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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.)

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.)

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)

Background: The Model Spinal Cord Injury System (MSCIS) program, which began in 1 970, has had a positive impact on the health and well being of thousands of individuals with disabilities. Not only has the program been instrumental in improving the delivery of services for individuals with spinal cord injury (SCI), but also MSCIS is acknowledged as a leader in the advancement of science and practice in SCI rehabilitation. MSCIS is funded by grants awarded in 5-year cycles by the National Institute on Disability and Rehabilitation Research. In the current cycle (2000-2005), 1 6 SCI programs received funding as "model systems.", Summary: This series (1) describes the impact of the MSCIS since its inception; (2) reviews the national, multicenter data collection effort and its effects on the field; (3) reviews the initial goals and objectives of current research projects, and (4) forecasts the impact of current work on the field of SCI medicine. This introductory article provides an overview for this special section, as well as a brief synopsis of the history of the MSCIS program.

Study designThis is a focused review article.ObjectivesThis 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.MethodsThe methods include a summary of topics discussed during a two-day workshop, conceptual discussion of upper extremity COAs and additional focused literature review.ResultsCOAs 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.ConclusionsWith 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.SponsorsCraig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.

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. 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. 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. 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. Not applicable. Not applicable. 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. 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. [ABSTRACT FROM AUTHOR]

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). Cross-sectional survey study. Three academic medical centers and a Veterans Affairs treatment facility. 376 caregivers of civilians (n=213) and service members/veterans (n=163) with TBI (N=376). N/A. 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). 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. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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). Longitudinal patient-reported outcomes assessment replicated through secondary analysis of an independent data set. A total of 8 SCI Model Systems rehabilitation hospitals in the United States. 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). 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. 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). 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). 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. [ABSTRACT FROM AUTHOR]

To explore trajectories of functional recovery that occur during the first 2 years after spinal cord injury (SCI). Observational cohort study. Eight SCI Model System sites. 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). None. SCI-FI Basic Mobility/Capacity (C), Fine Motor Function/C, Self-care/C, and Wheelchair Mobility/Assistive Technology (AT) item banks. 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. 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. [ABSTRACT FROM AUTHOR]

• Assessing outcomes using common metrics facilitates cumulative science. • The Spinal Cord Injury–Functional Index (SCI-FI) measures physical function after injury. • Linked SCI-FI Basic Mobility measure to PROMIS. • Researchers can now compare injury-specific mobility scores with PROMIS. 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. Observational study Six SCI Model Systems rehabilitation hospitals in the United States. Adults with SCI (n=855) and healthy individuals (n=730) (N=1585). Not applicable. Three SCI-FI item banks (Basic Mobility, Fine Motor Function, Self-Care), PROMIS PF v1.0 item bank. 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. 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). [ABSTRACT FROM AUTHOR]

To evaluate the psychometric properties of the Spinal Cord Injury–Functional Index (SCI-FI) instruments in a community-dwelling sample. Cross-sectional study. Community setting. Individuals (N=269) recruited from 6 SCI Model Systems sites. Not applicable. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. 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. Two SCI Model System centers in the United States. Fourteen adults who work with individuals with traumatic SCI and 14 clinicians who work with individuals with SCI. 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. 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). 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. [ABSTRACT FROM AUTHOR]

To understand the factor structure of health-related quality of life specific to caregivers of people living with traumatic brain injury (TBI). Prospective, cross-sectional data collection. Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. 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. Not applicable. 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). 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. 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. [ABSTRACT FROM AUTHOR]

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

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. 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. Five TBI Model Systems centers in the United States. Community-dwelling adults with TBI (N=556). None. 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. 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. 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. [ABSTRACT FROM AUTHOR]

To develop an item response theory (IRT)-calibrated, patient-reported outcome measure of subjective independence for individuals with traumatic brain injury (TBI). Large-scale item calibration field testing; confirmatory factor analysis (CFA) and graded response model IRT analyses. Five TBI Model System centers across the United States. Adults with complicated mild, moderate, or severe TBI (N=556). Traumatic Brain Injury–Quality of Life (TBI-QOL) Independence item bank and the TBI-QOL Asking for Help scale. 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. 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. [ABSTRACT FROM AUTHOR]

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. 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. Three medical centers in the United States. Community-dwelling adults (n=504) with a history of TBI. Not applicable. TBI-QOL. 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). 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract 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. [ABSTRACT FROM AUTHOR]

Abstract 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. [ABSTRACT FROM AUTHOR]

Abstract 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. Highlights • The TBI-CareQOL measurement system includes new and existing self-report measures. • Measures were developed specific to caring for someone with traumatic brain injury. • Generic measures also evaluate important quality of life constructs for caregivers. [ABSTRACT FROM AUTHOR]

Abstract 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. Highlights • Patient-Reported Outcomes Measurement Information System (PROMIS) social health measures are both reliable and valid in caregivers. • PROMIS social health measures are brief (<45s for each measure). • Caring for an individual with a brain injury can significantly affect social health. [ABSTRACT FROM AUTHOR]

Abstract 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. [ABSTRACT FROM AUTHOR]

Abstract 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. Highlights • The Patient-Reported Outcomes Measurement Information System (PROMIS) sleep and fatigue measures are both reliable and valid. • The PROMIS sleep and fatigue measures are clinically relevant for caregivers. • Caregivers of persons with brain injury have problems with sleep and fatigue. [ABSTRACT FROM AUTHOR]

Objectives To describe the unique and overlapping content of the newly developed Environmental Factors Item Banks (EFIB) and 7 legacy environmental factor instruments, and to evaluate the EFIB's construct validity by examining associations with legacy instruments. Design Cross-sectional, observational cohort. Setting Community. Participants A sample of community-dwelling adults with stroke, spinal cord injury, and traumatic brain injury (N=568). Interventions None. Main Outcome Measures EFIB covering domains of the built and natural environment; systems, services, and policies; social environment; and access to information and technology; the Craig Hospital Inventory of Environmental Factors (CHIEF) short form; the Facilitators and Barriers Survey/Mobility (FABS/M) short form; the Home and Community Environment Instrument (HACE); the Measure of the Quality of the Environment (MQE) short form; and 3 of the Patient Reported Outcomes Measurement Information System's (PROMIS) Quality of Social Support measures. Results The EFIB and legacy instruments assess most of the International Classification of Functioning, Disability and Health (ICF) environmental factors chapters, including chapter 1 (products and technology; 75 items corresponding to 11 codes), chapter 2 (natural environment and human-made changes; 31 items corresponding to 7 codes), chapter 3 (support and relationships; 74 items corresponding to 7 codes), chapter 4 (attitudes; 83 items corresponding to 8 codes), and chapter 5 (services, systems, and policies; 72 items corresponding to 16 codes). Construct validity is provided by moderate correlations between EFIB measures and the CHIEF, MQE barriers, HACE technology mobility, FABS/M community built features, and PROMIS item banks and by small correlations with other legacy instruments. Only 5 of the 66 legacy instrument correlation coefficients are moderate, suggesting they measure unique aspects of the environment, whereas all intra-EFIB correlations were at least moderate. Conclusions The EFIB measures provide a brief and focused assessment of ICF environmental factor chapters. The pattern of correlations with legacy instruments provides initial evidence of construct validity. [ABSTRACT FROM AUTHOR]

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., [ABSTRACT FROM AUTHOR]

Objectives To develop functional ability levels for the Spinal Cord Injury Functional Index (SCI-FI) and to validate them using calibration and reliability samples. Design Three-phase strategy involved (1) performing quantitative synthesis of SCI-FI data to create item maps; (2) using a panel of experts to identify functional ability levels after the bookmarking and Delphi consensus-building process; and (3) performing quantitative analyses to examine demographic characteristics across 2 samples, assessing the distribution pattern across functional ability levels, and examining concurrent validity using the self-reported functional measure and the observer-rated FIM. Setting Inpatient and community settings. Participants People 18 years or older with traumatic spinal cord injury (N=1124) were recruited from the Spinal Cord Injury Model Systems programs and stratified by diagnosis, severity, and time since injury (n=855 and n=269 for calibration and reliability samples, respectively). Interventions Not applicable. Main Outcome Measure SCI-FI. Results Five functional ability levels were identified for all SCI-FI domains, except fine motor having 4 functional ability levels. Statistical test results indicated no significant differences in the distribution pattern across the 2 samples across functional ability levels for all domains except for ambulation. Known-group comparisons were able to discern the spinal cord injury population as expected. Basic mobility, self-care, and wheelchair mobility domains had a cluster of persons with paraplegia and incomplete lesions at higher functional ability levels and persons with tetraplegia and complete lesions at lower functional ability levels. For the ambulation domain, the distribution was skewed to the lower end, with a relatively small percentage of persons with incomplete lesions (paraplegia and tetraplegia) at higher functional ability levels. For the fine motor domain, the distribution was skewed to higher functional ability levels, with a high percentage of persons with paraplegia at the highest level (complete and incomplete lesions). Concurrent validity analyses revealed SCI-FI functional levels to be significantly ( P <.001) positively correlated with both the self-reported functional measure and the observer-rated FIM. Conclusions Clinicians can use functional ability levels to discuss patients' functional capabilities with them and their family. [ABSTRACT FROM AUTHOR]

Objective To develop and evaluate the psychometric properties of an item set measuring economic quality of life (QOL) for use by individuals with disabilities. Design Survey. Setting Community settings. Participants Individuals with disabilities completed individual interviews (n=64), participated in focus groups (n=172), and completed cognitive interviews (n=15). Inclusion criteria included the following: traumatic brain injury, spinal cord injury, or stroke; age ≥18 years; and ability to read and speak English. We calibrated the items with 305 former rehabilitation inpatients. Interventions None. Main Outcome Measure Economic QOL. Results Confirmatory factor analysis showed acceptable fit indices (comparative fit index=.939, root mean square error of approximation=.089) for the 37 items. However, 3 items demonstrated local item dependence. Dropping 9 items improved fit and obviated local dependence. Rasch analysis of the remaining 28 items yielded a person reliability of .92, suggesting that these items discriminate about 4 economic QOL levels. Conclusions We developed a 28-item bank that measures economic aspects of QOL. Preliminary confirmatory factor analysis and Rasch analysis results support the psychometric properties of this new measure. It fills a gap in health-related QOL measurement by describing the economic barriers and facilitators of community participation. Future development will make the item bank available as a computer adaptive test. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract: 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 &y& Elsevier]

Abstract: Tulsky DS, Jette AM, Kisala PA, Kalpakjian C, Dijkers MP, Whiteneck G, Ni P, Kirshblum S, Charlifue S, Heinemann AW, Forchheimer M, Slavin MD, Houlihan B, Tate DG, Dyson-Hudson T, Fyffe D, Williams S, Zanca J. Spinal Cord Injury-Functional Index: item banks to measure physical functioning in individuals with spinal cord injury. Objectives: To develop a comprehensive set of patient-reported items to assess multiple aspects of physical functioning relevant to the lives of people with spinal cord injury (SCI), and to evaluate the underlying structure of physical functioning. Design: Cross-sectional. Setting: Inpatient and community. Participants: Item pools of physical functioning were developed, refined, and field tested in a large sample of individuals (N=855) with traumatic SCI stratified by diagnosis, severity, and time since injury. Interventions: None. Main Outcome Measure: Spinal Cord Injury-Functional Index (SCI-FI) measurement system. Results: Confirmatory factor analysis (CFA) indicated that a 5-factor model, including basic mobility, ambulation, wheelchair mobility, self-care, and fine motor function, had the best model fit and was most closely aligned conceptually with feedback received from individuals with SCI and SCI clinicians. When just the items making up basic mobility were tested in CFA, the fit statistics indicated strong support for a unidimensional model. Similar results were demonstrated for each of the other 4 factors, indicating unidimensional models. Conclusions: Though unidimensional or 2-factor (mobility and upper extremity) models of physical functioning make up outcomes measures in the general population, the underlying structure of physical function in SCI is more complex. A 5-factor solution allows for comprehensive assessment of key domain areas of physical functioning. These results informed the structure and development of the SCI-FI measurement system of physical functioning. [Copyright &y& Elsevier]

Abstract: Jette AM, Tulsky DS, Ni P, Kisala PA, Slavin MD, Dijkers MP, Heinemann AW, Tate DG, Whiteneck G, Charlifue S, Houlihan B, Williams S, Kirshblum S, Dyson-Hudson T, Zanca J, Fyffe D. Development and initial evaluation of the Spinal Cord Injury-Functional Index. Objectives: To describe the calibration of the Spinal Cord Injury-Functional Index (SCI-FI) and report on the initial psychometric evaluation of the SCI-FI scales in each content domain. Design: Cross-sectional survey followed by calibration data simulations. Setting: Inpatient and community settings. Participants: A sample of participants (N=855) with traumatic spinal cord injury (SCI) recruited from 6 SCI Model Systems and stratified by diagnosis, severity, and time since injury. Interventions: None. Main Outcome Measure: SCI-FI instrument. Results: Item response theory analyses confirmed the unidimensionality of 5 SCI-FI scales: basic mobility (54 items), fine motor function (36 items), self-care (90 items), ambulation (39 items), and wheelchair mobility (56 items). All SCI-FI scales revealed strong psychometric properties. High correlations of scores on simulated computer adaptive testing (CAT) with the overall SCI-FI domain scores indicated excellent potential for CAT to accurately characterize functional profiles of adults with SCI. Overall, there was very little loss of measurement reliability or precision using CAT compared with the full item bank; however, there was some loss of reliability and precision at the lower and upper ranges of each scale, corresponding to regions where there were few questions in the item banks. Conclusions: Initial evaluation revealed that the SCI-FI achieved considerable breadth of coverage in each content domain and demonstrated acceptable psychometric properties. The use of CAT to administer the SCI-FI will minimize assessment burden, while allowing for the comprehensive assessment of the functional abilities of adults with SCI. [Copyright &y& Elsevier]

Objectives To evaluate the psychometric properties of the Spinal Cord Injury–Functional Index/Assistive Technology (SCI-FI/AT) short forms (SFs) in the domains of basic mobility, self-care, fine motor function, and ambulation based on internal consistency; correlations between SFs and full item banks, and a 10-item computerized adaptive test (CAT) version; magnitude of ceiling and floor effects; and measurement precision across a broad range of function in a sample of adults with spinal cord injury (SCI). Design Cross-sectional cohort study. Setting Nine national Spinal Cord Injury Model Systems programs. Participants A sample of adults with traumatic SCI (N=460) stratified by level of injury (paraplegia/tetraplegia), completeness of injury, and time since SCI. Interventions Not applicable. Main Outcome Measures SCI-FI/AT full item bank, 10-item CAT, and SFs (with separate Self-Care and Fine Motor Function SFs for persons with tetraplegia and paraplegia). Results The SCI-FI/AT SFs demonstrated very good internal consistency, group-level reliability, and excellent correlations between SFs and scores based on the CAT version and the total item bank. Ceiling and floor effects are acceptable (except for unacceptable ceiling effects for persons with paraplegia on the Self-Care and Fine Motor Function SFs). The test information functions are excellent across a broad range of functioning typical of persons with paraplegia and tetraplegia. Conclusions Clinicians and researchers should consider using the SCI-FI/AT SFs to assess functioning with the use of assistive technology when CAT applications are not available. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To evaluate the psychometric properties of the Spinal Cord Injury-Functional Index (SCI-FI) short forms (basic mobility, self-care, fine motor, ambulation, manual wheelchair, and power wheelchair) based on internal consistency; correlations between short forms banks, full item bank forms, and a 10-item computer adaptive test version; magnitude of ceiling and floor effects; and test information functions. Design: Cross-sectional cohort study. Setting: Six rehabilitation hospitals in the United States. Participants: Individuals with traumatic spinal cord injury (N=855) recruited from 6 national Spinal Cord Injury Model Systems facilities. Interventions: Not applicable. Main Outcome Measures: SCI-FI full item bank, 10-item computer adaptive test, and parallel short form scores. Results: The SCI-FI short forms (with separate versions for individuals with paraplegia and tetraplegia) demonstrate very good internal consistency, group-level reliability, excellent correlations between short forms and scores based on the total item bank, and minimal ceiling and floor effects (except ceiling effects for persons with paraplegia on self-care, fine motor, and power wheelchair ability and floor effects for persons with tetraplegia on self-care, fine motor, and manual wheelchair ability). The test information functions are acceptable across the range of scores where most persons in the sample performed. Conclusions: Clinicians and researchers should consider the SCI-FI short forms when computer adaptive testing is not feasible. [Copyright &y& Elsevier]

Abstract: Carlozzi NE, Tulsky DS, Kisala PA. Traumatic brain injury patient-reported outcome measure: identification of health-related quality-of-life issues relevant to individuals with traumatic brain injury. 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 &y& Elsevier]

Wilde EA, Whiteneck GG, Bogner J, Bushnik T, Cifu DX, Dikmen S, French L, Giacino JT, Hart T, Malec JF, Millis SR, Novack TA, Sherer M, Tulsky DS, Vanderploeg RD, von Steinbuechel N. Recommendations for the use of common outcome measures in traumatic brain injury research. This article summarizes the selection of outcome measures by the interagency Traumatic Brain Injury (TBI) Outcomes Workgroup to address primary clinical research objectives, including documentation of the natural course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies. Consistent with other Common Data Elements Workgroups, the TBI Outcomes Workgroup adopted the standard 3-tier system in its selection of measures. In the first tier, core measures included valid, robust, and widely applicable outcome measures with proven utility in TBI from each identified domain, including global level of function, neuropsychological impairment, psychological status, TBI-related symptoms, executive functions, cognitive and physical activity limitations, social role participation, and perceived health-related quality of life. In the second tier, supplemental measures were recommended for consideration in TBI research focusing on specific topics or populations. In the third tier, emerging measures included important instruments currently under development, in the process of validation, or nearing the point of published findings that have significant potential to be superior to some older (“legacy”) measures in the core and supplemental lists and may eventually replace them as evidence for their utility emerges. [Copyright &y& Elsevier]

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. [ABSTRACT FROM AUTHOR]

The importance of activities and community participation for persons with spinal cord injury (SCI) has been recognized for decades and yet theoretical and empirical advances have been limited. This report summarizes the recommendations for researchers on the topic of measuring activity and participation among persons with SCI formulated by the Spinal Cord Injury workgroup at the State-of-the-Art Conference on Outcome Measures in Rehabilitation held in January 2010. Activity and participation were defined as independent constructs ideally measured in reference to personal values and environmental influences. Measures of activity, participation, and factors influencing activity and participation are reviewed and critiqued. Gaps in available measures are described, measures in development are discussed, and suggestions for future research are made. [ABSTRACT FROM AUTHOR]