Exploring symptom clusters in mild cognitive impairment and dementia with the NIH Toolbox.

OBJECTIVE: Symptom clustering research provides a unique opportunity for understanding complex medical conditions. The objective of this study was to apply a variable-centered analytic approach to understand how symptoms may cluster together, within and across domains of functioning in mild cognitive impairment (MCI) and dementia, to better understand these conditions and potential etiological, prevention, and intervention considerations. METHOD: Cognitive, motor, sensory, emotional, and social measures from the NIH Toolbox were analyzed using exploratory factor analysis (EFA) from a dataset of 165 individuals with a research diagnosis of either amnestic MCI or dementia of the Alzheimer's type. RESULTS: The six-factor EFA solution described here primarily replicated the intended structure of the NIH Toolbox with a few deviations, notably sensory and motor scores loading onto factors with measures of cognition, emotional, and social health. These findings suggest the presence of cross-domain symptom clusters in these populations. In particular, negative affect, stress, loneliness, and pain formed one unique symptom cluster that bridged the NIH Toolbox domains of physical, social, and emotional health. Olfaction and dexterity formed a second unique cluster with measures of executive functioning, working memory, episodic memory, and processing speed. A third novel cluster was detected for mobility, strength, and vision, which was considered to reflect a physical functioning factor. Somewhat unexpectedly, the hearing test included did not load strongly onto any factor. CONCLUSION: This research presents a preliminary effort to detect symptom clusters in amnestic MCI and dementia using an existing dataset of outcome measures from the NIH Toolbox.

Establishing severity levels for patient-reported measures of functional communication, participation, and perceived cognitive function for adults with acquired cognitive and language disorders.

PURPOSE: To empirically assign severity levels (e.g., mild, moderate) to four relatively new patient-reported outcome measures (PROMs) for adults with acquired cognitive/language disorders. They include the Communicative Participation Item Bank, the Aphasia Communication Outcome Measure, and Neuro-QoL's item banks of Cognitive Function (v2.0) and Ability to Participate in Social Roles and Activities (v1.0). METHOD: We conducted 17 focus groups that comprised 22 adults with an acquired cognitive/language disorder from stroke, Parkinson's disease, or traumatic brain injury; 30 care partners of an adult with an acquired cognitive/language disorder; and 42 speech-language pathologists who had experience assessing/treating individuals with those and other cognitive/language disorders. In a small, moderated focus-group format, participants completed "PROM-bookmarking" procedures: They discussed hypothetical vignettes based on PROM item responses about people with cognitive/language disorders and had to reach consensus regarding whether their symptoms/function should be categorized as within normal limits or mild, moderate, or severe challenges. RESULTS: There was generally good agreement among the stakeholder groups about how to classify vignettes, particularly when they reflected very high or low functioning. People with aphasia described a larger range of functional communication challenges as "mild" compared to other stakeholder types. Based on a consensus across groups, we present severity levels for specific score ranges for each PROM. CONCLUSION: Standardized, stakeholder-informed severity levels that aid interpretation of PROM scores can help clinicians and researchers derive better clinical meaning from those scores, for example, by identifying important clinical windows of opportunity and assessing when symptoms have returned to a "normal" range.

Initial Evidence for Reliable and Valid Use of Scores on the 8-Item Econ-QOL Short Form to Measure Economic Quality of Life in Caregivers of Persons With Traumatic Brain Injury.

OBJECTIVE: To provide reliability and validity data to support the clinical utility of Economic Quality of Life Measure (Econ-QOL) scores in caregivers of civilians and service members/veterans with traumatic brain injury (TBI). DESIGN: Cross-sectional survey study. SETTING: Three academic medical centers and a Veterans Affairs treatment facility. PARTICIPANTS: 376 caregivers of civilians (n=213) and service members/veterans (n=163) with TBI (N=376). INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: Econ-QOL and several patient-reported outcome measures (Traumatic Brain Injury Caregiver Quality of Life Caregiver-Specific Anxiety and Caregiver Strain, Patient-Reported Outcomes Measurement Information System sleep-related impairment, Neurological Quality of Life Measurement System positive affect and well-being) and measures of financial status (self-reported income). RESULTS: Internal consistency reliability of the Econ-QOL Short Form scores were excellent (all Cronbach's alphas ≥.92). There were no floor or ceiling effects for scores. There was evidence of convergent and discriminant validity, with the Econ-QOL scores having the strongest relationships with self-reported income (convergent validity evidence) and weak relationships with the other measures (discriminant validity evidence). Individuals with scores that were "below or possibly below" the poverty line (according to 2016 federal government poverty level thresholds) reported worse economic quality of life relative to those individuals who were definitely above the poverty line, supporting known-groups validity. CONCLUSIONS: This article establishes the clinical utility of scores on the Econ-QOL Short Form in caregivers of persons with TBI and provides evidence that it is valid and appropriate to use such scores not only in a variety of different disability populations (eg, spinal cord injury, stroke) but also in caregivers.

Identifying Health-Related Quality of Life Domains After Upper Extremity Transplantation.

OBJECTIVE: To identify the most important health-related quality of life (HRQOL) domains and patient-reported outcomes after upper extremity transplantation (UET) in individuals with upper extremity amputation. DESIGN: Verbatim audio-recordings of individual interviews and focus groups were analyzed using qualitative, grounded theory-based methods to identify important domains of HRQOL and provide guidance for outcomes measurement after UET. SETTING: Individual interviews were conducted by phone. Focus groups were conducted at 5 upper extremity vascularized composite allotransplantation (VCA) centers in the US and at an international conference of VCA experts. PARTICIPANTS: Individual phone interviews were conducted with 5 individuals with lived experience of UET. Thirteen focus groups were conducted with a total of 59 clinical professionals involved in UET. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: Twenty-eight key HRQOL domains were identified, including physical functioning and medical complications, positive and negative emotional functioning, and social participation, relations, and independence. We identified key constructs for use in evaluation of the potentially substantial physical, medical, social, and emotional effects of UET. CONCLUSIONS: This study provides an overview of the most important issues affecting HRQOL after UET, including several topics that are unique to individuals with UET. This information will be used to establish systematic, comprehensive, and longitudinal measurement of post-UET HRQOL outcomes.

Measurement invariance of physical, mental, and social health PROMIS measures across individuals with spinal cord injury and traumatic brain injury.

PURPOSE: The present study tested the fit and comparability of the tripartite model of health (Physical Health, Mental Health, and Social Health) proposed by the NIH PROMIS for adults with SCI and TBI. METHODS: Participants were 630 adults with spinal cord injury (SCI; n = 336) and traumatic brain injury (TBI; n = 294) who completed 8 PROMIS short forms. The Physical Health domain is composed of the Physical Function, Pain Interference, and Fatigue scales. The Mental Health domain included the Depression, Anxiety, and Anger scales. Social Health included the Social Emotional Support scale. RESULTS: Confirmatory factor analyses supported the tripartite model of health over a unifactorial model of health for both SCI and TBI groups. Measurement invariance testing indicated the tripartite model met the level of configural and metric invariance for TBI and SCI groups, suggesting comparable structure and factor loadings. Failure to meet the level of scalar invariance indicated unequal intercepts across groups. Physical Function was identified as the source of noninvariance, and a partial scalar invariance model permitting different Physical Function intercepts across conditions was supported. CONCLUSION: Consistent with theory, findings supported construct validity of the PROMIS tripartite structure of health composed of Physical, Mental, and Social Health. PROMIS measures appeared to tap domains of health consistent with what is accepted for SCI and TBI populations, although the measurement of Physical Function was not equivalent across groups. Findings support the utility of PROMIS broadly as well as the need for condition-optimized measurement.

Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances.

The Spinal Cord Injury-Functional Index (SCI-FI) is a system of patient-reported outcome measures of functional activities developed specifically with and for individuals with spinal cord injury (SCI). The SCI-FI was designed to overcome limitations in measurement of the full range of activities and breadth of content of physical functioning commonly used in SCI research. Generic measurement tools of physical function (ie, those focused on the general population) tend to overemphasize mobility and do not contain enough items at the lower end of the functional range (eg, items appropriate for individuals with tetraplegia). The SCI-FI consists of 9 item response theory-calibrated item banks that represent relevant and meaningful item content for individuals with SCI, span a wide range of functional abilities, and subdivide physical functioning into important subdomains, including basic mobility, self-care, and fine motor function. Since the original publication of the SCI-FI in 2012, there have been significant advances in and publications on the reliability and psychometric properties of the measures. The manuscripts presented in this special section clarify the SCI-FI structure and present new research on the SCI-FI measurement system.

Linking the Spinal Cord Injury-Functional Index (SCI-FI) to the PROMIS Physical Functioning Item Bank.

OBJECTIVE: To link 3 Spinal Cord Injury-Functional Index (SCI-FI) item banks (Basic Mobility, Fine Motor Function, Self-Care) to the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) metric. DESIGN: Observational study SETTING: Six SCI Model Systems rehabilitation hospitals in the United States. PARTICIPANTS: Adults with SCI (n=855) and healthy individuals (n=730) (N=1585). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Three SCI-FI item banks (Basic Mobility, Fine Motor Function, Self-Care), PROMIS PF v1.0 item bank. RESULTS: SCI-FI item banks (including 30 items from the PROMIS PF item bank) were administered to 855 adults with SCI as part of the original SCI-FI development study. The data were used to attempt to link 3 SCI-FI banks to the PROMIS PF metric via 2 item-response theory methods: fixed-parameter calibration and separate calibration. Sixteen items common to SCI-FI and PROMIS and verified as free of differential item functioning were used as anchor items to implement the methods. Of the 3 banks, only SCI-FI Basic Mobility could be linked with sufficient precision to PROMIS PF. Comparisons of actual vs linked PROMIS PF scores and test characteristic curves suggested the fixed-parameter method provided slightly more precision than the separate calibration method. CONCLUSIONS: The linkage between PROMIS PF and SCI-FI Basic Mobility was considered satisfactory for group-level usage. Score equivalents computed from SCI-FI Basic Mobility will be useful for researchers comparing functional levels in SCI to those observed in other clinical and nonclinical groups (eg, in comparative effectiveness research).

Applying a Bookmarking Approach to Setting Clinically Relevant Interpretive Standards for the Spinal Cord Injury-Functional Index/Capacity Basic Mobility and Self-Care Item Bank Scores.

OBJECTIVES: To develop clinically relevant interpretive standards for the Spinal Cord Injury-Functional Index/Capacity (SCI-FI/C) Basic Mobility and Self-Care item bank scores. DESIGN: Modified "bookmarking" standard-setting methodology, including 2 stakeholder consensus meetings with individuals with spinal cord injury (SCI) and SCI clinicians, respectively, and a final, combined (consumers and clinicians) "convergence" meeting. SETTING: Two SCI Model System centers in the United States. PARTICIPANTS: Fourteen adults who work with individuals with traumatic SCI and 14 clinicians who work with individuals with SCI. MAIN OUTCOME MEASURES: Placement of bookmarks between vignettes based on SCI-FI Basic Mobility and Self-Care T scores. Bookmarks were placed between vignettes representing "No Problems," "Mild Problems," "Moderate Problems," and "Severe Problems" for each item bank. RESULTS: Each consensus group resulted in a single set of scoring cut points for the SCI-FI/C Basic Mobility and Self-Care item banks. The cut points were similar but not identical between the consumer and clinician groups, necessitating a final convergence meeting. For SCI-FI/C Basic Mobility, the convergence group agreed on cut scores of 61.25 (no problems/mild problems), 51.25 (mild problems/moderate problems), and 41.25 (moderate problems/severe problems). For SCI-FI/C Self-Care, the convergence group agreed on cut scores of 56.25 (no/mild), 51.25 (mild/moderate), and 38.75 (moderate/severe). CONCLUSIONS: The results of this study provide straightforward interpretive guidelines for SCI researchers and clinicians using the SCI-FI/C Basic Mobility and Self-Care instruments. These results are appropriate for the full bank, computer adaptive test, and short-form versions of the SCI-FI/C Basic Mobility and Self-Care item banks.

Validation of the Spinal Cord Injury-Functional Index for Use in Community-Dwelling Individuals With SCI.

OBJECTIVE: To evaluate the psychometric properties of the Spinal Cord Injury-Functional Index (SCI-FI) instruments in a community-dwelling sample. DESIGN: Cross-sectional study. SETTING: Community setting. PARTICIPANTS: Individuals (N=269) recruited from 6 SCI Model Systems sites. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Participants completed computer adaptive test and short form versions of 4 SCI-FI/Capacity (C) banks (ie, Ambulation, Basic Mobility, Fine Motor, Self-Care) and 1 SCI-FI/Assistive Technology (AT) bank (Wheelchair Mobility) at baseline and after 2 weeks. The Self-Report Functional Measure (SRFM) and the clinician-rated motor FIM were used to evaluate evidence of convergent validity. RESULTS: Pearson correlations, intraclass correlation coefficients, minimal detectable change, and Bland-Altman plots supported the test-retest reliability of the SCI-FI instruments. Correlations were large with the SRFM (.69-.89) and moderate-to-large for the FIM instrument (.44-.64), supporting convergent validity. Known-groups validity was demonstrated by a significant main effect of injury level on all instruments and a main effect of injury completeness on the SCI-FI/C instruments. A ceiling effect was detected for individuals with incomplete paraplegia on the Fine Motor/C and Self-Care/C Short Forms. CONCLUSION: Findings support the test-retest reliability, convergent validity, and known-groups validity of the SCI-FI/C instruments and the SCI-FI/AT Wheelchair Mobility instruments for use by community-dwelling individuals.

Physical Function Recovery Trajectories After Spinal Cord Injury.

OBJECTIVE: To explore trajectories of functional recovery that occur during the first 2 years after spinal cord injury (SCI). DESIGN: Observational cohort study. SETTING: Eight SCI Model System sites. PARTICIPANTS: A total of 479 adults with SCI completed 4 Spinal Cord Injury-Functional Index (SCI-FI) item banks within 4 months of injury and again at 2 weeks, 3, 6, 12, and 24 months after baseline assessment (N=479). INTERVENTION: None. MAIN OUTCOME MEASURES: SCI-FI Basic Mobility/Capacity (C), Fine Motor Function/C, Self-care/C, and Wheelchair Mobility/Assistive Technology (AT) item banks. RESULTS: Growth mixture modeling was used to identify groups with similar trajectory patterns. For the Basic Mobility/C and Wheelchair Mobility/AT domains, models specifying 2 trajectory groups were selected. For both domains, a majority class exhibited average functional levels and gradual improvement, primarily in the first 6 months. A smaller group of individuals made gradual improvements but had greater initial functional limitations. The Self Care/C domain exhibited a similar pattern; however, a third, small class emerged that exhibited substantial improvement in the first 6 months. Finally, for individuals with tetraplegia, trajectories of Fine Motor Function/C scores followed 2 patterns, with individuals reporting generally low initial scores and then making either modest or large improvements. In individual growth curve models, injury/demographic factors predicted initial functional levels but less so regarding rates of recovery. CONCLUSIONS: Trajectories of functional recovery followed a small number of change patterns, although variation around these patterns emerged. During the first 2 years after initial hospitalization, SCI-FI scores showed modest improvements; however, substantial improvements were noted for a small number of individuals with severe limitations in fine motor and self-care function. Future studies should further explore the personal, medical, and environmental characteristics that influence functional trajectories during these first 2 years and beyond.

Spinal Cord Injury-Functional Index/Capacity: Responsiveness to Change Over Time.

OBJECTIVE: To establish responsiveness of 3 Spinal Cord Injury-Functional Index/Capacity (SCI-FI/C) item banks in the first year after spinal cord injury (SCI). DESIGN: Longitudinal patient-reported outcomes assessment replicated through secondary analysis of an independent data set. SETTING: A total of 8 SCI Model Systems rehabilitation hospitals in the United States. PARTICIPANTS: Study 1 participants included 184 adults with recent (≤4 months) traumatic SCI and 221 community-dwelling adults (>1 year post injury) (N=405). Study 2 participants were 418 individuals with recent SCI (≤4 months) (N=418). INTERVENTIONS: In study 1, SCI-FI/C computer adaptive tests were presented in a standardized interview format either in person or by phone call at baseline and 6-month follow-up. Responsiveness was examined by comparing 6-month changes in SCI-FI scores within and across samples (recently injured vs community-dwelling) because only the recent injury sample was expected to exhibit change over time. Effect sizes were also computed. In study 2, the study 1 results were cross-validated in a second sample with recent SCI 1 year after baseline measurement. Study 2 also compared the SCI-FI/C measures' responsiveness to that of the Self-reported Functional Measure (SRFM) and stratified results by injury diagnosis and completeness. MAIN OUTCOME MEASURES: The SCI-FI Basic Mobility/C, Self-care/C and Fine Motor/C item banks (study 1 and study 2); Self-reported Functional Measure SRFM (study 2 only). RESULTS: In study 1, changes in SCI-FI/C scores between baseline and 6-month follow-up were statistically significant (P<.01) for recently injured individuals. SCI-FI Basic Mobility/C, Self-care/C, and Fine Motor/C item banks demonstrated small to medium effect sizes in the recently injured sample. In the community-dwelling sample, all SCI-FI/C effects were negligible (ie, effect size<0.08). Study 2 results were similar to study 1. As expected, SCI-FI Basic Mobility/C and Self-care/C were responsive to change for all individuals in study 2, whereas the SCI-FI Fine Motor/C was responsive only for individuals with tetraplegia and incomplete paraplegia. The SRFM demonstrated a medium effect size for responsiveness (effect size=0.65). CONCLUSIONS: The SCI-FI Basic Mobility/C and Self-care/C banks demonstrate adequate sensitivity to change at 6 months and 1 year for all individuals with SCI, while the SCI-FI/C Fine Motor item bank is sensitive to change in individuals with tetraplegia or incomplete paraplegia. All SCI-FI/C banks demonstrate stability in a sample not expected to change. Results provide support for the use of these measures for research or clinical use.

Greener on the other side? an analysis of the association between residential greenspace and psychological well-being among people living with spinal cord injury in the United States.

STUDY DESIGN: Secondary analysis of cross-sectional data from a multisite survey study. OBJECTIVES: To describe associations between residential greenspace and psychological well-being among adults living with chronic spinal cord injury (SCI). SETTING: Community. METHODS: Participants were from the Spinal Cord Injury-Quality of Life (SCI-QOL) Calibration Study (N = 313). Geographic Information Systems (GIS) analysis was used to define five- and half-mile buffer areas around participants' residential addresses to represent community and neighborhood environments, respectively, and to create measures of natural and developed open greenspace. Associations of greenspace measures with two SCI-QOL psychological well-being domains (positive affect and depressive symptoms) were modeled using ordinary least squares (OLS) regression, adjusted for demographic, injury-related, and community socioeconomic characteristics. RESULTS: People living in a community with a moderate amount of natural greenspace reported less positive affect and more depressive symptoms compared to people living in a community with low natural greenspace. At the neighborhood level, a moderate amount of developed open space was associated with less positive affect and more depressive symptoms than a low amount of developed open space. CONCLUSIONS: Contrary to expectations, residential greenspace had a negative relationship with psychological well-being in this sample of adults with SCI. Understanding how and why natural spaces are associated with quality of life for people with mobility disabilities can influence public policy and urban planning designs to ensure that residential greenspaces are accessible and beneficial to all.

Effect of parental education and household poverty on recovery after traumatic brain injury in school-aged children.

OBJECTIVE: While prior studies have found parental socioeconomic status (SES) affects the outcomes of pediatric traumatic brain injury (TBI), the longitudinal trajectory of this effect is not well understood. METHODS: This prospective cohort study included children 8-18 years of age admitted to six sites with a complicated mild (n = 123) or moderate-severe TBI (n = 47). We used caregiver education and household poverty level as predictors, and multiple quality of life and health behavior domains as outcomes. Differences at 6, 12, and 24 months from baseline ratings of pre-injury functioning were compared by SES. We examined the association between measures of SES and domains of functioning over the 24 months post-injury in children with a complicated mild or moderate- severe TBI, and determined how this association varied over time. RESULTS: Parental education was associated with recovery among children with complicated mild TBI; outcomes at 6, 12, and 24 months were substantially poorer than at baseline for children with the least educated parents. After moderate-severe TBI, children in households with lower incomes had poorer outcomes compared to baseline across time. IMPLICATIONS: Parental education and household income were associated with recovery trajectories for children with TBI of varying severity.

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.

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.

Measuring Pain in TBI: Development of the TBI-QOL Pain Interference Item Bank and Short Form.

OBJECTIVE: To develop a pain interference item bank, computer adaptive test (CAT), and short form for use by individuals with traumatic brain injury (TBI). DESIGN: Cross-sectional survey study. SETTING: Five TBI Model Systems rehabilitation hospitals. PARTICIPANTS: Individuals with TBI (N=590). INTERVENTIONS: Not applicable. OUTCOME MEASURES: Traumatic Brain Injury-Quality of Life (TBI-QOL) Pain Interference item bank. RESULTS: Confirmatory factor analysis provided evidence of a single underlying trait (χ2 [740]=3254.030; P<.001; Comparative Fix Index=0.988; Tucker-Lewis Index=0.980; Root Mean Square Error of Approximation=0.076) and a graded response model (GRM) supported item fit of 40 Pain Interference items. Items did not exhibit differential item functioning or local item dependence. GRM calibration data were used to inform the selection of a 10-item static short form and to program a TBI-QOL Pain Interference CAT. Comparative analyses indicated excellent comparability and reliability across test administration formats. CONCLUSION: The 40-item TBI-QOL Pain Interference item bank demonstrated strong psychometric properties. End users can administer this measure as either a 10-item short form or CAT.

Establishing the Factor Structure of a Health-Related Quality of Life Measurement System for Caregivers of Persons Living With Traumatic Brain Injury.

OBJECTIVES: To understand the factor structure of health-related quality of life specific to caregivers of people living with traumatic brain injury (TBI). DESIGN: Prospective, cross-sectional data collection. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=558) of people who have sustained a TBI (344 caregivers of civilians and 214 caregivers of service members or veterans; 85% women; 58% spouses; mean age, 46.12±14.07y) who have provided care for an average of 5.82±5.40 years. INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: The Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) measurement system including 10 Patient-Reported Outcomes Measurement Information System item banks (anger, anxiety, depression, social isolation, sleep disturbance, fatigue, ability to participate in social roles and activities, satisfaction with social roles and activities, emotional support, informational support) and 5 TBI-CareQOL banks (feelings of loss-self, feelings of loss-person with TBI, feeling trapped, caregiver-specific anxiety, caregiver strain). RESULTS: Confirmatory factor analysis model fit indices were compared for 14 empirically derived and 5 theoretically derived models. Confirmatory factor analysis results indicated that the best model fit was for a 6-factor model with dimensions that included mental health, social support, social participation, social isolation, physical health, and caregiver emotion. CONCLUSIONS: Results indicated that a 6-factor model provided the best model fit for health-related quality of life in caregivers of individuals with TBI. These results have utility for both research and clinical applications. Establishing the TBI-CareQOL's factor structure provides preliminary evidence of the measurement system's construct validity, helps inform the selection of measures for specific research or clinical interventions, and informs the development of composite scores.

Emotional Suppression and Hypervigilance in Military Caregivers: Relationship to Negative and Positive Affect.

OBJECTIVE: To investigate the relationship of 2 health-related quality-of-life (QOL) item banks (Emotional Suppression and Caregiver Vigilance), developed for caregivers of service members/veterans with traumatic brain injury (TBI), to caregivers' positive and negative affect. SETTING: Community. PARTICIPANTS: One hundred sixty-five caregivers of service members/veterans with TBI. DESIGN: Retrospective database analysis. MAIN MEASURES: TBI-CareQOL Emotional Suppression; TBI-CareQOL Caregiver Vigilance; measures of negative (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, PROMIS Anger, TBI-CareQOL Caregiver-Specific Anxiety, National Institutes of Health Toolbox [NIHTB] Perceived Stress, GAD-7) and positive affect (Neuro-QOL Positive Affect and Well-being, NIHTB Self-efficacy, NIHTB General Life Satisfaction, Family Resilience Scale for Veterans, TBI-QOL Resilience). RESULTS: When considered separately, linear regression showed that higher levels of Emotional Suppression and greater Caregiver Vigilance were individually associated with more negative affect and less positive affect. When considered together, the pattern of findings was generally consistent for both Emotional Suppression and Caregiver Vigilance with regard to negative affect and for Emotional Suppression with regard to positive affect. However, when considered together, Caregiver Vigilance was no longer related to positive affect. CONCLUSIONS: Caregivers with high emotional suppression and/or vigilance are more likely to show emotional distress and less likely to have positive affect than caregivers with lower levels of emotional suppression and vigilance. A combination of education and individual counseling targeting coping with negative emotions and TBI-related problems may be beneficial.

Determining a transitional scoring link between PROMIS® pediatric and adult physical health measures.

PURPOSE: Having independent versions of the PROMIS® scales (for Pediatric and Adults) is problematic as scores cannot be evaluated longitudinally as individuals move from childhood into adulthood. The primary aim of this research project is to use item response theory (IRT) to develop a transitional scoring link (or "crosswalk") between the PROMIS adult and pediatric physical health measures. SETTING: Sample 1 was collected at 6 rehabilitation hospitals in the U.S., and participants in Sample 2 were recruited from public health insurance programs and an online research panel. METHODS: PROMIS pediatric and adult physical function, mobility, upper extremity, fatigue, and pain measures were administered to a sample of 874 individuals aged 14-20 years old with special health needs and a sample of 641 individuals aged 14-25 years with a disability. IRT-based scores were linked using a linear approximation to calibrated projection. RESULTS: Estimated latent variable correlations ranged between 0.84 and 0.95 for the PROMIS pediatric and adult scores. Root Expected Mean Square Difference values were below the 0.08 threshold in all cases except when comparing genders on the Mobility (0.097) and Pain (0.10) scales in the special health care needs sample. Sum score conversion tables for the pediatric and adult PROMIS measures are presented. CONCLUSIONS: The linking coefficients can be used to calculate scale scores on PROMIS adult measures from pediatric measure scores and vice versa. This may lead to more accurate measurement in cross-sectional studies spanning multiple age groups or longitudinal studies that require comparable measurement across distinct developmental stages.