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‘New’ and effective tool for predicting concussion outcomes? University oversells MRI study

New MRI method aids long-term concussion prognosis

Our Review Summary

This news release from the University of California – San Francisco (UCSF) describes how functional MRI (fMRI) could be a predictive tool for physicians in determining a patient’s prognosis after a concussion. Researchers scanned the brains of 75 patients aged 18 to 55 to assess the connectivity of certain neural networks, particularly those active in the resting brain. They found that patients with reduced connectivity in “resting state networks” were more likely to do worse on cognitive and behavorial tests. They argued that this could also predict post-concussive symptoms in patients who showed no evidence of bruising or bleeding in the brain right after a mild traumatic brain injury (mTBI).

Although the news release does a good job explaining the nuts and bolts of the study, we felt the wording was ambiguous or misleading at times. For example, fMRI is not exactly a new technology, as it was first introduced to the world in 1991, and it’s not clear from the release why the research is novel.

Other important details that were missing were discussions on the study limitations and the scope of the benefits. In this case, how effective was fMRI in predicting changes in brain activity and long-term symptoms after a concussion? Some numbers would have been welcome here.

We acknowledge that the original journal article also used comparative wording without referring to any quantitative data. However, we feel the news release could have clarified some points by directly asking the researchers for more information.

 

Why This Matters

Health care costs are increasing at an annual rate of 7 percent a year, and one of the main causes is the overuse of medical technology. According to The Hastings Center, new or increased use of medical technology contributes 40 to 50 percent to annual cost increases.

One way to control spiraling costs is to stop the overuse of medical technology. In other words, medical imaging studies should be pursued only when it is appropriate. News releases shouldn’t tout every “new” technology as the next medical miracle and should instead develop a more cautionary tone to discourage patients from undergoing unnecessary scans for questionable results. However, if a new technology has the potential to dramatically improve health outcomes, then it should, of course, be reported to the public.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Medical imaging studies are known to be expensive, and MRIs are no exception. Functional magnetic resonance imaging (fMRI) is a relatively new procedure that uses MRI techniques to measure metabolic changes in an active part of the brain. MRIs focus on a body part’s anatomical structure, while fMRIs mainly concentrate on its metabolic processes.

Consumer websites estimate an MRI to cost between $400 and $3,500, depending on the type of procedure, body part and center location. According to the Healthcare Bluebook, a brain MRI (with or without contrast) should cost around $1,212.

Since the news release doesn’t discuss these costs, we give it a Not Satisfactory rating here.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release talks about the benefits of getting a fMRI early on — in this case, within the first two weeks of the mTBI. It states fMRI highlights abnormal patterns of brain activity, which helps physicians predict which patients are at a higher risk for post-concussive symptoms after six months.

But there’s no mention of any quantitative data to help readers understand the scope of the benefit. How accurate was the fMRI in distinguishing patients who might later experience symptoms? Did all mTBI patients exhibit reduced connectivity in the “default mode network?” And how much worse did mTBI patients perform on cognitive and behavioral tests?

Since only comparative words are used without any quantitative data, we give the news release a Not Satisfactory rating here.

The original journal article also doesn’t give numbers so it falls on the shoulders of the writer to seek clarity from the researchers when benefits are being claimed.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

MRIs are generally deemed to be a safe procedure, since no ionizing radiation is used. Adverse events for MRI scans are rare, but like any medical procedure, they do carry some risk, especially for patients with implants and external and accessory devices — like artificial joints, insulin pumps and ventilators. For these patients, risks include device malfunction or heating of the implanted medical device and the surrounding tissue, which could lead to burns.

According to the FDA, the use of gadolinium-based contrast agents (GBCAs) also carries some risk, including side effects such as allergic reactions. For patients with kidney disease, GBCAs could cause a rare and potentially fatal condition known as nephrogenic systemic fibrosis.

Since harms are not mentioned, we give the news release a Not Satisfactory rating.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

In general, the news release does a good job describing the overall study design: 75 patients aged 18 to 55 who had previously experienced mTBIs had their brains scanned with fMRI to track activity in certain brain networks. Six months later, these patients underwent behavioral and cognitive tests.

But the news release doesn’t mention a few important points. First, this study was controlled with 47 healthy subjects aged 20 to 38 without any previous diagnosis of TBI or neurological/psychiatric disorders. Although the neuroradiologist reviewing each imaging scan was blinded to the data, this was not a randomized study (impossible to do so in this case) – something that could still introduce bias.

A possible confounding factor is the discrepancy in age between the patient group and control group. Since some cognitive abilities – like memory and processing speed – decrease naturally with age, how can researchers attribute a decrease in cognition to mTBI alone?

Since the news release doesn’t go into detail and evaluate the evidence, we give it a Not Satisfactory rating here.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in this news release.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The funding sources for this research project included the National Institutes of Health and the Department of Defense. In the original journal article, all authors stated they were free of competing financial interests.

Since the news release disclosed the funding sources, we give it a Satisfactory rating here.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The news release mentions that rest and counseling are helpful treatments for patients who suffered a concussion. However, effective primary drug treatments for mild traumatic brain injury don’t yet exist, the release adds.

Depending on the severity of the case, there are medications to limit secondary damage to the brain immediately following injury. These include diuretics to decrease pressure in the brain, anti-seizure drugs and coma-inducing drugs.

We feel the news release does an adequate job comparing alternatives, which is why we give it a Satisfactory rating.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Compared to other imaging technologies like MRI and CT, fMRI is not as widespread, but it’s becoming increasingly common as a diagnostic method to assess brain function. Most academic centers are equipped with fMRI machines, especially hospitals conducting neuroscience research.

Since the news release doesn’t discuss availability, we give it a Not Satisfactory rating here.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The news release touts fMRI as a “new MRI method” in the headline and talks about a “new non-invasive magnetic resonance imaging (MRI) method” in the first sentence.

But fMRI is not exactly a new technology, as it’s been around since 1991. And fMRI has already been used and studied as a possible detection tool to evaluate brain abnormalities in patients, who had previously suffered concussions. Other research has also looked into brain function, including resting state functional connectivity (like in the UCSF study), through fMRI in order to detect residual brain differences in the weeks to months after concussion.

From the news release, it’s difficult to understand how exactly this research is novel. Researchers wrote in the original journal article that their study was the first to “relate alterations in early resting-state functional connectivity to long-term postconcussive symptoms and cognitive outcome in a large and clinically well-defined mTBI sample.”

For these reasons, we give it a Not Satisfactory rating.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release does not include unjustifiable, sensational language.

Total Score: 4 of 10 Satisfactory

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