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.

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.

Development of Composite Scores for the TBI-QOL.

OBJECTIVE: To develop a set of composite scores that can be used for interpreting quality of life (QOL) after traumatic brain injury (TBI) using 9 of the patient-reported outcomes measures from the Traumatic Brain Injury Quality of Life (TBI-QOL) measurement system. DESIGN: Participants completed 20 item banks from the TBI-QOL as part of a larger assessment. Composite index scores were created with normalized transformation with nonlinear area conversion using scores from 9 of the banks, and are expressed in index score units, with higher composite scores indicating better functioning. For descriptive purposes, associations among composites and individual banks were evaluated using regression, along with patterns of composite scores by injury severity groups using analysis of variance. SETTING: Three medical centers in the United States. PARTICIPANTS: Community-dwelling adults (n=504) with a history of TBI. INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURE: TBI-QOL. RESULTS: Five composite indices were generated: global QOL, physical health, emotional health, cognitive health, and social health. Lookup tables are provided herein. Composite scores were highly intercorrelated (all r>.60, P<.0001), and individual TBI-QOL banks all correlate strongly with the global QOL composite in the expected direction (all r>.50, P<.0001). CONCLUSION: Researchers and clinicians can use the TBI-QOL global QOL, physical health, emotional health, cognitive health, and social health composite scores to aggregate results from multiple TBI-QOL banks, which is anticipated to ease interpretation and reliability. This work additionally highlights the importance of considering nonphysical symptoms as outcomes variables for TBI research, as cognitive, social, and emotional domains were some of the most strongly correlated banks with the global QOL composite.

Gender differences in employment and economic quality of life following traumatic brain injury.

OBJECTIVE: Due to limited systematic research on gender differences in health and quality of life outcomes following traumatic brain injury (TBI), the present study sought to contribute to the growing literature on gender differences in postinjury employment while also adding an examination of postinjury economic quality of life, an emerging area in disability research. METHOD: Independent variables included demographic and injury characteristics. Outcome variables included postinjury employment and economic quality of life, measured by the Participation Assessment With Recombined Tools-Objective and the Economic QOL, respectively. Hypotheses that women would experience poorer outcomes in postinjury employment and economic quality of life were tested with logistic and linear regression models. RESULTS: Postinjury employment was associated with gender, higher educational attainment, and preinjury employment. Those with greater injury severity and those identifying as Black or African American were less likely to be employed postinjury. For men and women who were unemployed prior to injury, the odds of postinjury employment for men were 184% higher than for women. Men reported significantly greater economic quality of life. Contrary to hypotheses, postinjury employment was inversely related to economic quality of life in the final model. CONCLUSION: The results suggest that if unemployed prior to injury, women with TBI are less likely to be employed postinjury and also experience decreased economic quality of life postinjury, regardless of employment status. Although further research is needed to determine which strategies will improve economic quality of life for women with TBI, clinicians may utilize these preliminary findings to guide treatment and advocacy efforts. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative.

Traumatic brain injury (TBI) is a global public health problem that affects the long-term cognitive, physical, and psychological health of patients, while also having a major impact on family and caregivers. In stark contrast to the effective trials that have been conducted in other neurological diseases, nearly 30 studies of interventions employed during acute hospital care for TBI have failed to identify treatments that improve outcome. Many factors may confound the ability to detect true and meaningful treatment effects. One promising area for improving the precision of intervention studies is to optimize the validity of the outcome assessment battery by using well-designed tools and data collection strategies to reduce variability in the outcome data. The Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, conducted at 18 sites across the United States, implemented a multidimensional outcome assessment battery with 22 measures aimed at characterizing TBI outcome up to 1 year postinjury. In parallel, through the TBI Endpoints Development (TED) Initiative, federal agencies and investigators have partnered to identify the most valid, reliable, and sensitive outcome assessments for TBI. Here, we present lessons learned from the TRACK-TBI and TED initiatives aimed at optimizing the validity of outcome assessment in TBI.

Key dimensions of impairment, self-report, and environmental supports in persons with traumatic brain injury.

PURPOSE/OBJECTIVES: To determine key dimensions relevant to recovery in the postacute period for persons with traumatic brain injury (TBI) and to determine the ability of scores on these dimensions to predict participation outcomes for persons with TBI. RESEARCH METHOD/DESIGN: This was a prospective cohort, observational study of 504 persons with medically documented TBI. Participants completed a comprehensive battery of measures including cognitive tests; questionnaires assessing self-report of physical, cognitive, and emotional symptoms and strengths; environmental supports; and a measure of participation outcome. RESULTS: Participants were a predominantly male, ethnically/racially diverse sample of persons with complicated mild, moderate, and severe TBI. Variable cluster analysis identified 12 key dimensions of cognitive function, neurobehavioral complaints, personal strengths, physical symptoms and function, environmental supports, and performance validity. In unadjusted analyses, all 12 dimensions were predictive of participation outcome. In multivariable regression analysis with adjustment of all predictors for all other predictors, dimensions measuring memory, independence and self-esteem, resilience, emotional distress, physical functioning, and economic and family support made unique contributions to predicting participation outcome. CONCLUSIONS/IMPLICATIONS: Findings add to our understanding of key aspects of functioning and self-perception for persons with TBI. Knowledge of the profile of an individual patient on these 12 dimensions may assist with development of a treatment approach for the person with TBI. (PsycINFO Database Record

Relationship of caregiver and family functioning to participation outcomes after postacute rehabilitation for traumatic brain injury: a multicenter investigation.

OBJECTIVE: To investigate the contribution of caregiver emotional functioning and family functioning to participation outcomes after postacute rehabilitation for traumatic brain injury (TBI). DESIGN: Prospective cohort study. SETTING: Three postacute comprehensive-integrated postacute rehabilitation programs associated with National Institute on Disability and Rehabilitation Research-funded TBI Model Systems Centers. PARTICIPANTS: Persons with medically documented TBI (N=136; 57% with severe TBI, 12% moderate, 31% mild), primarily men and 69% white. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Community Integration Questionnaire and Craig Handicap Assessment and Reporting Technique (CHART). RESULTS: After accounting for age, education, sex, and race/ethnicity, there was a significant interaction between caregiver emotional functioning and time since injury for CHART Occupation and Social Integration Scale scores. Better emotional functioning in caregivers was associated with greater occupation and social integration outcomes for persons who entered the postacute rehabilitation program within 6 months of injury, but not for those >6 months postinjury. There was no relationship of family functioning to participation outcomes, and no interaction between family functioning and time since injury. CONCLUSIONS: Caregiver distress should be accounted for in studies investigating the effectiveness of postacute rehabilitation after TBI. Screening of caregivers early during postacute rehabilitation can target those who need assistance to improve their support of the person with TBI.

Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research.

OBJECTIVES: To conduct a systematic review of behavioral assessment scales for disorders of consciousness (DOC); provide evidence-based recommendations for clinical use based on their content validity, reliability, diagnostic validity, and ability to predict functional outcomes; and provide research recommendations on DOC scale development and validation. DATA SOURCES: Articles published through March 31, 2009, using MEDLINE, CINAHL, Psychology and Behavioral Sciences Collection, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Biomedical Reference Collection, and PsycINFO. Thirteen primary terms that defined DOC were paired with 30 secondary terms that defined aspects of measurement. Scale names, abbreviations, and authors were also used as search terms. Task force members identified additional articles by using personal knowledge and examination of references in reviewed articles. STUDY SELECTION: Primary criteria included the following: (1) provided reliability, diagnostic validity, and/or prognostic validity data; (2) examined a cohort, case control, or case series sample of persons with DOC who were age older than or equal to 18 years; and (3) assessed in an acute care or rehabilitation setting. Articles were excluded if peer review was not conducted, original data were not reported, or an English language article was not available. The initial search yielded 580 articles. After paired rater review of study abstracts, guideline development was based on 37 articles representing 13 DOC scales. DATA EXTRACTION: Rater pairs classified studies addressing diagnostic and prognostic validity by using the American Academy of Neurology 4-tier level of evidence scheme, and reliability by using a task force-developed 3-tier evidence scheme. An independent quality review of ratings was conducted, and corrections were made. DATA SYNTHESIS: The Coma Recovery Scale-Revised (CRS-R), Sensory Stimulation Assessment Measure (SSAM), Wessex Head Injury Matrix (WHIM), Western Neuro Sensory Stimulation Profile (WNSSP), Sensory Modality Assessment Technique (SMART), Disorders of Consciousness Scale (DOCS), and Coma/Near-Coma Scale (CNC) have acceptable standardized administration and scoring procedures. The CRS-R has excellent content validity and is the only scale to address all Aspen Workgroup criteria. The SMART, SSAM, WHIM, and WNSSP demonstrate good content validity, containing items that could distinguish persons who are in a vegetative state, are in a minimally conscious state (MCS), or have emerged from MCS. The Full Outline of UnResponsiveness Score (FOUR), WNSSP, CRS-R, Comprehensive Levels of Consciousness Scale (CLOCS), and Innsbruck Coma Scale (INNS) showed substantial evidence of internal consistency. The FOUR and the CRS-R showed substantial evidence of good interrater reliability. Evidence of diagnostic validity and prognostic validity in brain injury survivor samples had very high levels of potential bias because of methodologic issues such as lack of rater masking. CONCLUSIONS: The CRS-R may be used to assess DOC with minor reservations, and the SMART, WNSSP, SSAM, WHIM, and DOCS may be used to assess DOC with moderate reservations. The CNC may be used to assess DOC with major reservations. The FOUR, INNS, Glasgow-Liege Coma Scale, Swedish Reaction Level Scale-1985, Loewenstein Communication Scale, and CLOCS are not recommended at this time for bedside behavioral assessment of DOC because of a lack of content validity, lack of standardization, and/or unproven reliability.

Outcome assessment in traumatic brain injury clinical trials and prognostic studies.

Large numbers of investigations have sought to evaluate prediction of outcome after traumatic brain injury (TBI) and the effectiveness of interventions designed to address post-TBI deficits. Unfortunately, failure to attend to key issues in experimental design regarding outcome assessment has limited the utility of these investigations. Increased attention to 5 issues in outcome assessment will increase the evidence base for TBI prognosis and treatment and increase the relevance of findings to end users of research such as other investigators, rehabilitation providers, policy makers, persons with TBI, and family members of persons with TBI. These 5 issues are (1) masking of outcome examiners, (2) retention of study participants, (3) use of surrogate informants to capture data from a wider range of study participants, (4) relevance of study outcomes to stakeholders, and (5) cultural considerations in outcome assessment.

Multidimensional assessment of acute confusion after traumatic brain injury.

OBJECTIVES: To describe the phenomenology of posttraumatic confusional state (PTCS) and to provide preliminary validation of a new procedure, the Confusion Assessment Protocol (CAP), for assessing PTCS. DESIGN: Criterion standard investigation. SETTING: Inpatient traumatic brain injury (TBI) rehabilitation program. PARTICIPANTS: Two consecutive series of patients (n=62, n=93) with TBI admitted for inpatient rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Clinical diagnosis of delirium based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria, classification of posttraumatic amnesia (PTA) based on the Galveston Orientation and Amnesia Test (GOAT), and Disability Rating Scale score at time of rehabilitation hospital discharge. Results Agreement between the diagnosis of PTCS with the CAP and DSM-IV classification of delirium was 87%, and agreement between PTCS and PTA using GOAT criteria was 90%. Patients classified as in PTCS sustained more severe injuries and required longer rehabilitation stays. Confusion status was associated with poorer functional status at rehabilitation discharge. CONCLUSIONS: The CAP is a brief, structured, repeatable measure of multiple neurobehavioral aspects of PTCS. Confusion status as determined by CAP assessment contributed to prediction of outcome at rehabilitation discharge after adjustment for other potential predictors.

Use of the WCST and the WCST-64 in the assessment of traumatic brain injury.

The Wisconsin Card Sorting Test (WCST) has been found to be valid in characterizing cognitive dysfunction in a variety of neurological disorders including traumatic brain injury (TBI). However, the test has been criticized as being too lengthy and frustrating for severely impaired patients. As a result, shortened versions of the WCST have been proposed. The utility of one of these shortened versions, the Wisconsin Card Sorting Test-64 (WCST-64), was examined in 106 persons with TBI. Findings showed strong associations between scores derived from the two tests. WCST scores were predicted from WCST-64 scores with sufficient accuracy for research purposes with adjusted R-squared values ranging from .74 to .87. Using the standard cutpoint of < 40T to indicate impairment or normal performance for perseverative responses from each of the two tests, 91 (86%) of 106 subjects received the same classification showing substantial agreement (Kappa statistic 0.71; 95% CI 0.58-0.84). The WCST and the WCST-64 also performed comparably in predicting functional status at discharge from inpatient rehabilitation using the first score from a principal components analysis as a summary measure (both significant with p = .0002). These findings support theuse of the WCST-64 in early evaluations of persons with moderate and severe TBI.

Neuropsychological assessment and employment outcome after traumatic brain injury: a review.

While there may be many reasons for obtaining neuropsychological assessment after traumatic brain injury (TBI), prediction of real world functioning is generally a key goal. The present paper reviews 23 studies concerning the relationship between neuropsychological test results and employment outcome after TBI. The review was conducted in accordance with guidelines developed by the Committee on Empirically Supported Practice of Division 40 (Neuropsychology) of the American Psychological Association. Results of the review support a Category A (strongly supported) recommendation for the use of early neuropsychological assessment to predict late employment outcome. Studies of late neuropsychological assessment and subsequent employment outcome and studies of concurrent neuropsychological assessment and employment outcome were inconclusive regarding either support or contraindication for neuropsychological assessment to predict employment outcome. Almost all studies conducted at these late or concurrent time points had significant limitations with regard to study type or adequacy of methodology. However, there is no conceptual basis for believing that neuropsychological findings obtained closer in time to assessment of employment outcome should be less predictive of this outcome than neuropsychological findings obtained at an earlier time.