The American Association of Neurological Surgeons (AANS) and its partner organizations NeuroPoint Alliance (NPA) and the Neurosurgery Research and Education Foundation (NREF) are establishing a new registry effort directed at better understanding long-term care of women suffering from mild traumatic brain injury (mTBI). The registry, entitled BRAIN-SCORE (BRAin INjury and Sports Concussion Outcomes REgistry) aims to partner with other entities conducting and sponsoring research in this space, including The Chuck Noll Foundation, researchers at the University of Pittsburgh, Magee-Women’s Research Institute and Foundation, the TRACK-TBI network, the National Academies of Science, Education and Medicine TBI Forum and the AANS/CNS Joint Section on Neurotrauma and Critical Care. Initial efforts will focus on assessments of health groffcare delivery patterns (including socio-economic obstacles to access to care), recognition of patterns of referral and impact on overall life functioning related to injury, with potential future growth in the area of patient-reported outcomes measures after mTBI.
Mild traumatic brain injury (mTBI) (including concussion) is the most common form of TBI, with an incidence of more than 600 cases per 100,000 people per year, and an estimated cost of approximately 44% of the $60 billion annual cost of TBI in the United States. There is increasing recognition of undiagnosed mTBI in women, including under-reporting of assault-related injuries and intimate partner violence. Although many patients recover fully within days after the injury, at least 20% of affected individuals may experience persistent symptoms for more than three months. Some studies report persistent symptoms in more than 50% of individuals by one year following mTBI. Currently, predictors of recovery, symptom persistence and the need for further intervention are areas of research interest, but lacking evidence. Gender related differences is one potentially important, yet under-studied, predictive factor of outcomes after mTBI.
Socioeconomic factors uniquely impact recovery and long-term clinical outcomes from TBI. Women utilize more healthcare resources compared to men up to two years after the injury. Additionally, women have been reported as more likely to report persistent symptoms, such as pain, headache, dizziness, fatigue, irritability and decreased concentration. However, no significant differences have been observed with respect to return to work and worker’s compensation. In the long term, women are more likely to report persistent post-concussion symptoms and to repeatedly seek medical care for these symptoms, suggesting that symptoms commonly reported by women following mTBI may often be dismissed in current health care settings.
National prospectively collected databases and longitudinal registries include the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) network of TBI research centers, and the Care Consortium sponsored by the National Collegiate Athletic Association (NCAA) and the U.S. Department of Defense (DoD). This group tracks long-term outcomes from TBI in collegiate athletes and military personnel. The National Institute of Neurological Disorders and Stroke (NINDS) maintains a roster of Related Concussion Common Data Elements (CDE) useful for clinical research, and a subset for sports-related concussion. The American College of Surgeons maintains the National Trauma Data Bank (NTDB); however, this sample is based on hospitalized patients. A “real-world” quality dataset focused on TBI has yet to be developed on a national scale; this effort aims to fill part of that gap and supplement knowledge gained by existing research networks, with special emphasis on women and girls.
While sex and/or gender may be among the baseline patient characteristics collected in existing research registries, outcomes related to the persistent symptoms of mTBI/concussion that may affect patient executive function and quality of life, but not necessarily interfering with return to play or to work, are not as widely available in existing databases. Moreover, clinically unique aspects of the care of women, such as reproductive and menstrual abnormalities encountered following mTBI20 are not commonly evaluated. Publications often evaluate patient outcomes based on the various sports and individual mechanisms of injury and define clinical recovery as the ability to return to play or baseline activities. However, the persistent long-term cognitive and mental health implications of mTBI, as well as PROs specifically relevant to women suffering mTBI largely go unreported.
Prospective collection of healthcare delivery data and clinical data on a national level would encourage research into open questions on mTBI in women with a representative sample, adequate statistical power and appropriate focus on outcomes relevant to female patients with mTBI. Filling current knowledge gaps to further elucidate patterns of care, and ultimately underlying pathophysiologic mechanisms, potential predisposing factors and important predictors of recovery, as well as ways to prevent and treat post-concussive symptoms in women suffering mTBI, will be an important contribution of the AANS. This endeavor will be critical in terms of maximizing the new registry’s reach and optimizing its efficiency regarding prospective data collection.
Financial sustainability is critical when it comes to building a new registry. Given the resources required to build, maintain and coordinate a new registry, support from the NREF and extramural sources will be critical in the development of this novel registry. With the increased emphasis on evidence-based, data-driven strategies for quality improvement in health care, prospective registries provide real-world data pertaining to patient care and clinical outcomes. Registries allow for assessment of the current status of care provided for a specific condition, establishment of national benchmarks and inter-institutional comparisons. By assessing patient groups (e.g., in a given health care system or insurance plan), and comparing to national benchmarks, specific data-driven plans oriented to improvement of care delivery can be made. In the future, prospectively collected data could also be used to further neurosurgical research on mTBI in women, to identify predictors of functional outcomes, guide treatments and define optimal longitudinal care for women recovering from mTBI.
Developing a new registry dedicated to mTBI in women in accordance with NPA registry principles will contribute to better understanding of etiologies and care disparities with the ultimate goal of improving the quality of care provided to women suffering mTBI.
