Advancing integrated research in psychological health and traumatic brain injury: common data elements

Thurmond VA, Hicks R, Gleason T, Miller AC, Szuflita N, Orman J, Schwab K. Advancing integrated research in psychological health and traumatic brain injury: common data elements.In civilian, military, and veteran populations, there is increased recognition of the interrelationship between traumatic brain injury (TBI) and some psychological health (PH) disorders and the need to better understand the relationships by integrating research for these topics. The use of different measures to assess similar study variables and/or assess outcomes may limit important advances in PH and TBI research. Without a set of common data elements (CDEs; to include variable definitions and recommended measures for the purpose of this discussion), comparison of findings across studies is challenging. The federal agencies involved in PH and TBI research, the National Institute of Neurological Disorders and Stroke, Department of Veterans Affairs, National Institute on Disability and Rehabilitation Research, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, and Defense and Veterans Brain Injury Center, therefore cosponsored a scientific initiative to develop CDEs for PH and TBI research. Scientific experts were invited to participate in 1 of 8 working groups to develop recommendations for specific topic-driven CDEs. Draft recommendations were presented and discussed in the workshop “Advancing Integrated Research in Psychological Health and Traumatic Brain Injury: Common Data Elements (CDE)” held on March 23-24, 2009, in Silver Spring, MD. The overall process leading to the workshop and subsequent recommendations by the working groups are presented in this article. Topic-driven recommendations for CDEs are presented in individual reports in this edition.     

Common data elements for traumatic brain injury: recommendations from the interagency working group on demographics and clinical assessment

Maas AI, Harrison-Felix CL, Menon D, Adelson PD, Balkin T, Bullock R, Engel DC, Gordon W, Langlois Orman J, Lew HL, Robertson C, Temkin N, Valadka A, Verfaellie M, Wainwright M, Wright DW, Schwab K. Common data elements for traumatic brain injury: recommendations from the Interagency Working Group on Demographics and Clinical Assessment.Comparing results across studies in traumatic brain injury (TBI) has been difficult because of the variability in data coding, definitions, and collection procedures. The global aim of the Working Group on Demographics and Clinical Assessment was to develop recommendations on the coding of clinical and demographic variables for TBI studies applicable across the broad spectrum of TBI, and to classify these as core, supplemental, or emerging. The process was consensus driven, with input from experts over a broad range of disciplines. Special consideration was given to military and pediatric TBI. Categorizing clinical elements as core versus supplemental proved difficult, given the great variation in types of studies and their interests. The data elements are contained in modules, which are grouped together in categories. Three levels of detail for coding data elements were developed: basic, intermediate, and advanced, with the greatest level of detail in the advanced version. In every case, the more detailed coding can be collapsed into the basic version. Templates were produced to summarize coding formats, motivation of choices, and recommendations for procedures. Work is ongoing to include more international participation and to provide an electronic data entry format with pull-down menus and automated data checks. This proposed standardization will facilitate comparison of research findings across studies and encourage high-quality meta-analysis of individual patient data.     

Common data elements for traumatic brain injury: recommendations from the biospecimens and biomarkers working group

Manley GT, Diaz-Arrastia R, Brophy M, Engel D, Goodman C, Gwinn K, Veenstra TD, Ling G, Ottens AK, Tortella F, Hayes RL. Common data elements for traumatic brain injury: recommendations from the Biospecimens and Biomarkers Working Group.Recent advances in genomics, proteomics, and biotechnology have provided unprecedented opportunities for translational research and personalized medicine. Human biospecimens and biofluids represent an important resource from which molecular data can be generated to detect and classify injury and to identify molecular mechanisms and therapeutic targets. To date, there has been considerable variability in biospecimen and biofluid collection, storage, and processing in traumatic brain injury (TBI) studies. To realize the full potential of this important resource, standardization and adoption of best practice guidelines are required to insure the quality and consistency of these specimens. The aim of the Biospecimens and Biomarkers Working Group was to provide recommendations for core data elements for TBI research and develop best practice guidelines to standardize the quality and accessibility of these specimens. Consensus recommendations were developed through interactions with focus groups and input from stakeholders participating in the interagency workshop on Standardization of Data Collection in TBI and Psychological Health held in Washington, DC, in March 2009. With the adoption of these standards and best practices, future investigators will be able to obtain data across multiple studies with reduced costs and effort and accelerate the progress of genomic, proteomic, and metabolomic research in TBI.     

Common data elements in radiologic imaging of traumatic brain injury

Duhaime AC, Gean AD, Haacke EM, Hicks R, Wintermark M, Mukherjee P, Brody D, Latour L, Riedy G, Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. Common data elements in radiologic imaging of traumatic brain injury.Radiologic brain imaging is the most useful means of visualizing and categorizing the location, nature, and degree of damage to the central nervous system sustained by patients with traumatic brain injury (TBI). In addition to determining acute patient management and prognosis, imaging is crucial for the characterization and classification of injuries for natural history studies and clinical trials. This article is the initial result of a workshop convened by multiple national health care agencies in March 2009 to begin to make recommendations for potential data elements dealing with specific radiologic features and definitions needed to characterize injuries, as well as specific techniques and parameters needed to optimize radiologic data acquisition. The neuroimaging work group included professionals with expertise in basic imaging research and physics, clinical neuroradiology, neurosurgery, neurology, physiatry, psychiatry, TBI research, and research database formation. This article outlines the rationale and overview of their specific recommendations. In addition, we review the contributions of various imaging modalities to the understanding of TBI and the general principles needed for database flexibility and evolution over time to accommodate technical advances.     

The American Congress of Rehabilitation Medicine Diagnostic Criteria for Mild Traumatic Brain Injury

ObjectiveTo develop new diagnostic criteria for mild traumatic brain injury (TBI) that are appropriate for use across the lifespan and in sports, civilian trauma, and military settings.DesignRapid evidence reviews on 12 clinical questions and Delphi method for expert consensus.ParticipantsThe Mild Traumatic Brain Injury Task Force of the American Congress of Rehabilitation Medicine Brain Injury Special Interest Group convened a Working Group of 17 members and an external interdisciplinary expert panel of 32 clinician-scientists. Public stakeholder feedback was analyzed from 68 individuals and 23 organizations.ResultsThe first 2 Delphi votes asked the expert panel to rate their agreement with both the diagnostic criteria for mild TBI and the supporting evidence statements. In the first round, 10 of 12 evidence statements reached consensus agreement. Revised evidence statements underwent a second round of expert panel voting, where consensus was achieved for all. For the diagnostic criteria, the final agreement rate, after the third vote, was 90.7%. Public stakeholder feedback was incorporated into the diagnostic criteria revision prior to the third expert panel vote. A terminology question was added to the third round of Delphi voting, where 30 of 32 (93.8%) expert panel members agreed that ‘the diagnostic label ‘concussion’ may be used interchangeably with ‘mild TBI’ when neuroimaging is normal or not clinically indicated.’ConclusionsNew diagnostic criteria for mild TBI were developed through an evidence review and expert consensus process. Having unified diagnostic criteria for mild TBI can improve the quality and consistency of mild TBI research and clinical care.     

Common data elements for research on traumatic brain injury and psychological health: current status and future development

Whyte J, Vasterling J, Manley GT. Common data elements for research on traumatic brain injury and psychological health: current status and future development.The National Institute of Neurologic Disorders and Stroke, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, National Institute on Disability and Rehabilitation Research, and Defense and Veterans Brain Injury Center jointly supported an effort to develop common data elements (CDEs, ie, consensus-based content domains of importance and recommended ways to measure them) for research on traumatic brain injury and psychological health. The authors served as participants in this effort as well as editors of the resulting articles. This article describes the current status of this multiagency endeavor, the obstacles encountered, and possible directions for future development. Challenges that occurred within the working groups that developed the CDE recommendations and similarities and differences among the articles that describe those recommendations were reviewed. Across all of the working groups, there were challenges in striking a balance between specificity in recommendations to researchers and the need to tailor the selection of variables to specific study aims. The domains addressed by the different working groups varied in the research available to guide the selection of important content areas to be measured and the specific tools for measuring them. The working groups also addressed this challenge in somewhat different ways. The CDE effort must enhance consensus among researchers with similar interests while not stifling innovation and scientific rigor. This will require regular updating of the recommendations and may benefit from more standardized criteria for the selection of important content areas and measurement tools across domains.     

Recommendations for the use of common outcome measures in traumatic brain injury research

Wilde EA, Whiteneck GG, Bogner J, Bushnik T, Cifu DX, Dikmen S, French L, Giacino JT, Hart T, Malec JF, Millis SR, Novack TA, Sherer M, Tulsky DS, Vanderploeg RD, von Steinbuechel N. Recommendations for the use of common outcome measures in traumatic brain injury research.This article summarizes the selection of outcome measures by the interagency Traumatic Brain Injury (TBI) Outcomes Workgroup to address primary clinical research objectives, including documentation of the natural course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies. Consistent with other Common Data Elements Workgroups, the TBI Outcomes Workgroup adopted the standard 3-tier system in its selection of measures. In the first tier, core measures included valid, robust, and widely applicable outcome measures with proven utility in TBI from each identified domain, including global level of function, neuropsychological impairment, psychological status, TBI-related symptoms, executive functions, cognitive and physical activity limitations, social role participation, and perceived health-related quality of life. In the second tier, supplemental measures were recommended for consideration in TBI research focusing on specific topics or populations. In the third tier, emerging measures included important instruments currently under development, in the process of validation, or nearing the point of published findings that have significant potential to be superior to some older (“legacy”) measures in the core and supplemental lists and may eventually replace them as evidence for their utility emerges.     

Sexual functioning 1 year after traumatic brain injury: findings from a prospective traumatic brain injury model systems collaborative study

Sander AM, Maestas KL, Pappadis MR, Sherer M, Hammond FM, Hanks R, and the NIDRR Traumatic Brain Injury Model Systems Module Project on Sexuality After TBI. Sexual functioning 1 year after traumatic brain injury: findings from a prospective Traumatic Brain Injury Model Systems collaborative study.ObjectiveTo investigate the incidence and types of sexual difficulties in men and women with traumatic brain injury (TBI) 1 year after injury, as well as their comfort level in discussing problems with health care professionals.DesignProspective cohort study.SettingCommunity.ParticipantsPersons with TBI (N=223; 165 men and 58 women) who had been treated at 1 of 6 participating TBI Model Systems inpatient rehabilitation units and were living in the community.InterventionsNone.Main Outcome MeasuresDerogatis Interview for Sexual Functioning-self-report (DISF-SR); Global Sexual Satisfaction Index (GSSI); structured interview regarding changes in sexual functioning; and comfort level discussing sexuality with health care professionals.ResultsWomen with TBI scored significantly below the normative sample for all subscales of the DISF-SR, including sexual cognition/fantasy, arousal, sexual behavior/experience, and orgasm. Men scored significantly below the normative sample on all scales except arousal. Women reported greater dysfunction than men for sexual cognition/fantasy and arousal. Twenty-nine percent of participants reported dissatisfaction with sexual functioning on the GSSI, with a greater percentage of men reporting dissatisfaction. Sixty-eight percent of participants indicated that they would spontaneously raise issues of sexual difficulties with health care professionals, while the remainder would either bring it up only if directly asked or would not discuss it at all.ConclusionsSexual difficulties were present in a substantial portion of community-dwelling people with TBI at 1 year after injury. Educational interventions to increase awareness among people with TBI and rehabilitation professionals are warranted, as well as interventions to improve sexual functioning.     

Comparison of the Traumatic Brain Injury (TBI) Model Systems national dataset to a population-based cohort of TBI hospitalizations

OBJECTIVE: To determine whether severity alone accounts for differences observed between a population-based cohort of acute care hospitalizations for traumatic brain injury (TBI) and the Traumatic Brain Injury Model Systems (TBIMS) national dataset. DESIGN: Prospective cohort. SETTING: Acute care hospitals in South Carolina and TBIMS rehabilitation centers. PARTICIPANTS: Subjects enrolled in the TBIMS national dataset and the South Carolina TBI Follow-up Registry (SCTBIFR). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Comparable variables in the 2 datasets included demographic characteristics, etiology of injury, initial Glasgow Coma Scale score, Abbreviated Injury Scale score for the head region derived from International Classification of Diseases codes, presence of computed tomography (CT) abnormalities, acute hospital length of stay, and payer source. RESULTS: As hypothesized, TBIMS participants showed greater initial injury severity, frequency of abnormal CT scans, and longer lengths of acute care hospitalization, explaining over 75% of cohort membership. Counter to a priori hypotheses, when all other factors were held constant, there were also differences in racial and ethnic background and insurance payer source. CONCLUSIONS: Differences between the TBIMS cohort and patients acutely hospitalized with TBI are primarily due to injury severity; however, an additional difference in payer source may need to be taken into account when generalizing findings. Results showed that TBIMS and SCTBIFR datasets are complementary, each having different strengths for understanding factors that impact long-term recovery after TBI. Recommendations are made for methodologic improvements in both data collection for the TBIMS and future outcome surveillance.     

Financial and vocational outcomes 2 years after traumatic brain injury

Purpose.?To determine outcomes for persons with traumatic brain injury (TBI) in terms of employment status, income and public assistance received at 2 years after injury.

Method.?This study was part of a non-experimental, longitudinal survey. Participants included 49 persons with new TBI from one US national Traumatic Brain Injury Model Systems centre. Main outcome measures included employment status, earned monthly income and monthly income from public sources, at the time of injury and at 2-years follow-up.

Results.?At 2-year follow-up, individuals with TBI reported higher levels of employment and earned income than was previously reported for 1-year post-injury, but continued to experience declines relative to pre-injury baseline. Frequency and amount of major public agency payments continued to be increased relative to baseline.

Conclusions.?The costs associated with brain injury remain high for individuals, families and society, as those with TBI move into the more chronic phase of recovery.     

Preinjury emotional and family functioning in caregivers of persons with traumatic brain injury

OBJECTIVE: To characterize the preinjury family functioning, emotional distress, and social support of caregivers of persons with traumatic brain injury (TBI). DESIGN: Inception cohort. SETTING: Three Traumatic Brain Injury Model Systems centers' inpatient rehabilitation facilities. PARTICIPANTS: One hundred ninety-one caregivers, primarily white and female, of persons with TBI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The Brief Symptom Inventory, Family Assessment Device, Multidimensional Scale of Perceived Social Support, and history of medical and psychiatric illness. RESULTS: Thirty-seven percent of caregivers indicated symptoms of emotional distress consistent with psychiatric diagnoses for the month before injury, whereas 27% reported a history of psychiatric or psychologic treatment at some point in the past. Between 25% and 33% of caregivers reported unhealthy family functioning in 1 or more areas for the month before injury. Persons with an annual income less than US dollars 10,000 reported less healthy preinjury family functioning. Caregivers reported good satisfaction with preinjury social support, and very few caregivers reported a history of substance abuse. CONCLUSION: A substantial proportion of caregivers reported emotional distress and/or unhealthy family functioning before injury. Such difficulties may make them more vulnerable to the stress associated with injury and result in greater coping difficulties.     

Use of neighborhood characteristics to improve prediction of psychosocial outcomes: a traumatic brain injury model systems investigation

Corrigan JD, Bogner J, Pretz C, Mellick D, Kreider S, Whiteneck GG, Harrison-Felix C, Dijkers MP, Heinemann AW. Use of neighborhood characteristics to improve prediction of psychosocial outcomes: a Traumatic Brain Injury Model Systems investigation.ObjectiveTo determine whether use of neighborhood characteristics derived from U.S. Census Bureau information contributes to the prediction of outcomes after traumatic brain injury (TBI) beyond the variance accounted for by individual characteristics.DesignCross-sectional analysis of follow-up interviews conducted 1, 2, and 5 years postinjury.SettingTwelve Traumatic Brain Injury Model Systems (TBIMS) centers.ParticipantsPatients 16 years of age and older with moderate or severe TBI enrolled in the TBIMS National Database (N=472).InterventionsNone.Main Outcome MeasuresSatisfaction With Life Scale and Participation Assessment with Recombined Tools-Objective.ResultsIndividual characteristics alone accounted for 26% and 48% of variance in life satisfaction and participation, respectively; neighborhood characteristics alone accounted for 6% and 9% of variance, respectively. Models combining both types of characteristics included significant neighborhood and individual predictors for participation but not life satisfaction; however, for participation, prediction only improved beyond that found for individual characteristics alone by 1.2%.ConclusionsThe results did not support the hypotheses that characteristics of a person's neighborhood would increase outcome prediction beyond that which can be accomplished based on characteristics of the individual alone. Though neighborhood characteristics were statistically significant in prediction models, the improvement in percent of variance accounted for was negligible. Refinements in conceptualization and methodology are suggested for continued exploration of the contribution of neighborhood characteristics to TBI outcomes.     

Financial and vocational outcomes 1 year after traumatic brain injury

OBJECTIVE: To characterize financial and vocational outcomes among persons with traumatic brain injury (TBI) in terms of employment status, earned and private income, and public assistance received at the time of injury and at 1 year after injury. DESIGN: Nonexperimental, longitudinal study. SETTING: Inpatient TBI rehabilitation unit and participants' community of residence. PARTICIPANTS: Thirty-five persons with new TBI from 1 national Traumatic Brain Injury Model Systems center. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Employment status, earned and private monthly income, and public assistance received monthly at the time of injury and at 1-year follow-up. RESULTS: From the time of injury until 1-year follow-up, the percentage of persons employed decreased from 69% to 31%; the percentage unemployed increased from 11% to 49%; the average earned monthly income declined 51% (from US dollars 1,491 to US dollars 726); and the mean total public assistance received per month increased 275% (from US dollars 153 to US dollars 421). CONCLUSION: Assuming that this study sample is representative of national statistics for TBI, during the first year after injury, TBI is associated with an estimated $642 million in lost wages, US dollars 96 million in lost income taxes, and US dollars 353 million in increased public assistance.     

Validation of a model for evaluating outcome after traumatic brain injury

OBJECTIVE: To validate a model that examines the contribution of premorbid variables, injury severity, and functional and cognitive status to outcome 1 year after traumatic brain injury (TBI). DESIGN: Cross-validation study using a larger, national, prospective, longitudinal sample. SETTING: Acute inpatient rehabilitation hospitals at Traumatic Brain Injury Model Systems centers. PARTICIPANTS: Two sample populations followed through acute rehabilitation to 1 year after TBI. The original sample included 107 patients, and the cross-validation sample included 294 patients. Participants were predominantly young men who had experienced moderate to severe TBI in motor vehicle crashes. INTERVENTIONS: Acute medical and rehabilitation care. MAIN OUTCOME MEASURES: Disability Rating Scale, Community Integration Questionnaire, and return to employment. RESULTS: Structural equation modeling was used to compare the fit of the data to a path analysis developed through clinical use and previous research. Both samples provided adequate goodness of fit, supporting the model's validity. Injury severity affected cognitive and functional status, and cognitive and functional status significantly influenced 1-year outcome. Premorbid factors and injury severity did not directly influence outcome. CONCLUSIONS: Both samples supported the proposed model, which was cross-validated. Injury severity indirectly influences outcome through its effects on cognitive and functional status. Although treatment to decrease injury severity is obviously important, concentrated rehabilitation interventions aimed at improving patients' cognitive and functional status may have a more significant impact on 1-year outcome and should be the focus of future research.     

Violent traumatic brain injury: occurrence,patient characteristics,and risk factors from the Traumatic Brain Injury Model Systems project

OBJECTIVES: To examine the occurrence of and characteristics associated with violent traumatic brain injury (TBI) in the Traumatic Brain Injury Model Systems (TBIMS) project for 4 of the 5 original Model Systems centers and to determine the patient characteristics of this group, as well as the risk factors for sustaining such an injury. DESIGN: Prospective evaluation of individuals with violent TBI over a 10-year period. SETTING: Four TBIMS centers. PARTICIPANTS: A total of 1,229 individuals who received acute hospitalization and inpatient rehabilitation care for TBI. INTERVENTIONS: Not applicable. Main Outcome Measure: The occurrence of a violent TBI. RESULTS: Twenty-six percent of the participants in the TBIMS project sustained a violent TBI. This type of injury was more common in African-American men who were single and slightly older than the average TBI patient, were unemployed before injury, and had had a previous TBI. A higher injury rate was noted in the earlier part of the evaluation period. Those who sustained a violent TBI had higher levels of caregiver burden and disability, as well as decreased productivity and community reintegration at rehabilitation discharge and at 1 and 2 years postinjury. CONCLUSIONS: The occurrence of violent TBI in the TBIMS project is consistent with national trends of decreasing incidence of violent injuries in the 1990s. These results present a profile of those who have been injured through violence. The relative risks for sustaining such an injury appear to be well defined when considering demographic and temporal factors.     

Invited Commentary on “The Report to Congress on the Management of Traumatic Brain Injury in Children”

The Centers for Disease Control and Prevention (CDC) published “The Report to Congress on the Management of Traumatic Brain Injury in Children” in the spring of 2018. The report is a call to action for professionals providing care for children with traumatic brain injury in the health, social, and educational sectors and for researchers, administrators, and agencies to develop strategies to improve outcomes. For pediatric rehabilitation providers there are clear opportunities to improve service delivery for individual patients and for the population of children after traumatic brain injury more generally. Notably there is a workforce shortage, and fragmentation exists among the various systems that serve children with traumatic brain injuries and their families.     

Evaluation of the relationship between slow-waves of intracranial pressure,mean arterial pressure and brain tissue oxygen in TBI: a CENTER-TBI exploratory analysis

Journal of Clinical Monitoring and Computing - Brain tissue oxygen (PbtO2) monitoring in traumatic brain injury (TBI) has demonstrated strong associations with global outcome. Additionally, PbtO2...     

Traumatic brain injuries sustained in the Afghanistan and Iraq wars

OVERVIEW: When traumatic brain injury (TBI) occurs simultaneously with more obviously life-threatening wounds, it may go unrecognized. Civilians and military personnel working in or near combat zones are at risk for this injury. Blast-related and closed-head injuries, rather than penetrating injuries, constitute the majority of TBIs in this population. The authors describe the experiences of the Defense and Veterans Brain Injury Center team at Walter Reed Army Medical Center in Washington, DC, and present a composite case to illustrate the nurse's role in the assessment and care of the TBI patient.     

Potential impact of the new medicare prospective payment system on reimbursement for traumatic brain injury inpatient rehabilitation

OBJECTIVE: To evaluate the potential impact of the new Medicare prospective payment system (PPS) on traumatic brain injury (TBI) rehabilitation. DESIGN: Retrospective cohort study of patients with TBI. Patients were assigned to their appropriate case-mix group (CMG) based on Medicare criteria. SETTING: Fourteen urban rehabilitation facilities throughout the United States. PARTICIPANTS: Patients with TBI admitted to inpatient rehabilitation and enrolled in the Traumatic Brain Injury Model Systems from 1998 to 2001 (N=1807). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Cost of inpatient rehabilitation admission, length of stay (LOS), and functional outcomes. RESULTS: The median cost of inpatient rehabilitation for patients with TBI exceeded median PPS payments for all TBI CMGs by 16%. Only 3 of the 14 hospitals received reimbursement under PPS that exceeded costs for their TBI patients. CONCLUSIONS: Compared with current costs, the new Medicare payment system may reimburse facilities significantly less than their costs for the treatment of TBI. To maintain their current financial status, facilities may have to reduce LOS and/or reduce resource use. With a decreased LOS, inpatient rehabilitation services will have to improve FIM efficiency or discharge patients with lower discharge FIM scores.