BrainScope Company, Inc. today announced a publication describing the use of its flagship product, BrainScope One, in an independent clinical trial demonstrating the potential reduction of one-third (33.3%) of unnecessary computed tomography (CT) scans of mildly presenting head injured patients in hospital emergency rooms (ERs). The study entitled "Referrals for CT scans in mild TBI patients can be aided by the use of a brain electrical activity biomarker" was published online in the peer-reviewed American Journal of Emergency Medicine.
According to recent publications, approximately five million patients are seen in U.S. hospital ERs each year with closed head injuries, and millions more do not seek evaluation. The vast majority (>80%) of these patients receive a CT scan, of which over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients. Further, 95% of all head injured patients who visit the ER present with mild symptoms. Extrapolating the 33.3% potential reduction using BrainScope One across the incidence rate of mildly presenting TBI patients who receive unnecessary CT scans in ERs, there is the potential for a reduction of over 1 million unnecessary CT scans per year by incorporating BrainScope One into standard clinical practice.
The study compared two different decision pathways for CT scan referrals in mild head injured patients. The first was clinical site practice (referral decision of the evaluating physician), and the second was based on the BrainScope One Structural Injury Classifier, indicating whether a patient would likely be CT positive. Use of the BrainScope output resulted in a 33.3% reduction in the number of false positives (those referred for a CT scan that was found to be negative) compared with clinical site practice. In addition, a significantly lower (p<0.01) false discovery rate (the proportion of those referred for CT scans that are found to be CT negative) was found using the BrainScope One output.
"BrainScope One showed the potential to significantly reduce over-scanning without compromising overall clinical performance as evidenced by the one-third reduction of false positives," said Michael Singer, CEO of BrainScope. "Given patient and physician concerns about unnecessary radiation exposure from head CT scans and wait times in ERs measured in multiple hours, the use of BrainScope One in clinical practice could have a significant positive impact on long term patient health and satisfaction, as well as substantial savings to the healthcare system."
The use of CT scans has risen in the last 20 years. Resulting exposure to medical radiation has increased more than six times between the 1980s and 2006, according to the National Council on Radiation Protection & Measurements. The radiation doses of CT scans are 100 to 1,000 times higher than conventional X-rays. According to the "Choosing Wisely Campaign" from the American College of Emergency Physicians (ACEP), the first of the "Ten Things Physicians and Patients Should Question" is "to avoid computed tomography (CT) scans of the head in emergency department patients with minor head injury who are at low risk based on validated decision rules." The Campaign further states, "As CT scans expose patients to ionizing radiation, increasing patients' lifetime risk of cancer, they should only be performed on patients at risk for significant injuries."
Dr. J. Stephen Huff, Professor of Emergency Medicine and Neurology at the University of Virginia School of Medicine and the lead author on the study noted, "This retrospective analysis from the pivotal trial that resulted in FDA clearance for BrainScope One suggests that CT scanning may be safely reduced in appropriately selected patients based on BrainScope One results. This is consistent with goals of the Choosing Wisely project."
Cleared by FDA in September of last year, BrainScope One (registered as the Ahead 300) can be used to help clinicians provide a rapid, objective assessment of mildly presenting head injured patients 18-85 years old across the full spectrum of brain injury at the point of care for up to three days following injury. BrainScope One is designed to help the clinician determine the proper disposition of the patient by directly addressing two key questions in making their clinical diagnosis:
- Is it likely that the mildly presenting head injured patient has a traumatic structural brain injury which would be visible on a CT scan (the gold standard used in ERs)?
- Is there evidence of something functionally abnormal with the brain after head injury which could be concussion?
To answer these two key questions, BrainScope One leverages state-of-the-art handheld technology and a proprietary disposable sensor headset. BrainScope One features BrainScope's patent-protected EEG capabilities utilizing advanced signal processing, sophisticated algorithms and machine learning to help in the evaluation of head injured patients with objective biomarkers of brain electrical activity.