Search

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.

Purpose: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale., Methods and Results: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being., Conclusion: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

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., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

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., (© 2022. The Author(s).)

A series of recent reports have shed light on the pervasive nature of motor impairments in children with ASD (Bhat, 2020, 2021, Bhat et al., 2022), underscoring the importance of providing ASD clinicians efficient and accurate tools for motor screening. The Developmental Coordination Disorder-Questionnaire (DCD-Q) is a widely used motor screening tool, yet scant evidence exists regarding its psychometric properties in children with ASD. In a recent Exploratory Factor Analysis (EFA) of the 15-item DCD-Q in a large sample of children with ASD (SPARK study), we found a 5-factor latent structure that identified unique motor impairments in a large sample of children with ASD (Bhat et al., 2022). In the current study, we extend this work by cross-replicating the EFA findings of unique ASD-related motor issues using Confirmatory Factor Analysis (CFA) in a new, more recent wave of children with ASD from the SPARK study (N = 9721). The fits and interpretability of 11 hypothesis-driven CFA models, including 8 correlated-factors, 1 second-order, and 2 bifactor models were compared. Our findings supported the previous 5-factor model with 2 gross motor subdomains, 1 fine motor domain (similar to the original DCD-Q) and 2 general coordination subdomains. This model demonstrated acceptable fit in the new sample as well as superior fit compared to several other parsimonious correlated-factors models. However, the second-order and bifactor models fit slightly better and supported the presence of a general motor skills factor, although 38% of the common variance in the DCD-Q items remained attributable to the 5 subdomains. Using one of the bifactor models, measurement invariance was also supported for DCD-Q across sex, race, and co-occurring conditions of language disorder and intellectual disability. Only partial invariance was supported when testing DCD-Q scores across different age groups. These findings reveal a more complex dimensional picture of the DCD-Q in children with ASD. Results suggest that the DCD-Q can be used in two ways, total scores adequately assess general motor skills for brief screening and subdomain scores offer unique information on the multidimensional motor problems of children with ASD. If subdomain data are of interest, our findings call into question the practice of relying on 3 original subscales of the DCD-Q when screening for ASD-related motor difficulties, whereas 4 out of 5 subscale scores may better highlight domain-specific motor problems. Future studies should continue to further validate DCD-Q's ability to screen for multidimensional motor problems., (© 2023 International Society for Autism Research and Wiley Periodicals LLC.)

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., (Copyright © 2022 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Upper extremity transplantation offers the promise of restored function and regained quality of life (QOL) for individuals who have sustained hand or arm amputation. However, a major challenge for this procedure becoming an accessible treatment option for patients is the lack of standard measures to document benefits to QOL. Patient-reported outcomes (PRO) measures are well-suited for this kind of intervention, where the perspective of the patient is central to defining treatment success. To date, qualitative work with experts, clinicians, and patients has been used to identify the most important domains of QOL for PRO item development. Specifically, our group's qualitative work has identified several domains of QOL that are unique to individuals who have received upper extremity transplants, which are distinct from topics covered by existing PRO measures. These include emotional and social aspects of upper extremity transplant, such as Expectations and Perceived Outcomes, Integration and Assimilation of Transplant, Fitting in, and Post-Surgical Challenges and Complications. The broad topic of Satisfaction with Transplant was subdivided into three subtopics: Function, Sensation, and Aesthetics. Satisfaction with Sensation was also identified as a unique domain not evaluated by existing PRO measures. This report operationalizes these eight QOL domains by presenting scoping definitions. This manuscript describes the work that has been completed for domain characterization as an early step toward developing standardized PRO measures to evaluate these important outcomes specific to upper extremity transplantation., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Tyner, Slotkin, Kisala, Levin, Tintle and Tulsky.)

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., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Motor impairments are pervasive and persistent in children with autism spectrum disorder (ASD) throughout childhood and adolescence. Based on recent studies examining motor impairments in children with ASD between 5 and 15 years (i.e., SPARK study sample), 87-88% of this population is at-risk for a motor impairment, these problems persisted until 15 years, and related to their core (social communication skills and repetitive behaviors [RBs]) and comorbid (language, cognitive, and functional) impairments. Persistent motor impairments extending into adolescence/adulthood could negatively impact their independent daily living skills, physical fitness/activity levels, and physical/mental health. While multiple studies have examined relations between motor dimensions and core/comorbid impairments in young children with ASD, few studies have examined such relations in school-age children/adolescents with ASD. This paper conducts a further multidimensional study of which motor domains (i.e., gross-motor including visuo-motor or multilimb coordination/planning, fine motor [FM] or general coordination [GC] skills) best distinguish subgroups of school-age children/adolescents with ASD and help predict core and comorbid impairments after accounting for age and sex. Visuomotor, FM and certain GC skills were better at explaining variations in/predicting social communication impairments whereas FM skills were slightly better at explaining variations in/predicting RB severity. Multilimb coordination/planning and FM skills explained variations in/predicted cognitive delays whereas visuomotor and FM skills explained variations in and better predicted language delays. All three motor dimensions explained variations in/predicted functional delays. This study provides further evidence for inclusion of motor impairments within the ASD definition (criteria or specifiers). LAY SUMMARY: Gross-motor skills were related to social communication and functional delays of children with ASD (visuomotor skills related to language delays and multilimb coordination/planning skills related to cognitive delays). Fine-motor skills were related to repetitive behavior severity, language, cognitive, and functional delays in ASD. Diagnosticians should recommend systematic motor screening, further evaluations, and treatments for children at-risk for and diagnosed with ASD. Motor advocacy and enhanced public/clinical community awareness is needed to fulfill the unmet motor needs of children with ASD., (© 2022 International Society for Autism Research and Wiley Periodicals LLC.)

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., Competing Interests: All TBI-QOL items, parameters, and data are ©2016 David Tulsky. All rights reserved. All TBI-QOL items originally from Neuro-QoL are ©2008–2013 David Cella on behalf of the National Institute for Neurological Disorders and Stroke. All items are freely available to the public upon request (contact TBI-QOL@udel.edu). The contents represent original work and have not been published elsewhere., (Copyright © 2022 Tyner, Kisala, Boulton, Sherer, Chiaravalloti, Sander, Bushnik and Tulsky.)

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., (Copyright © 2021. Published by Elsevier Inc.)

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., (Copyright © 2021. Published by Elsevier Inc.)

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)., (Copyright © 2021 The American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2020 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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., (© 2021. The Author(s), under exclusive licence to International Spinal Cord Society.)

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., (Copyright © 2021 The American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Background Patient-reported outcome (PRO) measures produce scores that do not always have obvious clinical meaning. The PRO-bookmarking procedure is a new and promising way to make PRO measures more meaningful and interpretable. However, the materials and procedures of the task may benefit from adaptations to be more accessible to individuals with cognitive and language disorders. Aims This study aims to provide an overview of the iterative refinement process used to modify the materials and procedures of the PRO-bookmarking task so that they are more accessible to adults with acquired cognitive and language impairments. Method and Procedures Our team of health psychologists, neuropsychologists, and speech-language pathologists (SLPs) conducted two focus groups with SLPs and care partners of people with aphasia using the same PRO-bookmarking materials and procedures as previous reports. These PRO-bookmarking materials and procedures were then refined iteratively based on discussion with those who participated in focus groups and among the research team, and three more times in the course of 16 additional focus groups of different stakeholders: people with Parkinson's disease, aphasia, or traumatic brain injury; care partners of people with those conditions; and SLPs who have experience with those, and other adult-acquired conditions. Outcomes and Results The PRO-bookmarking materials and procedures underwent four iterations to make them clearer, simpler, and more accessible. For example, the materials included more structured text and graphic supports where appropriate and the procedures were clustered into smaller discrete tasks and displayed graphically when possible and appropriate. Conclusions PRO-bookmarking materials and procedures were made simpler and more structured to increase their accessibility to adults with cognitive and language impairments. In fact, these adaptations made the tasks simpler and clearer for all types of stakeholders.

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.

Purpose: Family disruption is often an indirect consequence of providing care for a person with traumatic brain injury (TBI). This article describes the development and preliminary validation of a Family Disruption scale designed for inclusion within the TBI-CareQOL measurement system., Method/design: Five hundred thirty-four caregivers of persons with TBI (service member/veteran n = 316; civilian n = 218) completed the Family Disruption scale, alongside several other measures of caregiver strain and health-related quality of life. Classical test theory and item response theory (IRT)-based analyses were conducted to develop, and establish reliability and validity of, this scale., Results: Exploratory and confirmatory factor analysis, as well as Samejima's graded response model-related IRT fit analyses, supported the development of a 3-item scale. This final scale is scored on a T score metric ( M = 50; SD = 10); higher scores are indicative of more family disruption. Reliability (internal consistency; test-retest stability) was supported for both caregiver groups, and average administration times were under 10 s. Convergent and discriminant validity were supported by strong correlations between Family Disruption and measures of caregiver burden, and smaller correlations with positive aspects of caregiving. As evidence of known-groups validity, caregivers of lower-functioning persons with TBI experienced more family disruption than caregivers of higher functioning individuals., Conclusions: The TBI-CareQOL Family Disruption scale is a brief, reliable, and valid assessment of caregiver perceptions of how caring for an individual with a TBI interferes with family life. This measure is well-suited for inclusion in studies seeking to support family functioning in persons with TBI. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Objective: The Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) is a patient-reported outcome measurement system that is specific to caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI). This measurement system includes 26 item banks that represent both generic (i.e., borrowed from existing measurement systems) and caregiver-specific components of health-related quality of life (HRQOL). This report provides reliability and validity data for measures within the TBI-CareQOL that have not previously been reported (i.e., 4 caregiver-specific and 7 generic measures of HRQOL)., Design: Three hundred eighty-five caregivers of persons with TBI completed caregiver-specific computer adaptive tests (CATs) for Feelings of Loss-Self, Caregiver Strain, Caregiver-Specific Anxiety, and Feeling Trapped, as well as generic measures of HRQOL from complementary measurement systems (i.e., Neuro-QoL Positive Affect and Well-Being; PROMIS Sleep-Related Impairment; NIH Toolbox Perceived Stress, General Life Satisfaction, and Self Efficacy; TBI-QOL Resilience and Grief/Loss). Caregivers also completed several additional measures to establish convergent and discriminant validity, as well as the Mayo Portland Adaptability Index, 4th ed., Results: Findings support the internal consistency reliability (all alphas > .85) and test-retest stability (all alphas >.73) of the TBI-CareQOL measures. Convergent validity was supported by moderate to high correlations between the TBI-CareQOL measures and related measures, whereas discriminant validity was supported by low correlations between the TBI-CareQOL measures and unrelated constructs. Known-groups validity was also supported., Conclusions: Findings support the reliability and validity of the item banks that comprise the TBI-CareQOL Measurement System. These measures should be considered for any standardized assessment of HRQOL in caregivers of civilians and SMVs with TBI. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Objective: Caregivers of individuals with traumatic brain injury (TBI) frequently experience anxiety related to the caregiver role. Often this is due to a caregiver's perceived need to avoid people and situations that might upset or "trigger" the care recipient. There are currently no self-report measures that capture these feelings; thus, this article describes the development and preliminary validation efforts for the TBI-Caregiver Quality of Life (CareQOL) Caregiver Vigilance item bank., Design: A sample of 532 caregivers of civilians ( n = 218) or service members/veterans (SMVs; n = 314) with TBI completed 32 caregiver vigilance items, other measures of health-related quality of life (RAND-12, Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, PROMIS Social Isolation, Caregiver Appraisal Scale), and the Mayo-Portland Adaptability Inventory-4., Results: The final item bank contains 18 items, as supported by exploratory and confirmatory factor analysis, item response theory graded response modeling (GRM), and differential item functioning investigations. Expert review and GRM calibration data informed the selection of a 6-item short form and programming of a computer adaptive test. Internal consistency reliability for the different administration formats were excellent (reliability coefficients ≥ .90). Three-week test-retest stability was supported (i.e., r ≥ .78). Correlations between vigilance and other self-report measures supported convergent and discriminant validity (0.01 ≤ r ≤ .69). Known-groups validity was also supported., Conclusions: The new TBI-CareQOL Caregiver Vigilance computer adaptive test and corresponding 6-item short form were developed using established rigorous measurement development standards, providing the first self-report measure to evaluate caregiver vigilance. This development work indicates that this measure exhibits strong psychometric properties. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Background: Barriers in the built environment, enduring stereotypes and biases, and limited disability competency of health care providers compromise access to and quality of reproductive health care for women with physical disabilities. One way to improve our understanding of critical factors that drive reproductive health inequity and its impact on access to care is to use patient-reported outcome measures (PROMs) that capture relevant and meaningful information about experience. In this study, we developed a conceptual framework as the foundation for relevant and clinically meaningful patient-reported outcome measures targeting the interface of disability and reproductive health. Materials and Methods: We conducted semistructured focus groups and interviews to assess women's experiences around their reproductive health and contextual factors related to disability. We used deductive and inductive qualitative coding approaches to develop the conceptual framework. Results: Eighty-one women between the ages of 16 and 50 with a self-reported physical disability, defined by an impairment of mobility, participated in 13 focus groups ( N  = 64) and 17 individual interviews. Five major themes characterized the conceptual framework that emerged-knowledge about reproductive health, communication about reproductive health, relationships, the reproductive health care environment, and self-advocacy/identity-all of which had some relationship with five major reproductive health issues-pregnancy and labor/delivery, periods and menstrual management, contraception, sexuality and sexual functioning, and pelvic examinations. Conclusions: This conceptual framework will serve as a foundation for PROM and guide intervention development to reduce reproductive health inequity and improve reproductive health outcomes of women with physical disabilities.

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., (Copyright © 2020 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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.

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., (Copyright © 2019 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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 (χ 2 [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., (Copyright © 2019 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To link scores on commonly used measures of anxiety (7-item Generalized Anxiety Disorder Scale; GAD-7) and depression (9-item Patient Health Questionnaire; PHQ-9) to the Traumatic Brain Injury Quality of Life (TBI-QOL) measurement system., Setting: 5 Traumatic Brain Injury Model Systems., Participants: A total of 385 individuals with traumatic brain injury (TBI) (31% complicated mild; 14% moderate; and 54% severe)., Design: Observational cohort., Main Measures: GAD-7, PHQ-9, TBI-QOL Anxiety v1.0 and TBI-QOL Depression v1.0., Results: Item response theory-based linking methods were used to create crosswalk tables that convert scores on the GAD-7 to the TBI-QOL Anxiety metric and scores on the PHQ-9 to the TBI-QOL Depression metric. Comparisons between actual and crosswalked scores suggest that the linkages were successful and are appropriate for group-level analysis. Linking functions closely mirror crosswalks between the GAD-7/PHQ-9 and the Patient-Reported Outcomes Measurement Information System (PROMIS), suggesting that general population linkages are similar to those from a TBI sample., Conclusion: Researchers and clinicians can use the crosswalk tables to transform scores on the GAD-7 and the PHQ-9 to the TBI-QOL metric for group-level analyses.

Objective: To develop and calibrate new patient-reported outcome measures of cognitive concerns for individuals with traumatic brain injury (TBI)., Setting: Five TBI model systems rehabilitation centers in the United States., Participants: Adults with medically confirmed history of TBI., Design: Cross-sectional survey in interview format., Main Measures: Traumatic Brain Injury-Quality of Life (TBI-QOL) Executive Function and TBI-QOL Cognition-General Concerns item banks., Results: A total of 569 adults with complicated-mild, moderate, or severe TBI completed preliminary item pools, which included 65 Executive Function items and 56 Cognition-General Concerns items. Confirmatory factor analysis supported the retention of 37 Executive Function and 39 Cognition-General Concerns items. Samejima's graded response model was used to estimate item parameters for associated computer adaptive test administrations, and informed the selection of corresponding static short forms. Data from an independent sample of 77 adults with complicated-mild, moderate, or severe TBI supported the test-retest reliability of these newly developed measures., Conclusion: The TBI-QOL Executive Function and Cognition-General Concerns item banks provide researchers and clinicians with reliable tools for assessing patient-reported post-TBI cognitive difficulties as part of the comprehensive TBI-QOL measurement system.

Objectives: To describe the development and field testing of the patient-reported outcome measures of Mobility and Upper Extremity function from the Traumatic Brain Injury Quality of Life (TBI-QOL) measurement system, and to evaluate the use of computer adaptive testing., Setting: Five rehabilitation facilities funded as part of the TBI Model Systems network., Participants: Individuals with complicated mild, moderate, or severe traumatic brain injury (n = 590)., Interventions: Not available., Outcome Measures: TBI-QOL Mobility and Upper Extremity item banks., Results: Item response theory and factor analyses supported the unidimensionality of the Mobility and Upper Extremity banks. Descriptive statistics showed a ceiling effect for both measures. Simulated computer adaptive tests (CATs) showed that measurement precision was maintained across administration formats for both measures. The Upper Extremity CAT showed a loss of precision for individuals without impairment and that a higher number of items were required to achieve sufficiently precise measurement, compared to the Mobility CAT., Conclusions: The TBI-QOL Upper Extremity and Mobility item banks achieved good breadth of coverage, particularly among those individuals who have experienced some degree of functional limitation. The use of CAT administration minimizes respondent burden, while allowing for the comprehensive assessment of adults with TBI. The combined use of the TBI-QOL with performance-based measures could guide the development of targeted rehabilitation treatments.

Objective: To develop a traumatic brain injury (TBI)-specific, item response theory (IRT)-calibrated Fatigue item bank, short form, and computer adaptive test (CAT) as part of the Traumatic Brain Injury-Quality of Life (TBI-QOL) measurement system., Setting: Five TBI Model Systems rehabilitation centers in the US PARTICIPANTS:: Adults with complicated mild, moderate, or severe TBI confirmed by medical record review., Design: Cross-sectional field testing via phone or in-person interview., Main Measures: TBI-QOL Fatigue item bank, short form, and CAT., Results: A total of 590 adults with TBI completed 95 preliminary fatigue items, including 86 items from the Patient-Reported Outcomes Measurement Information System (PROMIS) and 9 items from the Quality of Life in Neurological Disorders (Neuro-QOL) system. Through 4 iterations of factor analysis, 22 items were deleted for reasons such as local item dependence, misfit, and low item-total correlations. Graded response model IRT analyses were conducted on the 73-item set, and Stocking-Lord equating was used to transform the item parameters to the PROMIS (general population) metric. A short form and CAT, which demonstrate similar reliability to the full item bank, were developed. Test-retest reliability of the CAT was established in an independent sample (Pearson's r and intraclass correlation coefficient = 0.82 [95% confidence interval: 0.72-0.88])., Conclusions: The TBI-QOL Fatigue item bank, short form, and CAT provide rehabilitation researchers and clinicians with TBI-optimized tools for assessment of the patient-reported experience and impact of fatigue on individuals with TBI.

Objective: To develop an item response theory (IRT)-based patient-reported outcome measure of functional communication for adults with traumatic brain injury (TBI)., Setting: Five medical centers that were TBI Model Systems sites., Participants: A total of 569 adults with TBI (28% complicated-mild; 13% moderate; and 58% severe)., Design: Grounded theory-based qualitative item development, large-scale item calibration testing, confirmatory factor analyses, psychometric analyses with graded response model IRT., Main Measure: Traumatic Brain Injury-Quality of Life (TBI-QOL) Communication Item Bank, version 1.0., Results: From an initial pool of 48 items, 31 items were retained in the final instrument based on adequate fit to a unidimensional model and absence of bias across several demographic and clinical subgroupings. The TBI-QOL Communication Item Bank demonstrated excellent score precision (reliability ≥ 0.95) across a wide range of communication impairment levels, particularly for individuals with more severe difficulties. The TBI-QOL Communication Item Bank is available as a full item bank, fixed-length short form, and as a computerized adaptive test., Conclusions: The TBI-QOL Communication Item Bank permits precise measurement of patient-reported functional communication after TBI. Future development will validate the instrument against performance-based, clinician-reported, and surrogate-reported assessments.

Objective: To develop, calibrate, and evaluate the test-retest reliability of a new patient-reported outcome measure of headache pain relevant for individuals with traumatic brain injury (TBI)., Setting: Six TBI Model Systems rehabilitation centers in the United States., Participants: Adults with medically confirmed documentation of TBI., Design: Cross-sectional calibration field testing and test-retest reliability analyses., Main Measures: Traumatic Brain Injury-Quality of Life Headache Pain item bank., Results: Thirteen headache pain items were calibrated as a unidimensional measure using data from 590 participants. The new measure was reliable (α = .98; item-total correlation range: 0.71-0.91). Item parameter estimates were estimated using Samejima's Graded Response Model and a 10-item calibrated short form was created. Simulation testing confirmed that both the computer-adaptive test and the short-form administrations were equivalent to the full item bank. One- to-2-week test-retest reliability of the computer-adaptive test was high (Pearson r and intraclass correlation coefficients = 0.81). Approximately two-thirds of the sample reported at least 1 headache symptom., Conclusion: The Traumatic Brain Injury-Quality of Life Headache Pain item bank and short form provide researchers and clinicians with reliable measures of the subjective experience of headache symptoms for individuals with a history of TBI.

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.

Objective: To assess differential item functioning and observed mean differences across two modes of administration for PROMIS® measure scores in a sample of adults with traumatic injury., Method: Items from 7 PROMIS® adult measures (v1.0 Physical Function, Fatigue, Pain Interference, Anger, Anxiety, and Depression and v2.0 Social Health-Emotional Support) were administered as fixed-length short forms in random order to a cross-sectional sample. Participants were randomly assigned to interviewer-administered (phone or in-person) or self-administered (via the Assessment Center website) conditions. The research was conducted at 5 medical rehabilitation institutions across the U.S. Participants included 277 adults with spinal cord injury (n = 148) or traumatic brain injury (n = 129)., Results: DIF analyses indicated that all items were invariant to mode of administration. There was no significant effect of mode of administration for the majority of PROMIS® measures tested. Regarding observed scores, there were small but significant effects of mode of administration on the Emotional Support and Depression measures, with participants in the interview condition reporting better support/fewer symptoms., Conclusions: PROMIS® instruments demonstrated measurement equivalence across interviewer-administered and self-administered conditions. These findings are particularly important for research or clinical applications where administration of PROMIS® measures by independent web- or tablet-based administration is not ideal, for example with individuals with physical or cognitive disabilities or with individuals who lack computer and/or Internet access. PROMIS® v1.0 Depression and PROMIS® v2.0 Emotional Support scores displayed a tendency toward social desirability that should be considered when these measures are interviewer-administered. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Objective: To examine group differences among caregivers of service members or veterans (SMVs) and civilians with traumatic brain injury (TBI)., Design: An observational research study examining the group differences between caregivers of SMVs and civilians with TBI. The data presented was collected as part of a larger study that calibrated and validated the Traumatic Brain Injury-Care Quality of Life (TBI-CareQOL) item banks., Setting: Participants in this multicenter study completed an online survey via a study-specific website. Surveys were completed at the study site, at home, or via phone interview. Civilian caregivers were recruited from 4 rehabilitation hospitals and caregivers of SMVs were recruited through community outreach and collaboration with the Hearts of Valor., Participants: Participants (N=473) consisted of 344 caregivers of civilians with TBI and 129 caregivers of SMVs with TBI., Interventions: Not applicable., Main Outcome Measures: Zarit Burden Interview Scale, TBI-CareQOL, and Mayo Portland Adaptability Inventory, 4th revision (MPAI-4)., Results: Of the independent variables included in the logistic regression model that classified military-affiliated vs civilian caregivers, 5 were statistically significant: age, spousal status, time since injury, MPAI-4 Adjustment, and TBI-CareQOL Feeling Trapped., Conclusions: The results indicate that caregivers of SMVs were more likely to report worse emotional and social adjustment among the individuals with TBI and caregivers of SMVs were more likely to report greater levels of feeling trapped by their caregiving duties., (Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To examine the reliability and validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures of sleep disturbance and fatigue in traumatic brain injury (TBI) caregivers and to determine the severity of fatigue and sleep disturbance in these caregivers., Design: Cross-sectional survey data collected through an online data capture platform., Setting: A total of 4 rehabilitation hospitals and Walter Reed National Military Medical Center., Participants: Caregivers (N=560) of civilians (n=344) and service member/veterans (SMVs) (n=216) with TBI., Intervention: Not applicable., Main Outcome Measures: PROMIS sleep and fatigue measures administered as both computerized adaptive tests (CATs) and 4-item short forms (SFs)., Results: For both samples, floor and ceiling effects for the PROMIS measures were low (<11%), internal consistency was very good (all α≥0.80), and test-retest reliability was acceptable (all r≥0.70 except for the fatigue CAT in the SMV sample r=0.63). Convergent validity was supported by moderate correlations between the PROMIS and related measures. Discriminant validity was supported by low correlations between PROMIS measures and measures of dissimilar constructs. PROMIS scores indicated significantly worse sleep and fatigue for those caring for someone with high levels versus low levels of impairment., Conclusions: Findings support the reliability and validity of the PROMIS CAT and SF measures of sleep disturbance and fatigue in caregivers of civilians and SMVs with TBI., (Copyright © 2018 American Congress of Rehabilitation Medicine. All rights reserved.)

Objective: To investigate the association of the sociocultural variables race/ethnicity, education, and poverty level to caregivers' positive and negative appraisals following traumatic brain injury., Design: Survey., Setting: Community., Participants: Caregivers (N=344; 216 white; 69 black; 39 Hispanic) of persons with complicated mild to severe TBI at least 1-year postinjury., Intervention: Not applicable., Main Outcome Measures: Modified Caregiver Appraisal Scale (M-CAS); Zarit Burden Interview (ZBI)., Results: Black caregivers reported lower levels of perceived burden on both the M-CAS and the ZBI. Black and Hispanic caregivers reported more traditional caregiver ideology (caregiving as a responsibility) than did whites. Greater poverty was associated with higher burden on the M-CAS, lower caregiver satisfaction, and less mastery. Higher education was associated with higher burden on the ZBI and with lower caregiver mastery., Conclusions: Treatment professionals should be culturally sensitive to the different perspectives that caregivers may have based on sociocultural factors. Sociocultural factors should be considered in research investigating caregiver outcomes, including appraisals., (Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To develop a new measurement system, the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL), that can evaluate both general and caregiving-specific aspects of health-related quality of life (HRQOL) in caregivers of persons with traumatic brain injury (TBI)., Design: New item pools were developed and refined using literature reviews, qualitative data from focus groups, and cognitive debriefing with caregivers of civilians and service members/veterans with TBI, as well as expert review, reading level assessment, and translatability review; existing item banks and new item pools were assessed using an online data capture system. Exploratory and confirmatory factor analysis, item response theory, and differential item functioning analyses were utilized to develop new caregiver-specific item banks. Known-groups validity was examined using a series of independent samples t tests comparing caregivers of low-functioning vs high-functioning persons with TBI for each of the new measures, as well as for 10 existing Patient-Reported Outcomes Measurement Information System (PROMIS) measures., Setting: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility., Participants: Caregivers (N=560) of civilians (n=344) or service members/veterans with TBI (n=216)., Interventions: Not applicable., Main Outcome Measures: The TBI-CareQOL measurement system (including 5 new measures and 10 existing PROMIS measures)., Results: Exploratory and confirmatory factor analysis, item response theory, and differential item functioning analyses supported the development of 5 new item banks for Feelings of Loss-Self, Feelings of Loss-Person with TBI, Caregiver-Specific Anxiety, Feeling Trapped, and Caregiver Strain. In support of validity, individuals who were caring for low-functioning persons with TBI had significantly worse HRQOL than caregivers that were caring for high-functioning persons with TBI for both the new caregiver-specific HRQOL measures, and for the 10 existing PROMIS measures., Conclusions: The TBI-CareQOL includes both validated PROMIS measures and newly developed caregiver-specific measures. Together, these generic and specific measures provide a comprehensive assessment of HRQOL for caregivers of civilians and service members/veterans with TBI., (Copyright © 2018 American Congress of Rehabilitation Medicine. All rights reserved.)

Objectives: To establish the reliability and validity of the newly developed TBI-CareQOL patient-reported outcome (PRO) measures in caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI) so that they can be used with confidence in clinical research and practice., Design: Computer-based surveys delivered through an on-line data capture platform., Setting: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility., Participants: Caregivers (N=560) of individuals with TBI; this included 2 different study samples: 344 caregivers of civilians with TBI and 216 caregivers of SMVs with TBI., Intervention: Not Applicable., Main Outcome Measures: Five Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) item banks., Results: Reliabilities for the TBI-CareQOL measures were excellent (all Cronbach's α >.88); 3-week test-retest reliability ranged from .75 to .90 across the 2 samples. Convergent validity was supported by moderate to high associations among the TBI-CareQOL measures and moderate correlations between the TBI-CareQOL measures and other measures of health-related quality of life (HRQOL) and caregiver burden. Discriminant validity was supported by low correlations between the TBI-CareQOL measures and less-related constructs (eg, caregiver satisfaction). Known-groups validity was supported: caregivers of individuals that were low functioning had worse HRQOL than caregivers of high-functioning individuals., Conclusions: Results provide psychometric support for the new TBI-CareQOL item banks. As such, these measures fill a significant gap in the caregiver literature where sensitive PRO measures that capture changes in HRQOL are needed to detect improvements for interventions designed to assist family caregivers., (Copyright © 2018 American Congress of Rehabilitation Medicine. All rights reserved.)

Objective: To examine the reliability and validity of the short form (SF) and computer adaptive test (CAT) versions of the Patient-Reported Outcomes Measurement Information System (PROMIS) measures of social health of caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI)., Design: Self-report questionnaires administered through an online data collection platform., Setting: Hospital and community-based outreach at 3 TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility., Participants: Caregivers (N=560) (344 civilians and 216 military) of individuals with a documented TBI., Intervention: Not applicable., Main Outcome Measures: A total of 5 PROMIS social health measures., Results: All 5 PROMIS social health measures exceeded the a priori criterion for internal consistency reliability (≥0.70); most PROMIS measures met the criterion for test-retest reliability (≥0.70) in the civilian sample; in the SMV sample, test-retest reliability was generally below this criterion, except for social isolation. For both samples, convergent validity was supported by moderate correlations between the 5 PROMIS social health measures and related measures, and discriminant validity was supported by low correlations between PROMIS social health measures and measures of dissimilar constructs. Most PROMIS scores indicated significantly worse social health in both samples of those caring for individuals who were low functioning. Finally, impairment rates in social health were elevated for those caring for low-functioning individuals, especially in the SMV sample., Conclusions: The PROMIS CAT and SF social health measures have potential clinical utility for use in caregivers of civilians and SMVs with TBI., (Copyright © 2018 American Congress of Rehabilitation Medicine. All rights reserved.)

Purpose The purpose of this study was to evaluate the internal consistency and construct validity of the Traumatic Brain Injury Quality of Life Communication Item Bank (TBI-QOL COM) short form as a parent-proxy report measure. The TBI-QOL COM is a patient-reported outcome measure of functional communication originally developed as a self-report measure for adults with traumatic brain injury (TBI), but it may also be valid as a parent-proxy report measure for children who have sustained TBI. Method One hundred twenty-nine parent-proxy raters completed the TBI-QOL COM short form 6 months postinjury as a secondary aim of a multisite study of pediatric TBI outcomes. The respondents' children with TBI were between 8 and 18 years old ( M age = 13.2 years old) at the time of injury, and the proportion of TBI severity mirrored national trends (73% complicated-mild; 27% moderate or severe). Results The parent-proxy report version of the TBI-QOL COM displayed strong internal consistency (ordinal α = .93). It also displayed evidence of known-groups validity by virtue of more severe injuries associated with more abnormal scores. The instrument also showed evidence of convergent and discriminant validity by displaying a pattern of correlations with other constructs according to their conceptual relatedness to functional communication. Conclusions This preliminary psychometric investigation of the TBI-QOL COM supports the further development of a parent report version of the instrument. Future development of the TBI-QOL COM with this population may include expanding the content of the item bank and developing calibrations specifically for parent-proxy raters. Supplemental Material https://doi.org/10.23641/asha.7616534.

Purpose/objective: To compare and contrast how individuals with traumatic brain injury (TBI) are classified (positive or negative screen) by different cut-offs on two self-report measures of depressive symptoms: the PHQ-9, which assesses somatic symptoms, and the TBI-QOL Depression item bank, which does not. Research Method/Design: Three hundred eighty-five individuals with TBI were recruited from six rehabilitation hospitals in the U.S. as part of the calibration data collection for the TBI-QOL patient-reported outcome measurement system., Results: The TBI-QOL and PHQ-9 total scores correlated strongly (disattenuated r = .83). The correlation was even stronger (disattenuated r = .92) when the four PHQ-9 somatic items were removed from the total score. When the PHQ-9 was scored traditionally, the rate of agreement was approximately 80-85% using standard cut-offs for each scale. Depending on the cut-off score, 23-26% of participants screened positive on the PHQ-9, whereas 9-38% screened positive on the TBI-QOL Depression. Individuals who screened positive on the PHQ-9 alone reported more somatic symptoms than those who screened positive on the TBI-QOL alone. Individuals who screened positive on the TBI-QOL alone were at slightly greater risk for other negative psychological functioning than individuals who screened positive on the PHQ-9 alone., Conclusions/implications: The PHQ-9 and TBI-QOL Depression performed similarly in screening for depressive symptoms among individuals with TBI. The PHQ-9 identified more individuals with somatic symptoms, which may overlap with other medical issues, whereas the TBI-QOL Depression instrument identified more individuals who reported other forms of emotional distress. (PsycINFO Database Record, ((c) 2018 APA, all rights reserved).)

Study Design: This is a focused review article., Objectives: This review presents important features of clinical outcomes assessments (COAs) in human spinal cord injury research. Considerations for COAs by trial phase and International Classification of Functioning, Disability and Health are presented as well as strengths and recommendations for upper extremity COAs for research. Clinical trial tools and designs to address recruitment challenges are identified., Methods: The methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review., Results: COAs must be appropriate to trial phase and particularly in mid-late-phase trials, should reflect recovery vs. compensation, as well as being clinically meaningful. The impact and extent of upper vs. lower motoneuron disease should be considered, as this may affect how an individual may respond to a given therapeutic. For trials with broad inclusion criteria, the content of COAs should cover all severities and levels of SCI. Specific measures to assess upper extremity function as well as more comprehensive COAs are under development. In addition to appropriate use of COAs, methods to increase recruitment, such as adaptive trial designs and prognostic modeling to prospectively stratify heterogeneous populations into appropriate cohorts should be considered., Conclusions: With an increasing number of clinical trials focusing on improving upper extremity function, it is essential to consider a range of factors when choosing a COA., Sponsors: Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

Objective: To develop modern patient-reported outcome measures that assess pain interference and pain behavior after spinal cord injury (SCI)., Design: Grounded-theory based qualitative item development; large-scale item calibration field-testing; confirmatory factor analyses; graded response model item response theory analyses; statistical linking techniques to transform scores to the Patient Reported Outcome Measurement Information System (PROMIS) metric., Setting: Five SCI Model Systems centers and one Department of Veterans Affairs medical center in the United States., Participants: Adults with traumatic SCI., Interventions: N/A., Outcome Measures: Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference item bank, SCI-QOL Pain Interference short form, and SCI-QOL Pain Behavior scale., Results: Seven hundred fifty-seven individuals with traumatic SCI completed 58 items addressing various aspects of pain. Items were then separated by whether they assessed pain interference or pain behavior, and poorly functioning items were removed. Confirmatory factor analyses confirmed that each set of items was unidimensional, and item response theory analyses were used to estimate slopes and thresholds for the items. Ultimately, 7 items (4 from PROMIS) comprised the Pain Behavior scale and 25 items (18 from PROMIS) comprised the Pain Interference item bank. Ten of these 25 items were selected to form the Pain Interference short form., Conclusions: The SCI-QOL Pain Interference item bank and the SCI-QOL Pain Behavior scale demonstrated robust psychometric properties. The Pain Interference item bank is available as a computer adaptive test or short form for research and clinical applications, and scores are transformed to the PROMIS metric.

Purpose/objective: Metrics to estimate premorbid cognitive ability, such as word reading tests, are important for clinical determination of cognitive changes following brain injury. In the present study, reading adjusted scores for the National Institutes of Health Toolbox Cognition Battery (NIHTB-CB) fluid tests were developed and validated with a sample of individuals with traumatic brain injury (TBI), to evaluate the clinical utility of reading-adjusted scores. Research Method/Design: The development sample included 843 adult participants, ages 20-85, from the NIHTB-CB standardization sample. A sample of 158 participants with complicated mild or moderate TBI (n = 74) or severe TBI (n = 84) were administered the NIHTB-CB, and comprised the validation sample. Scores were derived for the five fluid tests using four adjustment models: age-only, demographic-only, age-and-reading, and demographic-and-reading referenced scores., Results: Estimated premorbid ability varies depending on the reference model. Scores from each of the four reference models differentiated the comparison and TBI samples at the group level. However, performance varied by premorbid ability., Conclusions/implications: Premorbid ability affects identification of cognitive difficulties after TBI. Reading referenced scores provide an individualized estimate of the effects of premorbid ability than demographic characteristics alone. Each model identified a similar number of individuals as having cognitive difficulties; however, the models differed on which individuals had cognitive difficulties. The models had higher disagreement rates in the clinical compared with the comparison sample, particularly for individuals with lower premorbid ability. Clinical use and caveats are discussed. (PsycINFO Database Record, ((c) 2017 APA, all rights reserved).)