Mood Tracker: A Randomized Controlled Trial of a Self-Monitoring Intervention for Emotional Distress After Traumatic Brain Injury.

OBJECTIVE: Persons with traumatic brain injury (TBI) frequently experience emotional distress (ED) manifested in anxiety and depression. However, they may not access mental health services due to external (eg, access, transportation, and cost) or internal (eg, stigma and discomfort with traditional counseling) barriers. Based on substantial literature indicating that self-monitoring can ameliorate several health conditions, we conducted a randomized, parallel group, wait-list control (WLC) trial of a self-monitoring intervention to decrease ED after TBI. SETTING: Community in the southwestern United States. PARTICIPANTS: Persons with medically documented complicated mild, moderate, and severe TBI. DESIGN: About 127 participants were randomized in blocks of 6 to an active treatment (AT) group, wherein they completed multiple assessments of ED each week over a 6-week period via a smartphone app, or a WLC group in a parallel group, controlled trial. Participants received weekly support calls to promote self-monitoring of ED using ecological momentary assessment. MAIN MEASURES: ED (Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7), Satisfaction with Life Scale, and Participation Assessment with Recombined Tools-Objective. RESULTS: Analysis of the primary study outcome at 6 weeks after initiation of treatment for the AT group did not demonstrate that self-monitoring was effective in decreasing ED as compared to the WLC group. Brief support calls made weekly to promote compliance with self-monitoring were effective in achieving the target number of self-assessments. About 80% of support calls lasted less than 5 minutes. Greater ED was associated with lower life satisfaction and lower participation indicating the importance of addressing ED in persons with TBI. CONCLUSION: Additional work is needed to develop nontraditional interventions to circumvent barriers that prevent persons with TBI from accessing care for ED. Brief support calls may be an effective, low-cost intervention to improve compliance with self-monitoring or self-management interventions.

Generalized anosognosia, anosodiaphoria, and visual hallucinations with bilateral enucleation after severe bifrontal brain injury: a case report describing similarities with and differences from Anton syndrome.

Visual anosognosia, associated with confabulations and cortical blindness in the context of occipital lobe injury, is known as Anton syndrome. Patients with this syndrome strongly deny their vision loss and confabulate to compensate for both visual loss and memory impairments. In this article, we present a case of a patient with some similarities to Anton syndrome, however, with several differences in clinical presentation. Bifrontal brain injury, bilateral enucleation, affective indifference (anosodiaphoria), generalized anosognosia, and the conviction that vision will resume mark clear clinical differences with Anton syndrome. Differentiating these findings from Anton syndrome will help occupational therapists, neuropsychologists, speech-language pathologists, physical therapists, and physicians when assessing frontal lobe brain injury with total and partial visual loss. This case demonstrates that visual anosognosia and confabulations can occur without occipital lobe dysfunction or cortical blindness.

Assessing the benefits and risks of amantadine for irritability and aggression after traumatic brain injury.

OBJECTIVE: To quantify the benefits versus harms of amantadine in the treatment of irritability and aggression following traumatic brain injury. METHODS: Secondary outcome data from a randomized controlled multisite trial of amantadine 100 mg twice daily were used to calculate number-needed-to-treat (NNT). Given prior findings of positive clinician-perceived effects and low incidence of adverse events, we hypothesized low number-needed-to-treat for benefit (NNTB; high benefit) and high number-needed-to-treat for harm (NNTH; low risk) based on the clinician ratings, supporting the use of amantadine in clinical practice. Specifically, NNTB values were calculated using number of individuals with improvement on the Clinician Global Impressions-Global Improvement scale (GI). NNTB values were computed using number of individuals with worsening on the GI and experiencing serious and any adverse events. RESULTS: Based on clinician ratings, on average for every six patients treated with amantadine rather than placebo, one extra patient would be expected to improve (NNTB = 6.4; 95% confidence interval [CI]: [3.3-76.8]). More participants in the placebo group worsened than in the amantadine group, but the result was not statistically significant (NNTH = -92.4; 95% CI: [NNTB -32.9 to infinity to NNTH -19.2]). The amantadine and placebo groups did not differ on the numbers of adverse events experienced during the trial. CONCLUSION: Clinician ratings suggest modest benefit of amantadine 100 mg twice daily with low risk to appropriately selected patients with adequate renal clearance. Thus, amantadine should be considered a treatment option for the experienced brain injury clinician. These data may support treatment decisions when a pharmaceutical agent is being considered to control irritability/aggression.

Feasibility and Utility of a Flexible Outcome Assessment Battery for Longitudinal Traumatic Brain Injury Research: A TRACK-TBI Study.

The effects of traumatic brain injury (TBI) are difficult to measure in longitudinal cohort studies, because disparate pre-injury characteristics and injury mechanisms produce variable impairment profiles and recovery trajectories. In preparation for the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, which followed patients with injuries ranging from uncomplicated mild TBI to coma, we designed a multi-dimensional Flexible outcome Assessment Battery (FAB). The FAB relies on a decision-making algorithm that assigns participants to a Comprehensive (CAB) or Abbreviated Assessment Battery (AAB) and guides test selection across all phases of recovery. To assess feasibility of the FAB, we calculated the proportion of participants followed at 2 weeks (2w) and at 3, 6, and 12 months (3m, 6m, 12m) post-injury who completed the FAB and received valid scores. We evaluated utility of the FAB by examining differences in 6m and 12m Glasgow Outcome Scale-Extended (GOSE) scores between participant subgroups derived from the FAB-enabled versus traditional approach to outcome assessment applied at 2w. Among participants followed at 2w (n = 2094), 3m (n = 1871), 6m (n = 1736), and 12m (n = 1607) post-injury, 95-99% received valid completion scores on the FAB, in full or in part, either in person or by telephone. Level of function assessed by the FAB-enabled approach at 2w was associated with 6m and 12m GOSE scores (proportional odds p < 0.001). These findings suggest that the participant classification methodology afforded by the FAB may enable more effective data collection to improve detection of natural history changes and TBI treatment effects.

Relationships of self-awareness and facial affect recognition to social communication ability in persons with traumatic brain injury.

Traumatic brain injury (TBI) can cause changes to the injured person's physical ability, cognitive functioning, and social interactions. Since these attributes largely determine a person's concept of who they are, TBI poses a threat to sense of self. Due to the importance of social communication skills for community integration, impairment of these skills is a particular threat to sense of self. The present investigation sought to explore characteristics that influence social communication abilities. We hypothesized that both ability to interpret facial affect and self-awareness would be associated with communication ability. We also expected that facial affect recognition would influence self-awareness and that the effect of facial affect recognition on social communication would be partially mediated by self-awareness. For this prospective cohort study, participants were 77 individuals with documented TBI. Of these, 65% were male and 83% sustained severe injuries. The hypothesized association of facial affect recognition with social communication was demonstrated with path analysis as was the effect of facial affect recognition on self-awareness. However, the effect of facial affect recognition on social communication was not mediated by self-awareness. In addition, social communication was associated with employment, social integration, and loneliness. Findings highlighted the importance of social communication after TBI.

Predictors of Missed Follow-up Visits in the National Traumatic Brain Injury Model Systems Cohort Study.

OBJECTIVE: To identify key variables that could predict risk of loss to follow-up (LTFU) in a nationally funded longitudinal database of persons with traumatic brain injury. DESIGN: Secondary analysis of a prospective longitudinal cohort study. SETTING: Traumatic Brain Injury Model System (TBIMS) Centers in the US. PARTICIPANTS: A total of 17,956 TBIMS participants (N=17,956) with interview status data available were included if eligible for 1-, 2-, 5-, 10-, 15-, or 20-year follow-ups between October 31, 1989, and September 30, 2020. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Follow-up data collection completion status at years 1, 2, 5, 10, 15, and 20. RESULTS: Information relevant to participants' history, injury characteristics, rehabilitation stay, and patterns of follow-up across 20 years were considered using a series of logistic regression models. Overall, LTFU rates were low (consistently <20%). The most robust predictors of LTFU across models were missed earlier follow-ups and demographic factors including Hispanic ethnicity, lower education, and lack of private health insurance. CONCLUSIONS: Efforts to retain participants in such social disadvantaged or minority groups are encouraged given their disproportionate rate of LTFU. Repeated attempts to reach participants after a previously missed assessment are beneficial because many participants that missed 1 or more follow-ups were later recovered.

Responsiveness of the Traumatic Brain Injury Quality of Life Cognition Banks in Recent Brain Injury.

Patient report of functioning is one component of the neurocognitive exam following traumatic brain injury, and standardized patient-reported outcomes measures are useful to track outcomes during rehabilitation. The Traumatic Brain Injury Quality of Life measurement system (TBI-QOL) is a TBI-specific extension of the PROMIS and Neuro-QoL measurement systems that includes 20 item banks across physical, emotional, social, and cognitive domains. Previous research has evaluated the responsiveness of the TBI-QOL measures in community-dwelling individuals and found clinically important change over a 6-month assessment interval in a sample of individuals who were on average 5 years post-injury. In the present study, we report on the responsiveness of the TBI-QOL Cognition-General Concerns and Executive Function item bank scores and the Cognitive Health Composite scores in a recently injured sample over a 1-year study period. Data from 128 participants with complicated mild, moderate, or severe TBI within the previous 6 months were evaluated. The majority of the sample was male, white, and non-Hispanic. The participants were 18-92 years of age and were first evaluated from 0 to 5 months post-injury. Eighty participants completed the 1-year follow-up assessment. Results show acceptable standard response mean values (0.47-0.51) for all measures and minimal detectable change values ranging from 8.2 to 8.8 T-score points for Cognition-General Concerns and Executive Functioning measures. Anchor rating analysis revealed that changes in scores on the Executive Function item bank and the Cognitive Health Composite were meaningfully associated with participant-reported changes in the areas of attention, multitasking, and memory. Evaluation of change score differences by a variety of clinical indicators demonstrated a small but significant difference in the three TBI-QOL change scores by TBI injury severity grouping. These results support the responsiveness of the TBI-QOL cognition measures in newly injured individuals and provides information on the minimal important differences for the TBI-QOL cognition measures, which can be used for score interpretation by clinicians and researchers seeking patient-reported outcome measures of self-reported cognitive QOL after TBI.

Understanding loss to follow-up in a longitudinal study of people with traumatic brain injury.

OBJECTIVE: To examine factors related to attrition in a traumatic brain injury (TBI) study sample assessed up to 15 years after injury. PARTICIPANTS: One thousand twenty-eight participants with TBI who completed the year 1 follow-up assessment at a TBI Model Systems Center between 1992 and 2018. METHOD: Secondary analysis of data from a prospective longitudinal cohort study considering follow-up data collection completion status at years 1, 2, 5, 10, and 15. RESULTS: In univariable analyses, multiple factors were associated with loss to follow-up (LOFU) including being a member of a socially disadvantaged group, substance use history, residence, payor, cause of injury, and results of earlier follow-up attempts. In a multiple logistic regression analysis examining the prediction of follow-up condition at 10 or 15 years post-injury, only payor and race/ethnicity were significant predictors. Hispanic ethnicity was associated with higher odds of LOFU, and these participants often spoke Spanish and were born outside of the United States. CONCLUSIONS: The findings suggest a need to understand sociodemographic variables and their influence on participant attrition in longitudinal TBI research. With a better understanding of these predictors, procedures can be developed to address retention of participants who are identified as being at increased risk for study drop out.

Latent Profile Analysis of Neuropsychiatric Symptoms and Cognitive Function of Adults 2 Weeks After Traumatic Brain Injury: Findings From the TRACK-TBI Study.

Importance: Heterogeneity across patients with traumatic brain injury (TBI) presents challenges for clinical care and intervention design. Identifying distinct clinical phenotypes of TBI soon after injury may inform patient selection for precision medicine clinical trials. Objective: To investigate whether distinct neurobehavioral phenotypes can be identified 2 weeks after TBI and to characterize the degree to which early neurobehavioral phenotypes are associated with 6-month outcomes. Design, Setting, and Participants: This prospective cohort study included patients presenting to 18 US level 1 trauma centers within 24 hours of TBI from 2014 to 2019 as part of the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study. Data were analyzed from January 28, 2020, to January 11, 2021. Exposures: TBI. Main Outcomes and Measures: Latent profiles (LPs) were derived from common dimensions of neurobehavioral functioning at 2 weeks after injury, assessed through National Institutes of Health TBI Common Data Elements (ie, Brief Symptom Inventory-18, Patient Health Questionnaire-9 Depression checklist, Posttraumatic Stress Disorder Checklist for DSM-5, PROMIS Pain Intensity scale, Insomnia Severity Index, Rey Auditory Verbal Learning Test, Wechsler Adult Intelligence Scale-Fourth Edition Coding and Symbol Search subtests, Trail Making Test, and NIH Toolbox Cognitive Battery Pattern Comparison Processing Speed, Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, and Picture Sequence Memory subtests). Six-month outcomes were the Satisfaction With Life Scale (SWLS), Quality of Life after Brain Injury-Overall Scale (QOLIBRI-OS), Glasgow Outcome Scale-Extended (GOSE), and Rivermead Post-Concussion Symptoms Questionnaire (RPQ). Results: Among 1757 patients with TBI included, 1184 (67.4%) were men, and the mean (SD) age was 39.9 (17.0) years. LP analysis revealed 4 distinct neurobehavioral phenotypes at 2 weeks after injury: emotionally resilient (419 individuals [23.8%]), cognitively impaired (368 individuals [20.9%]), cognitively resilient (620 individuals [35.3%]), and neuropsychiatrically distressed (with cognitive weaknesses; 350 individuals [19.9%]). Adding LP group to models including demographic characteristics, medical history, Glasgow Coma Scale score, and other injury characteristics was associated with significantly improved estimation of association with 6-month outcome (GOSE R2 increase = 0.09-0.19; SWLS R2 increase = 0.12-0.22; QOLIBRI-OS R2 increase = 0.14-0.32; RPQ R2 = 0.13-0.34). Conclusions and Relevance: In this cohort study of patients with TBI presenting to US level-1 trauma centers, qualitatively distinct profiles of symptoms and cognitive functioning were identified at 2 weeks after TBI. These distinct phenotypes may help optimize clinical decision-making regarding prognosis, as well as selection and stratification for randomized clinical trials.

A randomized controlled trial of acceptance and commitment therapy for psychological distress among persons with traumatic brain injury.

Psychological distress is common in persons with traumatic brain injury (TBI) but treatments remain underdeveloped. This randomized controlled trial of Acceptance and Commitment Therapy (ACT) was designed to address this gap. Ninety-three persons with medically-documented complicated mild to severe TBI, normal-to-mildly impaired memory, and clinically significant psychological distress in the chronic phase of recovery were randomized to receive eight weeks of ACT (manualized with adaptations to address TBI-related cognitive impairments) or a single session of needs assessment, brief counseling/education, and referral. The ACT group showed significantly greater reduction of psychological distress (Brief Symptom Inventory 18) and demonstrated improvements in psychological flexibility and commitment to action (Acceptance and Action Questionnaire-II (AAQ-II) scores). The number of treatment responders (post-treatment BSI 18 GSI T scores <63) was larger in the ACT group than in the control group. Entry of AAQ-II scores into the model of between-group differences in BSI 18 GSI T scores indicated that core ACT processes explained the variance in treatment group outcomes. Provision of ACT reduces psychological distress in persons with TBI in the chronic phase of recovery when adaptations are made to accommodate TBI-related cognitive impairments. Additional clinical trials with a structurally equivalent control group are needed.

Brain Injury Functional Outcome Measure (BI-FOM): A Single Instrument Capturing the Range of Recovery in Moderate-Severe Traumatic Brain Injury.

OBJECTIVE: To develop a measure of global functioning after moderate-severe TBI with similar measurement precision but a longer measurement range than the FIM. DESIGN: Phase 1: retrospective analysis of 5 data sets containing FIM, Disability Rating Scale, and other assessment items to identify candidate items for extending the measurement range of the FIM; Phase 2: prospective administration of 49 candidate items from phase 1, with Rasch analysis to identify a unidimensional scale with an extended range. SETTING: Six TBI Model System rehabilitation hospitals. PARTICIPANTS: Individuals (N=184) with moderate-severe injury recruited during inpatient rehabilitation or at 1-year telephone follow-up. INTERVENTIONS: Participants were administered the 49 assessment items in person or via telephone. MAIN OUTCOME MEASURES: Item response theory parameters: item monotonicity, infit/outfit statistics, and Factor 1 variance. RESULTS: After collapsing misordered rating categories and removing misfitting items, we derived the Brain Injury Functional Outcome Measure (BI-FOM), a 31-item assessment instrument with high reliability, greatly extended measurement range, and improved unidimensionality compared with the FIM. CONCLUSIONS: The BI-FOM improves global measurement of function after moderate-severe brain injury. Its high precision, relative lack of floor and ceiling effects, and feasibility for telephone follow-up, if replicated in an independent sample, are substantial advantages.

Impaired Self-Awareness and Denial During the Postacute Phases After Moderate to Severe Traumatic Brain Injury.

While a number of empirical studies have appeared on impaired self-awareness (ISA) after traumatic brain injury (TBI) over the last 20 years, the relative role of denial (as a psychological method of coping) has typically not been addressed in these studies. We propose that this failure has limited our understanding of how ISA and denial differentially affect efforts to rehabilitate persons with TBI. In this selective review paper, we summarize early findings in the field and integrate those findings with more recent observations (i.e., 1999-2019). We believe that this synthesis of information and expert clinical opinion will inform future research on ISA and denial as well as approaches to rehabilitation for persons with TBI.

Post-traumatic Confusional State: A Case Definition and Diagnostic Criteria.

In response to the need to better define the natural history of emerging consciousness after traumatic brain injury and to better describe the characteristics of the condition commonly labeled posttraumatic amnesia, a case definition and diagnostic criteria for the posttraumatic confusional state (PTCS) were developed. This project was completed by the Confusion Workgroup of the American Congress of Rehabilitation Medicine Brain Injury Interdisciplinary Special Interest group. The case definition was informed by an exhaustive literature review and expert opinion of workgroup members from multiple disciplines. The workgroup reviewed 2466 abstracts and extracted evidence from 44 articles. Consensus was reached through teleconferences, face-to-face meetings, and 3 rounds of modified Delphi voting. The case definition provides detailed description of PTCS (1) core neurobehavioral features, (2) associated neurobehavioral features, (3) functional implications, (4) exclusion criteria, (5) lower boundary, and (6) criteria for emergence. Core neurobehavioral features include disturbances of attention, orientation, and memory as well as excessive fluctuation. Associated neurobehavioral features include emotional and behavioral disturbances, sleep-wake cycle disturbance, delusions, perceptual disturbances, and confabulation. The lower boundary distinguishes PTCS from the minimally conscious state, while upper boundary is marked by significant improvement in the 4 core and 5 associated features. Key research goals are establishment of cutoffs on assessment instruments and determination of levels of behavioral function that distinguish persons in PTCS from those who have emerged to the period of continued recovery.

Patterns of Cognitive Test Scores and Symptom Complaints in Persons with TBI Who Failed Performance Validity Testing.

OBJECTIVE: To determine clinically meaningful subgroups of persons with traumatic brain injury (TBI) who have failed performance validity testing. METHOD: Study participants were selected from a cohort of 674 participants with definitive medical evidence of TBI. Participants were those who failed performance validity testing (the Word Memory Test, using the standard cutoffs). Participants were administered cognitive tests and self-report questionnaires. Test and questionnaire results were summarized as 12 dimension scores. Cluster analysis using the k-means method was performed. RESULTS: Cluster analysis for the 143 retained participants indicated three subgroups. These subgroups differed on patterns of scores. Subgroup 1 was impaired for memory and had no excessive complaints. Subgroup 2 had impaired memory and processing speed as well as concern regarding cognition function. Subgroup 3 showed impairment on all cognitive tests and excess complaints in multiple areas. CONCLUSIONS: These results provide a preliminary basis for improved understanding of poor performance validity.

The Discrepancy Between Cognitive Complaints and Neuropsychological Test Findings in Persons With Traumatic Brain Injury.

OBJECTIVE: To better identify variables related to discrepancies between subjective cognitive complaints and objective neuropsychological findings in persons with traumatic brain injury (TBI). SETTING: Three rehabilitation centers in the United States. PARTICIPANTS: In total, 504 community-dwelling adult survivors of TBI following discharge from inpatient rehabilitation. DESIGN: Prospective cohort observation study. MAIN MEASURES: Wechsler Adult Intelligence Scale, Fourth Edition, Digit Span; Rey Auditory Verbal Learning Test; Trail Making Test, Part B; Word Memory Test; Patient Health Questionnaire-9; Neurobehavioral Symptom Inventory; TBI-Quality of Life item bank. RESULTS: Statistical analyses revealed multiple factors associated with subjective-objective discrepancies in attention, memory, and executive functions. Depression was consistently associated with underestimation of cognitive abilities. However, subjective-objective discrepancies varied by cognitive domains in regard to other factors related to underestimation and overestimation of abilities. CONCLUSIONS: Reconciling and interpreting subjective-objective discrepancies regarding cognitive functions following TBI are important tasks for case conceptualization and treatment planning. Depression is an important patient characteristic to consider when discrepancy patterns indicate underestimation of cognitive abilities. This study highlights the importance of assessing mood, a modifiable patient characteristic, with self-report symptom inventories. Future studies are needed to connect these findings with TBI outcomes.

Development and Psychometric Characteristics of the TBI-QOL Independence Item Bank and Short Form and the TBI-QOL Asking for Help Scale.

OBJECTIVE: To develop an item response theory (IRT)-calibrated, patient-reported outcome measure of subjective independence for individuals with traumatic brain injury (TBI). DESIGN: Large-scale item calibration field testing; confirmatory factor analysis (CFA) and graded response model IRT analyses. SETTING: Five TBI Model System centers across the United States. PARTICIPANTS: Adults with complicated mild, moderate, or severe TBI (N=556). OUTCOME MEASURES: Traumatic Brain Injury-Quality of Life (TBI-QOL) Independence item bank and the TBI-QOL Asking for Help scale. RESULTS: A total of 556 individuals completed 44 items in the Independence item pool. Initial factor analyses indicated that items related to the idea of "asking for help" were measuring a different construct from other items in the pool. These 9 items were set aside. Twenty-two other items were removed because of bimodal distributions and/or low item-total correlations. CFA supported unidimensionality of the remaining Independence items. Graded response model IRT analysis was used to estimate slopes and thresholds for the final 13 Independence items. An 8-item fixed-length short form was also developed. The 9 Asking for Help items were analyzed separately. One misfitting item was deleted, and the final 8 items became a fixed-length IRT-calibrated scale. Reliability was high for both measures. CONCLUSIONS: The IRT-calibrated TBI-QOL Independence item bank and short form and TBI-QOL Asking for Help scale may be used to measure important issues for individuals with TBI in research and clinical applications.

Development and Calibration of the TBI-QOL Ability to Participate in Social Roles and Activities and TBI-QOL Satisfaction With Social Roles and Activities Item Banks and Short Forms.

OBJECTIVE: To develop traumatic brain injury (TBI)-optimized versions of the Quality of Life in Neurological Disorders (Neuro-QoL) Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities item banks, evaluate the psychometric properties of the item banks developed for adults with TBI, develop short form and computer adaptive test (CAT) versions, and report information to facilitate research and clinical applications. DESIGN: We used a mixed methods design to develop and evaluate Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities items. Focus groups defined the constructs, cognitive interviews guided item revisions, and confirmatory factor analysis and item response theory methods helped calibrate item banks and evaluate differential item functioning related to demographic and injury characteristics. SETTING: Five TBI Model Systems centers in the United States. PARTICIPANTS: Community-dwelling adults with TBI (N=556). INTERVENTIONS: None. OUTCOME MEASURES: Traumatic Brain Injury-Quality of Life (TBI-QOL) Ability to Participate in Social Roles and Activities and TBI-QOL Satisfaction with Social Roles and Activities item banks. RESULTS: Forty-five Ability to Participate in Social Roles and Activities and 41 Satisfaction with Social Roles and Activities items demonstrated good psychometric properties. Although some of the items are new, most were drawn from analogous banks in the Neuro-QoL measurement system. Consequently, the 2 TBI-QOL item banks were linked to the Neuro-QoL metric, and scores are comparable with the general population. All CAT and short forms correlated highly (>0.90) with the full item banks and demonstrate comparable construct coverage and measurement error. CONCLUSION: The TBI-QOL Ability to Participate in Social Roles and Activities and TBI-QOL Satisfaction with Social Roles and Activities item banks are TBI-optimized versions of the Neuro-QoL Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities item banks and demonstrate excellent measurement properties in individuals with TBI. These measures, particularly in CAT or short form format, are suitable for efficient and precise measurement of social outcomes in clinical and research applications.

Responsiveness of the Traumatic Brain Injury-Quality of Life (TBI-QOL) Measurement System.

OBJECTIVE: To assess the responsiveness of the Traumatic Brain Injury-Quality of Life (TBI-QOL) measurement system. DESIGN: Participants completed the 20 TBI-QOL item banks and the Participation Assessment with Recombined Tools-Objective (PART-O) Productivity Subscale at baseline and 6-month follow-up assessments. Participants were categorized into 4 groups (increased productivity, unchanged productivity, and decreased productivity) based on PART-O Productivity scores. Paired sample t tests were used to compare TBI-QOL scores at baseline and 6 months, and standardized response means and Cohen's d were computed to estimate effect sizes. SETTING: Three traumatic brain injury (TBI) Model Systems rehabilitation centers in the United States. PARTICIPANTS: Two hundred one community-dwelling adults with TBI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: 20 TBI-QOL item banks. RESULTS: As expected, given that there was no intervention, group mean TBI-QOL subdomain scores for the entire sample showed no change or small improvement over the 6-month study period. At the follow-up assessment, 72 participants reported increased productivity, 71 reported decreased productivity, and 58 reported the same level of productivity as they had 6 months prior. When compared with participants who reported unchanged or decreased productivity, participants who reported increased productivity on the PART-O subscale had clinically meaningful (d≥0.30) improvements on 7 TBI-QOL measures. The largest improvement was in the Independence subdomain (mean change, 7.06; df=0.84), with differences also observed in the Mobility, Positive Affect and Well-Being, Resilience, Grief/Loss, Ability to Participate, and Satisfaction with Participation subdomains. CONCLUSIONS: The 20 TBI-QOL item banks demonstrate responsiveness to change and measurement stability in a community-dwelling sample. Researchers may use the TBI-QOL to detect changes in HRQOL after a clinical intervention and clinicians may use it in their daily practices to monitor patient recovery.

Conceptual Structure of Health-Related Quality of Life for Persons With Traumatic Brain Injury: Confirmatory Factor Analysis of the TBI-QOL.

OBJECTIVE: To determine the factor structure of the Traumatic Brain Injury-Quality of Life (TBI-QOL) measurement system. DESIGN: Observational. SETTING: 3 TBI Model Systems rehabilitation centers. PARTICIPANTS: Twenty TBI-QOL item banks were administered to a sample of community-dwelling adults with TBI (N=504) as part of a study of TBI classification. A subsample of participants (n=200) was randomly selected for exploratory factor analyses, while data from the remaining participants (n=304) were used for the confirmatory factor analysis. To examine a wide range of conceptual models, confirmatory factor analyses were conducted on a total of 16 models, ranging from 1 to 7 factors. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: Initial exploratory factor analysis yielded support for a 5-factor model (negative emotion, cognitive impairment, functioning and participation, positive emotion, pain). Confirmatory factor analysis results, however, indicated a 7-factor model including physical function, physical symptoms, cognition, negative emotion, positive emotion, sense of self, and social participation (model 16; robust fit statistics root mean square error of approximation =.063, standardized root mean square residual =.035, comparative fit index =.955, Tucker-Lewis Index =.943, Bayes Information Criterion =40059.44). CONCLUSIONS: The complex 7-factor model of the TBI-QOL provides a more nuanced framework for understanding health-related quality of life for persons with TBI than the commonly used 3-factor model including physical health, mental health, and social health.