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BACKGROUND: Traumatic brain injury (TBI) involves several aspects of a patient's condition, including physical, mental, emotional, cognitive, social, and functional changes. Therefore, a clinical trial with individuals with TBI should consider outcome measures that reflect their global status. METHODS: We present the work of the National Institute of Child Health and Development-sponsored Traumatic Brain Injury Clinical Trials Network Outcome Measures subcommittee and its choice of outcome measures for a phase III clinical trial of patients with complicated mild to severe TBI. RESULTS: On the basis of theoretical and practical considerations, the subcommittee recommended the adoption of a core of 9 measures that cover 2 different areas of recovery: functional and cognitive. These measures are the Extended Glasgow Outcome Scale; the Controlled Oral Word Association Test; the Trail Making Test, Parts A and B; the California Verbal Learning Test-II; the Wechsler Adult Intelligence Scale-III Digit Span subtest; the Wechsler Adult Intelligence Scale-III Processing Speed Index; and the Stroop Color-Word Matching Test, Parts 1 and 2. CONCLUSIONS: The statistical methods proposed to analyze these measures using a global test procedure, along with research and methodological and regulatory issues involved with the use of multiple outcomes in a clinical trial, are discussed. Language: en

Primary objective To examine return to driving and variables associated with that activity in a longitudinal database. Research design Retrospective analysis of a large, national database. Methods and procedures The sample was comprised of people with predominantly moderate-severe traumatic brain injury (TBI) enrolled in the TBI Model System national database at 16 centres and followed at 1 (n = 5942), 2 (n = 4628) and 5 (n = 2324) years after injury. Main outcomes and results Respondents were classified as driving or not driving at each follow-up interval. Five years after injury, half the sample had returned to driving. Those with less severe injuries were quicker to return to driving, but, by 5 years, severity was not a factor. Those who were driving expressed a higher life satisfaction. Functional status at rehabilitation discharge, age at injury, race, pre-injury residence, pre-injury employment status and education level were associated with the odds of a person driving. Conclusions Half of those with a moderate-severe TBI return to driving within 5 years and most of those within 1 year of injury. Driving is associated with increased life satisfaction. There are multiple factors that contribute to return to driving that do not relate to actual driving ability.

To consider the duration of post-traumatic amnesia (PTA) as a single predictor variable to determine whether categories of PTA duration exist that predict 1-year outcomes after traumatic brain injury (TBI).Using the TBI Model System database (n = 5250), the duration of PTA that predicts 1-year outcomes was calculated. Logistic regression was used to determine whether a single predictive threshold value existed. Classification and regression tree analysis then determined whether multiple threshold values existed. The area under the ROC curve and percentage correct classification were also calculated to discriminate classification accuracy and choose the best predictive thresholds.A single threshold value of PTA days was identified for all variables. At 1 year, PTA that extended into week 7 after injury predicted total FIM and FIM sub-scales. One-year employment and global outcomes were predicted by PTA extending into week 4 after injury. Independent living was predicted by PTA extending into the 8th week after injury.After moderate-to-severe TBI, determining the presence of PTA at weekly intervals can efficiently determine injury severity while providing meaningful precision when used in research and clinical outcome prediction.

Employment outcomes of racial and ethnic minority groups with traumatic brain injury (TBI) have not been thoroughly examined in the research literature beyond five years. The objective of this study was to examine differences in employment outcomes 10 years after TBI among racial and ethnic minorities. Using a multi-center, nationwide database, 382 participants (194 minorities and 188 whites) with primarily moderate to severe TBI from 16 TBI Model System Centers were examined. A logistic regression model indicated that the odds of being competitively employed versus not competitively employed at 10 years follow-up were 2.370 times greater for whites as compared to minorities after adjusting for age at injury, pre-injury employment status, cause of injury, and total length of stay (LOS). In addition, the odds of being competitively employed at 10 years follow-up versus not being competitively employed ranged from being 1.485 to 2.553 greater for those who were younger, employed at injury, had shorter total LOS, and non-violent injuries, respectively. This study supports previous research illustrating that compared to whites, employment is less promising for minorities after TBI both short and long term. Recommendations are suggested to help rehabilitation professionals target the specific needs of minorities with TBI in order to address employment disparities through culturally-based interventions and service delivery.

Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established. Citicoline, a naturally occurring endogenous compound, offers the potential of neuroprotection, neurorecovery, and neurofacilitation to enhance recovery after TBI. Citicoline has a favorable side-effect profile in humans and several meta-analyses suggest a benefit of citicoline treatment in stroke and dementia. COBRIT is a randomized, double-blind, placebo-controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate, and severe TBI. In all, 1292 patients will be recruited over an estimated 32 months from eight clinical sites with random assignment to citicoline (1000 mg twice a day) or placebo (twice a day), administered enterally or orally. Functional outcomes are assessed at 30, 90, and 180 days after the day of randomization. The primary outcome consists of a set of measures that will be analyzed as a composite measure using a global test procedure at 90 days. The measures comprise the following core battery: the California Verbal Learning Test II; the Controlled Oral Word Association Test; Digit Span; Extended Glasgow Outcome Scale; the Processing Speed Index; Stroop Test part 1 and Stroop Test part 2; and Trail Making Test parts A and B. Secondary outcomes include survival, toxicity, and rate of recovery.

Hanks RA, Millis SR, Ricker JH, Giacino JT, Nakese-Richardson R, Frol AB, Novack TA, Kalmar K, Sherer M, Gordon WA. The predictive validity of a brief inpatient neuropsychologic battery for persons with traumatic brain injury. Objective To examine the predictive validity of a brief neuropsychologic test battery consisting of the Galveston Orientation and Amnesia Test, the California Verbal Learning Test–II, Trail-Making Test (TMT), Symbol Digit Modalities Test, grooved pegboard, phonemic and categorical word generation tasks, the Wechsler Test of Adult Reading (WTAR), and the Wisconsin Card Sorting Test–64 relative to functional outcome at 1 year in persons with traumatic brain injury. Design Inception cohort study. Follow-up period of 12 months. Setting Seven Traumatic Brain Injury Model System centers. Neuropsychologic testing was conducted during the acute inpatient rehabilitation stay and functional outcome measures were obtained at 1-year outpatient follow-up. Participants Adults (N=174) who met criteria for admission to inpatient brain injury rehabilitation. Interventions Not applicable. Main Outcome Measures FIM instrument, Disability Rating Scale, Supervision Rating Scale, Satisfaction With Life Scale (SWLS), and Glasgow Outcome Scale−Extended. Results Multiple regression analyses revealed that performance on the neuropsychologic test battery was predictive of outcome at 1 year postinjury for all outcome measures, except FIM motor scores and the SWLS. Cognitive performance using this battery was found to predict 1-year outcomes above and beyond functional variables and injury severity variables collected during inpatient rehabilitation, thereby indicating incremental validity for this test battery. Individual tests that were found to be significant predictors of 1-year outcomes included the WTAR and TMT part B. Conclusions These findings support the clinical utility and ecological validity of this battery with respect to level of disability, functional independence, and supervision required.

Rehabilitation using cognitive and behavioural treatment methods (i.e., experience-based interventions) faces particular challenges in improving its evidence base through rigorous studies such as randomised controlled trials (RCTs). Experience-based treatments are often complex, with multiple "active ingredients" that may be difficult to characterise. In addition to the difficulty in specifying treatment ingredients, experience-based rehabilitation researchers face challenges in designing or selecting appropriate control or comparison conditions to test the efficacy of complex treatments. Based on lessons learned in designing a cognitive-behavioural intervention for anger self-management for people with traumatic brain injury (TBI) for the National Institutes of Health (NIH)-funded TBI Clinical Trials Network, we review the advantages, disadvantages and applications of a variety of control conditions for experience-based interventions. We discuss controls in which active treatments are withheld (no-treatment controls, waitlist controls, and placebo-analogue designs); controls that involve comparison to naturally occurring or devised usual care treatments; and conditions that compare active treatments (dismantling designs, dose controls, and equivalence trials). Recommendations for selecting and developing control groups that maximise both equipoise and participant enrolment/retention are discussed.

Patterns of recovery from traumatic brain injury (TBI) vary greatly across individuals. Using archival data from the Traumatic Brain Injury Model Systems, recovery of memory following TBI as measured by scores on the Rey Auditory Verbal Learning Test (RAVLT) through 5 years postinjury was examined via mixed-effects modeling. Individual-level variables of age and posttraumatic amnesia duration were significant predictors of 1-year RAVLT total score. None of the variables examined predicted the trajectory of memory recovery after 1 year. Mixed-effects analyses can be helpful in determining the effect of intervention while allowing for missing data across time points.

OBJECTIVE: To (1) identify groups of persons with traumatic brain injury (TBI) who differ on 12 dimensions of cognitive function: cognitive, emotional, and physical symptoms; personal strengths; physical functioning; environmental supports; and performance validity; and (2) describe patterns of differences among the groups on these dimensions and on participation outcome. SETTING: Three centers for rehabilitation of persons with TBI. PARTICIPANTS: A total of 504 persons with TBI living in the community who were an average (standard deviation) of 6.3 (6.8) years postinjury and who had capacity to give consent, could be interviewed and tested in English, and were able to participate in an assessment lasting up to 4 hours. DESIGN: Observational study of a convenience sample of persons with TBI. MAIN MEASURES: Selected scales from the Traumatic Brain Injury Quality of Life measures, Neurobehavioral Symptom Inventory, Economic Quality of Life Scale, Family Assessment Device General Functioning Scale, measures of cognitive function, Word Memory Test, and Participation Assessment with Recombined Tools-Objective (PART-O) scale. RESULTS: Cluster analysis identified 5 groups of persons with TBI who differed in clinically meaningful ways on the 12 dimension scores and the PART-O scale. CONCLUSION: Cluster groupings identified in this study could assist clinicians with case conceptualization and treatment planning. Language: en

Walker WC, Marwitz JH, Kreutzer JS, Hart T, Novack T. Occupational categories and return to work after traumatic brain injury: a multicenter study. Objective To further evaluate determinants of return to work (RTW) after traumatic brain injury (TBI), with focus on the relation between preinjury occupational category and RTW outcome. Design Prospective collaborative cohort study. Setting Seventeen National Institute on Disability and Rehabilitation Research–designated Traumatic Brain Injury Model Systems. Participants Consecutive sample of 1341 patients (age range, 18–62y) who were hospitalized with a TBI diagnosis, received both acute neurotrauma services and inpatient rehabilitation services, consented to participate, were employed before injury, and completed a 1-year follow-up assessment. Intervention An inpatient interdisciplinary brain injury rehabilitation program. Main Outcome Measure Competitive employment at 1 year postinjury. Results Participants were categorized into 1 of 3 groups depending on preinjury occupational title: professional/managerial (n=192), skilled (n=751), or manual labor (n=398). Chi-square analyses were computed to examine changes across occupation groups between preinjury occupation group and postinjury RTW. The rate of successful RTW was greatest for professional/managerial (56%), lower for skilled (40%), and lowest for manual labor (32%), yielding an odds ratio of 2.959 between the highest and lowest groups. Of those with successful RTW, most did so within the same occupational category grouping. A multiple logistic regression showed that preinjury occupation, education level, discharge FIM score, age, sex, marital status, and hospital length of stay each influenced RTW. Conclusions Prior research has shown that preinjury employment status (employed vs unemployed) greatly influences the odds of successful RTW after TBI. A related hypothesis, that occupational classification also influences RTW outcome, has been understudied and has yielded conflicting results. The current study shows convincingly that the type of occupation influences RTW outcome, with the best prospect for RTW among people with professional/managerial jobs. Occupational category should be examined in the future development of predictive models for RTW after TBI.

Primary objective: To investigate the relationship between performance on the Useful Field of View Test (UFOV) and driving performance following traumatic brain injury (TBI).Participants: Sixty people with TBI referred for driving evaluation.Measures: Useful Field of View Test, Global Rating Scale and Driver Assessment Scale.Results: Subject performance diminished as the complexity of the UFOV sub-tests increased. There was a significant relationship between UFOV performance, particularly on the second sub-test, and on-road driving performance. Subject age and Trail Making Test, Part B were also predictive of driving performance.Conclusions: The UFOV can be used as a screening measure to determine readiness to participate in an on-road driving assessment.

To investigate empirically change in medical decision-making capacity (MDC) in patients with traumatic brain injury (TBI).Longitudinal study comparing control and TBI groups at hospitalization and at 6 months postinjury.Inpatient brain injury rehabilitation unit.Twenty healthy controls and 24 patients with moderate to severe TBI.Not applicable.MDC was measured by using the Capacity to Consent to Treatment Instrument (CCTI). The CCTI evaluates performance on a series of 4 accepted consent abilities, or standards: S1 (evidencing/communicating choice), S3 (appreciating consequences), S4 (reasoning about treatment), and S5 (understanding the treatment situation and choices), and 1 experimental standard [S2] (making the reasonable treatment choice when the alternative choice is unreasonable). In addition, TBI patients were assigned 1 of 3 capacity outcomes (capable, marginally capable, incapable) for each standard.At hospitalization, TBI patients performed equivalently with controls on standards S1 and [S2] but significantly below controls on S3 ( P.001), S4 ( P.02), and S5 ( P.001). At 6-month follow-up, TBI patients showed significant within-group improvement on these 3 standards (S3, S4, S5) but continued to fall significantly below controls on S3 ( P.006) and S5 ( P.001). A group by time interaction emerged on S5 ( P.02). The TBI group showed increasing proportions of capable outcomes on all standards over the 6 months.Patients with TBI showed initial impairment and subsequent partial recovery of MDC over a 6-month period. Complex consent abilities of appreciation, reasoning, and understanding were significantly impaired in hospitalized acute TBI patients. At follow-up, TBI patients showed substantial recovery of reasoning and partial recovery of appreciation and understanding consent abilities. The study suggests the importance in the rehabilitation setting of serial evaluations of MDC in patients with TBI.

The validity, reliability, and factor structure of the Center for Epidemiological Studies-Depression Scale (CES-D) was examined with 253 patients seen for neuropsychological evaluation following traumatic brain injury (TBI). All patients completed the CES-D; 31 also completed the Beck Depression Inventory (BDI) and 17 completed the Minnesota Multiphasic Personality Inventory-II (MMPI-II). The CES-D demonstrated good concurrent, construct validity, significantly correlating with the BDI (r = .673, p < .0001) and the MMPI-II (Depression Scale T score r = .536, p = .027). The CES-D also demonstrated good internal consistency (coefficient alpha = .8195) and split-half reliability (Spearman–Brown r = .8284). Principal components factor analysis with varimax rotation resulted in a four-factor solution that accounted for 56.01% of the variance. The factor structure differed from the originally reported factor structure, and indicated that somatic difficulties were strongly associated with dysphoric affect in TBI patients. The CES-D is a valid and reliable screening instrument for use with TBI patients.

Objective: To examine whether the Wide Range Achievement Test–3 (WRAT-3) Reading subtest (S. Jastak & G. S. Wilkenson, 1984; G. S. Wilkinson, 1993) measures premorbid intelligence in persons with traumatic brain injury (TBI). Participants: Sixty individuals (63% male, 78% Caucasian, mean age 38 years) tested during acute rehabilitation hospitalization following TBI and 1 year later. Results: Slight (4.4 points) increase in WRAT-3 Reading scores was observed but with greater, although nonsignificant (p .12), increase for those with greater injury severity. Conclusions: The WRAT-3 Reading subtest is a better hold test for individuals who sustain mild TBI.

Bush BA, Novack TA, Malec JF, Stringer AY, Millis SR, Madan A. Validation of a model for evaluating outcome after traumatic brain injury. Arch Phys Med Rehabil 2003;84:1803–7. 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 predominately 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.

Alderson AL, Novack TA. Reliable serial measurement of cognitive processes in rehabilitation: the Cognitive Log. Arch Phys Med Rehabil 2003;84:668-72. Objective: To evaluate the reliability and utility of a brief quantitative measure of cognitive recovery, the Cognitive Log (Cog-Log), developed for daily use with rehabilitation inpatients to provide information about the recovery of higher neurocognitive processes including verbal recall, attention, working memory, motor sequencing, and response inhibition. Design: Descriptive study of the Cog-Log's normative scores, reliability (interrater, internal consistency), and validity as shown by its relationship to standard neuropsychologic measures. Setting: Inpatient rehabilitation hospital affiliated with a large university medical center. Participants: One hundred fifty neurorehabilitation inpatients with acquired brain injury; 83 young adults without acquired brain injury were included to provide normative data. Interventions: Not applicable. Main Outcome Measures: The Cog-Log; standardized neuropsychologic measures of memory (Wechsler Memory Scale-Revised, Rey Auditory Verbal Learning Test), language, attention (Wechsler Adult Intelligence Scale-Revised), and reasoning (Trail Making Test). Results: Reliability analysis showed strong interrater reliability across items (Spearman r , .749–1.00) and high internal consistency (Cronbach α=.778). Factor analysis of the Cog-Log using principal components extraction revealed a unitary factor (eigenvalue=3.48). Cog-Log items designed to measure working memory and immediate and delayed verbal memory were most strongly predictive of performance on similar standardized neuropsychologic measures administered on the same day. Conclusion: The Cog-Log appears to be a reliable and efficient tool for measuring ongoing neurocognitive recovery during inpatient rehabilitation.

Background: Traumatic brain injury (TBI) caused by a high-speed transportation accident results in a mechanism of injury commonly described as diffuse axonal injury (DAI), which is associated with a reduction in dopamine turnover in the brain. Because of its affect on both dopamine and N-methyl-D-aspartate (NMDA) channels, amantadine has been the subject of considerable interest and clinical use in acute TBI. Participants: In this study, 35 subjects, who had a TBI in a transportation accident and were initially seen with a Glasgow Coma Scale score of 10 or less within the first 24 hours after admission, were randomly assigned to a double-blind, placebo-controlled, crossover design trial. Main Outcome Measures: Amantadine, 200 mg, or placebo was each administered for 6 weeks (12 weeks total) to patients who were recruited consecutively. Results: There was an improvement in the Mini-Mental Status (MMSE) scores of 14.3 points (PD .0185), Disability Rating Scale (DRS) score of 9.8 points (PD .0022), Glasgow Outcome Scale (GOS) score of 0.8 points (PD .0077), and in the FIM Cognitive score (FIM-cog) TM of 15.1 points (PD .0033) in the group that received amantadine during the first 6 weeks (group 1), but there was no improvement in the second 6 weeks on placebo (P> .05). In group 2 (active drug second 6 weeks), there was an improvement in the MMSE of 10.5 points, in the DRS of 9.4 points (PD .0006), in the GOS of 0.5 points (PD .0231), and in the FIM-cog of 11.3 points (PD .0030, Wilcoxon signed rank) spontaneously in the first 6 weeks on placebo (PD .0015). However, group 2 gained a statistically significant additional 6.3 points of recovery in the MMSE (PD .0409), 3.8 points in the DRS (PD .0099), 0.5 points in the GOS (PD .4008), and 5.2 points in the FIM-cog (PD .0173, Wilcoxon signed rank) between the sixth week and the twelfth week of treatment on the active drug. Conclusions: There was a consistent trend toward a more rapid functional improvement regardless of when a patient with DAI-associated TBI was started on amantadine in the first 3 months after injury. Key words: amantadine, diffuse axonal injury

To further evaluate the use of the orientation log (O-Log) in an acute rehabilitation program for adults with traumatic brain injury (TBI), specifically focusing on prediction of rehabilitation outcome, possible use of the O-Log to promote recovery, and development of templates of orientation recovery.Stepwise discriminant function analysis was used in one study and ANOVA based on between-groups comparisons in another. Confidence intervals were established in the third study.Acute rehabilitation hospital.Samples were taken from an overall pool of 389 subjects with predominantly severe TBI based on Glasgow Coma Scale score.A combination of initial O-Log performance, time since injury, and number of O-Log assessments correctly predicted resolution of disorientation for 76% of the sample. Individuals attaining orientation before discharge achieved higher discharge scores on functional measures. Administration of the O-Log 3 versus 5 times a week did not result in more rapid resolution of disorientation. A similar pattern of steady improvement in orientation was evident for mild-moderate and severe injury cases across 10 administrations.Recovery of orientation provides important information about recovery following TBI and is predictive of rehabilitation outcome. More frequent administration of a formal orientation measure does not seem to expedite the recovery of orientation, which on average seems to progress at a steady pace in a rehabilitation setting regardless of the time since injury or severity of injury.

In 1804, Troxler discovered that, when an observer fixates on a point in central vision and attends to a peripheral stationary stimulus, the peripheral stimulus eventually fades from awareness. This phenomenon is known as Troxler's effect and is allegedly influenced by spatial attention. Asymmetries in Troxler's effect along horizontal and vertical meridian were a recent discovery. However, viewer- and environment-centered reference frames were aligned in prior studies, making it impossible to assess whether asymmetries correspond to viewer-versus environment-centered coordinate systems. This study was undertaken to (a) replicate the asymmetries in the upright condition among 39 participants without health issues and (b) use the asymmetrics to test contrasting predictions made by viewer- and environment-centered coordinate systems when they are decoupled using an experimental head-tilt condition. The horizontal and vertical asymmetries were replicated and consistent with a viewer-centered rather than an environment-centered reference frame.

BACKGROUND: Traumatic brain injury (TBI) survivors often have sensory and cognitive impairments that may interfere with driving ability. The Useful Field of View (UFOV) is a measure of visual information processing that is a good predictor of vehicle crash risk in older adults. OBJECTIVE: The objective of this study was to explore the possibility that UFOV is compromised after TBI. DESIGN: UFOV performance of 23 TBI survivors and 18 young adults without neurological impairment were compared. CONCLUSION: TBI survivors had higher UFOV scores than young adults, which indicated a greater functional loss of peripheral vision. The results suggest that the UFOV may be a valuable instrument for assessing driving readiness in TBI survivors.

Given the growing patient population with hemoglobinopathies needing total joint arthroplasty (TJA) and paucity of literature addressing this cohort, we examined the in-hospital complications in patients with hemoglobinopathies undergoing TJA. International Classification of Diseases, Ninth Revision codes were used to search the Nationwide Inpatient Sample database for hemoglobinopathy patients undergoing primary or revision TJA. Hemoglobinopathy patients had a significant increase in cardiac, respiratory, and wound complications; blood product transfusion; pulmonary embolism; surgical site infection; and systemic infection events, while there was no significant effect on deaths, deep vein thrombosis, and renal complications. It may be prudent to implement blood conservation strategies as well as diligent postoperative protocols to minimize the need for transfusion and related complications in this patient population.

Objective To investigate recovery of medical decision-making capacity (MDC) over 6 months in persons with traumatic brain injury (TBI) stratified by injury severity. Design Longitudinal study comparing controls and patients with TBI 1 month after injury (t1) and 6 months after injury (t2). Setting Inpatient TBI rehabilitation unit and outpatient neurology department. Participants Participants (N=151) consisted of control subjects (n=60) and patients with TBI (n=91) stratified by injury severity: mild TBI (mTBI; n=27), complicated mild TBI (cmTBI; n=20), and moderate/severe TBI (msevTBI; n=44). Interventions Not applicable. Main Outcome Measures We used the Capacity to Consent to Treatment Instrument to evaluate MDC performance on 5 consent standards (expressing choice, reasonable choice, appreciation, reasoning, and understanding). We also assigned capacity impairment ratings on the consent standards to each participant with TBI using cut scores referenced to control performance. Results Control performance was stable across time on the consent standards. Patients with mTBI and cmTBI performed below controls on the understanding standard at t1 but not t2. Patients with msevTBI performed below controls on appreciation, reasoning, and understanding at t1, and on appreciation and understanding at t2, but showed substantial improvement over time. Conclusions Regardless of injury severity, all groups with TBI demonstrated baseline impairment of MDC with subsequent partial or full recovery of MDC over a 6-month period. However, a sizeable proportion of individual patients with TBI in each group continued to demonstrate capacity compromise at 6 months postinjury. Clinically, this finding suggests that individuals with TBI, regardless of injury severity, need continued monitoring regarding MDC for at least 6 months after injury.

Restlessness and agitation following traumatic brain injury are potential barriers to successful rehabilitation. Although there are several ways to address the problem, including environmental management, physical restraint, and medication, the type of treatment which would be most appropriate under particular circumstances has not been established. Existing treatment studies often suffer from an emphasis on anecdotal information rather than measurement of restlessness/agitation. Use of the Agitated Behavior Scale would help remedy this situation by allowing more consistent decisions about beginning and altering treatment and providing a measurement device to clarify research results, particularly with respect to the use of medications.

BACKGROUND:: An estimated 40% to 60% of individuals who experience a moderate to severe traumatic brain injury (TBI) return to driving. However, little is known about driving behavior post-TBI and how this may be related to demographic, injury, and outcome factors. METHODS:: A total of 184 participants who experienced moderate to severe TBI were included in this study. Participants completed a telephone survey regarding return to driving and current driving behavior. Structural equation modeling was used to analyze predicted relationships between demographic and injury-related variables with driving exposure and avoidance within 5 years of injury. RESULTS:: The model indicated that participants who were older and female tended to avoid a greater number of challenging everyday driving scenarios. Participants who had more severe injuries and those with poorer performance on cognitive measures at the time of rehabilitation discharge were likely to drive less frequently and over less distances at follow-up, though they did not avoid challenging driving situations. CONCLUSIONS:: Young men and those with more severe injuries may require additional attention regarding their driving behavior following TBI. Language: en

Meythaler JM, Peduzzi JD, Eleftheriou E, Novack TA. Current concepts: diffuse axonal injury–associated traumatic brain injury. Arch Phys Med Rehabil 2001;82:1461-71. Objectives: To review the probable physical, physiologic mechanisms that result in the medical and neuropsychologic complications of diffuse axonal injury (DAI)–associated traumatic brain injury (TBI). Data Sources: Various materials were accessed: MEDLINE, textbooks, scientific presentations, and current ongoing research that has been recently reported. Study Selection: Included were scientific studies involving TBI, particularly direct injury to the axons and glia of the central nervous system (CNS) in both in vitro and in vivo models. These studies include pathologic findings in humans as well as the medical complications and behavioral outcomes of DAI. Studies that addressed animal models of DAI as well as cellular and/or tissue models of neuronal injury were emphasized. The review also covered work on the physical properties of materials involved in the transmission of energy associated with prolonged acceleration-deceleration injuries. Data Extraction: Studies were selected with regard to those that addressed the mechanism of TBI associated with DAI and direct injury to the axon within the CNS. The material was generally the emphasis of the article and was extracted by multiple observers. Studies that correlate the above findings with the clinical picture of DAI were included. Data Synthesis: Concepts were developed by the authors based on the current scientific findings and theories of DAI. The synthesis of these concepts involves expertise in physical science, basic science concepts of cellular injury to the CNS, acute medical indicators of DAI, neuropsychologic indicators of DAI, and rehabilitation outcomes from TBI. Conclusions: The term DAI is a misnomer. It is not a diffuse injury to the whole brain, rather it is predominant in discrete regions of the brain following high-speed, long-duration deceleration injuries. DAI is a consistent feature of TBI from transportation-related injuries as well as some sports injuries. The pathology of DAI in humans is characterized histologically by widespread damage to the axons of the brainstem, parasagittal white matter of the cerebral cortex, corpus callosum, and the gray-white matter junctions of the cerebral cortex. Computed tomography and magnetic resonance imaging scans taken initially after injury are often normal. The deformation of the brain due to plastic flow of the neural structures associated with DAI explains the micropathologic findings, radiologic findings, and medical and neuropsychologic complications from this type of injury mechanism. There is evidence that the types of cellular injury in TBI (DAI, anoxic, contusion, hemorrhagic, perfusion-reperfusion) should be differentiated, as all may involve different receptors and biochemical pathways that impact recovery. These differing mechanisms of cellular injury involving specific biochemical pathways and locations of injury may, in part, explain the lack of success in drug trials to ameliorate TBI. © 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

To establish whether or not the serotonin reuptake inhibitor (SSRI) sertraline can improve arousal and alertness of patients with traumatic brain injury (TBI) and associated diffuse axonal injury (DAI). Serotonin is a major inhibitory as well an excitatory neurotransmitter, and serotonergic neurons modulate the activity of brain regions responsible for motor control, arousal, attention, and emotional regulation.Tertiary care inpatient rehabilitation centre directly attached to a university hospital level-one trauma centre.Prospective placebo-controlled randomized trial utilizing sertraline on admission to acute rehabilitation.Eleven subjects, post-high speed motor vehicle crash and post-severe TBI (GCSor = 8) with presumed DAI randomized to receive either sertraline 100mg per day or placebo for 2 weeks. All subjects were within 2 weeks of acute injury. Outcome measures recorded were the Orientation Log (daily), Agitated Behaviour Scale (daily), and the Galveston Orientation and Amnesia Test (weekly).Both placebo and active medication groups demonstrated similar rates of improvement on all three scales. There was no difference in the rates of recovery for either study group (p0.05, ANOVA with repeated measures). The groups did not demonstrate a statistically significant negative effect on recovery either, although the size is too small for a statistically reliable beta-effect.This pilot study fails to establish whether the early use of sertraline may improve alertness, decrease agitation or improve cognitive recall of material. This may be due to the small size of the study group, the brief duration of treatment or by a skewed placebo group. Larger studies will be required to prove any efficacy. There were no complications with its use and sertraline did not demonstrate a detrimental effect on recovery. This indicates that sertraline may be safe to use in the treatment of psychiatric or behavioural complications attributable to TBI.

This study evaluated the ability of the Orientation Log (O-Log) to predict cognitive outcome at rehabilitation discharge, as well as future neuropsychological outcome. The hypothesis was that patients who demonstrated better orientation upon admission would achieve superior functional cognitive outcome at discharge and on subsequent neuropsychological assessment. Sixty individuals receiving inpatient rehabilitation following a new-onset TBI participated. Orientation data was collected using the O-Log during morning bedside rounds. Outcome data was collected at 6 and 12 months post-injury. Significant correlations were found between the O-log and measures of memory, executive functioning, basic verbal skills, and estimated intellectual ability. When compared to the other predictor variables, step-wise multiple regression analyses revealed that the minimum O-Log score was the primary significant predictor of performance on six neuropsychological and functional outcome measures. Results of this study suggest that evaluating orientation with the O-Log during acute rehabilitation may reflect level of injury severity and aid in predicting cognitive outcome.

Objective: To introduce a brief quantitative measure of cognitive orientation (to place, time, and situation) developed for daily use at bedside with rehabilitation inpatients. The Orientation Log (O-Log) is a 10-item scale that allows for partial credit based on responsiveness to logical, multiple-choice, or phonemic cueing. It is formatted for rapid visual analysis of orientation trends that can be used to evaluate pharmacologic and cognitive-behavioral interventions. Design: Descriptive study of the O-Log's reliability (interrater and internal consistency). Setting: Inpatient rehabilitation center affiliated with a large university medical school. Patients: Fifteen neurorehabilitation inpatients. Results: For individual items, Spearman rho interrater reliability coefficients ranged from .851 to 1.00. The interrater reliability of the total score was .993. O-Log internal consistency (coefficient alpha) was .922. Conclusions: The O-Log is a reliable and easily administered scale that promises to be a useful tool in monitoring cognitive recovery during rehabilitation.

Survivors of traumatic brain injury often have long-term sensory, cognitive and motor deficits that may impair vehicle operation. However, relatively little is known about the driving status and driving characteristics of brain injury survivors. To better understand driving following traumatic brain injury, a survey of driving status, driving exposure, advice received about driving and evaluations of driving competency was administered to a convenience sample of traumatic brain injury survivors (n = 83). The majority of survey participants had experienced either moderate or severe traumatic brain injuries based on the Glasgow Coma Scale. A total of 60% of the survey participants reported that they were currently active drivers. Most individuals (> 60%) who had returned to driving reported driving every day and more than 50 miles per week. Traumatic brain injury survivors frequently received advice about driving from family members, physicians or non-physician health care professionals, but over half (63%) had not been professionally evaluated for driving competency. The presence of high driving exposure, coupled with a lack of widespread driving fitness testing, suggests that some traumatic brain injury survivors have characteristics that may evaluate their risk for vehicle crashes. However, subsequent prospective studies that directly assess driver safety will be needed to confirm this possibility.

Psychiatric disturbance is common and disabling after traumatic brain injury (TBI). Few studies have investigated the trajectory of psychiatric symptoms in the first 6 months postinjury, when monitoring and early treatment might prevent persistent difficulties. The aim of this study was to examine the trajectory of psychiatric symptoms 1–6 months post-TBI, the patient/injury characteristics associated with changes, and characteristics predictive of persisting symptoms. A secondary analysis was performed on data from a clinical trial with three data collection points. Across eight centers, 872 participants with complicated mild to severe TBI were administered the Brief Symptom Inventory (BSI) at 30, 90, and 180 days postinjury. Mixed-effects models were used to assess longitudinal changes in the BSI Global Severity Index (GSI). Multi-variate logistic regression was used to assess predictors of clinically significant GSI elevations persisting to 6 months post-TBI. In general, GSI scores improved over time. Women improved faster than men; race/ethnicity was also significantly associated with rate of change, with Hispanics showing the most and African Americans the least improvement. Clinically significant psychiatric symptoms (caseness) occurred in 42% of the sample at 6 months, and more than one type of symptom was common. Significant predictors of caseness included African American race, age from 30 to 60 years, longer post-traumatic amnesia (PTA) duration, pre-TBI unemployment, and pre-TBI risky alcohol use. Findings indicate that psychiatric symptoms are common in the first 6 months post-TBI and frequently extend beyond the depression and anxiety symptoms that may be most commonly screened. Patients with longer PTA and preinjury alcohol misuse may need more intensive monitoring for symptom persistence.

This article reviews cellular energy transformation processes and neurochemical events that take place at the time of brain injury and shortly thereafter, emphasizing hypoxia-ischemia, cerebrovascular accident, and traumatic brain injury. New interpretations of established concepts, such as diffuse axonal injury, are discussed; specific events, such as free radical production, excess production of excitatory amino acids, and disruption of calcium homeostasis, are reviewed. Neurochemically-based interventions are also presented: calcium channel blockers, excitatory amino acid antagonists, free radical scavengers, and hypothermia treatment. Concluding remarks focus on the role of clinical neuropsychologists in validation of treatment interventions.

The performance of 35 individuals with severe traumatic brain injury (TBI) on the California Verbal Learning Test (CVLT) was examined on two occasions averaging 2 and 5 months postonset. Severe deficits in learning across trials, delayed recall, cued recall, and recognition were noted initially, with improvement evident at the second evaluation. Subjects with TBI did not reach normal levels of performance, however, based on comparisons with a control sample. Intrusion of inappropriate information during recall was more common among TBI subjects, and use of memory strategies was less than anticipated.

Traumatic brain injury (TBI) is a serious public health problem in the United States, yet no treatment is currently available to improve outcome after TBI. Approved for use in TBI in 59 countries, citicoline is an endogenous substance offering potential neuroprotective properties as well as facilitated neurorepair post injury.To determine the ability of citicoline to positively affect functional and cognitive status in persons with complicated mild, moderate, and severe TBI.The Citicoline Brain Injury Treatment Trial (COBRIT), a phase 3, double-blind randomized clinical trial conducted between July 20, 2007, and February 4, 2011, among 1213 patients at 8 US level 1 trauma centers to investigate effects of citicoline vs placebo in patients with TBI classified as complicated mild, moderate, or severe.Ninety-day regimen of daily enteral or oral citicoline (2000 mg) or placebo.Functional and cognitive status, assessed at 90 days using the TBI-Clinical Trials Network Core Battery. A global statistical test was used to analyze the 9 scales of the core battery. Secondary outcomes were functional and cognitive improvement, assessed at 30, 90, and 180 days, and examination of the long-term maintenance of treatment effects.Rates of favorable improvement for the Glasgow Outcome Scale-Extended were 35.4% in the citicoline group and 35.6% in the placebo group. For all other scales the rate of improvement ranged from 37.3% to 86.5% in the citicoline group and from 42.7% to 84.0% in the placebo group. The citicoline and placebo groups did not differ significantly at the 90-day evaluation (global odds ratio [OR], 0.98 [95% CI, 0.83-1.15]); in addition, there was no significant treatment effect in the 2 severity subgroups (global OR, 1.14 [95% CI, 0.88-1.49] and 0.89 [95% CI, 0.72-1.49] for moderate/severe and complicated mild TBI, respectively). At the 180-day evaluation, the citicoline and placebo groups did not differ significantly with respect to the primary outcome (global OR, 0.87 [95% CI, 0.72-1.04]).Among patients with traumatic brain injury, the use of citicoline compared with placebo for 90 days did not result in improvement in functional and cognitive status.clinicaltrials.gov Identifier: NCT00545662.

To understand the course of changes in function and need for assistance in the chronic stages of TBI; and to identify factors associated with these changes.Longitudinal review of participants in the TBI Model Systems Database, who have been prospectively followed for at least 10 years.Four hundred and seventy-eight individuals with TBI that occurred between 25 October 1988 and 31 December 1998, enrolled in the TBI Model Systems National Database, eligible for 10-year follow-up when data was extracted, with completed data collection at either year 1 or 2 and year 10.Significant between age group differences were found for FIM toileting, bladder, bowel, toilet transfers, locomotion, problem-solving and memory; SRS; DRS level of functioning, employability and total; and GOS. With regard to functional independence, there were significant differences by age category for all FIM components except memory. Significant differences were noted for age category and level of dependence as measured by the DRS (LOF 1.5-5) and GOS (GOS 2-4). Supervision needs significantly increased as a function of age. Significant differences were found for diminished function over time. Significant differences were noted for residence at 10 years post-injury.For those individuals that survive to 10 years post-TBI, age is a major factor in requiring assistance of another person for supervision as well as assistance in basic self-care, continence and mobility.

Objective: To investigate medical decision-making capacity (MDC) in patients with acute traumatic brain injury (TBI) across a range of injury severity. Methods: We evaluated MDC cross-sectionally 1 month after injury in 40 healthy controls and 86 patients with TBI stratified by injury severity (28 mild [mTBI], 15 complicated mild [cmTBI], 43 moderate/severe [msevTBI]). We compared group performance on the Capacity to Consent to Treatment Instrument and its 5 consent standards (expressing choice, reasonable choice, appreciation, reasoning, understanding). Capacity impairment ratings (no impairment, mild/moderate impairment, severe impairment) on the consent standards were also assigned to each participant with TBI using cut scores referenced to control performance. Results: One month after injury, the mTBI group performed equivalently to controls on all consent standards. In contrast, the cmTBI group was impaired relative to controls on the understanding standard. No differences emerged between the mTBI and cmTBI groups. The msevTBI group was impaired on almost all standards relative to both control and mTBI groups, and on the understanding standard relative to the cmTBI group. Capacity compromise (mild/moderate or severe impairment ratings) on the 3 clinically complex standards (understanding, reasoning, appreciation) occurred in 10%–30% of patients with mTBI, 50% of patients with cmTBI, and 50%–80% of patients with msevTBI. Conclusions: One month following injury, MDC is largely intact in patients with mTBI, but is impaired in patients with cmTBI and msevTBI. Impaired MDC is prevalent in acute TBI and is strongly related to injury severity.

Objective: To longitudinally investigate financial capacity (FC) following traumatic brain injury (TBI). Design: Longitudinal study comparing FC in cognitively healthy adults and persons with moderate to severe TBI at time of acute hospitalization (Time 1) and at 6 months postinjury (Time 2). Setting: Inpatient brain injury rehabilitation unit. Participants: Twenty healthy adult controls and 24 adult persons with moderate to severe TBI. Main Outcome Measures: Participants were administered the Financial Capacity Instrument (FCI-9), a standardized instrument that measures performance on 18 financial tasks, 9 domains, and 2 global scores. Between- and within-group differences were examined for each FCI-9 domain and global scores. Using control group referenced cut scores, participants with TBI were also assigned an impairment rating (intact, marginal, or impaired) on each domain and global score. Results: At Time 1, participants with TBI performed significantly below controls on the majority of financial variables tested. At Time 2, participants with TBI demonstrated within group improvement on both simple and complex financial domains, but continued to perform below adult controls on complex financial domains and both global scores. Group by time interactions were significant for four domains and both global scores. At Time 1, high percentages of participants with TBI were assigned either "marginal" or "impaired" ratings on the domains and global scores, with significant percentage increases of "intact" ratings at Time 2. Conclusions: Immediately following acute injury, persons with moderate to severe TBI show global impairment of FC. Findings indicate improvement of both simple and complex financial skills over a 6-month period, but continued impairment on more complex financial skills. Future studies should examine loss and recovery of FC following TBI over longer time periods and a wider range of injury severity. (PsycINFO Database Record (c) 2012 APA, all rights reserved). Language: en

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.

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.

Objective: To assess the efficacy of sertraline administered in the first 3 months after moderate to severe traumatic brain injury (TBI) in improving cognitive and behavioral outcomes. Design: Double-blind, randomized controlled trial. Setting: Academic medical center. Participants: Ninety-nine individuals randomized to placebo (n = 50) or sertraline 50 mg (n = 49) conditions. There were no group differences in age, gender, education, or severity of injury. Interventions: Participants were enrolled an average of 21 days after injury (none > 8 weeks), followed by oral administration of placebo or sertraline 50 mg for 3 months. Main Outcome Measures: Wechsler Memory Scale—Third Edition Logical Memory, Trail Making Test, Wechsler Adult Intelligence Scale—Third Edition Working Memory Index, Symbol-Digit Modalities Test, Wisconsin Card Sorting Test (64-item), Neurobehavioral Functioning Inventory administered 3, 6, and 12 months after the onset of injury. Results: Early administration of sertraline did not result in improved cognitive functioning during the year after injury compared with placebo administration. Those receiving placebo performed marginally better than the treatment group on a measure of executive function, but this appeared to be inauthentic. The treatment group followed expected recovery patterns based on existing literature. The placebo group performed better than expected on some measures, primarily due to differential dropout. Conclusions: Sertraline does not appear to prevent development of cognitive and behavioral problems following TBI, although this does not negate evidence for the treatment (as opposed to prophylactic) role of sertraline to address emotional and neurobehavioral problems in individuals with TBI.

Introduction Traumatic brain injury (TBI) is an important public health issue in the USA, with estimates of over 1.5 million new cases a year, most commonly due to motor vehicle accidents and falls [1]. TBI ranges in severity from mild to severe and results in some disturbance in cognitive, behavioral, emotional, or physical functioning. Often the effects of TBI are not physically observable to others, and thus are not well understood or appreciated by the general public. For persons with mild injuries, these effects may be first recognized, diagnosed, and treated by neuropsychologists. Thus, it is imperative that neuropsychologists have a good understanding of the short- and long-term cognitive, neurobehavioral, and psychosocial effects of TBI and how these effects change over the course of TBI recovery. Although no particular demographic group is biologically predisposed to brain injury, certain groups are at higher risk. In adults, rates for TBI peak between the ages of 15 and 24 years and for persons older than 64 [2]. Other than for the very young or the very old, TBI rates are universally higher for men than women [3]. Other risk factors for brain injury include alcohol consumption [4], prior brain injury [5], and low socioeconomic status [6]. TBIs related to sports and recreation activities are receiving more attention, with an estimated 300,000 sports-related injuries with loss of consciousness each year [7].