Impact of COVID-19 monoclonal antibodies on outcomes of COVID-19 infection in hematopoietic stem cell transplant and chimeric antigen receptor therapy recipients.

BACKGROUND: Hematopoietic stem cell transplant (HSCT) and chimeric antigen receptor T-cell therapy (CAR-T) recipients are at higher risk of serious complications of COVID-19 infection than the general population. Though there is evidence that monoclonal antibodies (MCA) against COVID-19 reduce the risk of death and hospitalization in the general population, data regarding their efficacy in HSCT and CAR-T recipients remains scarce. METHODS: We conducted a retrospective review of HSCT and CAR-T recipients to compare 30-day outcomes between patients who did and did not receive MCA after their first episode of COVID-19 between May 1, 2020 and December 31, 2022. Outcomes were defined as the most severe complication experienced out of the following: 30-day emergency department visit, hospitalization, intensive care unit admission, and death after COVID-19 infection. RESULTS: We identified 166 patients comprised of 53.6% allogeneic HSCT, 35.5% autologous HSCT, and 10.8% CAR-T recipients; 107 had received a COVID-19 vaccine >2 weeks prior to testing positive, and 40 were treated with MCA. After adjusting for age, presence of symptoms at the initial positive test, and COVID-19 vaccination status, patients who did not receive MCA were five times more likely to develop complications after COVID-19 infection (adjusted odds ratio 5.0 [95% CI, 1.9-12.8], p = .001). CONCLUSION: HSCT and CAR-T recipients who received MCA following COVID-19 infection were far less likely to develop COVID-related complications than those who did not receive MCA, regardless of vaccination status. This underscores the potential benefit of developing novel MCA with efficacy against circulating COVID-19 strains.

Pivoting From Influenza to COVID-19 Vaccinations: How a Minnesota Vaccination Program Reduced Barriers for Refugee, Immigrant, and Migrant Communities Accessing Vaccines During the COVID-19 Pandemic.

The Minnesota Immunization Networking Initiative (MINI) led by Fairview Health Services has addressed barriers to accessing immunizations through partnerships with community organizations to provide free influenza vaccinations to historically underserved communities, especially refugee, immigrant, and migrant communities. Once the COVID-19 vaccine was available, MINI quickly pivoted operations to distribute the vaccine and provide technical assistance to community partners amidst rapidly evolving guidance. With infrastructure and a vaccination team in place, MINI responded to new and emerging needs, eg, implementing a more accessible and low-tech scheduling system, increasing staffing to meet growing needs, and expanding partnerships with community organizations and leaders. From February 2021 to September 2023, MINI organized 1120 community-based vaccine clinics and administered 43,123 COVID-19 vaccinations. Of those vaccine recipients, 88% identified as Black, Indigenous, and other people of color, and for preferred language, over half stated that they preferred a language other than English. These demographics are similar to those of the earlier influenza clinics, even as average annual clinics have tripled and average total vaccinations have quadrupled since the pivot to COVID-19 vaccination clinics. Some keys to success were: (1) consistent, bidirectional communication and shared decision-making with community partners; (2) prioritizing sustainable staffing models with the support of administrative leadership and resources; and (3) having a community-informed approach supported by the practice of hiring staff from communities served. Because of the effectiveness of this model, MINI is primed to respond to planned and unplanned emergent public health crises.

Exclusion of Families Who Speak Languages Other than English from Federally Funded Pediatric Trials.

OBJECTIVE: To determine whether individuals in the United States who speak languages other than English (LOE) are excluded from federally funded pediatric clinical trials and whether such trials adhere to the National Institutes of Health policy regarding inclusion of members of minority groups. STUDY DESIGN: Using ClinicalTrials.gov, we identified all completed, federally funded, US-based trials inclusive of children ≤17 and focused on one of 4 common chronic childhood conditions (asthma, mental health, obesity, and dental caries) as of June 18, 2019. We reviewed ClinicalTrials.gov online content, as well as published manuscripts linked to ClinicalTrials.gov entries, to abstract information about language-related exclusion criteria. Trials were deemed to exclude LOE participants/caregivers if explicit statements regarding exclusion were identified in the study protocol or published manuscript. RESULTS: Of total, 189 trials met inclusion criteria. Two-thirds (67%) did not address multilingual enrollment. Of the 62 trials that did, 82% excluded LOE individuals. No trials addressed the enrollment of non-English, non-Spanish-speaking individuals. In 93 trials with nonmissing data on ethnicity, Latino individuals comprised 31% of participants in trials that included LOE individuals and 14% of participants in trials that excluded LOE individuals. CONCLUSIONS: Federally funded pediatric trials in the United States do not adequately address multilingual enrollment, a seeming violation of federal and contractual requirements for accommodation of language barriers by entities receiving federal funding.

PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Public Libraries for Public Health: COVID-19 Response Efforts in Prince George's County, Maryland.

Public libraries-trusted institutions with broad population reach-are well positioned to partner with public health departments to advance community health. In 2020 through 2022, Prince George's County Memorial Library System assumed increasing responsibility in the local COVID-19 pandemic response by providing information and expanded services to county residents. With additional private funding, staffing, and public health resources, this library system codeveloped interventions to address information gaps, improve language access, and connect residents to more than 120 500 KN95 masks, more than 124 300 self-test kits, and more than 2400 vaccines. (Am J Public Health. 2023;113(6):623-626. https://doi.org/10.2105/AJPH.2023.307246).

Implementing HIV Prevention in Sub-Saharan Africa: A Systematic Review of Interventions Targeting Systems, Communities, and Individuals.

HIV remains a threat to global public health, disproportionately affecting countries across Sub-Saharan Africa. Although treatment and access to care have improved, prevention remains critical to ending new HIV infections by 2030. A variety of prevention strategies exist, yet their effectiveness is difficult to measure and variable due to the nature of the interventions and vulnerability of the intervention during implementation. This systematic review of 51 studies synthesizes data on the implementation and evaluation of evidence-based HIV prevention interventions across Sub-Saharan Africa. Studies were included if they occurred between January 1, 2008, and December 31, 2019, inclusive in Sub-Saharan Africa, were written in English, implemented an HIV prevention intervention in the field, and had reportable results. Using a modified social-ecological model for HIV prevention, we divided studies into three categories: interventions targeting health systems (n = 16), communities (n = 8), and individuals (n = 27). Across all categories, the data emphasized preventing mother-to-child transmission (PMTCT), medical interventions, and psychosocial interventions. The most successful programs bundled several interventions that were integrated into the health system. There is a notable lack of interventions targeting key populations and there are significant rates of loss to follow up (LTFU) across many studies. This review provides insight into the prioritization of evidence-based HIV prevention interventions across Sub-Saharan Africa.

A Systematic Review of HIV Testing Implementation Strategies in Sub-Saharan African Countries.

HIV/AIDS remains a looming presence in public health across the world, particularly in Sub-Saharan Africa. The HIV Care Cascade hinges on testing and knowledge of HIV status. Though significant advances have been made in diagnosing people living with HIV (PLHIV), limitations in understanding which strategies are best suited to certain regions or populations have contributed to the uneven distribution in the success of various HIV testing strategies. Here, we present a conceptual framework that outlines effective HIV testing strategies for four target groups. This framework is based on a systematic literature review of articles published from January 1st, 2008, to December 31st, 2019. The effectiveness of HIV testing strategies depends on various factors including the setting, type of test and service providers. Multiple strategies are needed to reach the UNAIDS target of 95% of individuals knowing their HIV status. Expansion of community-based approaches, self-testing and HIV testing services in antenatal care will further improve the state of HIV testing in Sub-Saharan Africa.

A Systematic Review of Linkage-to-Care and Antiretroviral Initiation Implementation Strategies in Low- and Middle-Income Countries Across Sub-Saharan Africa.

Linkage to care (LTC) and initiation of antiretroviral therapy (ART) are key components in the longitudinal care cascade for people living with HIV. Many strategies to optimize these stages of HIV care have been implemented, though there is a paucity of analyses comparing the outcomes of these efforts in low- and middle-income countries. We conducted a systematic review of studies assessing interventions along all stages of the HIV care continuum published between 2008 and 2020. A comprehensive search strategy reviewed five electronic databases to capture studies assessing HIV testing, LTC, ART initiation, ART adherence, and viral suppression. Of the 388 articles that met the inclusion criteria, 78 described interventions for improving LTC/ART initiation. Efforts focused on empowering patients through integrative approaches generally yielded more substantive results compared to provider-initiated non-adaptive LTC interventions or cash incentives. Specifically, tailoring care and incorporating ART initiation into existing infrastructures, such as maternal clinics, had a high impact across settings. Moreover, strategies such as home-based HIV counseling and testing (HBHCT) appear to be most effective when implemented in tandem with other approaches including motivational counseling and point-of-care CD4 testing.

Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study.

PURPOSE: Adults living with mechanical circulatory support (MCS) present with unique challenges (e.g., left ventricular assist device [LVAD]-related self-care, adverse events) to research study enrollment, engagement, and completion. The purpose of this study was to understand the experiences of adults with MCS who were eligible for and enrolled in a study of health-related quality of life (HRQOL). METHODS: In a secondary analysis of data from the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life study, we used a mixed-methods approach to evaluate research engagement and experiences among adults preparing to undergo or currently living with MCS implant. First, we assessed the cascade of study engagement. Second, we assessed research experiences using a structured interview developed for this study. RESULTS: Of 1011 participants approached for the study, 86.7% enrolled, 12.7% declined, and 0.6% were ineligible. Of 877 participants enrolled, 272 were pre-implant (of whom 88% completed assessments; "respondents") and 605 were post-implant (of whom 74% completed assessments). Only 14% of respondents reported difficulty completing the questionnaires, 54% had previously used an iPad to complete questionnaires, and 62% reported that their experience was "as expected." Respondents qualitatively described both positive (e.g., value of research) and negative (e.g., too much time) research experiences, difficulties completing questionnaires (e.g., online platform, health literacy issues), and provided recommendations for the questionnaires and delivery. CONCLUSIONS: Participants enjoyed participating in HRQOL research focused on MCS and had unique perspectives for improving the questionnaires. It is important to minimize the burden of participation and critical to be flexible to meet participant preferences for research engagement. TRIAL REGISTRATION: NCT03044535 (accessible at https://clinicaltrials.gov/ct2/show/NCT03044535 ), registered February 7, 2017.

A Low Literacy, Multimedia Health Information Technology Intervention to Enhance Patient-Centered Cancer Care in Safety Net Settings Increased Cancer Knowledge in a Randomized Controlled Trial.

We tested whether a low-literacy-friendly, multimedia information and assessment system used in daily clinical practice enhanced patient-centered care and improved patient outcomes. This was a prospective, parallel-group, randomized controlled trial with 2 arms, CancerHelp-Talking Touchscreen (CancerHelp-TT) versus control, among adults with Stage I-III breast or colorectal cancer receiving chemotherapy and/or radiation therapy in safety net settings. Each patient was assessed for outcomes at 4 timepoints: after starting treatment (baseline), during treatment, immediately after treatment, and at follow-up assessment. The primary outcomes were health beliefs, cancer knowledge, self-efficacy, and satisfaction with communication about cancer and its treatments. Health-related quality of life (HRQOL) was a secondary outcome. A total of 129 patients participated in the study (65 intervention and 64 control), and approximately 50% of these completed the study. Patients randomized to receive the CancerHelp-TT program had a significantly larger increase in their cancer knowledge in comparison to those randomized to the control arm (effect size = .48, P = .05). While effect sizes for differences between randomized groups in self-efficacy, health beliefs, HRQOL, and satisfaction with communication were small (.10-.48), there was a consistent trend that participants in the intervention group showed larger increases over time in all outcomes compared to the control group. The CancerHelp-TT software was favorably rated by intervention participants. The CancerHelp-TT program showed promise to increase vulnerable cancer patients' cancer knowledge and adaptive health beliefs and attitudes. However, vulnerable patients may need additional interventional support in settings outside cancer clinics.

Rasch Analysis of Social Attitude Barriers and Facilitators to Participation for Individuals with Disabilities.

OBJECTIVES: To develop item banks of social attitude barriers and facilitators to participation and validate them with established instruments. DESIGN: We used the Rasch model to identify misfitting items and rating scale problems, calibrate items, and develop KeyForms and short forms. Correlations between the Social Attitude Barriers and Facilitators item banks with the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain and National Institutes of Health Toolbox Emotional Battery Social Relationships domain were computed to evaluate convergent and divergent validity. SETTING: Community-dwelling individuals traveled to 3 academic medical centers for testing. PARTICIPANTS: Participants (N=558) who had a primary impairment of stroke, spinal cord injury, or traumatic brain injury (mean age, 47.0±16.0y) completed 31 social attitude facilitator and 51 barrier items using a 5-point rating scale. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Item banks to measure social attitude barriers and facilitators for individuals with disabilities. RESULTS: After combining the "never" and "rarely" rating scale categories, 30 Facilitator items fit the Rasch model and demonstrated person reliability of 0.93. After collapsing the "never" and "rarely" rating scale categories, 45 Barrier items fit the Rasch model and demonstrated person reliability of 0.95. Ceiling and floor effects were negligible for both item banks. Facilitators and Barriers item banks were negatively correlated, and these banks were moderately correlated with PROMIS and Toolbox measures, providing evidence of convergent and divergent validity. CONCLUSIONS: Findings support the reliability and validity of the Social Attitude Facilitators and Barriers item banks. These item banks allow investigators and clinicians to measure perceptions of social attitudes, providing information that can guide individual interventions to reduce barriers and promote facilitators. Moderate correlations between the Social Attitude banks and PROMIS and Toolbox variables provide support for the measurement and theory of environmental influences on social health and participation.

REAPing the benefits: development and use of a structured evaluation framework to codify learning resources for Global Health professionals.

BACKGROUND: The learning opportunities for global health professionals have expanded rapidly in recent years. The diverse array of learners and wide range in course quality underscore the need for an improved course vetting process to better match learners with appropriate learning opportunities. METHODS: We developed a framework to assess overall course quality by determining performance across four defined domains Relevance, Engagement, Access, and Pedagogy (REAP). We applied this framework across a learning catalogue developed for participants enrolled in the Sustaining Technical and Analytic Resources (STAR) project, a global health leadership training program. RESULTS: The STAR learning activities database included a total of 382 courses, workshops, and web-based resources which fulfilled 531 competencies across three levels: core, content, and skill. RELEVANCE: The majority of activities were at an understanding or practicing level across all competency domains (486/531, 91.5%). Engagement: Many activities lacked any peer engagement (202/531, 38.0%) and had limited to no faculty engagement (260/531, 49.0%). Access: The plurality of courses across competencies were offered on demand (227/531, 42.7%) and were highly flexible in pace (240/531, 45.2%). Pedagogy: Of the activities that included an assessment, most matched activity learning objectives (217/531, 40.9%). CONCLUSIONS: Through applying REAP to the STAR project learning catalogue, we found many online activities lacked meaningful engagement with faculty and peers. Further development of structured online activities providing learners with flexibility in access, a range of levels of advancement for content, and opportunities to engage and apply learning are needed for the field of global health.

Assessing meaning & purpose in life: development and validation of an item bank and short forms for the NIH PROMIS®.

PURPOSE: A sense of meaning and purpose is important for people living with acute and chronic illness. It can buffer the effects of stress and facilitate adaptive coping. As part of the Patient-Reported Outcomes Measurement Information System (PROMIS), we developed and validated an item response theory (IRT)-based measure of meaning and purpose in life. METHODS: Informed by a literature review and patient and content-expert input, we wrote 52 items to assess meaning and purpose and administered them to a general population sample (n = 1000) along with the Meaning in Life Questionnaire-Presence of Meaning Subscale (MLQ-Presence) and the Life Engagement Test (LET). We split the sample in half for exploratory factor analysis (EFA) followed by confirmatory factor analysis (CFA). IRT analyses included assessments of differential item functioning (DIF). RESULTS: Participants had a mean age of 47.8 years and 50.3% were male. EFA revealed one dominant factor and CFA yielded a good fitting model for a 37-item bank (CFI = 0.962, TLI = 0.960, RMSEA = 0.085). All items were free of sex, age, education, and race DIF. Internal consistency reliability estimates ranged from α = 0.90 (4-item short form) to α = 0.98 (37-item bank). The 8-item Meaning and Purpose short form was correlated with the MLQ-Presence (r = 0.89), the LET (r = 0.79), and the full PROMIS Meaning and Purpose item bank (r = 0.98). CONCLUSIONS: The PROMIS Meaning and Purpose measures demonstrated sufficient unidimensionality and displayed good internal consistency, model fit, and convergent validity. Further psychometric testing of the PROMIS Meaning and Purpose item bank and short forms in people with chronic diseases will help evaluate the generalizability of this new tool.

The impact of HIV knowledge and attitudes on HIV testing acceptance among patients in an emergency department in the Eastern Cape, South Africa.

BACKGROUND: Transmission of HIV in South Africa continues to be high due to a large proportion of individuals living with undiagnosed HIV. Uptake of HIV testing is influenced by a multitude of factors including the patient's knowledge and beliefs about HIV. METHODS: This study sought to quantify the impact of knowledge and attitudes on HIV testing acceptance in an emergency department by co-administering a validated HIV knowledge and attitudes survey to patients who were subsequently offered HIV testing. RESULTS: During the study period 223 patients were interviewed and offered HIV testing. Individuals reporting more negative overall attitudes (p = 0.006), higher levels of stigma to HIV testing (p < 0.001), and individuals who believed their test was confidential (p < 0.001) were more likely to accept an HIV test. CONCLUSIONS: Interventions focused on improving patient perceptions around testing confidentiality will likely have the greatest impact on testing acceptance in the emergency department.

Investigation of a multimedia, computer-based approach to improve knowledge, attitudes, self-efficacy, and receptivity to cancer clinical trials among newly diagnosed patients with diverse health literacy skills.

BACKGROUND: Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. The authors tested an interactive technology designed for patients with diverse health literacy skills with the aim of improving patient receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials. METHODS: Patients presenting for their first oncology appointment were eligible. Patients viewed an interactive teaching video concerning clinical trials that was adapted from the National Institutes of Health. Validated surveys assessing receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials were administered before and after the test. RESULTS: A total of 120 patients with cancer were enrolled. Approximately 80% were non-Hispanic white, 33% were female, 69% had >high school education, and 8% reported an income <$20,000. Approximately 33% scored within the low health literacy range. Changes between pretest and posttest demonstrated increases in knowledge (P < .001), self-efficacy (P < .001), and positive beliefs (P = .004); a slight decrease in willingness (P = .009); and no difference in patient receptivity (P = .31). Higher health literacy was associated with improved willingness (P = .049) and non-Hispanic white race was associated with improved receptivity (P = .034). CONCLUSIONS: Interactive technology that was designed for patients with diverse health literacy skills demonstrated the ability to improve knowledge, self-efficacy, and positive beliefs regarding cancer clinical trials. Contrary to the hypothesis of the current study, patients with lower health literacy did not appear to derive a greater advantage from this technology. There was no improvement noted with regard to patient willingness or receptivity, and clinical trial enrollment remained at historical institutional levels. Talking touchscreen technology has a potential role as an important element in informed decision making for patients, but likely needs to be coupled with more robust and multitargeted interventions.

Calibration and initial validation of a general self-efficacy item bank and short form for the NIH PROMIS®.

AIMS: General self-efficacy is associated with adaptive coping and positive health outcomes. The Patient-Reported Outcomes Measurement Information System (PROMIS®) has developed self-efficacy item banks for managing chronic conditions, but lacks a general self-efficacy measure. We sought to refine and validate an item-response theory (IRT)-based measure of general self-efficacy for PROMIS®. METHODS: Ten items were modified from the NIH Toolbox® Self-Efficacy Item Bank by creating "confidence" response options, and administered to a general population sample (n = 1000) with the Toolbox® Self-Efficacy Item Bank, Life Orientation Test-Revised (LOT-R), and Generalized Expectancy for Success Scale (GESS). We split the sample in half for exploratory factor analysis (EFA) followed by confirmatory factor analysis (CFA). IRT analyses included evaluation of differential item functioning (DIF). RESULTS: Participants had a mean age of 47.8 years and 50.3% were male. EFA showed all items loaded onto one dominant factor and CFA yielded a good fitting model for a general self-efficacy bank with confidence response options (CFI = 0.987, TLI = 0.984, RMSEA = 0.090). Items showed no evidence of DIF by gender, age, education, or race. Internal consistency reliability was α = .94 and .88 for a new 10-item general self-efficacy bank and 4-item short form, respectively. The new bank was correlated with the LOT-R (r = .58), the GESS (r = .55), and the Toolbox® Self-Efficacy Item Bank (r = .87). CONCLUSIONS: The PROMIS® General Self-Efficacy measure demonstrated sufficient unidimensionality and displayed good internal consistency reliability, model fit, and convergent validity. Further psychometric testing of the PROMIS® General Self-Efficacy Item Bank and Short Form can evaluate its utility in people with chronic health conditions.

The Development of a New Computer-Adaptive Test to Evaluate Strain in Caregivers of Individuals With TBI: TBI-CareQOL Caregiver Strain.

OBJECTIVE: To develop a new measure of caregiver strain for use in caregivers of individuals with traumatic brain injury (TBI), Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) Caregiver Strain. DESIGN: Qualitative data, literature reviews, and 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 (n=344) or service members/veterans (SMVs) with TBI (n=216). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: TBI-CareQOL Caregiver Strain Item Bank. RESULTS: Exploratory and confirmatory factor analyses, a graded response model (GRM) and differential item functioning supported the retention of 33 items in the final measure. GRM calibration data was used to inform the selection of a 6-item static short form, and to program the TBI-CareQOL Caregiver Strain computer-adaptive test (CAT). CAT simulation analyses indicated a 0.97 correlation between the CAT scores and the full item-bank. Three-week test-retest reliability was strong (r=0.83). CONCLUSIONS: The new TBI-CareQOL Caregiver Strain CAT and corresponding 6-item short form were developed using established rigorous measurement development standards; this is the first self-reported measure developed to evaluate caregiver strain in caregivers of individuals with TBI.

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.

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.

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.