Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial.

PURPOSE: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). METHODS AND MATERIALS: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). RESULTS: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. CONCLUSIONS: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Efficient measurement of multiple ventricular assist device patient-reported outcomes: Creation of a 20-item profile from the MCS A-QOL study.

BACKGROUND: Patient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe the creation of 5 self-reported 4-item short forms and the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation. METHODS: Using a cross-sectional sample of patients (n = 620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created 5 4-item short forms: Satisfaction with Treatment, ventricular assist device (VAD) Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item profile. Analyses included intercorrelations among measures, Cronbach's alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity. RESULTS: The 620 patients were mean age = 57 years, 78% male, 70% White, and 56% on destination therapy LVADs. Intercorrelations among the 5 4-item measures were low to moderate (≤0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were ≥0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the 5 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures. CONCLUSIONS: Our 5 4-item short forms are reliable and valid and may be used individually or together as a 20-item profile to assess adjustment and HRQOL in patients who undergo LVAD implantation.

Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study.

BACKGROUND: Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist device adjustment and health-related quality of life (HRQOL). METHODS: Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n = 620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n = 154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n = 466]). We constructed 5 item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity. RESULTS: Of 620 participants, 56% (n = 345) were implanted as destination therapy, 51% (n = 316) were <12 months post-implantation, mean age = 57.3 years, 78% (n = 485) male, 70% (n = 433) White, 58% (n = 353) married/partnered, and 58% (n = 357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators. CONCLUSIONS: These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions.

COVID-19 Vaccine Confidence Mediates the Relationship between Health Literacy and Vaccination in a Diverse Sample of Urban Adults.

We sought to analyze the relationship between health literacy, confidence in COVID-19 vaccines, and self-reported vaccination. We hypothesized that the relationship between health literacy and vaccination would be mediated by vaccine confidence. We recruited (N = 271) English- and Spanish-speaking adults in Boston and Chicago from September 2018 to September 2021. We performed a probit mediation analysis to determine if confidence in COVID-19 vaccines and health literacy predicted self-reported vaccination. We hypothesized that the relationship between health literacy and vaccination would be mediated by vaccine confidence. Participants were on average 50 years old, 65% female, 40% non-Hispanic Black, 25% Hispanic, and 30% non-Hispanic White; 231 (85%) reported at least one COVID-19 vaccination. A higher mean vaccine confidence score (t = -7.9, p < 0.001) and higher health literacy (t = -2.2, p = 0.03) were associated with vaccination, but only vaccine confidence predicted vaccination in a multivariate model. Vaccine confidence mediated the relationship between health literacy and COVID-19 vaccination (mediated effects: 0.04; 95% CI [0.02, 0.08]). We found that using a simple tool to measure vaccine confidence identified people who declined or delayed COVID-19 vaccination in a diverse sample of adults with varying levels of health literacy. Simple short survey tools can be useful to identify people who may benefit from vaccine promotion efforts and evidence-based communication strategies.

A Standardized Protocol for Opioid Prescribing After Surgery Decreases Total Morphine Equivalents Prescribed.

INTRODUCTION: Perioperative opioid analgesia has been extensively reexamined during the opioid epidemic. Multiple studies have demonstrated over prescription of opioids, demonstrating the need for change in prescribing practices. A standard opioid prescribing protocol was implemented to evaluate opioid prescribing trends and practices. OBJECTIVES: To evaluate opioid use after primary ventral, inguinal, and incisional hernia repair and to assess clinical factors that may impact opioid prescribing and consumption. Secondary outcomes include the number of refills, patients without opioid requirement, difference in opioid use based on patient characteristics and adherence to prescribing protocol. METHODS: This is a prospective observational study examining patients undergoing inguinal, primary ventral and incisional hernias between February and November 2019. A standardized prescribing protocol was implemented and utilized for postoperative prescribing. All data was captured in the abdominal core health quality collaborative (ACHQC) and opioid use was standardized via morphine milligram equivalents (MME). RESULTS: 389 patients underwent primary ventral, incisional, and inguinal hernia repair, with a total of 285 included in the final analysis. 170 (59.6%) of patients reported zero opioid use postoperatively. Total opioid MME prescribed and high MME consumption were significantly higher after incisional hernia repair with a greater number of refills were required. Compliance with prescribing protocol resulted in lower MME prescription, but not actual lower MME consumption. CONCLUSIONS: Implementation of a standardized protocol for opioid prescribing after surgery decreases the total MME prescribed. Compliance with our protocol significantly reduced this disparity, which has the potential for decreasing abuse, misuse, and diversion of opioids by better estimating actual postoperative analgesic requirements.

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.

The mediating effect of health literacy on COVID-19 vaccine confidence among a diverse sample of urban adults in Boston and Chicago.

BACKGROUND: A high rate of COVID-19 vaccination is critical to reduce morbidity and mortality related to infection and to control the COVID-19 pandemic. Understanding the factors that influence vaccine confidence can inform policies and programs aimed at vaccine promotion. We examined the impact of health literacy on COVID-19 vaccine confidence among a diverse sample of adults living in two major metropolitan areas. METHODS: Questionnaire data from adults participating in an observational study conducted in Boston and Chicago from September 2018 through March 2021 were examined using path analyses to determine whether health literacy mediates the relationship between demographic variables and vaccine confidence, as measured by an adapted Vaccine Confidence Index (aVCI). RESULTS: Participants (N = 273) were on average 49 years old, 63 % female, 4 % non-Hispanic Asian, 25 % Hispanic, 30 % non-Hispanic white, and 40 % non-Hispanic Black. Using non-Hispanic white and other race as the reference category, Black race and Hispanic ethnicity were associated with lower aVCI (-0.76, 95 % CI -1.00 to -0.50; -0.52, 95 % CI -0.80 to -0.27, total effects from a model excluding other covariates). Lower education was also associated with lower aVCI (using college or more as the reference, -0.73 for 12th grade or less, 95 % CI -0.93 to -0.47; -0.73 for some college/associate's/technical degree, 95 % CI -1.05 to -0.39). Health literacy partially mediated these effects for Black and Hispanic participants and those with lower education (indirect effects -0.19 and -0.19 for Black race and Hispanic ethnicity; 0.27 for 12th grade or less; -0.15 for some college/associate's/technical degree). CONCLUSIONS: Lower levels of education, Black race, and Hispanic ethnicity were associated with lower scores on health literacy, which in turn were associated with lower vaccine confidence. Our findings suggest that efforts to improve health literacy may improve vaccine confidence, which in turn may improve vaccination rates and vaccine equity. CLINICAL TRIALS NUMBER: NCT03584490.

Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.

BACKGROUND: A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care. METHODS: Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes. RESULTS: Participants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5). CONCLUSIONS: The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life.

Resource and Reimbursement Barriers to Comprehensive Cancer Care Delivery: An Analysis of Association of Community Cancer Centers Survey Data.

PURPOSE: Comprehensive cancer care (CCC) delivery is recommended in guidelines and considered essential for high-quality cancer management. Barriers, such as insufficient reimbursement, prevent consistent access to and delivery of CCC. Association of Community Cancer Centers conducted a national survey to elucidate capacity and barriers to CCC delivery to inform policy and value-based payment reform. METHODS: Survey methodology included item generation with expert review, iterative piloting, and cognitive validity testing. In the final instrument, 27 supportive oncology services were assessed for availability, reasons not offered, and coverage/reimbursement. RESULTS: 204 of 704 member programs completed survey questions. Despite most services being reported as offered, a minority were funded through insurance reimbursement. The services least likely to obtain reimbursement were those that address practical and family/childcare needs (0.7%), caregiver support (1.5%), advanced care directives (1.7%), spiritual services (1.8%), and navigation (2.7%). These findings did not vary by region or practice type. CONCLUSION: There is a lack of sufficient reimbursement, staffing, and budget to provide CCC across the United States. Care models and reimbursement policies must include CCC services to optimize delivery of cancer care.

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.

Validation of a Short Form for Health Literacy Assessment Using Talking Touchscreen Technology.

BACKGROUND: Health literacy is an area of growing research and clinical interest, necessitating short, accurate measures of this complex construct. Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) measures prose, document, and quantitative literacy by self-administration on a touchscreen computer. OBJECTIVE: The objective of this study was to assess the validity of a short form of Health LiTT and to identify a meaningful cutoff score for adequate health literacy. METHODS: A subsample of 137 participants from the Literacy and Cognitive Function among Older Adults study completed a 10-item Health LiTT short form and three interviewer-administered health literacy measures: Test of Functional Health Literacy in Adults (TOFHLA), Rapid Estimate of Adult Literacy in Medicine (REALM), and Newest Vital Sign (NVS). Convergent validity was assessed by correlating scores for all measures, and known-groups validity was assessed by comparing mean Health LITT scores across TOFHLA levels (inadequate, marginal, adequate). Internal consistency reliability was estimated with Cronbach's alpha. A cutoff score for adequate health literacy was established using the TOFHLA cutoff for adequate versus inadequate/marginal health literacy. KEY RESULTS: Spearman correlations between Health LiTT scores and total TOFHLA, REALM, and NVS scores were 0.65, 0.69, and 0.56, respectively (all p < .001). Mean Health LiTT scores were significantly and meaningfully different across inadequate (40.4), marginal (50.1), and adequate (57.1) TOFHLA categories (F = 60.6; p < .001). Cronbach's alpha for the Health LiTT short form was .73. A cutoff score of 55 on Health LiTT showed acceptable sensitivity and specificity to identify adequate health literacy. CONCLUSIONS: This 10-item Health LiTT short form demonstrated excellent convergent and known-groups validity and acceptable internal consistency reliability in older adults. The established cutoff also showed excellent sensitivity and specificity. Validation of other custom Health LiTT short forms with varying items from the bank and computer adaptive test-generated Health LiTT scores is ongoing. [HLRP: Health Literacy Research and Practice. 2020;4(4):e200-e207.] PLAIN LANGUAGE SUMMARY: This article provides evidence of the need for and psychometric properties of a valid and reliable short form of the flexible, technologically advanced Health Literacy Assessment Using Talking Touchscreen Technology measure, as well as a cutoff score to note adequate versus marginal/inadequate health literacy.

Health literacy, health outcomes, and the caregiver role in traumatic brain injury.

Purpose/Objective: The purpose of this study is to estimate the occurrence of low health literacy among caregivers of people with traumatic brain injury (TBI), and to evaluate associations of health literacy with caregiver health-related quality of life (HRQOL) and perceptions of the caregiving role. Research Method/Design: The TBI-CareQOL measurement system assesses important self-reported outcomes for caregivers of civilians or service members/veterans (SMVs) with TBI. The validation phase included the Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT) measure. Multivariable regression evaluated the impact of low health literacy on generic and TBI-specific HRQOL and appraisals of the caregiving role, adjusted for caregiver gender, race/ethnicity and education, and the functional status of the TBI care recipient. Results: Among 131 caregivers, 28 (21%) had low health literacy. Compared with the high health literacy group, the group with low health literacy had fewer women, more racial/ethnic minorities, and lower education (all p < .05). The low health literacy group reported more subjective caregiving burden, less satisfaction with their relationship with the TBI recipient, less caregiving mastery, and poorer physical health (all p < .05). There were no differences between health literacy groups in caregiving ideology, caregiver-specific HRQOL or general mental health. Conclusions/Implications: A better understanding of the links between health literacy and caregiver HRQOL and the caregiving role can help identify strategies to meet the needs of this underserved population. Tailored interventions for caregivers with low health literacy could improve outcomes for both the caregiver and the care recipient. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

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.

Assessing vigilance in caregivers after traumatic brain injury: TBI-CareQOL Caregiver Vigilance.

OBJECTIVE: Caregivers of individuals with traumatic brain injury (TBI) frequently experience anxiety related to the caregiver role. Often this is due to a caregiver's perceived need to avoid people and situations that might upset or "trigger" the care recipient. There are currently no self-report measures that capture these feelings; thus, this article describes the development and preliminary validation efforts for the TBI-Caregiver Quality of Life (CareQOL) Caregiver Vigilance item bank. DESIGN: A sample of 532 caregivers of civilians (n = 218) or service members/veterans (SMVs; n = 314) with TBI completed 32 caregiver vigilance items, other measures of health-related quality of life (RAND-12, Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, PROMIS Social Isolation, Caregiver Appraisal Scale), and the Mayo-Portland Adaptability Inventory-4. RESULTS: The final item bank contains 18 items, as supported by exploratory and confirmatory factor analysis, item response theory graded response modeling (GRM), and differential item functioning investigations. Expert review and GRM calibration data informed the selection of a 6-item short form and programming of a computer adaptive test. Internal consistency reliability for the different administration formats were excellent (reliability coefficients ≥ .90). Three-week test-retest stability was supported (i.e., r ≥ .78). Correlations between vigilance and other self-report measures supported convergent and discriminant validity (0.01 ≤ r ≤ .69). Known-groups validity was also supported. CONCLUSIONS: The new TBI-CareQOL Caregiver Vigilance computer adaptive test and corresponding 6-item short form were developed using established rigorous measurement development standards, providing the first self-report measure to evaluate caregiver vigilance. This development work indicates that this measure exhibits strong psychometric properties. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Understanding domains that influence perceived stigma in individuals with Huntington disease.

PURPOSE/OBJECTIVE: Persons with Huntington's disease experience stigma because of their gene status. Whereas perceived stigma has been found to impact quality of life, it is unknown how different health domains (i.e., physical, emotional, cognitive, and social) are associated with feelings of stigma. In addition, stigma research has been limited by the use of cross-sectional analyses. The current study seeks to explore which domains are associated with stigma in a longitudinal assessment of persons with Huntington's disease. Research Method/Design: The current analysis used data from the HDQLIFE study, which included 479 participants at baseline, 315 participants at 12 months, and 277 participants at 24 months. A multilevel model (time nested within person) was used to examine the effect of physical, emotional, cognitive, and social health on perceived stigma (Neuro-QoL Stigma) while controlling for demographic factors. RESULTS: Findings indicate that physical, emotional, and cognitive health were associated with perceived stigma, whereas social health and demographic factors were not. Within-subject, time-varying predictors accounted for 20.2% of the variance in stigma. CONCLUSIONS/IMPLICATIONS: Our findings suggest that perceived stigma is influenced by physical, emotional, and cognitive health, which may be treated with physical therapy, emotional counseling, and cognitive rehabilitation. Application of these therapies may relieve the burden of perceived stigma; however, more research is needed in this area. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

TBI-CareQOL military health care frustration in caregivers of service members/veterans with traumatic brain injury.

PURPOSE: Caregivers of service members/veterans (SMVs) encounter a number of barriers when navigating the military health care system. The purpose of this study was to develop a new measure to assess potential caregiver frustration with the systems of care and benefits in the United States Departments of Defense and Veterans Affairs. METHOD: The TBI-CareQOL Military Health Care Frustration measure was developed using data from 317 caregivers of SMVs with TBI who completed an item pool comprised of 64 questions pertaining to anger or frustration with accessing military health care services. RESULTS: Exploratory and confirmatory factor analyses supported the retention of 58 items. Constrained graded response model (GRM) overall fit and item fit analyses and differential item functioning investigations of age and education factors supported the retention of 43 items in the final measure. Expert review and GRM item calibration products were used to inform the selection of two 6-item static short forms (TBI-CareQOL Military Health Care Frustration-Self; TBI-CareQOL Military Health Care Frustration-Person with TBI) and to program the TBI-CareQOL Military Health Care Frustration computer adaptive test (CAT). Preliminary data supported the reliability (i.e., internal consistency and test-retest reliability) as well as the validity (i.e., convergent, discriminant, and known-groups) of the new measure. CONCLUSIONS: The new TBI-CareQOL Military Health Care Frustration measure can be used to examine caregiver perceptions of and experience with the military health care system, to target improvements. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Reliability and validity data to support the clinical utility of the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL).

OBJECTIVE: The Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) is a patient-reported outcome measurement system that is specific to caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI). This measurement system includes 26 item banks that represent both generic (i.e., borrowed from existing measurement systems) and caregiver-specific components of health-related quality of life (HRQOL). This report provides reliability and validity data for measures within the TBI-CareQOL that have not previously been reported (i.e., 4 caregiver-specific and 7 generic measures of HRQOL). DESIGN: Three hundred eighty-five caregivers of persons with TBI completed caregiver-specific computer adaptive tests (CATs) for Feelings of Loss-Self, Caregiver Strain, Caregiver-Specific Anxiety, and Feeling Trapped, as well as generic measures of HRQOL from complementary measurement systems (i.e., Neuro-QoL Positive Affect and Well-Being; PROMIS Sleep-Related Impairment; NIH Toolbox Perceived Stress, General Life Satisfaction, and Self Efficacy; TBI-QOL Resilience and Grief/Loss). Caregivers also completed several additional measures to establish convergent and discriminant validity, as well as the Mayo Portland Adaptability Index, 4th ed. RESULTS: Findings support the internal consistency reliability (all alphas > .85) and test-retest stability (all alphas >.73) of the TBI-CareQOL measures. Convergent validity was supported by moderate to high correlations between the TBI-CareQOL measures and related measures, whereas discriminant validity was supported by low correlations between the TBI-CareQOL measures and unrelated constructs. Known-groups validity was also supported. CONCLUSIONS: Findings support the reliability and validity of the item banks that comprise the TBI-CareQOL Measurement System. These measures should be considered for any standardized assessment of HRQOL in caregivers of civilians and SMVs with TBI. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Responsiveness to Change Over Time: An Examination of the Neuro-QoL Social Function Measures in Persons with Huntington's Disease.

BACKGROUND: Social health is an important concern in persons with Huntington's disease (HD); however, there is little literature examining this construct in this population. OBJECTIVE: While cross-sectional data supports the clinical utility of two Neuro-QoL social health measures in persons with HD, data is still needed to establish their longitudinal validity. METHODS: Participants (N = 358) completed baseline and at least one follow-up (12- and 24-month) assessment that included the completion of Neuro-QoL Social Health computer adaptive tests (CATs) and short forms (for Ability to Participate in Social Roles and Activities [SRA] and Satisfaction with SRA). Test-retest reliability was examined using intra class correlations, and one-way ANOVAs with Bonferroni post-hoc contrasts were used to determine whether there were group differences among premanifest, early- and late-stage HD participants on the Social health measures. In addition, standardized response means were used to examine longitudinal responsiveness, and mixed or general linear models were used to examine change over time (relative to self-reported change on an associated anchor item about social health and clinician-rated change based on Total Functional Capacity scores from the UHDRS). RESULTS: Test-retest reliability of the measures was excellent (ICCs ranged from 0.82 to 0.87 across the different measures) and persons with greater disease burden reported more problems with social health than those at earlier stages in the disease process (all p < 0.0001). Responsiveness was supported for all measures except the Ability to Participate in SRA CAT; participants who had self-reported or clinician-rated declines in health generally had 12- and 24-month declines on the Neuro-QoL measures. CONCLUSIONS: Findings indicate that these measures may be useful for studies attempting to assess change in social health over time.