Another ‘simple blood test’ for concussion PR release over-promises

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

Not Satisfactory

We were glad to see a very brief mention in the release that if the biomarker research is confirmed in larger studies, it might someday replace what the release calls “expensive” CT scans used in emergency rooms to try to diagnose concussion. But there is a tacit assumption that the biomarker would replace the use of CT scans. Experience would suggest, however, that new tests tend not to replace existing methods but are simply added to them. We also want to point out that if this new biomarker test became a commonplace screening tool, it could result in over-screening. Tools for screening have to be evaluated very carefully to have the greatest benefit for the right patients.

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

Not Satisfactory

The release did not mention any potential harms of this screening tool. Just to mention one hypothetical case, it is possible that caregivers relying on the blood levels alone may err and fail to test in other ways for brain injury. In general, medical tests have two potential harms. The first is that the test does not demonstrate the presence of injury when in fact there is one. This would lead to under-diagnosis. The second is the test demonstrates the presence of injury when it does not exist. That would lead to over-diagnosis. While obvious, the report should have included some caveats to its otherwise glowing comments.

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

Not Satisfactory

The release makes some inaccurate statements about the published study:

“Researchers analyzed nearly 600 patients for 3 years. When cross-checked with scans, the blood test was able to detect mild to moderate traumatic brain lesions with up to 97 percent accuracy in patients 18 years and older. The blood test also indicated which patients were in need of life-saving neurosurgery. This suggests that the blood test could be used by clinicians for up to a week after injury to detect brain injury. This is important because many patients with concussion may not seek medical attention for days after injury.”

Let’s put this into perspective. First, the study lasted for 3 years and did not analyze 600 patients for 3 years. There is a big difference. Subjects in the study were followed for 180 hours. In reality there were two groups of subjects studied, trauma patients with (N=325) and without evidence (N=259) of mild to moderate traumatic brain injury. The blood test did distinguish between the 7 subjects who had severe injury (2 of whom underwent a neurosurgical procedure and 7 who required hospitalization in an intensive care unit (ICU). So the sample of those who truly had significant injury was small indeed.

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

Not Satisfactory

The release mentions that a lead researcher is “NIH funded” but does not specify funders for this study nor does it include a statement about potential conflicts of conflicts. (Just to clarify — we’re always pleased to see a statement even if no conflicts are known to exist.) The journal article itself has a disclosure footnote that states Papa is an unpaid consultant to Banyan Biomarkers, Inc., while Welch and Lewis disclosed receiving contract research funding from Banyan. Banyan is a for-profit biotech company in Florida seeking to commercialize a biomarker for head injury. We think this connection between the research and the biotech should have been mentioned in the release.

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

Not Satisfactory

This release includes some unjustified language. For starters, there is no such thing as a “simple blood test,” particularly one that tries to diagnose a brain injury based on a blood sample. We’ve addressed this in a previous review of an Orlando Health news release. We also have concerns about the use of the term “can” in the headline. This is still preliminary research and more studies are required to prove its usefulness.