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PATTY MITCHELL, RN | Legal Health Care Biomarkers: The Key to Diagnosis?
Traumatic brain injury (TBI) oc- curs when a blow, or jolt to the head causes injury to the brain with mild TBI (mTBI) found in 75 percent of reported cases. Moderate or severe TBI are easier to diagnose, treat and monitor due to clear evi- dence of clinical symptoms and o en quanti able lesions on imaging stud- ies.
Per the National Institute of Health, symptoms of mTBI may not occur until days or weeks a er the initial injury, with an estimated half of all TBIs occurring secondary to motor vehicle collisions (MVC). Diagnosis has historically been based on clini- cal symptoms and CT scan, although brain damage can be present without evidence on imaging.
Symptoms associated with mTBI include neck pain, headache, ear ring- ing, dizziness, nausea, trouble with memory, concentration, and atten- tion, personality changes, sensitivity to light and sound and fatigue. Mild TBI can cause long term cognitive impairment in 15 percent of those diagnosed, a ecting the individual’s ability to return to work or perform daily activities.
Lack of quanti able damages in the face of clinical symptoms can make these cases di cult to prove or refute in both the medical and legal arenas. Delayed recovery from mTBI a ects approximately 2 percent (5.3 million) of the U.S. population. Patients with symptoms lasting longer than three months are de ned as having post- concussion syndrome.
Criteria for diagnosis of mTBI cited by the International Brain Injury As- sociation include normal brain imag- ing studies (CT), no loss of conscious- ness greater than 30 minutes, no reduced consciousness or post-trau- matic amnesia greater than 24 hours, or no Glasgow Coma Score below 13.
ese are the patients diagnosed with “concussion” and discharged to home from the emergency department.
e underlying pathology of mTBI is o en at the cellular level, related to local pathophysiological changes, disruption of the blood brain barrier, alteration of cerebral blood ow, axo- nal and neuronal cell body injury and neuroin ammatory responses, unde- tectable with routine diagnostics.
is has prompted researchers to look for de nitive testing to show damage related to mild TBI, to help guide treatment and to di erentiate those patients with subjective com- plaints versus those with objective evidence of injury. Screening patients with the biomarker S100B has been performed in 16 European countries since 2000 to aid in diagnosis and treatment of TBI.
On Feb. 14, 2018, the FDA ap- proved a blood test called the Banyan Brain Trauma Indicator (BBTI) which monitors levels of two biomarkers UCH-L1 and GFAP found to be supe- rior to S100B and both released with- in one hour a er TBI. Biomarkers are substances generated by cellular inju- ry. e brain has a protective epitheli- al layer called the blood brain barrier which blocks water soluble molecules over a certain size from entering the brain. is barrier is damaged during TBI, making it more permeable and allowing these biomarkers to enter the blood stream.
Measurement of UCH-L1 and GFAP levels can be checked within 12 hours of the injury and have shown a 97.5 percent accuracy in detecting the presence of brain lesions and is 99.6 percent positive for those without le- sions. e test was designed to allevi- ate unnecessary CT scans, the stan- dard screening method, along with physical assessment for TBI. e test is not approved to con rm diagnosis
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of mTBI, although some have dubbed it the concussion test.
It is important to note that negative test results do not rule out something called a subconcussion, or mTBI without signs. Research related to BBTI is showing promise in use of the test to monitor recovery from TBI, with elevated levels months post-in- jury associated with worse outcomes. Studies have shown e cacy as a tool for assessment of return to play in athletes where there is concern about secondary concussions and develop- ment of chronic traumatic encepha- lopathy. Biomarkers are being tested as guides to treatment response for TBI patients.
e Department of Defense calls TBI the signature wound of recent wars with over 375,000 cases docu- mented since 2000. It is hoped that the BBTI will “ ll a critical need to quickly evaluate Troops in remote locations where there is a ‘knowledge gap’ in assessing how severe the in- jury is.” Early treatment of those diag- nosed with mTBI has been associated with better outcomes. Manufacturer Banyan Biomarker has stated they are working on shortening the result time from the current three to four hours to less than an hour, making testing even more attractive in cases of sus- pected TBI.
e approval of the BBTI test by the FDA is a step toward more de ni- tive diagnosis of mTBI. While BBTI is not a stand-alone prognosticator, when used in conjunction with clini- cal signs and symptoms, and some of the newer ad-
vanced imaging
studies (Spect scan,
DTI, fMRI) it can
assist in identifying
patients with mild
TBI.
Patty Mitchell, RN, BSN, CLNC is the president of Central Florida Legal Nurse Consultants. Her nursing career has spanned over 24 years, in the hospital acute care setting. She is a graduate of the Medical Legal Consulting Insti- tute and maintains her certi cation. Patty is the president elect of the Greater Orlando Chapter of the American Association of Legal Nurse Consultants. She has provided consulting services since 2014, to both plaintiff and defense attorneys on a wide variety of cases. She is a member of the National Association of Certi ed Legal Nurse Consultants, and Sigma Theta Tau, nursing honor society.
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