CNN wrongly reports that a new blood test can “help detect concussion”

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

Not Satisfactory

The story blunders when it states, “When compared with a CT scan, the blood test was 97.5% as effective in detecting concussion and 99.6% effective in ruling out concussion.”

In fact, the figures pertain to detecting brain lesions, not concussions.

It also states the most significant purported benefit: “The FDA believes that using the new blood test, imaging can be avoided in at least a third of patients who are suspected of having a concussion.”

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

Presumably the risks associated with this biomarker test are quite small, but this is not stated in the story.

There is no discussion of the potential harms of using a biomarker to rule out the need for a CT scan. For example, might some people who get a negative reading mistakenly think that means they don’t have a concussion? Would false positives lead to unnecessary CT scans or other intervensions?

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

We wish the story had done more to flag uncertainties about the quality of the evidence.

For example, while the FDA asserted that the test would reduce the need for CT scans, it’s unclear whether it will in practice. Reducing scans could be a challenge if other forces that compel their use — including clinicians’ fears about missing a clinically significant injury — aren’t addressed.

Further, the story’s reference to the fact that the biomarker test has been approved by the FDA might give readers the wrong impression that there were rigorous clinical trials. There’s no mention that the new breakthrough devices program under which this product was approved allows the FDA to accept what many consider to be a lower standard of evidence than what’s historically been required.

The story says the FDA evaluated a clinical study of 1,900 blood samples from people thought to have concussion or mild traumatic brain injury. It also refers to “clinical trials,” but no clinical trials are mentioned in the FDA’s news release.

This could be confusing to readers, who might not understand that what appears to be an observational “study” of available blood samples does not match the rigor of a clinical trial. The FDA’s news release does not contain details about how the data was gathered or analyzed, and some researchers have raised concerns about the evidence supporting the blood test.

On the positive side, the story does mention that a separate test has yet to be developed to detect damage from repeated hits.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

There’s no discussion of alternative strategies to decrease the use of CT scans, such as better educating parents and clinicians about their appropriate use.

Does the story establish the true novelty of the approach?

Not Satisfactory

The story states this is the first time the FDA has approved a blood test to “help detect concussion in adults.” Actually, the test does not detect concussions; it detects biomarkers for brain lesions.