Search

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.)

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: 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.

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).

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 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.)

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 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 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.)

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: To develop and evaluate a model of environmental factors-participation relationships for persons with traumatic brain injury (TBI), stroke, and spinal cord injury (SCI), and test whether this model differed across three diagnostic groups, as well as other demographic and clinical characteristics., Methods: A cross-sectional observational study included 545 community-dwelling adults with neurological disorders (TBI = 166; stroke = 189; SCI = 190) recruited at three academic medical centers. Participants completed patient-reported measures of environmental factors and participation., Results: The final structural equation model had acceptable fit to the data (CFI = 0.923; TLI = 0.898; RMSEA = 0.085; SRMR = 0.053), explaining 63% of the variance in participation in social roles and activities. Systems, services, and policies had an indirect influence on participation and this relation was mediated by social attitudes and the built and natural environment. Access to information and technology was associated with the built and natural environment which in turn influence on participation (ps < 0.001). The model was consistent across sex, diagnosis, severity/type of injury, education, race, age, marital status, years since injury, wheelchairs use, insurance coverage, personal or household income, and crystallized cognition., Conclusions: Social and physical environments appear to mediate the influence of systems, services, and policies on participation after acquired neurological disorders. These relations are stable across three diagnostic groups and many personal and clinical factors. Our findings inform health and disability policy, and provide guidance for implementing the initiatives in Healthy People 2020 in particular for people with acquired neurological disorders.

Purpose: The primary objective is to provide evidence of convergent and discriminant validity for the pediatric and parent-proxy versions of the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, Depression, Anger, Peer Relations, Mobility, Pain Interference, and Fatigue item banks, the Neurology Quality of Life measurement system (Neuro-QOL) Cognition-General Concerns and Stigma item banks, and the Traumatic Brain Injury Quality of Life (TBI-QOL) Executive Function and Headache item banks in a pediatric traumatic brain injury (TBI) sample., Methods: Participants were 134 parent-child (ages 8-18 years) days. Children all sustained TBI and the dyads completed outcome ratings 6 months after injury at one of six medical centers across the United States. Ratings included PROMIS, Neuro-QOL, and TBI-QOL item banks, as well as the Pediatric Quality of Life inventory (PedsQL), the Health Behavior Inventory (HBI), and the Strengths and Difficulties Questionnaire (SDQ) as legacy criterion measures against which these item banks were validated., Results: The PROMIS, Neuro-QOL, and TBI-QOL item banks demonstrated good convergent validity, as evidenced by moderate to strong correlations with comparable scales on the legacy measures. PROMIS, Neuro-QOL, and TBI-QOL item banks showed weaker correlations with ratings of unrelated constructs on legacy measures, providing evidence of discriminant validity., Conclusion: Our results indicate that the constructs measured by the PROMIS, Neuro-QOL, and TBI-QOL item banks are valid in our pediatric TBI sample and that it is appropriate to use these standardized scores for our primary study analyses.

Objectives: To develop a measure of natural environment and human-made change features (Chapter 2 of the international classification of functioning, disability, and health) and evaluate the influence of perceived barriers on health-related quality of life., Methods: A sample of 570 adults with stroke, spinal cord injury, and traumatic brain injury residing in community settings reported their functioning in home, outdoor, and community settings (mean age = 47.0 years, SD = 16.1). They rated 18 items with a 5-point rating scale to describe the influence of barriers to moving around, seeing objects, hearing sounds, hearing conversations, feeling safe, and regulating temperature and indicated whether any difficulties were due to environmental features. We used Rasch analysis to identify misfitting items and evaluate differential item functioning (DIF) across impairment groups. We computed correlations between barriers and patient-reported outcomes measurement information system (PROMIS) social domain measures and community participation indicators (CPI) measures., Results: The 18 items demonstrated person reliability of .70, discriminating nearly three levels of barriers. All items fit the Rasch model; impairment-related DIF was negligible. Ceiling effects were negligible, but 25 % of the respondents were at the floor, indicating that they did not experience barriers that they attributed to the built and natural environment. As anticipated, barriers correlated moderately with PROMIS and CPI variables, suggesting that although this new item bank measures a construct that is related to participation and health-related quality of life, it also captures something unique. Known-groups validity was supported by wheelchair users reporting a higher level of barriers than did ambulatory respondents., Conclusions: Preliminary evidence supports the reliability and validity of this new measure of barriers to the built and natural environment. This measure allows investigators and clinicians to measure perceptions of the natural environment and human-made changes, providing information that can guide interventions to reduce barriers. Moderate relationships between barriers and PROMIS and CPI variables provide support for the measurement and theory of environmental influences on social health and participation.

Background: The Patient Reported Outcomes Measurement Information System (PROMIS) was developed to provide patient-reported outcome measures that are designed as being universally relevant across health conditions, low burden, and precise. A major problem for research and clinical practice in cerebral palsy (CP) is the void of outcomes instruments that are capable of evaluating the wide range of abilities and broad age spectrum inherent in this clinical population. Given the tremendous potential of PROMIS, the research questions for this study were "How do PROMIS pediatric computer adaptive tests and short forms detect change in children with CP following elective musculoskeletal surgery?" and "How do PROMIS instruments compare to the Pediatric Quality of Life Inventory Cerebral Palsy Module Version 3.0 (PedsQL CP), Pediatric Outcomes Data Collection Instrument (PODCI), the Timed Up and Go (TUG), and the Gross Motor Functional Measure (GMFM).", Methods: PROMIS Pediatric computer adaptive tests and short forms and the PedsQL, PODCI, TUG, and GMFM were administered before and after surgery. Effect size (ES) and standardized response mean (SRM) were calculated. Floor and ceiling effects were evaluated and, exposure rates for the PROMIS item banks were examined., Results: ES and SRM for all PROMIS Pediatric Measures were nonsignificant. PedsQL CP detected significant, positive change in mobility at 6 (ES=0.26; SRM=0.31) and 12 (ES=0.36; SRM=0.36) months; pain at 12 months (ES=0.29; SRM=0.34); and fatigue at 6 (ES=0.24; SRM=0.22) and 12 (ES=0.36; SRM=0.41) months. Significant negative changes were detected by the PODCI (ES=-0.20; SRM=-0.26), GMFM (ES=-0.13; SRM=-0.24), and TUG (ES=-0.29; SRM=-0.25). Ceiling effects were high. Exposure to an appropriate range of the PROMIS Mobility item bank was limited., Conclusions: PROMIS measures were less able to detect change than other measures. PROMIS measures may be improved by tailoring start/stop rules or by adding items to include content appropriate for children with mobility impairments., Level of Evidence: Level III-diagnostic study.

Purpose: Research studies that measure health-related quality of life (HRQOL) in both children and adults and longitudinal studies that follow children into adulthood need measures that can be compared across these age groups. This study links the PROMIS pediatric and adult emotional distress measures using data from participants with diverse health conditions and disabilities., Methods: Analyses were conducted and compared in two separate samples to confirm the stability of results. One sample (n = 874) included individuals aged 14-20 years with special health care needs and who require health services. The other sample (n = 641) included individuals aged 14-25 years who have a physical or cognitive disability. Participants completed both PROMIS pediatric and adult measures. Item response theory-based scores were linked using the linear approximation to calibrated projection., Results: The estimated latent-variable correlation between pediatric and adult PROMIS measures ranged from 0.87 to 0.94. Regression coefficients β 0 (intercept) and β 1 (slope), and mean squared error are provided to transform scores from the pediatric to the adult measures, and vice versa., Conclusions: This study used a relatively new linking method, calibrated projection, to link PROMIS pediatric and adult measure scores, thus expanding the use of PROMIS measures to research that includes both populations.

Objective: To examine the clinical utility and psychometric properties of the Traumatic Brain Injury Quality of Life (TBI-QOL) scale in a US military population., Participants: One hundred fifty-two US military service members (age: M = 34.3, SD = 9.4; 89.5% men) prospectively enrolled from the Walter Reed National Military Medical Center and other nationwide community outreach initiatives. Participants included 99 service members who had sustained a mild traumatic brain injury (TBI) and 53 injured or noninjured controls without TBI (n = 29 and n = 24, respectively)., Procedure: Participants completed the TBI-QOL scale and 5 other behavioral measures, on average, 33.8 months postinjury (SD = 37.9)., Main Outcome Measures: Fourteen TBI-QOL subscales; Neurobehavioral Symptom Inventory; Posttraumatic Stress Disorder Checklist-Civilian version; Alcohol Use Disorders Identification Test; Combat Exposure Scale., Results: The internal consistency reliability of the TBI-QOL scales ranged from α = .91 to α = .98. The convergent and discriminant validity of the 14 TBI-QOL subscales was high. The mild TBI group had significantly worse scores on 10 of the 14 TBI-QOL subscales than the control group (range, P < .001 to P = .043). Effect sizes ranged from medium to very large (d = 0.35 to d = 1.13). The largest differences were found on the Cognition-General Concerns (d = 1.13), Executive Function (d = 0.94), Grief-Loss (d = 0.88), Pain Interference (d = 0.83), and Headache Pain (d = 0.83) subscales., Conclusion: These results support the use of the TBI-QOL scale as a measure of health-related quality of life in a mild TBI military sample. Additional research is recommended to further evaluate the clinical utility of the TBI-QOL scale in both military and civilian settings.

Objective: To use a patient-centered approach or participatory action research design combined with advanced psychometrics to develop a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with traumatic brain injury (TBI). This TBI Quality-of-Life (TBI-QOL) measurement system expands the work of other large PRO measurement initiatives, that is, the Patient-Reported Outcomes Measurement Information System and the Neurology Quality-of-Life measurement initiative., Setting: Five TBI Model Systems centers across the United States., Participants: Adults with TBI., Design: Classical and modern test development methodologies were used. Qualitative input was obtained from individuals with TBI, TBI clinicians, and caregivers of individuals with TBI through multiple methods, including focus groups, individual interviews, patient consultation, and cognitive debriefing interviews. Item pools were field tested in a large multisite sample (n = 675) and calibrated using item response theory methods., Main Outcomes Measures: Twenty-two TBI-QOL item banks/scales., Results: The TBI-QOL consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life., Conclusions: The TBI-QOL measurement system has potential as a common data element in TBI research and to enhance collection of health-related quality-of-life and PRO data in rehabilitation research and clinical settings.

Objective: To investigate unique factors that affect health-related quality of life (QOL) in individuals with military deployment-related traumatic brain injury (MDR-TBI) and to develop appropriate assessment tools, consistent with the TBI-QOL/PROMIS/Neuro-QOL systems., Participants: Three focus groups from each of the 4 Veterans Administration (VA) Polytrauma Rehabilitation Centers, consisting of 20 veterans with mild to severe MDR-TBI, and 36 VA providers were involved in early stage of new item banks development. The item banks were field tested in a sample (N = 485) of veterans enrolled in VA and diagnosed with an MDR-TBI., Design: Focus groups and survey., Outcome Measures: Developed item banks and short forms for Guilt, Posttraumatic Stress Disorder/Trauma, and Military-Related Loss., Results: Three new item banks representing unique domains of MDR-TBI health outcomes were created: 15 new Posttraumatic Stress Disorder items plus 16 SCI-QOL legacy Trauma items, 37 new Military-Related Loss items plus 18 TBI-QOL legacy Grief/Loss items, and 33 new Guilt items. Exploratory and confirmatory factor analyses plus bifactor analysis of the items supported sufficient unidimensionality of the new item pools. Convergent and discriminant analyses results, as well as known group comparisons, provided initial support for the validity and clinical utility of the new item response theory-calibrated item banks and their short forms., Conclusion: This work provides a unique opportunity to identify issues specific to individuals with MDR-TBI and ensure that they are captured in QOL assessment, thus extending the existing TBI-QOL measurement system.

The purpose of this study was to develop a conceptual framework that captures aspects of health-related quality of life (HRQOL) for caregivers of individuals with military-related traumatic brain injury (TBI). We analyzed qualitative data from nine focus groups composed of caregivers of wounded warriors with a medically documented TBI. Focus group participants were recruited through hospital-based and/or community outreach efforts at the Walter Reed National Military Medical Center, the University of Michigan, and Hearts of Valor support groups (Tennessee and Washington). Participants were the caregivers (n = 45) of wounded warriors who had sustained a mild, moderate, severe, or penetrating TBI. Qualitative frequency analysis indicated that caregivers most frequently discussed social health (44% of comments), followed by emotional (40%) and physical health (12%). Areas of discussion that were specific to this population included anger regarding barriers to health services (for caregivers and servicemembers), emotional suppression (putting on a brave face for others even when things are not going well), and hypervigilance (controlling one's behavior/environment to prevent upsetting the servicemember). Caring for wounded warriors with TBI is a complex experience that positively and negatively affects HRQOL. While some aspects of HRQOL can be evaluated with existing measures, evaluation tools for other important components do not exist. The development of military-specific measures would help facilitate better care for these individuals.

Context/objective: The Spinal Cord Injury--Quality of Life (SCI-QOL) measurement system was developed to address the shortage of relevant and psychometrically sound patient reported outcome (PRO) measures available for clinical care and research in spinal cord injury (SCI) rehabilitation. Using a computer adaptive testing (CAT) approach, the SCI-QOL builds on the Patient Reported Outcomes Measurement Information System (PROMIS) and the Quality of Life in Neurological Disorders (Neuro-QOL) initiative. This initial manuscript introduces the background and development of the SCI-QOL measurement system. Greater detail is presented in the additional manuscripts of this special issue., Design: Classical and contemporary test development methodologies were employed. Qualitative input was obtained from individuals with SCI and clinicians through interviews, focus groups, and cognitive debriefing. Item pools were field tested in a multi-site sample (n=877) and calibrated using item response theory methods. Initial reliability and validity testing was performed in a new sample of individuals with traumatic SCI (n=245)., Setting: Five Model SCI System centers and one Department of Veterans Affairs Medical Center across the United States., Participants: Adults with traumatic SCI., Interventions: n/a, Outcome Measures: n/a, Results: The SCI-QOL consists of 19 item banks, including the SCI-Functional Index banks, and 3 fixed-length scales measuring physical, emotional, and social aspects of health-related QOL (HRQOL)., Conclusion: The SCI-QOL measurement system consists of psychometrically sound measures for individuals with SCI. The manuscripts in this special issue provide evidence of the reliability and initial validity of this measurement system. The SCI-QOL also links to other measures designed for a general medical population.

Objectives: To describe the domain structure and calibration of the Spinal Cord Injury Functional Index for samples using Assistive Technology (SCI-FI/AT) and report the initial psychometric properties of each domain., Design: Cross sectional survey followed by computerized adaptive test (CAT) simulations., Setting: Inpatient and community settings., Participants: A sample of 460 adults with traumatic spinal cord injury (SCI) stratified by level of injury, completeness of injury, and time since injury., Interventions: None, Main Outcome Measure: SCI-FI/AT RESULTS: Confirmatory factor analysis (CFA) and Item response theory (IRT) analyses identified 4 unidimensional SCI-FI/AT domains: Basic Mobility (41 items) Self-care (71 items), Fine Motor Function (35 items), and Ambulation (29 items). High correlations of full item banks with 10-item simulated CATs indicated high accuracy of each CAT in estimating a person's function, and there was high measurement reliability for the simulated CAT scales compared with the full item bank. SCI-FI/AT item difficulties in the domains of Self-care, Fine Motor Function, and Ambulation were less difficult than the same items in the original SCI-FI item banks., Conclusion: With the development of the SCI-FI/AT, clinicians and investigators have available multidimensional assessment scales that evaluate function for users of AT to complement the scales available in the original SCI-FI.

Objective: To develop a calibrated item bank and computer adaptive test to assess anxiety symptoms in individuals with spinal cord injury (SCI), transform scores to the Patient Reported Outcomes Measurement Information System (PROMIS) metric, and create a statistical linkage with the Generalized Anxiety Disorder (GAD)-7, a widely used anxiety measure., Design: Grounded-theory based qualitative item development methods; large-scale item calibration field testing; confirmatory factor analysis; graded response model item response theory analyses; statistical linking techniques to transform scores to a PROMIS metric; and linkage with the GAD-7. Setting Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States. Participants Adults with traumatic SCI., Main Outcome Measures: Spinal Cord Injury-Quality of Life (SCI-QOL) Anxiety Item Bank, Results: Seven hundred sixteen individuals with traumatic SCI completed 38 items assessing anxiety, 17 of which were PROMIS items. After 13 items (including 2 PROMIS items) were removed, factor analyses confirmed unidimensionality. Item response theory analyses were used to estimate slopes and thresholds for the final 25 items (15 from PROMIS). The observed Pearson correlation between the SCI-QOL Anxiety and GAD-7 scores was 0.67., Conclusions: The SCI-QOL Anxiety item bank demonstrates excellent psychometric properties and is available as a computer adaptive test or short form for research and clinical applications. SCI-QOL Anxiety scores have been transformed to the PROMIS metric and we provide a method to link SCI-QOL Anxiety scores with those of the GAD-7.

Objective: To develop a calibrated item bank and computer adaptive test (CAT) to assess the effects of stigma on health-related quality of life in individuals with spinal cord injury (SCI)., Design: Grounded-theory based qualitative item development methods, large-scale item calibration field testing, confirmatory factor analysis, and item response theory (IRT)-based psychometric analyses., Setting: Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States., Participants: Adults with traumatic SCI., Main Outcome Measures: SCI-QOL Stigma Item Bank, Results: A sample of 611 individuals with traumatic SCI completed 30 items assessing SCI-related stigma. After 7 items were iteratively removed, factor analyses confirmed a unidimensional pool of items. Graded Response Model IRT analyses were used to estimate slopes and thresholds for the final 23 items., Conclusions: The SCI-QOL Stigma item bank is unique not only in the assessment of SCI-related stigma but also in the inclusion of individuals with SCI in all phases of its development. Use of confirmatory factor analytic and IRT methods provide flexibility and precision of measurement. The item bank may be administered as a CAT or as a 10-item fixed-length short form and can be used for research and clinical applications.

Objective: To develop a comprehensive, psychometrically sound, and conceptually grounded patient reported outcomes (PRO) measurement system for individuals with spinal cord injury (SCI)., Methods: Individual interviews (n=44) and focus groups (n=65 individuals with SCI and n=42 SCI clinicians) were used to select key domains for inclusion and to develop PRO items. Verbatim items from other cutting-edge measurement systems (i.e. PROMIS, Neuro-QOL) were included to facilitate linkage and cross-population comparison. Items were field tested in a large sample of individuals with traumatic SCI (n=877). Dimensionality was assessed with confirmatory factor analysis. Local item dependence and differential item functioning were assessed, and items were calibrated using the item response theory (IRT) graded response model. Finally, computer adaptive tests (CATs) and short forms were administered in a new sample (n=245) to assess test-retest reliability and stability., Participants and Procedures: A calibration sample of 877 individuals with traumatic SCI across five SCI Model Systems sites and one Department of Veterans Affairs medical center completed SCI-QOL items in interview format., Results: We developed 14 unidimensional calibrated item banks and 3 calibrated scales across physical, emotional, and social health domains. When combined with the five Spinal Cord Injury--Functional Index physical function banks, the final SCI-QOL system consists of 22 IRT-calibrated item banks/scales. Item banks may be administered as CATs or short forms. Scales may be administered in a fixed-length format only., Conclusions: The SCI-QOL measurement system provides SCI researchers and clinicians with a comprehensive, relevant and psychometrically robust system for measurement of physical-medical, physical-functional, emotional, and social outcomes. All SCI-QOL instruments are freely available on Assessment CenterSM.

Objective: To describe the development and psychometric properties of the SCI-QOL Psychological Trauma item bank and short form., Design: Using a mixed-methods design, we developed and tested a Psychological Trauma item bank with patient and provider focus groups, cognitive interviews, and item response theory based analytic approaches, including tests of model fit, differential item functioning (DIF) and precision., Setting: We tested a 31-item pool at several medical institutions across the United States, including the University of Michigan, Kessler Foundation, Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital and the James J. Peters/Bronx Veterans Administration hospital., Participants: A total of 716 individuals with SCI completed the trauma items, Results: The 31 items fit a unidimensional model (CFI=0.952; RMSEA=0.061) and demonstrated good precision (theta range between 0.6 and 2.5). Nine items demonstrated negligible DIF with little impact on score estimates. The final calibrated item bank contains 19 items, Conclusion: The SCI-QOL Psychological Trauma item bank is a psychometrically robust measurement tool from which a short form and a computer adaptive test (CAT) version are available.

Objective: To develop a self-reported measure of the subjective impact of pressure ulcers on health-related quality of life (HRQOL) in individuals with spinal cord injury (SCI) as part of the SCI quality of life (SCI-QOL) measurement system., Design: Grounded-theory based qualitative item development methods, large-scale item calibration testing, confirmatory factor analysis (CFA), and item response theory-based psychometric analysis., Setting: Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States., Participants: Adults with traumatic SCI., Main Outcome Measures: SCI-QOL Pressure Ulcers scale., Results: 189 individuals with traumatic SCI who experienced a pressure ulcer within the past 7 days completed 30 items related to pressure ulcers. CFA confirmed a unidimensional pool of items. IRT analyses were conducted. A constrained Graded Response Model with a constant slope parameter was used to estimate item thresholds for the 12 retained items., Conclusions: The 12-item SCI-QOL Pressure Ulcers scale is unique in that it is specifically targeted to individuals with spinal cord injury and at every stage of development has included input from individuals with SCI. Furthermore, use of CFA and IRT methods provide flexibility and precision of measurement. The scale may be administered in its entirety or as a 7-item "short form" and is available for both research and clinical practice.

Objective: To develop an item response theory (IRT) calibrated Grief and Loss item bank as part of the Spinal Cord Injury--Quality of Life (SCI-QOL) measurement system., Design: A literature review guided framework development of grief/loss. New items were created from focus groups. Items were revised based on expert review and patient feedback and were then field tested. Analyses included confirmatory factor analysis (CFA), graded response IRT modeling and evaluation of differential item functioning (DIF)., Setting: We tested a 20-item pool at several rehabilitation centers across the United States, including the University of Michigan, Kessler Foundation, Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital and the James J. Peters/Bronx Department of Veterans Affairs hospital., Participants: A total of 717 individuals with SCI answered the grief and loss questions., Results: The final calibrated item bank resulted in 17 retained items. A unidimensional model was observed (CFI=0.976; RMSEA=0.078) and measurement precision was good (theta range between -1.48 to 2.48). Ten items were flagged for DIF, however, after examination of effect sizes found this to be negligible with little practical impact on score estimates., Conclusions: This study indicates that the SCI-QOL Grief and Loss item bank represents a psychometrically robust measurement tool. Short form items are also suggested and computer adaptive tests are available.

Objective: To develop a calibrated spinal cord injury-quality of life (SCI-QOL) item bank, computer adaptive test (CAT), and short form to assess depressive symptoms experienced by individuals with SCI, transform scores to the Patient Reported Outcomes Measurement Information System (PROMIS) metric, and create a crosswalk to the Patient Health Questionnaire (PHQ)-9., Design: We used grounded-theory based qualitative item development methods, large-scale item calibration field testing, confirmatory factor analysis, item response theory (IRT) analyses, and statistical linking techniques to transform scores to a PROMIS metric and to provide a crosswalk with the PHQ-9., Setting: Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States., Participants: Adults with traumatic SCI., Main Outcome Measures: Spinal Cord Injury--Quality of Life (SCI-QOL) Depression Item Bank, Results: Individuals with SCI were involved in all phases of SCI-QOL development. A sample of 716 individuals with traumatic SCI completed 35 items assessing depression, 18 of which were PROMIS items. After removing 7 non-PROMIS items, factor analyses confirmed a unidimensional pool of items. We used a graded response IRT model to estimate slopes and thresholds for the 28 retained items. The SCI-QOL Depression measure correlated 0.76 with the PHQ-9., Conclusions: The SCI-QOL Depression item bank provides a reliable and sensitive measure of depressive symptoms with scores reported in terms of general population norms. We provide a crosswalk to the PHQ-9 to facilitate comparisons between measures. The item bank may be administered as a CAT or as a short form and is suitable for research and clinical applications.

Objective: To describe the development and psychometric properties of the Spinal Cord Injury--Quality of Life (SCI-QOL) Bladder Management Difficulties and Bowel Management Difficulties item banks and Bladder Complications scale., Design: Using a mixed-methods design, a pool of items assessing bladder and bowel-related concerns were developed using focus groups with individuals with spinal cord injury (SCI) and SCI clinicians, cognitive interviews, and item response theory (IRT) analytic approaches, including tests of model fit and differential item functioning., Setting: Thirty-eight bladder items and 52 bowel items were tested at the University of Michigan, Kessler Foundation Research Center, the Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital, and the James J. Peters VA Medical Center, Bronx, NY., Participants: Seven hundred fifty-seven adults with traumatic SCI., Results: The final item banks demonstrated unidimensionality (Bladder Management Difficulties CFI=0.965; RMSEA=0.093; Bowel Management Difficulties CFI=0.955; RMSEA=0.078) and acceptable fit to a graded response IRT model. The final calibrated Bladder Management Difficulties bank includes 15 items, and the final Bowel Management Difficulties item bank consists of 26 items. Additionally, 5 items related to urinary tract infections (UTI) did not fit with the larger Bladder Management Difficulties item bank but performed relatively well independently (CFI=0.992, RMSEA=0.050) and were thus retained as a separate scale., Conclusion: The SCI-QOL Bladder Management Difficulties and Bowel Management Difficulties item banks are psychometrically robust and are available as computer adaptive tests or short forms. The SCI-QOL Bladder Complications scale is a brief, fixed-length outcomes instrument for individuals with a UTI.

Objective: To describe the development and psychometric properties of the Spinal Cord Injury--Quality of Life (SCI-QOL) Resilience item bank and short form., Design: Using a mixed-methods design, we developed and tested a resilience item bank through the use of focus groups with individuals with SCI and clinicians with expertise in SCI, cognitive interviews, and item-response theory based analytic approaches, including tests of model fit and differential item functioning (DIF)., Setting: We tested a 32-item pool at several medical institutions across the United States, including the University of Michigan, Kessler Foundation, the Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital and the James J. Peters/Bronx Department of Veterans Affairs medical center., Participants: A total of 717 individuals with SCI completed the Resilience items., Results: A unidimensional model was observed (CFI=0.968; RMSEA=0.074) and measurement precision was good (theta range between -3.1 and 0.9). Ten items were flagged for DIF, however, after examination of effect sizes we found this to be negligible with little practical impact on score estimates. The final calibrated item bank resulted in 21 retained items., Conclusion: This study indicates that the SCI-QOL Resilience item bank represents a psychometrically robust measurement tool. Short form items are also suggested and computer adaptive tests are available.

Objective: To describe the development and psychometric properties of the Spinal Cord Injury-Quality of Life (SCI-QOL) Self-esteem item bank., Design: Using a mixed-methods design, we developed and tested a self-esteem item bank through the use of focus groups with individuals with SCI and clinicians with expertise in SCI, cognitive interviews, and item-response theory-(IRT) based analytic approaches, including tests of model fit, differential item functioning (DIF) and precision., Setting: We tested a pool of 30 items at several medical institutions across the United States, including the University of Michigan, Kessler Foundation, the Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital, and the James J. Peters/Bronx Department of Veterans Affairs hospital., Participants: A total of 717 individuals with SCI completed the self-esteem items., Results: A unidimensional model was observed (CFI=0.946; RMSEA=0.087) and measurement precision was good (theta range between -2.7 and 0.7). Eleven items were flagged for DIF; however, effect sizes were negligible with little practical impact on score estimates. The final calibrated item bank resulted in 23 retained items., Conclusion: This study indicates that the SCI-QOL Self-esteem item bank represents a psychometrically robust measurement tool. Short form items are also suggested and computer adaptive tests are available.

Objective: To develop an item response theory (IRT)-calibrated spinal cord injury (SCI)-specific Positive Affect and Well-being (PAWB) item bank with flexible options for administration., Design: Qualitative feedback from patient and provider focus groups was used to expand on the Neurological Disorders and Quality of Life (Neuro-QOL) positive affect & well-being item bank for use in SCI. New items were created and revised based on expert review and patient feedback and were then field tested. Analyses included confirmatory factor analysis, graded response IRT modeling and evaluation of differential item functioning (DIF)., Setting: We tested a 32-item pool at several rehabilitation centers across the United States, including the University of Michigan, Kessler Foundation, Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital and the James J. Peters/Bronx Department of Veterans Affairs hospital., Participants: A total of 717 individuals with SCI answered the PAWB questions., Results: A unidimensional model was observed (Confirmatory Fit Index=0.947; Root Mean Square Error of Approximation=0.094) and measurement precision was good (reliability in theta of -2.9 to 1.2 is roughly equivalent to classical reliability of 0.95 or above). Twelve items were flagged for DIF, however, after examination of effect sizes, the DIF was determined to be negligible and would have little practical impact on score estimates. The final calibrated item bank resulted in 28 retained items, Conclusions: This study indicates that the Spinal Cord Injury--Quality of Life PAWB bank represents a psychometrically robust measurement tool. Short form items are also suggested and a computer adaptive test is available.

Objective: To develop a spinal cord injury (SCI)-focused version of PROMIS and Neuro-QOL social domain item banks; evaluate the psychometric properties of items developed for adults with SCI; and report information to facilitate clinical and research use., 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 helped define the constructs; cognitive interviews helped revise items; 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 SCI Model System sites and one Veterans Administration medical center., Participants: The calibration sample consisted of 641 individuals; a reliability sample consisted of 245 individuals residing in the community., Results: A subset of 27 Ability to Participate and 35 Satisfaction items demonstrated good measurement properties and negligible differential item functioning related to demographic and injury characteristics. The SCI-specific measures correlate strongly with the PROMIS and Neuro-QOL versions. Ten item short forms correlate >0.96 with the full banks. Variable-length CATs with a minimum of 4 items, variable-length CATs with a minimum of 8 items, fixed-length CATs of 10 items, and the 10-item short forms demonstrate construct coverage and measurement error that is comparable to the full item bank., Conclusion: The Ability to Participate and Satisfaction with Social Roles and Activities CATs and short forms demonstrate excellent psychometric properties and are suitable for clinical and research applications.

Objectives: To identify aspects of health-related quality of life (HRQOL) that are relevant to caregivers of individuals with traumatic brain injury (TBI) and to propose an integrated conceptual framework based on this information., Design: Nine focus groups with caregivers of individuals with moderate-to-severe TBI were qualitatively analyzed to ascertain the effect that caring for an individual with a TBI has on caregiver HRQOL., Setting: University hospitals and rehabilitation treatment centers., Participants: Caregivers (N=55) of individuals with moderate-to-severe TBI., Interventions: Not applicable., Main Outcome Measures: Not applicable., Results: Qualitative analysis indicated that caregivers were most concerned about their social health (42% of comments). Other important issues were emotional health (34%), physical health (11%), cognitive health (3%), and feelings of loss (9%; feelings of loss related to changes in the future/potential of the care recipient or related to the caregiver). Areas of concern that were discussed that were specific to the caregiver and not fully evaluated by existing patient-reported outcomes (PROs) included feelings of loss, anxiety related to the caregiver role (reinjury concerns, worry about leaving the person alone, etc), and caregiver strain (burden, stress, feeling overwhelmed, etc)., Conclusions: Although existing PROs capture relevant aspects of HRQOL for caregivers, there are HRQOL domains that are not addressed. A validated and sensitive HRQOL tool for caregivers of individuals with TBI will facilitate initiatives to improve outcomes in this underserved group., (Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) provides adult and pediatric self-report measures of health-related quality of life designed for use across medical conditions and the general population. The purpose of this study was to examine the feasibility and validity of the PROMIS(®) Pediatric Short Form and computer-adaptive test (CAT) mobility measures in children with cerebral palsy (CP)., Methods: Eighty-two children with CP completed self-report (PROMIS(®) Mobility Short Form, PROMIS(®) Mobility CAT, Pediatric Quality of Life Inventory™) and performance-based assessments of mobility (Timed Up and Go, Gross Motor Function Measure). Parents provided three proxy reports of child mobility (Pediatric Outcomes Data Collection Instrument, Functional Assessment Questionnaire, Shriners Hospitals for Children CP-CAT). Validity of PROMIS(®) instruments was examined through correlations with other measures and "known groups" analyses determined by Gross Motor Function Classification System (GMFCS)., Results: On average, the PROMIS(®) CAT required less than seven items and 2 minutes to administer. Both PROMIS(®) measures showed moderate to high correlations with child- and parent-proxy report of child mobility; correlations with performance-based measure were small for the PROMIS(®) Short Form and non-significant for the PROMIS(®) CAT. All measures except for the PROMIS(®) CAT were able to distinguish between GMFCS categories., Conclusions: Results support the convergent and discriminant validity of the pediatric PROMIS(®) Mobility Short Form in children with CP. The PROMIS(®) Mobility CAT correlates well with child report and parent report of mobility but not with performance-based measures and does not differentiate between known mobility groups.

Objectives: To identify medically relevant aspects of blood pressure dysregulation (BPD) related to quality of life in individuals with spinal cord injury (SCI), and to propose an integrated conceptual framework based on input from both individuals with SCI and their clinical providers. This framework will serve as a guide for the development of a patient-reported outcome (PRO) measure specifically related to BPD., Design: Three focus groups with individuals with SCI and 3 groups with SCI providers were analyzed using grounded-theory based qualitative analysis to ascertain how blood pressure impacts health-related quality of life (HRQOL) in individuals with SCI., Setting: Focus groups were conducted at 2 Veterans Affairs medical centers and a research center., Participants: Individuals with SCI (n=27) in 3 focus groups and clinical providers (n=25) in 3 focus groups., Interventions: Not applicable., Main Outcome Measures: Not applicable., Results: Qualitative analysis indicated that all focus groups spent the highest percentage of time discussing symptoms of BPD (39%), followed by precipitators/causes of BPD (16%), preventative actions (15%), corrective actions (12%), and the impact that BPD has on social or emotional functioning (8%). While patient/consumer focus groups and provider focus groups raised similar issues, providers spent more time discussing precipitators/causes of BPD and preventative actions (38%) than patient/consumer groups (24%)., Conclusions: These results suggest that BPD uniquely and adversely impacts HRQOL in persons with SCI. While both individuals with SCI and their providers highlighted the relevant symptoms of BPD, the SCI providers offered additional detailed information regarding the precipitators/causes and what can be done to prevent/treat BPD. Further, the results suggest that persons with SCI are aware of how BPD impacts their HRQOL and are able to distinguish between subtle signs and symptoms. These findings exemplify the need for a validated and sensitive clinical measurement tool that can assess the extent to which BPD impacts HRQOL in patients with SCI., (Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

This qualitative study explored health-related quality of life (HRQOL) in individuals with Huntington disease (HD). Sixteen focus groups were conducted (n = 6 groups with symptomatic HD individuals; n = 5 with individuals who are at-risk or prodromal for HD; n = 3 non-clinical HD caregivers; n = 2 groups with HD clinicians). Qualitative analysis indicated that 28% of focus group comments were related to emotional health, 27% to social participation, 26% to physical health, 10% to cognitive health, and 9% to end of life issues. Findings highlight the importance of developing HD-targeted items to ensure sensitive assessment of HRQOL in HD research and clinical practice.

The articles in this supplement present recent advances in the measurement of patient-reported health-related quality-of-life (HRQOL) outcomes. Specifically, these articles highlight the combined efforts of the National Institutes of Health, National Institute for Neurological Disorders and Stroke, National Center on Medical Rehabilitation Research, National Institute on Disability and Rehabilitation Research, and Department of Veterans Affairs Rehabilitation Research and Development Service to improve HRQOL measurement. In addition, this supplement is intended to provide rehabilitation professionals with information about these efforts and the implications that these advances in outcomes measurement have for rehabilitation medicine and clinical practice. These new measurement scales use state-of-the-art method techniques, including item response theory and computerized adaptive testing. In addition, scale development involves both qualitative and quantitative methods, as well as the administration of items to hundreds or even thousands of research participants. The scales deliberately have been built with overlap of items between scales so that linkages and equivalency scores can be computed. Ultimately, these scales should facilitate direct comparison of outcomes instruments across studies and will serve as standard data elements across research trials without compromising the specificity of disease- or condition-targeted measures. This supplement includes the initial publications for many of these new measurement initiatives, each of which provides researchers and clinicians with better tools for evaluation of the efficacy of their interventions., (Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

This 2-part qualitative study explored health-related quality of life (HRQOL) in individuals with traumatic brain injury (TBI). A community-based participatory action research design was used, which emphasizes collaboration between researchers and individuals with disabilities to ensure that results are relevant for individuals with TBI. In study 1, community members (N=20) with TBI served as "experts" during 1-on-1 semistructured interviews, reviewing current HRQOL items and identifying HRQOL issues commonly experienced by individuals with TBI. Each participant identified at least 31 issues, with most generating more than 90 responses, highlighting the multifaceted nature of HRQOL in TBI. Study 2 consisted of 7 patient/consumer groups (33 individuals with TBI), 4 caregiver groups (17 caregivers), and 2 provider groups (15 providers). Qualitative analysis of patient focus groups indicated that 48% of focus group comments were related to emotional issues; 23%, to social functioning; 14%, to physical functioning; 11%, to cognition; and 7%, to personality changes (caregiver and provider focus group analysis indicated identical patterns of findings). In addition, both studies evaluated the applicability in TBI of generic items developed by the Patient-Reported Outcomes Measurement Information System and the Neurology Quality of Life Measurement initiative. Findings suggest that although there is some overlap between current generic measures of HRQOL and concepts reported by individuals with TBI, these generic measures do not capture the full complexity of HRQOL in TBI. TBI-targeted item banks are needed to ensure sensitive assessment of HRQOL in TBI., (Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To develop a spinal cord injury (SCI)-specific patient-reported outcome (PRO) measure of health-related quality of life (QOL) covering multiple domains of functioning, including physical, emotional, and social health., Design: Focus groups., Setting: Four SCI Model Systems rehabilitation hospitals., Participants: Individuals with SCI (n=65) and clinicians (n=42)., Interventions: Not applicable., Main Outcome Measure: Spinal Cord Injury Quality of Life Measurement System (SCI-QOL)., Results: Qualitative analysis yielded 3 domains of primary importance: physical-medical health, emotional health, and social participation. Results were used to guide domain and item decisions in the development of the SCI-QOL PRO measurement system. Qualitative data were used to develop item pools with item content specific to individuals with SCI across a wide spectrum of functioning. When possible, items from other major measurement initiatives were included verbatim in the item pools to link the measurement systems and facilitate cross-study and cross-population comparisons., Conclusions: Issues that affect individuals' QOL after SCI are varied and several issues are unique to individuals who have had a traumatic injury. From these qualitative data, 3 major domains and 18 subdomains of functioning were identified. Item pools were developed in each of these 18 areas to measure functioning related to physical-medical issues, emotional status, and social participation., (Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the influence of community-level socioeconomic status (SES) and urban composition on well-being after spinal cord injury (SCI) rehabilitation., Design: Retrospective analysis of cross-sectional survey data., Setting: Two participating centers in the SCI Model Systems (SCIMS) program., Participants: Persons (N=1454) with traumatic SCI from New Jersey and Alabama enrolled in the SCIMS database in 2000 to 2009., Intervention: Not applicable., Main Outcome Measures: Dichotomous measures of perceived health (ill vs good health), life satisfaction (dissatisfied vs satisfied), and depressive symptoms (presence of a syndrome vs not) to assess well-being., Results: Multilevel logistic regression was used to model community effects on each indicator of well-being. The likelihood of ill health and dissatisfaction with life in people with SCI, but not depressive symptoms, varied across communities. Community SES was related inversely to the odds of reporting ill health. However, the odds for dissatisfaction were higher in persons with SCI living in high SES and urban communities. Associations between community predictors and dissatisfaction with life were sustained after controlling for individual differences in injury severity, SES, and demographics, whereas individual SES was a stronger predictor of ill health than community SES., Conclusion: This research suggests that community stratification influences the likelihood for diminished well-being for persons with SCI after rehabilitation. Understanding the contribution of communities in long-term outcomes after SCI rehabilitation is needed to inform future interventions aimed at preventing disability in this population., (Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

The articles in the current supplement (Part II) present emerging issues in the measurement of quality of life (QOL). The articles were prepared based on presentations at a meeting held in November 2001. Part I (December 2002) provided important background information, definitions, and approaches that have been used in various rehabilitation populations. The articles in the current supplement are intended to provide information about new advances in QOL measurement. They review issues such as measuring QOL from the individual's perspective, adapting instruments for different cultures and illiteracy, and using advanced psychometric techniques to build a computer-adapted measurement system. Novel solutions are offered. We hope that this information can be used to set a research agenda for improving the measurement of QOL in rehabilitation medicine. The present article outlines these issues and provides a context for the information that has been presented in the 2 supplements.

In November 2001, a conference convened to discuss the state of the science of measuring of quality of life (QOL) in rehabilitation medicine. The meeting brought together leading researchers in areas of behavioral health and physical medicine and rehabilitation to address the fragmentation that exists across specialty areas and disciplines. The goal was to bridge terminology, techniques, and advances across the fields of behavioral and rehabilitation medicine. The 5 topic areas included: (1) general versus targeted measurement, (2) QOL in policy development, (3) measuring QOL from the patient's perspective, (4) cultural aspects of QOL measurement, and (5) the future of QOL research. This introduction synthesizes the information presented at the conference and provides context to the articles contained in this 2-part supplement., (Copyright 2002 by the American Congress of Rehabilitation Medicine)

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[subscript 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 [alpha] = 0.93). 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.