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 posttraumatic stress disorder research

Kaloupek DG, Chard KM, Freed MC, Peterson AL, Riggs DS, Stein MB, Tuma F. Common data elements for posttraumatic stress disorder research.An expert work group with 7 members was formed under the cosponsorship of 5 U.S. federal agencies to identify common data elements for research related to posttraumatic stress disorder (PTSD). The work group reviewed both previous and contemporary measurement standardization efforts for PTSD research and engaged in a series of electronic and live discussions to address a set of predefined aims. Eight construct domains relevant to PTSD were identified: (1) traditional demographics, (2) exposure to stressors and trauma, (3) potential stress moderators, (4) trauma assessment, (5) PTSD screening, (6) PTSD symptoms and diagnosis, (7) PTSD-related functioning and disability, and (8) mental health history. Measures assigned to the core data elements category have relatively low time-and-effort costs in order to make them potentially applicable across a wide range of studies for which PTSD is a relevant condition. Measures assigned to the supplemental data elements category have greater costs but generally demonstrate stronger psychometric performance and provide more extensive information. Accordingly, measures designated as supplemental are recommended instead of or in addition to corresponding core measures whenever resources and study design allow. The work group offered 4 caveats that highlight potential limitations and emphasize the voluntary nature of standardization for PTSD-related measurement.     

Self-reported psychosocial health among adults with traumatic brain injury

OBJECTIVE: To measure the subjective psychosocial health of a population-based sample of adults with traumatic brain injury (TBI). DESIGN: Retrospective, cohort study involving a 1-year postinjury interview. SETTING: Sixty-two acute care, nonfederal hospitals in South Carolina. PARTICIPANTS: Persons (> or =15y) hospitalized with TBI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The psychosocial health scales of the Medical Outcomes Study 36-Item Short-Form Health Survey. RESULTS: Of the 7612 participants, 29% reported poor psychosocial health. Factors associated with poor psychosocial well-being included younger age, female sex, Medicaid coverage, no health insurance, inadequate or moderate social support, comorbidities (eg, a preinjury substance abuse problem), cognitive complaints, and some or a lot of limitation with activities of daily living. Only 36% of participants who reported poor psychosocial health reported receiving any mental health services. CONCLUSIONS: A substantial proportion of persons hospitalized with TBI reported poor psychosocial health at 1 year postinjury. To optimize recovery, clinicians need to ensure that patients' psychosocial health needs are addressed during the postacute period.     

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.     

Recovery of ambulation after traumatic brain injury

OBJECTIVES: To identify variables that are predictive of independent ambulation after traumatic brain injury (TBI) and to define the time course of recovery. DESIGN: Retrospective review of consecutive admissions of patients with severe TBI over a 32-month period. SETTING: Brain injury unit in an acute, inpatient rehabilitation hospital. PARTICIPANTS: Of 264 patients screened, 116 met criteria that included the ability to participate in motor and functional evaluation on admission to acute rehabilitation, and the absence of other neurologic disorders or fractures that affect one's ability to ambulate. INTERVENTION: Inpatient rehabilitation on a specialized TBI unit by an interdisciplinary team.Main outcome measures Recovery of independent ambulation and time to recover independent ambulation. RESULTS: Of eligible patients, 73.3% achieved independent ambulation by latest follow-up (up to 5.1 mo). Patients who achieved independent ambulation were significantly younger (P<.05), had better gait scores on admission (P<.05), and tended to be less severely injured-based on duration of posttraumatic amnesia (PTA; P=.058)-than those who did not ambulate independently. There were no differences in recovery based on neuropathologic profile. Mean time to independent ambulation +/- standard deviation was 5.7+/-4.3 weeks; of those achieving independent ambulation, 82.4% did so by 2 months and 94.1% by 3 months. If not independent by 3 months postinjury, patients had a 13.9% chance of recovery. Multivariate regression analysis generated prediction models for time to independent ambulation, using admission FIM instrument scores and age (38% of variance); initial gait score, loss of consciousness, and age (40% of variance); or initial gait score and PTA (58% of variance), when restricted to just those patients with diffuse axonal injury. CONCLUSIONS: Most patients with severe TBI achieved independent ambulation; the vast majority did so within 3 months postinjury. Functional measures, injury severity measures, and age can help guide prognosis and expectations for time to recover.     

Functional oral intake and time to reach unrestricted dieting for patients with traumatic brain injury

Hansen TS, Engberg AW, Larsen K. Functional oral intake and time to reach unrestricted dieting for patients with traumatic brain injury.

Objectives

To investigate the status of functional oral intake for patients with severe traumatic brain injury (TBI) and time to return to unrestricted dieting; and to investigate whether severity of brain injury is a predictor for unrestricted dieting.

Design

Observational retrospective cohort study.

Setting

Subacute rehabilitation department, university hospital.

Participants

Patients age 16 to 65 years (N=173) with severe TBI (posttraumatic amnesia from 7d to >6mo) admitted over a 5-year period. Patients are transferred to the brain injury unit as soon as they ventilate spontaneously.

Intervention

Facial oral tract therapy.

Main Outcome Measure

Unrestricted dieting assessed by the Functional Oral Intake Scale (FOIS).

Results

We found that 93% of all patients had problems with functional oral intake at admission. Within 126 days of rehabilitation, 64% recovered to unrestricted dieting before discharge. The chance of returning to total oral diet depends on the severity of the brain injury and can be predicted by Glasgow Coma Scale (GCS; measured the day after cessation of sedation; Wald χ²=42.78, P<.01), Rancho Los Amigos Scale (RLAS) level (Wald χ²=11.84, P=.01), FIM instrument (Wald χ²=44.40, P<.01), and FOIS score at admission (Wald χ²=82.93, P<.01).

Conclusions

Impairment in functional oral intake was found to be very common for patients with severe TBI admitted to a subacute rehabilitation department. For those who recovered during hospital rehabilitation, return to unrestricted dieting happened within 126 days of rehabilitation. The chance of returning to unrestricted dieting depends on the severity of the brain injury and can be predicted by GCS score, RLAS level, FIM score, and functional oral intake at admission. These results are important when planning rehabilitation, giving information to patients and relatives, and designing efficacy studies of facial oral tract therapy, which are highly recommended.     

Position statement: definition of traumatic brain injury

Menon DK, Schwab K, Wright DW, Maas AI, on behalf of The Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury.A clear, concise definition of traumatic brain injury (TBI) is fundamental for reporting, comparison, and interpretation of studies on TBI. Changing epidemiologic patterns, an increasing recognition of significance of mild TBI, and a better understanding of the subtler neurocognitive neuroaffective deficits that may result from these injuries make this need even more critical. The Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health has therefore formed an expert group that proposes the following definition:

TBI is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force.

In this article, we discuss criteria for considering or establishing a diagnosis of TBI, with a particular focus on the problems how a diagnosis of TBI can be made when patients present late after injury and how mild TBI may be differentiated from non-TBI causes with similar symptoms. Technologic advances in magnetic resonance imaging and the development of biomarkers offer potential for improving diagnostic accuracy in these situations.     

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.     

Hyperbaric oxygen therapy for traumatic brain injury: still an enigma

Masel BE. Hyperbaric oxygen therapy for traumatic brain injury: still an enigma.With their article on the use of HBOT for post TBI dysautonomia, Lv and colleagues discuss a novel use for this form of treatment. Although HBOT has been a part of our TBI treatment armamentarium for many years, its use remains a very controversial issue. In this commentary, the science and research studies behind HBOT for TBI are reviewed, hopefully leaving the reader with an adequate knowledge base to answer a patient or family's inquiries as to the usefulness of HBOT for TBI.     

Outcome after traumatic brain injury: effects of aging on recovery

OBJECTIVE: To identify differences in outcome after traumatic brain injury (TBI) compared with orthopedic injuries as a function of age. DESIGN: Longitudinal data analyses from an inception cohort. SETTING: Outpatient rehabilitation program. PARTICIPANTS: Eighty-two orthopedic injury patients and 195 TBI patients. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Independent living, employment, and level of functioning 1 to 2 years after injury. RESULTS: Older patients and those with TBI were more likely to have increased dependence postinjury. Older TBI patients were more likely to have changes in employment status compared with orthopedic injury patients younger or TBI. The Mayo-Portland Adaptability Inventory and Disability Rating Scale were moderately predictive of level of functioning, return to employment, and independent living status 1 to 2 years postinjury. Injury severity was only mildly predictive of outcome. CONCLUSIONS: The effect of age on outcome affects recovery from neurologic injuries and, to a lesser extent, orthopedic injuries. Outcome after TBI is best predicted by patients' age and estimates of level of function at discharge. Findings suggest that older patients and those with TBI have a greater likelihood of becoming physically and financially dependent on others. Rehabilitation efforts should focus on maximizing levels of independence to limit financial and emotional costs to patients and their families.     

Major and minor depression after traumatic brain injury

Hart T, Brenner L, Clark AN, Bogner JA, Novack TA, Chervoneva I, Nakase-Richardson R, Arango-Lasprilla JC. Major and minor depression after traumatic brain injury.

Objective

To examine minor as well as major depression at 1 year posttraumatic brain injury (TBI), with particular attention to the contribution of depression severity to levels of societal participation.

Design

Observational prospective study with a 2-wave longitudinal component.

Setting

Inpatient rehabilitation centers, with 1-year follow up conducted primarily by telephone.

Participants

Persons with TBI (N=1570) enrolled in the TBI Model System database and followed up at 1-year postinjury.

Interventions

Not applicable.

Main Outcome Measures

FIM, Patient Health Questionnaire-9, Participation Assessment with Recombined Tools-Objective, Glasgow Outcome Scale-Extended, and the Satisfaction With Life Scale.

Results

Twenty-two percent of the sample reported minor depression, and 26% reported major depression at 1-year post-TBI. Both levels of depression were associated with sex (women), age (younger), preinjury mental health treatment and substance abuse, and cause of injury (intentional). There was a monotonic dose-response relationship between severity of depression and all 1-year outcomes studied, including level of cognitive and physical disability, global outcome, and satisfaction with life. With other predictors controlled, depression severity remained significantly associated with the level of societal participation at 1-year post-TBI.

Conclusions

Minor depression may be as common as major depression after TBI and should be taken seriously for its association to negative outcomes related to participation and quality of life. Findings suggest that, as in other populations, minor and major depression are not separate entities, but exist on a continuum. Further research should determine whether people with TBI traverse between the 2 diagnoses as in other patient groups.     

The association of functional oral intake and pneumonia in patients with severe traumatic brain injury

Hansen TS, Larsen K, Engberg AW. The association of functional oral intake and pneumonia in patients with severe traumatic brain injury.

Objectives

To investigate the incidence and onset time of pneumonia for patients with severe traumatic brain injury (TBI) in the early phase of rehabilitation and to identify parameters associated with the risk of pneumonia.

Design

Observational retrospective cohort study.

Setting

Subacute rehabilitation department in a university hospital in Denmark.

Participants

Patients (N=173) aged 16 to 65 years with severe TBI who were admitted during a 5-year period. Patients are transferred to the brain injury unit as soon as they ventilate spontaneously.

Interventions

Not applicable.

Main Outcome Measure

Pneumonia.

Results

Twenty-seven percent of the patients admitted to the brain injury unit were in treatment for pneumonia; pneumonia developed in 12% of the patients during rehabilitation; the condition occurred within 19 days of admission in all but 1 patient. Of these patients, 81% received nothing by mouth. Three factors identified patients at highest risk of pneumonia: Glasgow Coma Scale score less than 9 (1 day after cessation of sedation); Rancho Los Amigos Scale score less than 3 (on admission); and no oral intake on admission. Having a tracheotomy tube and/or feeding tube was also associated with a higher occurrence of pneumonia.

Conclusions

Among patients with severe TBI, 27% had pneumonia at transfer from the intensive care unit. Pneumonia developed in only 12% of the participants during rehabilitation. Patients with a low level of consciousness and patients with a tracheotomy tube or feeding tube had a higher likelihood of pneumonia.     

Brain injury research: lessons for reinventing the future. The 38th Zeiter Lecture

I discuss novel dynamics in brain injury medicine that will shape the field of physical medicine and rehabilitation over the next several years. I review the lessons from previous clinical trials and discuss how rapid biotechnologic changes will influence the lives of people with disabilities. This lecture focuses on prior paradigms and addresses lessons learned, novel strategies for reinvention (including person-specific therapies), conventional therapy programs, biomaterials and devices, cellular-based therapies, and potential therapeutic interventions.     

Dimensions of disordered attention in traumatic brain injury: further validation of the Moss Attention Rating Scale

OBJECTIVES: To investigate the factor structure of disordered attention in moderate to severe, acute traumatic brain injury (TBI) and to use factor analysis and item response theory to further validate and refine an observational rating scale of attention for clinical and research purposes. DESIGN: Multicenter inception cohort. SETTING: Inpatient rehabilitation units. PARTICIPANTS: Patients with TBI (N=372) consecutively admitted to 8 Traumatic Brain Injury Model System centers within 2 weeks prior to observation, who consistently followed commands and who were on stable doses of all psychotropic medications for a 3-day rating period. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Participants were rated independently by treating occupational and physical therapists at an average of 1 month postinjury on the Moss Attention Rating Scale (MARS), a 45-item, Likert-type scale of attention-related behavior. RESULTS: Exploratory and confirmatory factor analyses revealed 3 correlated factors of disordered attention, interpreted as restlessness/distractibility, initiation, and sustained/consistent attention. Item response (Rasch) analysis was used to eliminate redundant items and to fill gaps in item difficulty. The resulting MARS consists of 22 items that can produce 3 factor scores and a total score that covers the broad construct of disordered attention. CONCLUSIONS: The factor-scored MARS has potential utility as a quantitative observational method with which to assess and study different dimensions of disordered attention in acute TBI, and to monitor change over time and treatment response within these dimensions.     

Cholinergic augmentation with donepezil enhances recovery in short-term memory and sustained attention after traumatic brain injury

OBJECTIVE: To examine effects of donepezil on short-term memory and sustained attention in postacute patients with traumatic brain injury (TBI). DESIGN: A 24-week, randomized, placebo-controlled, double-blind crossover trial. SETTING: Outpatient clinics in 2 teaching hospitals. PARTICIPANTS: Eighteen postacute TBI patients with cognitive impairment. INTERVENTION: Patients were randomly assigned to group A or group B. Patients in group A received donepezil for the first 10 weeks and then a placebo for another 10 weeks. The 2 treatment phases were separated by a washout period of 4 weeks. Patients in group B received the preparations in the opposite order. MAIN OUTCOME MEASURES: Short-term memory and sustained attention were assessed by 2 indexes (Auditory Immediate Index [AII], Visual Immediate Index [VII]) of the Wechsler Memory Scale-III and the Paced Auditory Serial Addition Test (PASAT), at baseline, week 10, and week 24 of the trial. RESULTS: Intragroup comparison of different phases of the trial in both groups showed that donepezil significantly increased the testing scores of the AII and VII, as well as PASAT scores, compared with baseline. There was no significant change in the testing scores between assessment at baseline and the end of the placebo phase in group B. Intergroup comparison at the 10-week assessment showed significantly improved testing scores in group A with donepezil over group B with the placebo. The improved testing scores with donepezil in group A were sustained after the washout period and placebo phase, suggesting a carry-over effect of the medication. CONCLUSIONS: Donepezil increased neuropsychologic testing scores in short-term memory and sustained attention in postacute TBI patients. Cholinergic augmentation may be a viable approach to restore memory and attention after TBI.     

Spinal cord injury and co-occurring traumatic brain injury: assessment and incidence

Macciocchi S, Seel RT, Thompson N, Byams R, Bowman B. Spinal cord injury and co-occurring traumatic brain injury: assessment and incidence.

Objectives

To examine prospectively the incidence and severity of co-occurring traumatic brain injury (TBI) in persons with traumatic spinal cord injury (SCI) and to describe a TBI assessment process for SCI rehabilitation professionals.

Design

A prospective, cohort design to collect and analyze clinical variables relevant for diagnosing co-occurring TBI.

Setting

An urban, single-center National Institute of Disability and Rehabilitation Research Model Spinal Cord Injury System in the Southeastern United States.

Participants

People (N=198) who met inclusion criteria and provided consent within an 18-month recruitment window.

Interventions

Not applicable.

Main Outcome Measure

FIM cognitive scale.

Results

Based on participants' presence and duration of posttraumatic amnesia, initial Glasgow Coma Scale total score, and presence of cerebral lesion documented by neuroimaging, 60% of our traumatic SCI sample also sustained a TBI (n=118). Most co-occurring TBIs were mild (34%). Co-occurring mild complicated (10%), moderate (6%), and severe TBI (10%) were less common but still occurred in a significant percentage (26%) of persons with traumatic SCI. Persons with traumatic SCI who were injured in motor vehicle collisions and falls were more likely to sustain a co-occurring TBI. Cervical level traumatic SCI was associated with greater rates of TBI but not more severe injuries. Tree analyses established a practical algorithm for classifying TBI severity associated with traumatic SCI. Analysis of variance established criterion validity for the algorithm's TBI severity classifications.

Conclusions

Findings from our prospective study provide strong support that TBI is a common co-occurring injury with traumatic SCI. Incomplete acute care medical record documentation of TBI in the traumatic SCI population remains a considerable issue, and there is a significant need to educate emergency department and acute care personnel on the TBI clinical data needs of acute rehabilitation providers. A systematic algorithm for reviewing acute care medical records can yield valid estimates of TBI severity in the traumatic SCI population.     

Driving and community integration after traumatic brain injury

Rapport LJ, Coleman Bryer R, Hanks RA. Driving and community integration after traumatic brain injury.

Objective

To examine resumption of driving after traumatic brain injury (TBI) and its relation to community integration.

Design

Cross-sectional cohort study; survey and cognitive data.

Settings

Inpatient rehabilitation hospital of the Traumatic Brain Injury Model Systems and community.

Participants

Persons (N=261) ranging from 3 months to 15 years postinjury.

Interventions

Not applicable.

Main Outcome Measures

Barriers to Driving Questionnaire, Driver Survey, Community Integration Measure, and Craig Hospital Assessment and Reporting Technique.

Results

Forty-four percent of survivors had resumed driving; of nondrivers, 48% reported a strong desire to resume driving. Nondriver survivors who sought to resume driving generally rated themselves as currently fit to drive, viewed themselves as having physical and cognitive profiles like those of survivor drivers, and reported their greatest barriers to driving as social and resource related. However, cognitive functioning was similar to nondriver survivors who did not seek to resume driving and significantly worse than survivors who were currently driving. Nondrivers showed poorer community integration than did drivers, even after accounting for injury severity, social support, negative affectivity, and use of alternative transportation. Use of alternative transportation was common among nondrivers, but it was unrelated to community integration outcomes. Cognitive functioning moderated risk of adverse incident: among survivors with low cognitive functioning and high self-estimates of driving ability, which is indicative of unawareness of deficit, adverse incidents showed positive relation to amount of driving and inverse relation to cognitive functioning.

Conclusions

Driving status has unique and independent association with post-TBI community integration. Additional research is needed to evaluate transportation barriers that undermine full engagement in community living after TBI and to determine which barriers to driving reflect valid risk to survivors and the public.