Development of a New Measure of Housing Security: The REDD-CAT Housing Security Measure.

BACKGROUND: Housing security is a key social determinant of behavior related to health outcomes. OBJECTIVE: The purpose of this study was to develop a new patient-reported outcome measure that evaluates aspects of housing security for use in the Re-Engineered Discharge for Diabetes-Computer Adaptive Test (REDD-CAT) measurement system. DESIGN: Qualitative data, literature reviews, and cross-sectional survey study. PARTICIPANTS: A total of 225 people with T2DM provided responses to the items in this item pool. MAIN MEASURES: A new item pool that evaluates important aspects of housing security was developed using stakeholder data from focus groups of persons with T2DM. KEY RESULTS: For the Housing Affordability scale, factor analysis (both exploratory and confirmatory) supported the retention of six items. Of these items, none exhibited sparse cells or problems with monotonicity; no items were deleted due to low item-adjusted total score correlations. For the six affordability items, a constrained graded response model indicated no items exhibited misfit; thus, all were retained. No items indicated differential item functioning (examined for age, sex, education, race, and socioeconomic status). Thus, the final Affordability item bank comprised six items. A Housing Safety index (three items) and a Home Features index (eight items) were also developed. Reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measures were also supported. CONCLUSIONS: The REDD-CAT Housing Security Measure provides a reliable and valid assessment of housing affordability, safety, and home features in people with type 2 diabetes mellitus. Future work is needed to establish the clinical utility of this measure in other clinical populations.

Development and calibration data for the Medication Adherence Item Bank: a new computer adaptive test for persons with type 2 diabetes mellitus.

PURPOSE: To develop a new computer adaptive test that evaluates important aspects of medication adherence for persons with type 2 diabetes mellitus. METHODS: Two hundred and twenty-five people with type 2 diabetes mellitus completed 41 items related to medication adherence. RESULTS: Exploratory analysis supported the essential unidimensionality of the initial item pool. Five items were deleted due to low item-adjusted total score correlations (resulting in 36 items). Confirmatory factor analysis supported the retention of 27 items. A graded response model identified no items for exclusion, based on misfit. No items were flagged for meaningful differential item functioning (DIF). The final item bank is comprised of 27 items; an associated 6-item short form was constructed that balanced both psychometric factors (e.g., item information values) and clinical input. Initial analysis of the simulated CAT and static short form supported both the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known groups) of both administration formats. CONCLUSIONS: The new medication adherence item bank provides a reliable and valid assessment of the ability to take medications accurately among people with T2DM; it will be available in early 2023 through healthmeasures.net.

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.

Development and calibration data for the Healthcare Access 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 to evaluate the ability to receive medical services when needed among persons with type 2 diabetes mellitus. METHODS: The Healthcare Access measure was developed using data from 225 persons with type 2 diabetes mellitus who completed an item pool comprised of 54 questions pertaining to their experience accessing healthcare services. RESULTS: Exploratory and confirmatory factor analyses supported the retention of 45 items. In addition, a constrained graded response model (GRM), as well as analyses that examined item misfit and differential item functioning (investigated for age, sex, education, race, and socioeconomic status), supported the retention of 44 items in the final item bank. Expert review and GRM item calibration products were used to inform the selection of a 6-item static short form and to program the Healthcare Access computer adaptive test (CAT). Preliminary data supported the reliability (i.e., internal consistency and test-retest reliability) and validity (i.e., convergent, discriminant, and known-groups) of the new measure. CONCLUSIONS: The new Healthcare Access item bank can be used to examine the experiences that persons with type 2 diabetes mellitus have with healthcare access, to better target treatment improvements and mitigate disparities; it will be available as a part of the Neuro-Qol measurement system through healthmeasures.net and the PROMIS Application Programmable Interface (API) in early 2023.

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.

Daily Variation in Sleep Quality is Associated With Health-Related Quality of Life in People With Spinal Cord Injury.

OBJECTIVE: Although sleep difficulties are common after spinal cord injury (SCI), little is known about how day-to-day fluctuations in sleep quality affects health-related quality of life (HRQOL) among these individuals. We examined the effect of sleep quality on same-day HRQOL using ecological momentary assessment methods over a 7-day period. DESIGN: Repeated-measures study involving 7 days of home monitoring; participants completed HRQOL measures each night and ecological momentary assessment ratings 3 times throughout the day; multilevel models were used to analyze data. SETTING: Two academic medical centers. PARTICIPANTS: A total of 170 individuals with SCI (N=170). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Daily sleep quality was rated on a scale of 0 (worst) to 10 (best) each morning. Participants completed end-of-day diaries each night that included several HRQOL measures (Sleep Disturbance, Sleep-related Impairment, Fatigue, Cognitive Abilities, Pain Intensity, Pain Interference, Ability to Participate in Social Roles and Activities, Depression, Anxiety) and ecological momentary assessment ratings of HRQOL (pain, fatigue, subjective thinking) 3 times throughout each day. RESULTS: Multilevel models indicated that fluctuations in sleep quality (as determined by end-of-day ratings) were significantly related to next-day ratings of HRQOL; sleep quality was related to other reports of sleep (Sleep Disturbance; Sleep-related Impairment; Fatigue) but not to other aspects of HRQOL. For ecological momentary assessment ratings, nights of poor sleep were related to worse pain, fatigue, and thinking. Generally, sleep quality showed consistent associations with fatigue and thinking across the day, but the association between sleep quality and these ecological momentary assessment ratings weakened over the course of the day. CONCLUSIONS: Findings highlight the important association between sleep and HRQOL for people with SCI. Future work targeting sleep quality improvement may have positive downstream effects for improving HRQOL in people with SCI.

Understanding speech and swallowing difficulties in individuals with Huntington disease: Validation of the HDQLIFE Speech Difficulties and Swallowing Difficulties Item Banks.

PURPOSE: As Huntington disease (HD) progresses, speech and swallowing difficulties become more profound. These difficulties have an adverse effect on health-related quality of life (HRQOL), thus psychometrically robust measures of speech and swallowing are needed to better understand the impact of these domains across the course of the disease. Therefore, the purpose of this study is to establish the clinical utility of two new patient-reported outcome measures (PROs), HDQLIFE Speech Difficulties and HDQLIFE Swallowing Difficulties. METHODS: Thirty-one participants with premanifest or manifest HD, and 31 age- and sex-matched healthy control participants were recruited for this study. Participants completed several PROs [HDQLIFE Speech Difficulties, HDQLIFE Swallowing Difficulties, Communication Participation Item Bank (CPIB)], as well as several clinician-rated assessments of speech and functioning. A computational algorithm designed to detect features of spoken discourse was also examined. Analyses were focused on establishing the reliability and validity of these new measures. RESULTS: Internal consistency was good for Swallowing (Cronbach's alpha = 0.89) and excellent for Speech and the CPIB (both Cronbach's alpha ≥ 0.94), and convergent/discriminant validity was supported. Known groups validity for the PROs was supported by significant group differences among control participants and persons with different stages of HD (all p < 0.0001). All PROs were able to distinguish those with and without clinician-rated dysarthria (likelihood ratios far exceeded the threshold for clinical decision making [all ≥ 3.28]). CONCLUSIONS: Findings support the clinical utility of the HDQLIFE Speech and Swallowing PROs and the CPIB for use across the HD disease spectrum. These PROs also have the potential to be clinically useful in other populations.

HDQLIFE and neuro-QoL physical function measures: Responsiveness in persons with huntington's disease.

BACKGROUND: Huntington's disease (HD) is a neurological disorder that causes severe motor symptoms that adversely impact health-related quality of life. Patient-reported physical function outcome measures in HD have shown cross-sectional evidence of validity, but responsiveness has not yet been assessed. OBJECTIVES: This study evaluates the responsiveness of the Huntington Disease Health-Related Quality of Life (HDQLIFE) and the Quality of Life in Neurological Disorders (Neuro-QoL) physical function measures in persons with HD. METHODS: A total of 347 participants completed baseline and at least 1 follow-up (12-month and 24-month) measure (HDQLIFE Chorea, HDQLIFE Swallowing Difficulties, HDQLIFE Speech Difficulties, Neuro-QoL Upper Extremity Function, and/or Neuro-QoL Lower Extremity Function). Of the participants that completed the baseline assessment, 338 (90.9%) completed the 12-month assessment, and 293 (78.8%) completed the 24-month assessment. Standardized response means and general linear models evaluated whether the physical function measures were responsive to self-reported and clinician-rated change over time. RESULTS: Small to moderate effect sizes for the standardized response means supported 12-month and 24-month responsiveness of the HDQLIFE and Neuro-QoL measures for those with either self-reported or clinician-rated declines in function. General linear models supported 12-month and 24-month responsiveness for all HRQOL measures relative to self-reported declines in health, but generally only 24-month responsiveness was supported relative to clinician-rated declines in function. CONCLUSIONS: Longitudinal analyses indicate that the HDQLIFE and the Neuro-QoL physical function measures are sensitive to change over time in individuals with HD. Thus, these scales exhibit evidence of responsiveness and may be useful outcome measures in future clinical trials. © 2019 International Parkinson and Movement Disorder Society.

Responsiveness to change over time and test-retest reliability of the PROMIS and Neuro-QoL mental health measures in persons with Huntington disease (HD).

BACKGROUND: The majority of persons with Huntington disease (HD) experience mental health symptoms. Patient-reported outcome (PRO) measures are capable of capturing unobservable behaviors and feelings relating to mental health. The current study aimed to test the reliability and responsiveness to self-reported and clinician-rated change over time of Neuro-QoL and PROMIS mental health PROs over the course of a 24-month period. METHODS: At baseline, 12-months, and 24-months, 362 participants with premanifest or manifest HD completed the Neuro-QoL Depression computer adaptive test (CAT), PROMIS Depression short form (SF), Neuro-QoL Anxiety CAT, PROMIS Anxiety SF, PROMIS Anger CAT and SF, Neuro-QoL Emotional/Behavioral Dyscontrol CAT and SF, Neuro-QoL Positive Affect and Well-Being CAT and SF, and Neuro-QoL Stigma CAT and SF. Participants completed several clinician-administered measures at each time point, as well as several global ratings of change at 12- and 24-months. Reliability (test-retest reliability and measurement error) and responsiveness (using standardized response means and general linear models) were assessed. RESULTS: Test-retest reliability and measurement error were excellent for all PROs (all ICC ≥ .90 for test-retest reliability and all SEM percentages ≤ 6.82%). In addition, 12- and 24-month responsiveness were generally supported for the Neuro-QoL and PROMIS mental health PROs; findings relative to clinician-rated anchors of change (e.g., SRMs for the group with declines ranged from .38 to .91 for 24-month change and .09 to .45, with the majority above .25 for 12-month change) were generally more robust than those relative to self-reported anchors of change (e.g., SRMs for the group with declines ranged from .02 to .75, with the majority above .39 for 24-month change and .09 to .45, with the majority above .16 for 12-month change). CONCLUSIONS: The Neuro-QoL and PROMIS mental health PROs demonstrated strong psychometric reliability, as well as responsiveness to self-reported and clinician-rated change over time in people with HD.

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.

Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Reliability and Validity Data for the TBI-CareQOL Measurement System.

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.

Understanding Health-Related Quality of Life of Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Social Health Measures.

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.

Understanding Health-Related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Fatigue and Sleep Disturbance Item Banks.

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.

Understanding Health-related Quality of Life in Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury: Establishing the Reliability and Validity of PROMIS Mental Health Measures.

OBJECTIVE: To provide important reliability and validity data to support the use of the Patient-Reported Outcomes Measurement Information System (PROMIS) mental health measures in caregivers of civilians or service members/veterans (SMVs) with traumatic brain injury (TBI). DESIGN: Patient-reported outcome surveys administered through an electronic data collection 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 a documented TBI (344 civilians and 216 military). INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: PROMIS anxiety, depression, and anger item banks. RESULTS: Internal consistency for all the PROMIS Mental Health item banks was very good (all α>.86) and 3-week test-retest reliability was good to adequate (ranged from .65 to .85). Convergent validity and discriminant validity of the PROMIS measures were also supported. Caregivers of individuals who were low functioning had worse emotional health-related quality of life (HRQOL) (as measured by the 3 PROMIS measures) than caregivers of high-functioning individuals, supporting known groups validity. Finally, levels of distress, as measured by the PROMIS measures, were elevated for those caring for low-functioning individuals in both samples (rates ranged from 26.2% to 43.6% for caregivers of low-functioning individuals). CONCLUSIONS: Results support the reliability and validity of the PROMIS anxiety, depression, and anger item banks in caregivers of civilians and SMVs with TBI. Ultimately, these measures can be used to provide a standardized assessment of HRQOL because it relates to mental health in these caregivers.

The Development of a New Computer Adaptive Test to Evaluate Anxiety in Caregivers of Individuals With Traumatic Brain Injury: TBI-CareQOL Caregiver-Specific Anxiety.

OBJECTIVE: To design a new measure of caregiver-specific anxiety for use in caregivers of individuals with traumatic brain injury (TBI), the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver-Specific Anxiety item bank. DESIGN: Cross-sectional survey study. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Three hundred forty-four caregivers of civilians with TBI and 216 caregivers of service members/veterans with TBI (N=560). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: TBI-CareQOL Caregiver-Specific Anxiety item bank. RESULTS: The retention of 40 Caregiver-Specific Anxiety items was supported by exploratory and confirmatory factor analyses. Graded response model (GRM) and differential item functioning analyses supported the retention of 33 items in the final measure. Expert review and GRM calibration data was used to select a 6-item static short form, and GRM calibration data was used to program the TBI-CareQOL Caregiver-Specific Anxiety computer adaptive test (CAT). CONCLUSIONS: Established, rigorous measurement development standards were used to develop the new TBI-CareQOL Caregiver-Specific Anxiety CAT and corresponding 6-item short form. This measure is the first patient-reported outcome measure designed to assess caregiver-specific anxiety in caregivers of individuals with TBI. The measure exhibits strong psychometric properties.

The Development of Two New Computer Adaptive Tests To Evaluate Feelings of Loss in Caregivers of Individuals With Traumatic Brain Injury: TBI-CareQOL Feelings of Loss-Self and Feelings of Loss-Person With Traumatic Brain Injury.

OBJECTIVE: To develop new patient-reported outcome (PRO) measures to better understand feelings of loss in caregivers of individuals with traumatic brain injury (TBI). DESIGN: Cross-sectional survey study. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=560) of civilians with TBI (n=344) or service members/veterans (SMVs) with TBI (n=216). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Feelings of Loss-Self and TBI-CareQOL Feelings of Loss-Person with Traumatic Brain Injury item banks. RESULTS: While the initial exploratory and confirmatory factor analyses of the feelings of loss item pool (98 items) potentially supported a unidimensional set of items, further analysis indicated 2 different factors: Feelings of Loss-Self (43 items) and Feelings of Loss-Person with TBI (20 items). For Feelings of Loss-Self, an additional 13 items were deleted due to item-response theory-based item misfit; the remaining 30 items had good overall model fit (comparative fit index [CFI]=0.96, Tucker-Lewis index [TLI]=.96, root mean squared error of approximation [RMSEA]=.10). For Feelings of Loss-Other, 1 additional item was deleted due to an associated high correlated error modification index value; the final 19 items evidenced good overall model fit (CFI=0.97, TLI=.97, RMSEA=.095). The final item banks were developed to be administered as either a Computer Adaptive Test (CAT) or a short-form (SF). Clinical experts approved the content of the 6-item SFs of the 2 measures (3-week test-retest was r=.87 for Feelings of Loss-Self and r=.85 for Feelings of Loss-Person with TBI). CONCLUSIONS: The findings from this study resulted in the development of 2 new PROs to assess feelings of loss in caregivers of individuals with TBI; TBI-CareQOL Feelings of Loss-Self and TBI-CareQOL Feelings of Loss-Person with TBI. Good psychometric properties were established and an SF was developed for ease of use in clinical situations. Additional research is needed to determine concurrent and predictive validity of these measures in the psychological treatment of those caring for persons with TBI.

The TBI-CareQOL Measurement System: Development and Preliminary Validation of Health-Related Quality of Life Measures for Caregivers of Civilians and Service Members/Veterans With Traumatic Brain Injury.

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.

The Development of a New Computer Adaptive Test to Evaluate Feelings of Being Trapped in Caregivers of Individuals With Traumatic Brain Injury: TBI-CareQOL Feeling Trapped Item Bank.

OBJECTIVE: To develop a new patient-reported outcome measure that captures feelings of being trapped that are commonly experienced by caregivers of individuals with traumatic brain injury (TBI). DESIGN: Cross-sectional. SETTING: Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS: Caregivers (N=560) of civilians with TBI (n=344) and caregivers of service members/veterans with TBI (n=216). INTERVENTIONS: Not applicable. OUTCOME MEASURES: Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Feeling Trapped item bank. RESULTS: From an initial item pool of 28 items, exploratory and confirmatory factor analyses supported the retention of 16 items. After graded response model (GRM) and differential item functioning analyses were conducted, 15 items were retained in the final measure. GRM calibration data, along with clinical expert input, were used to choose a 6-item, static short form (SF), and the calibration data were used for programming of the TBI-CareQOL Feeling Trapped computer adaptive test (CAT). CAT simulation analyses produced an r=0.99 correlation between CAT scores and the full item bank. Three-week short-form test-retest reliability was very good (r=0.84). CONCLUSIONS: The new TBI-CareQOL Feeling Trapped item bank was developed to provide a sensitive and efficient examination of the effect that feelings of being trapped, due to the caregiver role, have on health-related quality of life for caregivers of individuals with TBI. Both the CAT and corresponding 6-item SF demonstrate excellent psychometric properties. Future work is needed to establish the responsiveness of this measure to clinical interventions for these caregivers.

Understanding the need for assistance with survey completion in people with Huntington disease.

PURPOSE: In Huntington disease (HD), motor, cognitive, and psychiatric changes can have a detrimental impact on health-related quality of life (HRQOL). The purpose of this paper is to describe the extent and type of assistance needed to complete online HRQOL surveys, and the impact of assistance on HRQOL scores. METHODS: A patient-reported outcome measurement system was developed for HD-specific HRQOL. Individuals across the prodromal and diagnosed disease severity spectrum (n = 532) completed surveys by computer, and reported the amount and type of assistance they received. RESULTS: Some participants (n = 56; 10.5%) did not complete all surveys; this group had larger proportions with late stage disease, racial/ethnic minority status, low education and single marital status, and poorer motor, independence and cognitive function compared to those who completed all surveys (n = 476). Overall, 72% of individuals did not receive assistance, 11% received computer assistance only, and 17% received assistance answering the survey questions. The majority of late stage individuals (78%) received some assistance compared to early stage (29%) and prodromal individuals (< 1%). Those who received assistance had higher proportions with late stage disease, were older, had less education, and had poorer functional and cognitive skills. Before and after adjustment for sociodemographic and clinical characteristics, those who received assistance had poorer scores on some HRQOL outcomes than those who did not receive assistance. CONCLUSIONS: Computer-based assessments are feasible for many persons with HD, although other methods may also be needed. Clinicians and researchers should develop strategies to assist people with HD to complete HRQOL surveys.

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.