Summary1
The universe of traumatic brain injury (TBI) is vast, encompassing everyday occurrences such as falls and injuries during recreational activities, as well as motor vehicle crashes, violence, and military armed conflict. TBI affects all segments of society because the circumstances that cause it are common and because a significant brain injury sustained by one family member causes emotional, physical, and often financial disruptions to the family system. Those who live with long-term consequences from TBI may require accommodations to support their fullest possible reintegration into communities in which they live, learn, and work. Individual, family, community, and societal costs from TBI are high.
IMPETUS FOR THE STUDY
Over the past several decades, awareness of the magnitude and consequences of TBI has increased, particularly in sports and among military service members, with new recommendations emerging for screening and management after suspected brain injuries. A 10-year National Research Action Plan for TBI and posttraumatic stress disorder was established in 2012 by executive order among key agencies involved in TBI research. Large translational research initiatives have been undertaken to learn about the pathophysiology of brain injury, patient trajectories, and interventions to support recovery. These efforts from federal agencies, philanthropic organizations, patient and Veterans’ advocacy groups, and the clinical care and research communities provide a foundation on which to build as the field looks to the decade ahead.
Despite prior efforts and progress, barriers and challenges remain, including unanswered questions about the most effective preventive, acute, rehabilitative, and long-term
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1 This Summary does not include reference citations. References for the information herein are provided in the full report.
care for TBI. Although interventions can prevent further injury and help manage symptoms, research has yet to yield Food and Drug Administration (FDA)-approved therapies for healing TBI. Moreover, not all patients and families have access to the best available care or to integrated follow-up across the care and recovery continuum throughout their lifespan. Box S-1 presents a sampling of statistics that illustrate the magnitude of the TBI problem today.
In this context, the Combat Casualty Care Research Program of the Department of Defense requested that the National Academies of Sciences, Engineering, and Medicine convene an ad hoc committee of experts to examine how progress can be advanced in TBI care and research and to develop a roadmap to help guide the field.
A ROADMAP FOR ACCELERATING PROGRESS IN TBI CARE AND RESEARCH
The committee’s recommendations for actions to advance TBI education, prevention, care, and research toward an optimized system are summarized in Box S-2 and detailed in the text that follows.
The term “traumatic brain injury” evokes an image of a sudden, isolated event; dramatic surgical or medical interventions; and, with good fortune, a cure, as with a broken bone that knits together. According to that image, the injury is clear, the intervention acute, and the episode time-delimited—TBI has a beginning, a treatment, and a predictable outcome. An overarching finding of this committee, however, is that this image is at best incomplete and at worst misleading for many people. Conceiving of TBI as an acute event with a clear endpoint also belies the burden it places on families, communities, and workplaces and its substantial financial and social costs.
It is far more accurate to view TBI through a wider lens encompassing at least four domains that drive the trajectory of recovery—biological, psychological, sociological, and ecological (including economic)—reflecting the mix of personal and social factors that
affect the experience of and recovery from conditions such as TBI. This “bio-psycho-socioecological” lens reveals that for many patients, TBI is more complex and more hidden and imposes a more chronic burden than a simple, event-based model would indicate.
Conclusion: TBI care in the United States often fails to meet the needs of individuals, families, and communities affected by this condition. TBI is an ongoing condition that poses significant burdens over time, including substantial financial and social costs. For the most part, the nation has no mechanism in place for long-term follow-up and care of adults or children with TBI. The results of this gap include needless death, squandered human potential, family stress, and soaring social costs. Because of this gap, the true morbidity, mortality, and cost attributable to TBI, though undoubtedly vast, are unknown.
The following recommendations reflect priorities identified by the committee as necessary for transforming TBI care and research to fill this gap. Achieving each of these priorities will require cooperative action among multiple organizations and communities and investments of substantial time and resources. The committee identified core actors to take each priority forward while emphasizing the critical role of a holistic framework for TBI.
Implement an Evidence-Guided Classification Scheme for Care and Research
The spectrum of initiating circumstances under the rubric of TBI is enormous, magnified by the fact that for many individuals, more than one TBI occurs in a lifetime. Causes range from high-energy kinetic or penetrant injuries to seemingly insignificant events, and result in diverse outcomes ranging from an immediate threat to life to subtle, persistent effects that may not initially be recognized as related to TBI but substantially affect health and function. Across this spectrum, the taxonomic categories of “mild, moderate, and severe,” derived from clusters of scores on the Glasgow Coma Scale, are inadequate to capture or guide either proper management of TBI or accurate prognostication of its outcome. The consequences of injuries classified as “mild” can prove, in some instances, to be insidious, and even lifelong in their impact. Conversely, injuries rated as “severe” can vary in long-term outcomes, from devastating disability to high function. Tools are needed to accurately inform clinical decisions, including withdrawal of life-sustaining treatment, a gap that leads to suboptimal care for people across the spectrum of TBI. Clinicians, patients, and payers need a more nuanced, personalized, and evidence-guided taxonomy for TBI, using clinical and biological markers to support more effective assessment, treatment, prognosis, and rehabilitation. Because initial assessment does not reliably predict ultimate outcome, regular reassessment is also essential as a person’s condition and needs change.
Recommendation 1. Create and implement an updated classification system for TBI. The current clinical classification scheme for TBI should be updated to be more accurate and informative for care and research:
- The National Institutes of Health (NIH) should convene a TBI Classification Workgroup to review data from recent large-scale clinical studies and determine which elements should be incorporated into a more descriptive, evidence-based, and precise classification system for clinical care and research. In this effort, NIH should engage professional communities that routinely diagnose and classify TBI.
- Relevant professional societies, including but not limited to those in emergency medicine, trauma care, and rehabilitation, should advise and train clinicians caring for people with TBI to classify patients based on their actual Glasgow Coma Scale (GCS) sum score (e.g., GCS 14) rather than the inaccurate and misleading three-category shorthand mild, moderate, or severe. Optimally, clinicians should also use results from neuroimaging and blood-based biomarkers, when available and clinically indicated, to classify patients. Clinicians should update the TBI classification for each patient as the person’s condition evolves.
Progress has been made in identifying markers that can inform TBI assessment, diagnosis, and prognostication since a 2007 National Institute of Neurological Disorders and Stroke (NINDS) workshop on this topic. As one of its initial actions, the Classification Workgroup should evaluate these advances, including the utility of various markers across different TBI populations and injury severities and in different care environments. Data elements that might be considered for incorporation into a revised and updated TBI classification system include advances in neuroimaging, blood-based biomarkers, and other areas.
Manage TBI as Both a Complex Acute and a Chronic Condition
The physical, psychological, and social effects of TBI, along the full range of severity and with time horizons beyond the acute phase of management, have significant impacts on a person’s function, relationships, and quality of life. Testimony from experts and people living with TBI conveyed these serious effects and the frequent failures of the health care system to even recognize them, let alone address them adequately. For many people, although thankfully not for all, a TBI is the portal to months, years, or a lifetime of motor, sensory, psychological, behavioral, and cognitive problems. TBI should be understood and managed as a condition with acute and chronic phases and challenges that evolve over time, challenges a truly responsive health care system would anticipate and meet. Instead, evidence suggests that many people with TBI find themselves without continuity of care, integrated professional support, or adequate health insurance downstream from their acute injury. Many TBI patients are lost to follow-up, leaving no mechanism for measuring the long-term effects of this condition.
Recommendation 2. Integrate acute and long-term person- and family-centered management of TBI. All people with TBI should have reliable and timely access to integrated, multidisciplinary, and specialized care to address physical, cognitive, and behavioral sequelae of TBI and comorbidities that influence quality of life.
- Relevant professional societies should encourage clinicians to recommend that all patients at discharge from inpatient and outpatient acute care settings have an opportunity for follow-up with a clinician experienced in managing TBI. Guidance to clinicians should also emphasize the need to connect patients and family caregivers with care navigation resources as needed.
- In their intake processes, health care and social services organizations should be aware of lifetime TBI exposure so they can identify those needing accommodations, as well as those at increased risk for TBI-related symptoms or declining trajectories in health and function. These organizations should also give providers guidance on practical strategies and accommodations that can help patients and families cope with TBI-related symptoms, and on resources that can increase reliable and timely access to and appropriateness of care for persons with TBI.
- Organizations that oversee or provide long-term care should consider the needs of families and caregivers for education and support as key components of long-term care plans.
Stronger commitment and strategies are needed to ensure quality and continuity of care for all people with TBI. Incorporating family and caregiver needs is also crucial, since many persons with TBI live with family and are dependent upon family members and other caregivers to address their needs, navigate health care and community services, and facilitate community integration.
Ensure Quality and Consistency of Care
Unwarranted variability and gaps in care guidance need to be addressed, and guidelines and best practices need to be consistently implemented, including to guide reimbursement practices. The evidence to inform TBI care decisions should be based on a range of rigorous methodologies for generating knowledge and include evidence obtained not only from randomized controlled trials but also from observational cohort and other study designs and from expert consensus on best practices.
Recommendation 3. Reduce unwarranted variability and gaps in administrative and clinical care guidance to ensure high-quality care for TBI. The federal agencies that lead the development of clinical practice guidelines for TBI, including the Department of Veterans Affairs, the Department of Defense, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention, should convene at regular intervals an expert panel to undertake the actions below in collaboration with clinical and patient community stakeholders. The Centers for Medicare & Medicaid Services (CMS) should be engaged in this effort to ensure alignment of coverage with clinical guidelines:
- Survey the landscape of existing clinical care guidelines for all elements of TBI care, during all phases of care, and involving all salient specialties. Synthesize best current clinical practice and evidence to develop consensus-based guidelines where evidence is currently limited, using rigorous methods for such consensus processes. Guidelines should be sensitive to local contexts and potential sources of inequity, such as race/ethnicity, rurality, and limited access to health care resources.
- Identify and resolve problems of inconsistency among current clinical care guidelines.
- Identify guidelines and practices that are contraindicated by current evidence, and issue guidance on their deimplementation.
- Identify common criteria for the inclusion of studies used to inform the development of guidelines and for how topics are covered for which limited evidence from randomized controlled trials or other rigorous study designs is available (see Recommendation 7).
- Identify gaps in the evidence base informing current clinical care guidelines, and recommend research to develop the necessary evidence (see also gaps identified in the research agenda presented later).
- Develop evidence-guided and consensus-based criteria for identifying patients who should be referred to inpatient and outpatient TBI rehabilitation (see Recommendation 5).
- Identify avenues for emerging best practices to guide third-party coverage of care, regardless of payer source and type of medical facility.
Relevant clinical organizations that have been active in TBI guideline development and can be engaged in this effort include the Brain Trauma Foundation, Concussion in Sport Group, American College of Surgeons, American Academy of Neurology, American College of Emergency Physicians, American Congress of Rehabilitation Medicine, Neurocritical Care Society, and others.
Enhance Awareness and Understanding of TBI
Like many neurologic and medical conditions, TBI is sociologically complex. For example, misunderstood, longer-term psychological consequences of TBI may be interpreted as problems of commitment or character rather than as treatable conditions. TBI care and outcomes can be improved with better understanding among clinicians, educators, and the public of the forms and clinical courses of these injuries, and of the medical and community supports needed to help persons living with TBI and their families cope and thrive. Similarly, underinvestment in research on the causes, types, and treatment of TBI may reflect, in part, underestimation by the public and policy makers of the magnitude of the burden TBI imposes on the population and progress that could potentially be made with levels of research support more commensurate with that burden—what quality-of-care researcher John Williamson termed “achievable benefit not achieved.”
Recommendation 4. Enhance awareness and identification of TBI by health care providers and the public. Education and awareness are essential for achieving high-quality care and improving outcomes, and are particularly important in the following areas:
- Public awareness. The Centers for Disease Control and Prevention, working with organizations in TBI prevention, care, and rehabilitation and those that work with at-risk groups, should enhance efforts to raise awareness among the public on the context, causes, and long-term effects of TBI; the importance of follow-up; and resources that may be available to the person with TBI.
- Professional awareness, education, and training. Education and training programs for health care professions should include information on the burden, risk factors, and signs and symptoms of TBI and should correct misconceptions about the condition. Materials should emphasize adherence to evidence-based guidelines where they exist to bring greater consistency to TBI care across the United States, while taking into account patient characteristics and preferences in order to provide personalized care. Guidance should also emphasize eliminating practices that are contraindicated by current evidence and reducing inequities in care and outcomes.
- Patient and family empowerment. National- and state-level patient and family organizations should work with clinical communities in primary care, acute care, and rehabilitation to ensure that all TBI patients and families receive anticipatory guidance on expected symptoms and trajectory, steps to decrease the risk of delayed recovery, and available TBI resources.
Groups at particular risk of experiencing a TBI include, but are not limited to, the elderly, those engaged in sports and recreation, and those at risk of experiencing forms of violence. Organizations working closely with these groups should be involved in efforts to develop and disseminate practical information on TBI. Given the prevalence and burden of TBI, multiple health care professionals, including physicians, nurses, emergency medical technicians, psychologists, and rehabilitation professionals, need sufficient training in and guidance on
its diagnosis and management. Investigators with complementary expertise in such areas as social sciences, implementation science, and health economics also form part of the roadmap for advancing TBI care (see the research agenda below). Ensuring broad awareness of and education about TBI can help engage these experts and stakeholders in the efforts that make up that roadmap.
Establish an Effective Care System for TBI
TBI and its care are embedded in and affected by the ecology of American communities. As in almost all aspects of U.S. health care access and quality, TBI care and outcomes demonstrate evidence of racial, geographic, and socioeconomic inequity. Achieving high-quality TBI care will require confronting this inequity at its sources and committing to measuring and monitoring progress toward its resolution. Where you live, who you are, and where you receive care should not determine if and how well you live. Yet, with TBI, as with many complex medical conditions, this ambitious goal is not achieved. The reasons are manifold, and overcoming these obstacles will depend on a careful redesign of TBI care as a system, as well as on incorporating into the nation’s TBI care the properties of a “learning health care system,” as described in National Academies reports of the past decade. Currently the United States has neither an integrated system of care for TBI nor a learning system capable of continual progress toward ideal TBI care everywhere and for everyone.
Individual patients would benefit if clinicians and health care organizations had the capacity and commitment to view the TBI care they provide—and the system’s duties—through the lens of the bio-psycho-socio-ecological model, and to do so not just once but continuously and repeatedly through each patient’s life journey, adjusting treatments, assessments, and community resources as the patient’s status and needs change. Doing so would require a level of continuity and acceptance of responsibility that American health care does not often achieve for chronic illnesses. At present, the majority of people with TBI cannot count on both the acute and longer-term care they need to achieve their full potential of health and well-being. The gap of “achievable benefit not achieved” is enormous.
Efforts by professional and accreditation societies should be leveraged to confront and mitigate the discontinuity of care; government and private philanthropy should invest in developing prototypes of integrated TBI care, including regional system designs; and public and private payers should ensure that benefit structures accord with the evidence for best practice in TBI care across all phases and environments of care.
Recommendation 5. Establish and reinforce local and regional integrated care delivery systems for TBI. The Secretary of Health and Human Services should work to establish geographically based, integrated care delivery systems for TBI, emphasizing the continuum of care across the acute, rehabilitation, and recovery phases and all severities. The effort should build on the nation’s success with regional trauma systems and incorporate practices and lessons learned from the Department of Defense (DoD) and the Department of Veterans Affairs (VA). Specifically:
- The American College of Surgeons (ACS) and other trauma verification systems should incorporate comprehensive standards for TBI care in trauma center verification processes and data systems and as a national trauma system evolves. As part of this effort, ACS should expand efforts to foster communication between acute care and rehabilitation care providers and expand outreach on the signs and management of TBI to the public, first responders, and acute care providers.
- Settings that provide TBI care across the post-acute rehabilitation continuum should meet standards for integrated, evidence-based, and individualized brain injury care, such as those required by the Commission on Accreditation of Rehabilitation Facilities for the Brain Injury Specialty. The Joint Commission should review and promulgate standards for high-quality TBI care in the broader spectrum of care settings that treat people with TBI, such as primary care, community hospitals, and concussion programs.
- The Department of Health and Human Services and the Center for Medicare & Medicaid Innovation should support local and regional pilot demonstration projects to create prototype civilian care infrastructures focused on providing continuity of care for follow-up, rehabilitation, and longer-term care and recovery from TBI. The demonstration projects should document best practices and effects on patient outcomes, and identify the components of a chronic care management model that are most effective for persons with TBI. Prototype systems should address the needs of TBI across the spectrum of severity and venues of care, including community-based services.
- The Centers for Medicare & Medicaid Services (CMS) and commercial health care insurers should align coverage for TBI care with clinical guidelines to ensure equity in access to, affordability of, and quality of care. For example, payers should use criteria identified under Recommendation 3 when authorizing inpatient and outpatient rehabilitation services, including for long-term TBI sequelae. CMS, the VA, and DoD should test alternative benefit structures for TBI rehabilitation care instead of relying on the current time-based metric (e.g., the “3-hour rule”) or preset benefits.
Make the TBI Care System into a Learning System
As observed above, TBI care needs to have the properties of a learning health care system. In addition to care and research, such a system encompasses processes for continual quality improvement and education. A full learning system for TBI also will involve public health agencies and community organizations across the phases of prevention, care, and recovery.
Recommendation 6. Integrate the TBI system of care and TBI research into a learning health care system. Reducing the burden of TBI will require a learning system capable of continual improvement. Important elements are thorough surveillance, standardized and longitudinal patient information, and accessibility of data. The Secretary of Health and Human Services (HHS) should therefore work to establish an integrated TBI data system, taking the following actions:
- Conduct thorough surveillance. The Centers for Disease Control and Prevention should expand efforts to track TBI mortality, morbidity, and long-term outcomes more completely and accurately, including by adding validated, standardized TBI questions to population-based and weighted surveys and working to ensure consistency of information across states and surveys. The Agency for Healthcare Research and Quality should modify and expand the Healthcare Cost and Utilization Project to enable improved analysis of TBI care patterns, costs, and outcomes, both acute and long-term.
- Standardize the capture of patient-level data. HHS should work with health care systems and electronic health record vendors to bring data infrastructure into line
- Emphasize longitudinal data, and integrate information across the continuum of care. HHS should work with the owners of national and regional TBI registries and databanks to crosslink patient-level data across sites and through time. In addition, data systems should collect clinical information in alignment with the refined TBI classification system proposed in Recommendation 1.
with the state of the science by investing in and developing the ability to capture high-quality, TBI-relevant data in medical records. This data infrastructure will help in identifying causal factors and longitudinal outcomes, enabling comparative effectiveness, implementation, and translation studies across health care systems.
Organizations in a learning system need access to high-quality data. Relevant databases to involve in these efforts include, for example, the National Highway Traffic Safety Administration’s (NHTSA’s) National Emergency Medical Services Information System (NEMSIS); the American College of Surgeons’ (ACS’s) National Trauma Databank and Trauma Quality Improvement Program; state trauma registries; the National Institute on Disability, Independent Living, and Rehabilitation Research’s (NIDILRR’s) TBI Model Systems database; the DoD Trauma Registry; and VA TBI registries. But a true learning system requires that organizations go further by using the data to drive real-time and iterative improvements in care.
Invest in Continued Research
Despite advances, major gaps remain in scientific understanding of the pathophysiology of TBI and the necessary foundations for novel acute and post-acute treatments that can achieve better outcomes than are achieved today. Compared with many other important conditions, such as cancer and heart disease, biomedical research on TBI has languished, with insufficient investment and no clear institutional ownership. Redesigning and transforming TBI care will require a new level of investment in clinical and basic research commensurate with the enormous burden of TBI. The committee’s recommendation for advancing the TBI research enterprise is given below; priority areas for research are detailed in Box S-3.
Recommendation 7. Improve the quality and expand the range of TBI studies and study designs. TBI research and investment by the National Institutes of Health, the Department of Defense, the Department of Veterans Affairs, and private-sector funders should be commensurate with the public health burden of the condition. The research agenda proposed herein identifies eight areas for further progress and additional attention. When identifying research priorities and requests for applications, the above funders should take the following actions:
- Significantly expand financial support and research efforts to address the priorities identified in the research agenda.
- Establish translational research and implementation science centers to undertake collaborative efforts toward improved standardization and clinical care for TBI throughout the continuum of care. These centers should use insights from implementation science to enable effective translation of study results from the laboratory to clinical trials and from clinical trials to practice.
- Encourage multidisciplinary and multistakeholder research efforts to strengthen the evidence base informing care. These efforts should:
- Use the TBI classification system called for in Recommendation 1 to better stratify participants in clinical trials of novel interventions for TBI.
- Engage patient and family voices early in study design by using stakeholder engagement (i.e., community-based participatory research) to identify unmet needs and refine research questions.
- Recruit diverse study participants to ensure that research is broadly representative of the people who experience TBI.
- Use all forms of rigorous study designs when appropriate to answer research questions. Study methods should be eclectic and adaptive, and should include not only randomized controlled trials for efficacy but also pragmatic trials, adaptive designs, comparative effectiveness trials, observational studies (including those using statistical control for causal inference), and mixed methods, as appropriate to the research questions.
- Engage laboratory scientists and clinicians to ensure better research translation, including rigorous parallels across animal and human injury models, therapeutic targets, comorbidities, and study design outcome metrics and endpoints.
Provide Leadership to Drive Collaboration and Change
The actions identified in Recommendations 1 through 7 are needed to advance TBI care and research, link acute and longer-term care, and better align payment models with improved outcomes. But multiple efforts can be uncoordinated or have goals that misalign because so many different agencies, organizations, professional communities, patient groups, and others have roles to play.
Conclusion: The United States lacks a comprehensive framework for addressing TBI. A barrier to dramatic improvement in TBI care and research is the absence of a strategic framework and a lead agency or organization with a systemic view, responsibility for articulating goals and overseeing progress, the capacity to foster change, and the ability to convene the many stakeholders required to address the necessary multiple lines of effort. Absent a leadership entity, no one owns the problem, and major progress is unlikely.
Federal leadership is needed to establish a strategic framework for dramatically improving TBI care. Because this framework will require the efforts of multiple partners as well as investment of substantial resources, it will be essential to develop early on a clear plan for implementation that includes a timeline and metrics of progress and is curated as circumstances change. This coordinated approach will support innovation and improvement in TBI research and care, and will align the expansive range of partners and stakeholders whose efforts are critical to establishing an optimized system that aims to achieve high-quality care and health equity among all groups and across the lifespan.
Recommendation 8. Create and promulgate a national framework and implementation plan for improving TBI care. The Secretary of Health and Human Services (HHS) should, under the aegis of the Assistant Secretary for Health, create, promulgate, and curate a strategic national framework and implementation plan for improving TBI care:
- To this end, the Secretary of HHS should establish, for a period of 10 years, a national Traumatic Brain Injury Task Force as a successor to the National Research Action Plan. The TBI Task Force should move beyond an emphasis solely on research coordination to encompass a focus on research implementation and application of the evidence in support of better treatment and systems of care delivery, engaging an expanded group of federal, private-sector, and philanthropic partners. It should enlist and help coordinate TBI-related care improvements among HHS components (such as the Centers for Medicare & Medicaid Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Administration for Community Living, the Agency for Healthcare Research and Quality, and the Health Resources and Services Administration, among others) and should include participation from other relevant departments, such as the Department of Veterans Affairs, the Department of Defense, the Social Security Administration, and the Department of Transportation.
- The TBI Task Force’s first actions should be to develop a strategic framework addressing the issues reflected in the committee’s recommendations and within 2 years, to release a specific implementation plan to guide and coordinate efforts within that framework. This plan should be curated and updated over time.
- The TBI Task Force should engage a multistakeholder public–private coalition to continually advance and accelerate implementation of the national framework and plan. Stakeholders in this coalition should include, but not be limited to, the federal agencies that provide funding for TBI research and clinical care, relevant patient and family advocacy organizations, Veterans service organizations, relevant professional societies, youth and adult sports associations, health payment organizations, philanthropic foundations, and companies developing new tools and treatments for TBI.
FINAL THOUGHTS
Compared with current TBI care management and research, what is needed is not merely improvement, but a transformation of attitudes, understanding, investments, and care systems. Evolutionary changes—such as better national data systems, redesign of insurance coverage for rehabilitation, reconciliation of disparate clinical care guidance, advances in preclinical and clinical research, and a modernized taxonomy for TBI itself—will help. But bringing the best achievable outcomes to persons with TBI and their families will require a wholesale redesign of TBI systems to reflect the timing and many manifestations of the condition, and to guarantee linked and coordinated care across time and sites of care to deliver what matters most to patients and their loved ones.
