Evaluation of the long-term outcomes of the University of Michigan's Practice-Oriented Research Training (PORT) program.

The University of Michigan created the Practice-Oriented Research Training (PORT) program and implemented it between 2008 and 2018. The PORT program provided research training and funding opportunities for allied healthcare professionals. The program consisted of weekly didactics and group discussion related to topics relevant to developing specific research ideas into projects and funding for a mentored research project for those who submitted a competitive grant application. The goal of this evaluation was to assess the long-term impact of the PORT program on the research careers of the participants. Ninety-two participants (74 staff and 18 faculty) participated in both phases of the program. A mixed-methods approach to evaluation was used; 25 participants who received funding for their research completed surveys, and semi-structured interviews were conducted with eight program participants. In addition, data were collected on participants' publication history. Fifteen out of the 74 staff participants published 31 first-authored papers after participating in PORT. Twelve out of 15 staff participants who published first-authored papers did so for the first time after participating in the PORT program. Results of quantitative and qualitative analyses suggest that the PORT program had positive impacts on both participants and the research community.

Implementing a mentoring program for clinical research professionals: A novel professional development initiative for university health research staff.

Clinical and translational research relies on a well-trained workforce, but mentorship programs designed expressly for this workforce are lacking. This paper presents the development of a mentoring program for research staff and identifies key programmatic outcomes. Research staff participating in this program were matched with a senior mentor. Focus groups were conducted to identify key program outcomes. Surveys were administered throughout the program period to assess participants' experience, gains in skill, and subsequent careers. Analysis of the resultant qualitative and quantitative data are used to characterize the implementation and impact of the program. A total of 47 mentees and 30 mentors participated in program between 2018 and 2023. A comprehensive logic model of short-, intermediate- and long-term outcomes was developed. Participants reported positive valuations of every programmatic outcome assessed including their program experience, learning and research careers. The pool of available mentors also grew as new mentors were successfully recruited for each cohort. This mentorship program developed and implemented by senior research staff successfully provided junior research staff with professional development support, mentorship, and professional development opportunities. Junior and senior health research staff built mentoring relationships that advanced their clinical and translational research careers.

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.

Reimagining a summer research program during COVID: Strategies for enhancing research workforce diversity.

Well-designed, accessible short-term research training programs are needed to recruit and retain underrepresented persons into clinical and translational research training programs and diversify the workforce. The Michigan Institute for Clinical and Health Research developed a summer research program, training over 270 students in 15 years. In response to the 2020 COVID-19 pandemic, we pivoted swiftly from an in-person format to a fully remote format. We describe this process, focusing on factors of diversity, equity, and inclusion including enabling student participation in remote research activities. We collected data about students' learning experiences since the program's inception; therefore, we could evaluate the impact of remote vs. in-person formats. We examined data from five cohorts: three in-person (2017-2019; n = 57) and two remote (2020-2021; n = 45). While there was some concern about the value of participating in a remote format, overall students in both formats viewed the program favorably, with students in the remote cohorts rating some aspects of the program significantly more favorably. In addition, more students who identified as Black or African American participated in the remote format than in the in-person format. We describe lessons learned from this unprecedented challenge and future program directions.

Assessments of Research Competencies for Clinical Investigators: A Systematic Review.

Although there is extensive research literature on clinical skill competencies and the use of competency-based frameworks for clinical research, the appropriate methods to assess these competencies are not as well understood. Our goal in this systematic literature review is to identify, compare, and critique assessments of clinical research competencies. Articles were included in this review if they examined clinical investigators or clinical investigators in training, focused on research-based skills, and included some form of assessment of research-based competencies. A total of 76 articles were identified as part of the initial search; 16 met the criteria for inclusion. Two types of assessments of clinical research competence were identified: subjective self-assessments (n = 13) and objective tests (n = 6). These assessments covered a wide range of competencies, but there were no competency domains common to all. Most assessments had limited validation. Training was consistently associated with self-assessed competence but had little relationship to objective measures of competence. In contrast, experience was consistently associated with objectively assessed competence but not with self-assessed competence. These findings have important implications for those interested in assessing medical education programs. We describe a recommended standard for validity for assessments used for the purposes of summative program assessment.

The Research Objective Structured Clinical Exam (R-OSCE): An Innovative Tool to Assess Clinical and Translational Research Competencies.

This article was migrated. The article was marked as recommended. Introduction The Research Objective Structured Clinical Exam (R-OSCE) described in this paper was designed as part of a comprehensive program to assess competency in specific domains of clinical and translational research (CTR) for students enrolled in a 12-week introductory summer research program. Methods The program curriculum was mapped to core competencies developed by the National Center for Translational Science (NCATS) and used to develop R-OSCE stations. Twelve stations were developed, with five administered during orientation as a practice test and seven administered post-program. A scoring rubric using an anchored scale of 1-5 was developed and six qualified raters were trained in its use. The exam was self-paced and delivered through a secure online computer-based platform. Results Forty-seven students (three cohorts) completed the post-program R-OSCE. Most respondents scored at 3 (developing competence) or higher on most stations for both the practice and post-program exams, the exceptions being the stations involving writing research questions and engaging communities in research. Students indicated they liked demonstrating CTR skills through the R-OSCE. Most participants agreed that exam tasks were related to stated program competencies and that stations were realistic. Discussion The R-OSCE is best used as part of a comprehensive assessment program and may be useful in providing formative feedback to trainees that they can share with their mentors. Additionally, this study demonstrated that it could feasibly be used to evaluate the effectiveness of research education programs. However, additional time was needed to train raters and score the R-OSCE. Modifications were made to administer the exam through use of an online format with a modest budget. The computer-based format provides a solution to the current need for assessments that can be administered remotely.

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).

The DIAMOND portal: An innovative platform for sharing translational research workforce training and assessment resources.

Although several initiatives have produced core competency domains for training the translational science workforce, training resources to help clinical research professionals advance these skills reside primarily within local departments or institutions. The Development, Implementation, and AssessMent of Novel Training in Domain (DIAMOND) project was designed to make this training more readily and publicly available. DIAMOND includes a digital portal to catalog publicly available educational resources and an ePortfolio to document professional development. DIAMOND is a nationally crowdsourced, federated, online catalog providing a platform for practitioners to find and share training and assessment materials. Contributors can share their own educational materials using a simple intake form that creates an electronic record; the portal enables users to browse or search this catalog of digital records and access the resources. Since September 2018, the portal has been visited more than 5,700 times and received over 280 contributions from professionals. The portal facilitates opportunities to connect and collaborate regarding future applications of these resources. Consequently, growing the collection and increasing numbers of both contributors and users remains a priority. Results from a small subset of users indicated over half accomplished their purpose for visiting the site, while qualitative results showed that users identified several benefits and helpful features of the ePortfolio.

Measuring emotional suppression in caregivers of adults with traumatic brain injury.

OBJECTIVE: Caregivers of individuals with traumatic brain injury (TBI) often feel pressure to maintain the appearance that they are emotionally well adjusted, despite feelings to the contrary. Because there are currently no measures examining this construct, this article focuses on the development of a new measure that is specific to caregivers of people with TBI. DESIGN: A total of 533 caregivers of civilians with TBI (n = 218) or service members/veterans (SMVs) with TBI (n = 315) completed 43 emotional suppression items, as well as other patient-reported outcomes and an estimate of the functional ability of the person with TBI. RESULTS: Exploratory and confirmatory factor analyses supported the retention of 25 items. Graded response model (GRM) analyses and differential item functioning (DIF) studies supported the retention of 21 items in the final measure. Expert review and GRM calibration data were used to develop a 6-item static short form (SF) and program a computer adaptive test (CAT). Internal consistency was excellent for both the CAT and SF (reliabilities ≥ 0.91); 3-week test-retest stability was good (all intraclass correlations ≥ 0.89). Convergent validity was supported by moderate associations between TBI-CareQOL Emotional Suppression and related measures (rs from 0.47 to 0.59); discriminant validity was supported by small correlations between Emotional Suppression and positive aspects of caregiving and physical health (rs from 0.14 to 0.28). Known-groups validity was also supported. CONCLUSIONS: The new TBI-CareQOL Emotional Suppression CAT and 6-item short form is the first self-report measure of this construct in this population. Our findings suggest this new measure has strong psychometric properties. (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).

Indices of Clinical Research Coordinators' Competence.

INTRODUCTION: There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual's preparedness to function efficiently in the clinical research enterprise as well as tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II). METHODS: CICRP-II was developed using data collected from clinical research coordinators (CRCs) participating in the "Development, Implementation and Assessment of Novel Training In Domain-Based Competencies" project at four clinical and translational science award (CTSA) hubs and partnering institutions. RESULTS: An exploratory factor analysis identified a two-factor structure: the first factor measures self-reported competence to perform routine clinical research functions while the second factor measures competence to perform advanced clinical functions. We demonstrate the between groups validity by comparing CRCs working in different research settings. DISCUSSION: The excellent psychometric properties of CICRP-II, its ability to distinguish between experienced CRCs at research intensive CTSA hubs and CRCs working in less intensive community-based sites coupled with the simplicity of alternative methods for scoring respondents make it a valuable tool for gauging an individual's perceived preparedness to function in the role of CRC as well as an equally valuable tool to evaluate the value and effectiveness of clinical research education and training programs.

Survey response burden in caregivers of civilians and service members/veterans with traumatic brain injury.

PURPOSE: Caregivers have expressed interest in survey research, yet there is limited information available about survey response burden, ie, the time, effort, and other demands needed to complete the survey. This may be particularly important for caregivers due to excessive time demands and/or stress associated with caregiving. METHOD: Survey response burden indicators were collected as part of a study to develop and validate a patient-reported outcome (PRO) measurement system for caregivers of civilians or service members/veterans (SMVs) with traumatic brain injury (TBI). RESULTS: Compared to the group caring for civilians (n=335), the group caring for SMVs (n=123) was comprised of all women, was younger, had fewer racial/ethnic minorities, had more education, and nearly all were the spouse of a person with TBI. All PRO outcomes were poorer for the group caring for SMVs. Although the caregivers of SMVs had poorer PRO outcomes compared to caregivers of civilians, they were more likely to report that they would recommend the study to others. Caregivers with less education and those from racial/ethnic minority groups had more favorable ratings of their study participation experience, even though they needed more help using the computer or answering the questions. CONCLUSION: The results of this study provide useful information about the acceptability of computer-based survey administration for caregiver PROs. PROs are widely gathered in clinical and health services research and could be particularly useful in TBI care programs. More data are needed to determine the best assessment strategies for individuals with lower education who are likely to require some assistance completing PRO surveys. Studies evaluating PROs administered by multimedia platforms could help researchers and clinicians plan the best strategies for assessing health-related quality of life in TBI caregivers.

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 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 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 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 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.

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.