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

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

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

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

Responsiveness of the Traumatic Brain Injury Quality of Life Cognition Banks in Recent Brain Injury.

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.

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

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

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

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

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

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

Physical Function Recovery Trajectories After Spinal Cord Injury.

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

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

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

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

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

Assessment of quality of life after upper extremity transplantation: Framework for patient-reported outcome scale domains.

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

Adapting a Patient-Reported Outcome Bookmarking Task to be Accessible to Adults With Cognitive and Language Disorders.

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

Reproductive Health in Women with Physical Disability: A Conceptual Framework for the Development of New Patient-Reported Outcome Measures.

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

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

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

Development and Psychometric Characteristics of the TBI-QOL Independence Item Bank and Short Form and the TBI-QOL Asking for Help Scale.

OBJECTIVE: To develop an item response theory (IRT)-calibrated, patient-reported outcome measure of subjective independence for individuals with traumatic brain injury (TBI). DESIGN: Large-scale item calibration field testing; confirmatory factor analysis (CFA) and graded response model IRT analyses. SETTING: Five TBI Model System centers across the United States. PARTICIPANTS: Adults with complicated mild, moderate, or severe TBI (N=556). OUTCOME MEASURES: Traumatic Brain Injury-Quality of Life (TBI-QOL) Independence item bank and the TBI-QOL Asking for Help scale. RESULTS: A total of 556 individuals completed 44 items in the Independence item pool. Initial factor analyses indicated that items related to the idea of "asking for help" were measuring a different construct from other items in the pool. These 9 items were set aside. Twenty-two other items were removed because of bimodal distributions and/or low item-total correlations. CFA supported unidimensionality of the remaining Independence items. Graded response model IRT analysis was used to estimate slopes and thresholds for the final 13 Independence items. An 8-item fixed-length short form was also developed. The 9 Asking for Help items were analyzed separately. One misfitting item was deleted, and the final 8 items became a fixed-length IRT-calibrated scale. Reliability was high for both measures. CONCLUSIONS: The IRT-calibrated TBI-QOL Independence item bank and short form and TBI-QOL Asking for Help scale may be used to measure important issues for individuals with TBI in research and clinical applications.

Development and Calibration of the TBI-QOL Ability to Participate in Social Roles and Activities and TBI-QOL Satisfaction With Social Roles and Activities Item Banks and Short Forms.

OBJECTIVE: To develop traumatic brain injury (TBI)-optimized versions of the Quality of Life in Neurological Disorders (Neuro-QoL) Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities item banks, evaluate the psychometric properties of the item banks developed for adults with TBI, develop short form and computer adaptive test (CAT) versions, and report information to facilitate research and clinical applications. DESIGN: We used a mixed methods design to develop and evaluate Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities items. Focus groups defined the constructs, cognitive interviews guided item revisions, and confirmatory factor analysis and item response theory methods helped calibrate item banks and evaluate differential item functioning related to demographic and injury characteristics. SETTING: Five TBI Model Systems centers in the United States. PARTICIPANTS: Community-dwelling adults with TBI (N=556). INTERVENTIONS: None. OUTCOME MEASURES: Traumatic Brain Injury-Quality of Life (TBI-QOL) Ability to Participate in Social Roles and Activities and TBI-QOL Satisfaction with Social Roles and Activities item banks. RESULTS: Forty-five Ability to Participate in Social Roles and Activities and 41 Satisfaction with Social Roles and Activities items demonstrated good psychometric properties. Although some of the items are new, most were drawn from analogous banks in the Neuro-QoL measurement system. Consequently, the 2 TBI-QOL item banks were linked to the Neuro-QoL metric, and scores are comparable with the general population. All CAT and short forms correlated highly (>0.90) with the full item banks and demonstrate comparable construct coverage and measurement error. CONCLUSION: The TBI-QOL Ability to Participate in Social Roles and Activities and TBI-QOL Satisfaction with Social Roles and Activities item banks are TBI-optimized versions of the Neuro-QoL Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities item banks and demonstrate excellent measurement properties in individuals with TBI. These measures, particularly in CAT or short form format, are suitable for efficient and precise measurement of social outcomes in clinical and research applications.

Responsiveness of the Traumatic Brain Injury-Quality of Life (TBI-QOL) Measurement System.

OBJECTIVE: To assess the responsiveness of the Traumatic Brain Injury-Quality of Life (TBI-QOL) measurement system. DESIGN: Participants completed the 20 TBI-QOL item banks and the Participation Assessment with Recombined Tools-Objective (PART-O) Productivity Subscale at baseline and 6-month follow-up assessments. Participants were categorized into 4 groups (increased productivity, unchanged productivity, and decreased productivity) based on PART-O Productivity scores. Paired sample t tests were used to compare TBI-QOL scores at baseline and 6 months, and standardized response means and Cohen's d were computed to estimate effect sizes. SETTING: Three traumatic brain injury (TBI) Model Systems rehabilitation centers in the United States. PARTICIPANTS: Two hundred one community-dwelling adults with TBI. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: 20 TBI-QOL item banks. RESULTS: As expected, given that there was no intervention, group mean TBI-QOL subdomain scores for the entire sample showed no change or small improvement over the 6-month study period. At the follow-up assessment, 72 participants reported increased productivity, 71 reported decreased productivity, and 58 reported the same level of productivity as they had 6 months prior. When compared with participants who reported unchanged or decreased productivity, participants who reported increased productivity on the PART-O subscale had clinically meaningful (d≥0.30) improvements on 7 TBI-QOL measures. The largest improvement was in the Independence subdomain (mean change, 7.06; df=0.84), with differences also observed in the Mobility, Positive Affect and Well-Being, Resilience, Grief/Loss, Ability to Participate, and Satisfaction with Participation subdomains. CONCLUSIONS: The 20 TBI-QOL item banks demonstrate responsiveness to change and measurement stability in a community-dwelling sample. Researchers may use the TBI-QOL to detect changes in HRQOL after a clinical intervention and clinicians may use it in their daily practices to monitor patient recovery.

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

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

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

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

Development and Psychometric Characteristics of the TBI-QOL Communication Item Bank.

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