may be less expensive than using CT. Similarly, if MRI replaces an invasive test associated with inpatient facility charges (such as a myelogram, cisternogram, or cerebral arteriogram), then the MRI cost is less than the total cost of the alternative. New fast-imaging sequences, contrast agents, and studies focused only on high-yield views for particular diagnoses can shorten examination times and improve efficiency at imaging centers.
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4. Stroke and Transient Ischemic Attacks
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4.2 No studies rated as using grade C or better methods have compared MRI with either noncontrast or contrast-enhanced CT. Further, the impact of MRI on final diagnosis or therapeutic choices for patients with stroke has been reported only once [40]. In that study, MRI reportedly led to a change in diagnosis of the cause of stroke for 16% of patients and to changes in anticoagulation management for 19%. Treatment changes were not tabulated or evaluated for appropriateness; biasing of case selection through the influence of referral or nonreferral for imaging by treating clinicians also was not considered. No studies have investigated changes in patient outcomes attributable to the use of MRI after stroke.
5. Carotid Artery Disease and Magnetic Resonance Angiography
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5.2 Diagnostic Accuracy
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5.3 Diagnostic Impact
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5.4 Therapeutic Impact
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6. Intracranial Hemorrhage and Aneurysms
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6.2 Magnetic resonance angiography and MRI may improve detection of small intracranial aneurysms [64-66], but spatial resolution is not adequate for planning of aneurysm surgery [67]. Leading centers have reported initial success doing stereotactic radiosurgery guided by MRI for vascular malformations [68, 69], but the therapeutic impact or patient outcomes for hemorrhage or aneurysm have not been studied rigorously.
7. Dementia
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7.2 No studies of the accuracy of MRI alone compared with CT for detection of treatable lesions in demented patients have been published. Older studies of CT as a diagnostic adjunct for dementia work-ups have shown little impact [79-82]. Fewer than 5% of patients with dementia have reversible causes and more than half are diagnosed by serum chemistry results rather than by imaging [81]. In a prospective study of 210 demented patients, 12% had a potentially treatable lesion discovered by CT or MRI. Only 4 had treatment, and none improved as a result [83].
8. Brain Injury and Head Trauma
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9. Brain Neoplasms
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9.2 Diagnostic Accuracy and Impact
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9.3 Magnetic resonance imaging is more sensitive than high-resolution contrast CT for detection of sellar or juxtasellar lesions [2, 112, 113]. Lesion margins are better defined by MRI [113, 114]. With either test, false-positive results may occur because of clinically silent pituitary abnormalities.
9.4 Therapeutic Impact and Patient Outcomes
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10. Epilepsy
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10.2 In the only study [128] reporting apparent false-positive findings on MRI, the investigators attributed the errors to incomplete tissue sampling at surgery rather than to misinterpretations of the MRI scans. Some asymmetry in temporal lobe structures is normal [129] and may be a source of misleading images. Recent studies rated as using grade B and C methods indicate that abnormalities or atrophy of the hippocampus seen on MRI correlates with abnormal pathologic findings [128] and predict the location of the seizure focus [130-133].
11. Infectious Diseases
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11.2 Human Immunodeficiency Virus and the Acquired Immunodeficiency Syndrome
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11.3 Although MRI is considered the most sensitive imaging modality for detection of infections and neoplastic complications of advanced HIV and the acquired immunodeficiency syndrome, no studies rated as using grade C or better methods have been published. Studies claiming high sensitivity for MRI [141] or changes in treatment plans [142] did not describe case-recruitment protocols that would ensure an unbiased selection of study patients. Recent expert opinion indicates that paramagnetic contrast agents should be reserved for unusual lesions because few diagnoses and fewer treatment plans would be altered by the routine use of these agents [143, 144]. No study has reported improved patient outcomes.
12. Multiple Sclerosis and Related Syndromes
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12.2 Diagnostic Accuracy and Impact
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12.3 Therapeutic Impact and Patient Outcomes
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13. Spinal Diseases
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13.2 In spinal trauma and cervical myelopathy, studies show high concordance between abnormal neurologic status and abnormal MRI findings in the cord [180-187]. The incremental gain from using MRI for prognosis is unknown, and clinicopathologic correlations are not available. Most authors [181] suggest that CT is required for patients with suspected bony injury and that MRI can replace myelography.
13.3 Within the intervertebral disk, loss of magnetic resonance signal intensity indicates physiologic degeneration of the disk. The prevalence of signal loss increases with age in asymptomatic patients and is highest in the L4-5 and L5-S1 disks [188, 189]. The relation between loss of disk signal and back pain syndromes is not clear. In patients with lumbar herniated disks, shrinkage of the herniated fragment seen on MRI correlates with symptomatic recovery in patients who do not have surgery [190].
13.4 In the postoperative spine, MRI differentiates scar tissue from recurrent disk herniations better than does plain or postmyelogram CT [191, 192]. Paramagnetic contrast agents enhance scar tissue and may improve definition of scar from disk [193].
13.5 Diagnostic Accuracy
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13.6 Studies [202, 203] of MRI in asymptomatic persons suggest that between 10% and 30% have herniated or bulging disks (Table 7). Similarly, from 5% to 30% of several series of asymptomatic patients had spinal stenosis by imaging, which could be considered false-positive results, depending on how abnormalities were defined [198]. Incidental asymptomatic anatomic findings of disk herniation or bulge are equally as common (10% to 30%) in the thoracic and cervical spine as in the lumbar spine [204, 205]. Asymptomatic herniations appear in 20% of middle-aged persons and in more than 50% of persons older than 64 years [206].
13.7 Diagnostic Impact
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14. Miscellaneous Diagnoses
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14.2 In the brainstem and posterior fossa, MRI shows more lesions of all types than does CT [2, 215]. In a well-designed and informative study [216], Scottish investigators randomized the choice of first test for a large series of patients with suspected posterior fossa problems, then allowed clinicians to proceed as they wished with the remainder of patient care decisions. When MRI was the first test, 6% of patients also had CT, whereas 19% of patients had MRI when CT was the first test (Table 2). Magnetic resonance imaging changed 23% of diagnoses made by CT, whereas CT changed 18% of MRI diagnoses; however, this result was not statistically significant. The major reason given for getting the other test after CT or MRI alone was a desire to further clarify the diagnosis. One other study [217] reported that MRI changed the final diagnosis in 16% of patients.
14.3 Therapeutic Impact and Patient Outcomes
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15. Other Diseases and Syndromes
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15.2 In common clinical syndromes where the prevalence of structural disease is already low, the diagnostic yield of MRI also is low. In several studies of headache, no clinically significant mass lesions were found [224-226]. Among patients with dizziness, abnormal MRI findings were as prevalent in controls as in the dizzy patients and no treatable causes could be identified [227, 228].
15.3 Magnetic resonance imaging may define structural correlates of parkinsonian syndromes and other degenerative diseases of brainstem or cerebellar nuclei [229, 230]. Other morphologic abnormalities of the brain seen on MRI may correlate with mental illness, such as depression [231, 232], tardive dyskinesia [233], or primary schizophrenia [234]. However, clinical usefulness has not been shown.
16. Discussion
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16.2 Formal assessment of the clinical efficacy for MRI has lagged behind its diffusion into clinical use for neurologic problems. Despite the installation of more than 2000 magnetic resonance scanners and the appearance of more than 5000 citations about neuroimaging with MRI, fewer than 30 studies are prospective controlled comparisons of diagnostic accuracy or changes in therapeutic choices, and no study documents a change in patient outcomes. Although the number of better-quality studies has increased from 6 in 1986 [2] to 29, this is fewer than 0.5% of the total of published reports about MRI. Editors of journals and reviewers of study proposals need to encourage more accurate and realistic appraisals of this valuable technology.
16.3 The way to improve diagnostic accuracy studies is already clear because the basic principles for completion of such studies have been known for more than a decade [235]. Because surgical confirmation of imaging findings often is impossible, determination of the final diagnosis may require several months of clinical follow-up and review of the total case by a "gold standards committee" [156, 196]. For assessment of diagnostic and therapeutic impact, the most successful protocol is the "randomized choice of first test" [216]. This study design is one of the few that can be followed through to an assessment of long-term patient outcomes.
16.4 The lack of high-quality clinical research and the widespread use of MRI pose a dilemma for evidence-based clinical technology assessment. The best compromise—between uncritical acceptance of usual clinical practices and silence about the appropriate guidelines for lack of evidence—is to present a set of suggested approaches, along with information about the quality of research used to support the suggestions. The Position Paper in this issue [4] gives such suggestions.
16.5 The trade-off between a higher sensitivity and a lower specificity (higher false-positive rate) for MRI has not been explored fully. A basic principle of signal detection theory and diagnostic testing is that more sensitive tests also have higher potential false-positive rates [236], and MRI is no exception. Because MRI is more likely than CT to show incidental findings or inconsequential pathologic results, MRI has a higher potential for false-positive interpretations than does CT. Determining the ultimate effect of such potential errors requires analysis of the consequences of false-positive and false-negative imaging results.
16.6 When MRI is equivalent to other diagnostic technologies, higher costs are a barrier to recommendations for MRI as the leading diagnostic test for neuroimaging. Costs can be decreased by finding more time-efficient imaging protocols, by decreasing the capital costs of scanners, and by restricting scanning to those patients most likely to benefit. Time efficiency may be achieved by development of faster imaging techniques and better receiver coils or by selective imaging focused only on the most important diagnostic possibilities. Either way, shorter imaging times would greatly improve the operating efficiency of MRI centers, which in turn should lower per-patient costs.
Author and Article Information
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