WASHINGTON — The labels of “mild,” “moderate,” and “severe” to classify traumatic brain injury (TBI) are outdated, imprecise, and do not effectively serve patients, clinicians, or payers, says a new report from the National Academies of Sciences, Engineering, and Medicine. The report recommends the creation of an updated TBI classification system to better guide patient care and inform research across the phases of TBI injury and rehabilitation.
“In today’s world of precision medicine, one could not imagine classifying cancer as ‘mild, moderate, or severe’ for its diagnosis, treatment, and prognosis,” said Donald Berwick, president emeritus and senior fellow at the Institute for Healthcare Improvement, and chair of the committee that wrote the report. “Implementing improved approaches for classifying TBI would allow for more personalized care for patients, better ongoing monitoring of their condition, and more successful translation of therapies from research to the clinic.”
TBI should not be treated as an isolated event, but as an evolving condition that may have long-term effects, says Traumatic Brain Injury: A Roadmap for Accelerating Progress. Providers and health care organizations should adjust treatments, assessments, and community resources as the patient’s status and needs change. The Centers for Medicare & Medicaid Services (CMS) and private payers should also ensure coverage for all phases of TBI care and rehabilitation is consistent with the latest clinical guidelines, the report recommends.
TBIs can affect every age group and vary in level of severity, and the causes are as diverse as falls, sports injuries, car accidents, and military combat. Each year, it is estimated that over 2 million people experience TBI in the U.S. For the 2 million TBIs recorded each year, the associated lifetime financial costs, including health care, lost income, and reduced quality of life are hard to measure, but have been projected to be as high as $750 billion. Many people with TBI also find themselves without follow-up care, facing challenges that could have been avoided.
An effective system of TBI care should have several elements, the report says. These include access to follow-up and high-quality, multidisciplinary rehabilitation care as soon as possible after injury; ongoing screening for risks and decline in health and function; services to address comorbidities, such as mental health disorders; and assistance with social needs, such as housing and return to work. The report also recommends interventions for the nation’s 2.5 million TBI family caregivers, who report significant stress and limited sources of ongoing support, especially after the first year following injury.
In addition, the U.S. secretary of health and human services should establish, for a period of 10 years, a national TBI Task Force, which would be a successor to the 2013 National Research Action Plan for TBI. Within two years, the task force should create a national framework and implementation plan to improve systems of TBI care.
A person with TBI can experience multiple handoffs in their care, from the site of injury, to departments within a hospital, to post-acute care, to community-level services. Standards for TBI care should be incorporated in assessment processes for the range of care settings that treat people with TBI, including trauma centers, rehabilitation services, concussion programs, and primary care practices. CMS should also support the creation of local and regional pilot programs for integrated TBI care.
TBI treatment needs to have the properties of a learning system, which not only encompasses care and research, but continual quality improvement and education. The U.S. Department of Health and Human Services should work to establish an integrated TBI data system that enhances the ability to track TBI mortality, morbidity, and long-term outcomes more accurately and completely. The system should also emphasize standardized capture of high-quality, TBI-relevant patient data in medical records and integration of information across care settings.
“Traumatic brain injury has resulted in preventable deaths, societal costs, and lost human potential,” said Victor J. Dzau, president of the National Academy of Medicine. “Now is the time to redesign research, ensure seamless care transitions, and develop a TBI learning system that strives for continuous quality improvement. Millions of people with TBI deserve this so they can achieve the care and quality of life that science can make possible for them.”
Updating the TBI Classification System
The current classification of TBI as “mild, moderate, or severe” promotes bias that can limit care, says the report. For example, someone with a “mild” TBI might have persistent symptoms, yet their treatment is withdrawn too soon. Conversely, with the right supports, someone with a “severe” injury can have a more favorable outcome than generally expected. The report recommends the National Institutes of Health convene a TBI Classification Workgroup to review data from recent large-scale clinical studies and determine which elements should be incorporated into a more evidence-based, precise classification system for clinical care and research.
Clinicians should also classify TBI patients based on their Glasgow Coma Scale (GCS) sum score, rather than the three-category shorthand. They should use clinical neuroimaging results (head CT scan and/or brain MRI) and FDA-approved blood biomarker results, where clinically indicated. New elements can be incorporated as research in clinical and biological markers advances.
Addressing Insurance Barriers
One major barrier to access to TBI follow-up care and rehabilitation is the “three-hour rule,” a common practice that requires that patients have sufficient energy and endurance to engage actively in therapies such as occupational, speech, or physical therapy for three hours per day, five days per week. Most insurers will cover comprehensive inpatient rehabilitative services for a patient only if this “three-hour rule” is met. However, there is a lack of evidence that three hours of therapy per day is tied to improved outcomes, says the report. It is better to align coverage with when, how much, and what types of rehabilitation are likely to be most effective.
Improving the Quality and Range of TBI Studies
TBI research investment by federal agencies and private funders should match the public health burden of the condition. Moreover, research has yet to yield Food and Drug Administration approved pharmaceutical treatments to heal TBI. The report specifies eight priority topics for expanded research. It also notes clinical research should be conducted over longer periods, to illuminate patients’ care trajectories beyond the acute injury stage.
The study — undertaken by the Committee on Accelerating Progress in Traumatic Brain Injury Research and Care — was sponsored by the U.S. Department of Defense. The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.
HIPRC Director, Monica S. Vavilala, MD, served on this taskforce.