Development and calibration data for the Illness Burden item bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: The purpose of this study was to develop a new measure, the Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) Illness Burden item bank, to evaluate the impact that a chronic condition has on independent living, the ability to work (including working at home), social activities, and relationships. METHODS: Semi-structured interviews were used to inform the development of an item pool (47 items) that captured patients' beliefs about how a diagnosis of type 2 diabetes interferes with different aspects of their lives. The Illness Burden item bank was developed and tested in 225 people with type 2 diabetes mellitus. RESULTS: No items had sparse response option cells or problems with monotonicity; two items were deleted due to low item-rest correlations. Factor analyses supported the retention of 29 items. With those 29 remaining items, a constrained (common slope) graded response model fit assessment indicated that two items had misfit; they were excluded. No items displayed differential item functioning by age, sex, education, or socio-economic status. The final item bank is comprised of 27 items. Preliminary data supported the reliability (internal consistency and test-retest reliability) and validity (convergent, discriminant, and known-groups) of the new bank. CONCLUSION: The Illness Burden item bank can be administered as a computer adaptive test or a 6-item short form. This new measure captures patients' perceptions of the impact that having type 2 diabetes has on their daily lives; it can be used in conjunction with the REDD-CAT measurement system to evaluate important social determinants of health in persons with type 2 diabetes mellitus.

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

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

Sociocultural Factors Influencing Caregiver Appraisals Following Traumatic Brain Injury.

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.

Rating Scales and Performance-based Measures for Assessment of Functional Ability in Huntington's Disease: Critique and Recommendations.

Limitation of functional ability is a major feature of Huntington's disease (HD). The International Parkinson and Movement Disorder Society (MDS) commissioned the appraisal of the use and clinimetric properties of clinical measures of functional ability that have been applied in HD studies and trials to date, to make recommendations regarding their use based on standardized criteria. After a systematic literature search, we included a total of 29 clinical measures grouped into two categories: (1) performance-based measures (e.g., balance, walking, and reaching/grasping), and (2) rating scales. Three performance-based measures are rated as "recommended": the Tinetti Mobility Test for screening of fall risk and for severity assessment of mobility in patients with manifest HD (up to stage III); the Berg Balance Scale for severity of balance impairment; and the Six-Minute Walk Test for assessment of walking endurance (severity) in HD subjects with preserved ambulation. No rating scale targeting functional ability reached a "recommended" status either for screening or severity measurement. The main challenges identified in this review include applying widely accepted conceptual frameworks to the identified measures, the lack of validation of clinical measures to detect change over time, and absence of validated measures for upper limb function. Furthermore, measures of capacity or ability to perform activities of daily living had ceiling effects in people with early and pre-manifest HD. We recommend that the MDS prioritize the development of new scales that capture small, but meaningful changes in function over time for outcome assessment in clinical trials, particularly in earlier stages of HD.

Suicidal Ideation Assessment in Individuals with Premanifest and Manifest Huntington Disease.

BACKGROUND: Huntington disease (HD) is associated with increased risk of suicide. OBJECTIVE: This study compares suicide ideation in HD to the general population, assesses factors associated with increased prevalence of suicidal thoughts, and compares clinician-rated to self-reported assessments of suicidal ideation. METHODS: We examined 496 participants with premanifest or manifest HD. Clinician-rated suicidal ideation was measured using the Problem Behaviors Assessment - short form. Self-reported ideation was measured using two items from the HDQLIFE Concern with Death and Dying item bank. Independent sample t-tests were conducted to compare the prevalence of suicidal thoughts between our HD sample and the U.S. POPULATION: Logistic regression analyses were used to determine characteristics associated with higher odds of clinically significant suicidal ideation. Kappa agreement coefficients were calculated to evaluate concurrence between clinician-rated and self-reported assessments. RESULTS: Our sample had a significantly higher occurrence of suicidal ideation (19.76%) and suicidal plans (2.1%) than the general population (p < 0.0001). Odds of clinically significant suicidal ideation were 6.8 times higher in females (p = 0.04) on the clinician measure, and Hispanic/Latinos had 10.9 times higher odds than non-Hispanics (p = 0.025) on the self-report measure. Clinician-rated assessment had fair agreement (k = 0.2-0.4) with self-reported assessments, except in early stage HD where there was no overlap in the identification of participants with clinically significant suicidal ideation. DISCUSSION: Assessment for suicidal ideation and clinically significant suicidal thoughts in HD with a multimodal approach that includes clinician-rated and self-report measures is critical at all stages of the disease.

A Latent Content Analysis of Barriers and Supports to Healthcare: Perspectives From Caregivers of Service Members and Veterans With Military-Related Traumatic Brain Injury.

OBJECTIVE: To identify barriers and supports that caregivers of individuals with military-related traumatic brain injury (TBI) encounter when navigating the military healthcare system; this information will be used as the foundation of a new patient-reported outcome measure. SETTING: Community. PARTICIPANTS: Forty-five caregivers of service members and veterans (SMV) who sustained a medically documented mild, moderate, severe, or penetrating TBI. DESIGN: Latent content analysis. MAIN MEASURES: Nine focus group discussions of barriers and supports to navigating the military healthcare system and community resources. RESULTS: Latent content analysis indicated that caregivers discussed barriers (66%) and supports (34%) to obtaining care within the military healthcare system and the community. Caregivers most frequently discussed SMVs' interactions with healthcare, their own interactions with healthcare, family care, and community organizations. CONCLUSIONS: Caregivers confront numerous challenges while pursuing healthcare services. Although much of the discussion focused on barriers and perceived unmet needs within the military healthcare system, caregivers also recognized supports within the military healthcare system and general community. Increased attention to accessibility and quality of services, as well as reducing financial burden, can lead to improved health-related quality of life for caregivers and their SMVs.

Caring for an individual with mild cognitive impairment: a qualitative perspective of health-related quality of life from caregivers.

OBJECTIVES: Little is known regarding the effect that caring for an individual with Mild Cognitive Impairment (MCI) has on health-related quality of life (HRQOL). We sought to identify the most important aspects of HRQOL related to caring for an individual with MCI. METHODS: Six focus groups were conducted with caregivers of individuals with MCI (n = 32). Qualitative frequency analysis was used to analyze the data. RESULTS: Findings indicated that caregivers most frequently discussed social health, including changes in social roles and an increased need for social support (51.2% of the total discussion). This was followed by mental health concerns (37.9%) centering on anger/frustration, and a need for patience in the caregiving role, as well as caregiver-specific anxiety. Other topics included physical health (10.0%; including the impact that stress and burden have on medical heath), and caregivers' cognitive health (0.9%; including memory problems in relation to caregiver strain, sleep disruption, and cognitive fatigue). CONCLUSIONS: Findings illustrate the multiple domains of HRQOL that are affected in individuals providing care for someone with MCI. Moreover, the findings highlight the need for extending support services to MCI caregivers, a group that is typically not offered support services due to the 'less severe' nature of an MCI diagnosis.

Health and Functional Literacy in Physical Rehabilitation Patients.

BACKGROUND: People with disabilities, who face multiple barriers to care, experience health disparities, yet few studies have measured health literacy in this population. OBJECTIVE: This study evaluated functional literacy, health literacy, fluid cognitive function, and self-reported health in people who live in community dwellings with spinal cord injury, stroke, or traumatic brain injury. METHODS: Participants with a traumatic spinal cord injury, stroke, or traumatic brain injury, one-year postinjury, and age 18 to 85 years, completed a battery of instruments at three medical centers in the Midwestern U.S.: functional literacy (word recognition, vocabulary knowledge), health literacy (comprehension of prose, document, and quantitative health information), fluid cognitive function (memory, executive function, and processing speed), and patient-reported outcomes (mobility, fatigue, sadness, anxiety, social function, and overall health). KEY RESULTS: There were strong correlations between functional literacy, health literacy, and fluid cognitive function. After adjustment for sociodemographic and clinical characteristics, higher health literacy was associated with better mobility, less anxiety, and better overall health; higher functional literacy was associated with less anxiety and better overall health; and higher fluid cognitive function was associated with better mobility, less sadness, better social function, and better overall health. CONCLUSIONS: To effectively address limited health literacy among people with spinal cord injury, stroke, and traumatic brain injury, and ensure that they are able to be informed partners in their health care, intervention is required at the level of patients, providers, and health care delivery systems. A special consideration is to ensure that health information is both well-targeted to people's health literacy levels and accessible for people with a range of physical, cognitive, and sensory limitations. The multimedia self-administered health literacy measure used in this study could be useful to rehabilitation providers and designers of health information and interfaces. [Health Literacy Research and Practice. 2017;1(2):e71-e85.]. PLAIN LANGUAGE SUMMARY: Health literacy represents people's abilities to obtain, understand, and use health information to make informed decisions about their health and health care. People with disabilities face physical, attitudinal, economic, and structural barriers to care. Consideration of health literacy in rehabilitation practice can enhance the effectiveness of the patient-clinician relationship and help address the needs of this population.

The Feasibility and Validity of PROMIS: A Novel Measure of Quality of Life among Children with Cleft Lip and Palate.

BACKGROUND: Health-related quality of life is inconsistently captured among children with cleft lip and palate. The Patient-Reported Outcomes Measurement Information System (PROMIS) captures health-related quality of life, with the added benefit of comparability across clinical conditions. In this study, the authors define the validity and feasibility of PROMIS among children with clefts. METHODS: Children with cleft lip and palate who were at least 5 years old and able to complete instruments independently were eligible for inclusion (n = 93). Children completed PROMIS anxiety, depression, and peer relationship item banks as short forms or computerized adaptive tests. Participants also completed the Pediatric Quality of Life Inventory. Construct validity was measured by Spearman correlations between PROMIS and the Pediatric Quality of Life Inventory controlling for race, sex, age, and income. Feasibility was measured using instrument completion time, reading level, and floor/ceiling effects. RESULTS: PROMIS computerized adaptive tests (peer relationship, r = 0.49; depression, r = -0.56; and anxiety, r = -0.36) and short forms (peer relationship, r = 0.65; depression, r = -0.54; and anxiety, r = -0.56) demonstrated moderate correlation with the Pediatric Quality of Life Inventory. Computerized adaptive tests had fewer floor (0 percent versus 0 percent) and ceiling (8.6 to 19.3 percent versus 21.8 to 41.9 percent) effects than short forms, and demonstrated better readability. Computerized adaptive tests required more time than short forms (peer relationship, 0.84 ± 0.67 versus 1.3 ± 0.92; depression, 0.52 ± 0.38 versus 1.1 ± 0.73; and anxiety, 0.53 ± 0.23 versus 1.1 ± 0.62; p = 0.001), as each computerized adaptive test included on average four more questions. CONCLUSIONS: PROMIS correlates well with the Pediatric Quality of Life Inventory and demonstrates similar accuracy, with better readability and efficiency. Use of PROMIS will improve our ability to compare children with cleft lip and palate to diverse populations and clinical conditions. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, II.

Measuring Environmental Factors: Unique and Overlapping International Classification of Functioning, Disability and Health Coverage of 5 Instruments.

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.

Environmental barriers and supports to everyday participation: a qualitative insider perspective from people with disabilities.

OBJECTIVE: To describe environmental factors that influence participation of people with disabilities. DESIGN: Constant comparative, qualitative analyses of transcripts from 36 focus groups across 5 research projects. SETTING: Home, community, work, and social participation settings. PARTICIPANTS: Community-dwelling people (N=201) with diverse disabilities (primarily spinal cord injury, traumatic brain injury, and stroke) from 8 states. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Environmental barriers and supports to participation. RESULTS: We developed a conceptual framework to describe how environmental factors influence the participation of people with disabilities, highlighting 8 domains of environmental facilitators and barriers (built, natural, assistive technology, transportation, information and technology access, social support and attitudes, systems and policies, economics) and a transactional model showing the influence of environmental factors on participation at the micro (individual), mesa (community), and macro (societal) levels. Focus group data validated some International Classification of Functioning, Disability and Health environmental categories while also bringing unique factors (eg, information and technology access, economic quality of life) to the fore. Data were used to construct items to enable people with disabilities to assess the impact of environmental factors on everyday participation from their firsthand experience. CONCLUSIONS: Participants with disabilities voiced the need to evaluate the impact of the environment on their participation at the immediate, community, and societal levels. The results have implications for assessing environmental facilitators and barriers to participation within rehabilitation and community settings, evaluating outcomes of environmental interventions, and effecting system and policy changes to target environmental barriers that may result in societal participation disparities versus opportunities.

Validity of the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) in individuals with Huntington disease (HD).

PURPOSE: The reliability and construct validity of the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) were examined in individuals with Huntington disease (HD). METHODS: We examined factor structure (confirmatory factor analysis), internal consistency reliability (Cronbach's alpha), floor and ceiling effects, convergent validity (Pearson correlations), and known-groups validity (multivariate analysis). RESULTS: Results of a confirmatory factor analysis replicated the six-factor latent model that reflects the six separate scales within the WHODAS 2.0 (understanding and communicating; getting around; self-care; getting along with others; life activities; participation). Cronbach's alpha for the scale was 0.94, suggesting good internal consistency reliability. The WHODAS demonstrated a ceiling effect for 19.5 % of participants; there were no floor effects. There was evidence for convergent validity; the WHODAS demonstrated moderate significant correlations with other general measures of health-related quality of life (HRQOL; i.e., RAND-12, EQ5D). Multivariate analyses indicated that late-stage HD participants indicated poorer HRQOL than both early-stage HD and prodromal HD participants for all HRQOL measures. CONCLUSIONS: Findings provide support for both the reliability and validity of the WHODAS 2.0 in individuals with HD.

Health-related quality of life in caregivers of individuals with traumatic brain injury: development of a conceptual model.

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.

The cognition battery of the NIH toolbox for assessment of neurological and behavioral function: validation in an adult sample.

This study introduces a special series on validity studies of the Cognition Battery (CB) from the U.S. National Institutes of Health Toolbox for the Assessment of Neurological and Behavioral Function (NIHTB) (Gershon, Wagster et al., 2013) in an adult sample. This first study in the series describes the sample, each of the seven instruments in the NIHTB-CB briefly, and the general approach to data analysis. Data are provided on test-retest reliability and practice effects, and raw scores (mean, standard deviation, range) are presented for each instrument and the gold standard instruments used to measure construct validity. Accompanying papers provide details on each instrument, including information about instrument development, psychometric properties, age and education effects on performance, and convergent and discriminant construct validity. One study in the series is devoted to a factor analysis of the NIHTB-CB in adults and another describes the psychometric properties of three composite scores derived from the individual measures representing fluid and crystallized abilities and their combination. The NIHTB-CB is designed to provide a brief, comprehensive, common set of measures to allow comparisons among disparate studies and to improve scientific communication.

Cognition assessment using the NIH Toolbox.

Cognition is 1 of 4 domains measured by the NIH Toolbox for the Assessment of Neurological and Behavioral Function (NIH-TB), and complements modules testing motor function, sensation, and emotion. On the basis of expert panels, the cognition subdomains identified as most important for health, success in school and work, and independence in daily functioning were Executive Function, Episodic Memory, Language, Processing Speed, Working Memory, and Attention. Seven measures were designed to tap constructs within these subdomains. The instruments were validated in English, in a sample of 476 participants ranging in age from 3 to 85 years, with representation from both sexes, 3 racial/ethnic categories, and 3 levels of education. This report describes the development of the Cognition Battery and presents results on test-retest reliability, age effects on performance, and convergent and discriminant construct validity. The NIH-TB Cognition Battery is intended to serve as a brief, convenient set of measures to supplement other outcome measures in epidemiologic and longitudinal research and clinical trials. With a computerized format and national standardization, this battery will provide a "common currency" among researchers for comparisons across a wide range of studies and populations.

Factor analysis of the Repeatable Battery for the Assessment of Neuropsychological Status.

A sample of 175 veterans' scores on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; Randolph, 1998) was examined to investigate the factor structure of this scale. First, we attempted to replicate a five-factor model to reflect the five Index Scores of the RBANS (immediate memory, visuospatial/constructional, language, attention, and delayed memory) from the 12 individual subtests, using confirmatory factor analysis (CFA). We were unable to identify a five-factor structure of the RBANS. The RBANS subtests were then subjected to an exploratory factor analysis with a maximum likelihood extraction and orthogonal rotation to determine a new dimensional model. Results indicated a two-factor structure that can roughly be described as memory and visuospatial function. CFA of this new structure indicated an adequate fit for this sample. Findings suggest that it may be appropriate to place more emphasis on the individual subtest scores than the index scores during interpretation.