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Applying a Bookmarking Approach to Setting Clinically Relevant Interpretive Standards for the Spinal Cord Injury - Functional Index/Capacity (SCI-FI/C) Basic Mobility and Self Care Item Bank Scores

Kisala, Pamela A; Victorson, David; Nandakumar, Ratna; Shermeyer, Andrew; Fyffe, Denise; Heinemann, Allen W; Dyson-Hudson, Trevor A; Tulsky, David S
OBJECTIVE:To develop clinically relevant interpretive standards for the Spinal Cord Injury - Functional Index/Capacity (SCI-FI/C) Basic Mobility and Self-Care item bank scores. DESIGN/METHODS:Modified "bookmarking" standard-setting methodology, including two stakeholder consensus meetings with individuals with SCI and SCI clinicians, respectively, and a final, combined (consumers and clinicians) "convergence" meeting. SETTING/METHODS:Two Spinal Cord Injury Model System centers in the U.S. PARTICIPANTS/METHODS:Adults with traumatic SCI and clinicians who work with individuals with SCI. MAIN OUTCOME MEASURES/METHODS:Placement of bookmarks between vignettes based on SCI-FI Basic Mobility and Self-Care T-scores. Bookmarks were placed between vignettes representing "No Problems," "Mild Problems," "Moderate Problems," and "Severe Problems" for each item bank. RESULTS:Each consensus group resulted in a single set of scoring cut points for the SCI-FI/C Basic Mobility and Self-Care item banks. The cut points were similar but not identical between the consumer and clinician groups, necessitating a final convergence meeting. For SCI-FI/C Basic Mobility, the convergence group agreed on cut scores of 61.25 (no problems/mild problems), 51.25 (mild problems/moderate problems), and 41.25 (moderate problems/severe problems). For SCI-FI/C Self Care, the convergence group agreed on cut scores of 56.25 (no/mild), 51.25 (mild/moderate), and 38.75 (moderate/severe). CONCLUSIONS:The results of this study provide straightforward interpretive guidelines for SCI researchers and clinicians using the SCI-FI/C Basic Mobility and Self-Care instruments. These results are appropriate for the full bank, computer adaptive test, and short form versions of the SCI-FI/C Basic Mobility and Self-Care item banks.
PMID: 33245941
ISSN: 1532-821x
CID: 4681142

Validation of the Spinal Cord Injury Functional Index (SCI-FI) for use in community dwelling individuals with SCI

Tyner, Callie E; Kisala, Pamela A; Heinemann, Allen W; Fyffe, Denise; Tate, Denise G; Slavin, Mary D; Jette, Alan M; Tulsky, David S
OBJECTIVE:To evaluate the psychometric properties of the Spinal Cord Injury Functional Index (SCI-FI) instruments in a community-dwelling sample. DESIGN/METHODS:Cross-sectional study. SETTING/METHODS:Community setting. PARTICIPANTS/METHODS:269 individuals recruited from six SCI Model Systems sites. INTERVENTIONS/METHODS:n/a MAIN OUTCOME MEASURES: Participants completed computer adaptive test (CAT) and short form versions of four SCI-FI/Capacity banks (SCI-FI/C; Ambulation, Basic Mobility, Fine Motor, Self-Care) and one SCI-FI/Assistive Technology (AT) bank (Wheelchair Mobility) at baseline and after two weeks. The Self Report Functional Measure (SRFM) and the clinician-rated motor Functional Independence Measure (FIM) were used to evaluate evidence of convergent validity. RESULTS:Pearson correlations, intraclass correlation coefficients, minimal detectable change, and Bland-Altman plots supported the test-retest reliability of the SCI-FI instruments. Correlations were large with the SRFM (.69-.89) and moderate-to-large for the FIM instrument (.44-.64), supporting convergent validity. Known-groups validity was demonstrated by a significant main effect of injury level on all instruments and a main effect of injury completeness on the SCI-FI/C instruments. A ceiling effect was detected for individuals with incomplete paraplegia on the Fine Motor/C and Self Care/C Short Forms. CONCLUSION/CONCLUSIONS:Findings support the test-retest reliability, convergent validity, and known-groups validity of the SCI-FI/C instruments and the SCI-FI/AT Wheelchair Mobility instruments for use by community-dwelling individuals.
PMID: 33453193
ISSN: 1532-821x
CID: 4760082

Linking the Spinal Cord Injury - Functional Index (SCI-FI) to the PROMIS Physical Functioning Item Bank

Boulton, Aaron J; Kisala, Pamela A; Ni, Pengsheng; Tulsky, David S
OBJECTIVE:To link three Spinal Cord Injury - Functional Index (SCI-FI) item banks (Basic Mobility, Fine Motor Function, Self-Care) to the PROMIS® Physical Function (PF) metric. DESIGN/METHODS:Observational study SETTING: 6 SCI Model Systems rehabilitation hospitals in the U.S. PARTICIPANTS/METHODS:855 adults with SCI and 730 healthy individuals. INTERVENTIONS/METHODS:Not applicable. MAIN OUTCOME MEASURES/METHODS:Three SCI-FI item banks (Basic Mobility, Fine Motor Function, Self-Care), PROMIS PF v1.0 item bank. METHODS AND RESULTS/RESULTS:SCI-FI item banks (including 30 items from the PROMIS PF item bank) were administered to 855 adults with SCI as part of the original SCI-FI development study. The data were used to attempt to link three SCI-FI banks to the PROMIS PF metric via two item-response theory methods: fixed-parameter calibration and separate calibration. Sixteen items common to SCI-FI and PROMIS and verified as free of DIF were used as anchor items to implement the methods. Of the three banks, only SCI-FI Basic Mobility could be linked with sufficient precision to PROMIS PF. Comparisons of actual versus linked PROMIS PF scores and test characteristic curves suggested the fixed-parameter method provided slightly more precision than the separate calibration method. CONCLUSION/CONCLUSIONS:The linkage between PROMIS PF and SCI-FI Basic Mobility was considered satisfactory for group-level usage. Score equivalents computed from SCI-FI Basic Mobility will be useful for researchers comparing functional levels in SCI to those observed in other clinical and non-clinical groups, for example, in comparative effectiveness research.
PMID: 33684365
ISSN: 1532-821x
CID: 4809122

Responsiveness of the Traumatic Brain Injury Quality of Life Cognition Banks in Recent Brain Injury

Tyner, Callie E; Kisala, Pamela A; Boulton, Aaron J; Sherer, Mark; Chiaravalloti, Nancy D; Sander, Angelle M; Bushnik, Tamara; Tulsky, David S
Patient report of functioning is one component of the neurocognitive exam following traumatic brain injury, and standardized patient-reported outcomes measures are useful to track outcomes during rehabilitation. The Traumatic Brain Injury Quality of Life measurement system (TBI-QOL) is a TBI-specific extension of the PROMIS and Neuro-QoL measurement systems that includes 20 item banks across physical, emotional, social, and cognitive domains. Previous research has evaluated the responsiveness of the TBI-QOL measures in community-dwelling individuals and found clinically important change over a 6-month assessment interval in a sample of individuals who were on average 5 years post-injury. In the present study, we report on the responsiveness of the TBI-QOL Cognition-General Concerns and Executive Function item bank scores and the Cognitive Health Composite scores in a recently injured sample over a 1-year study period. Data from 128 participants with complicated mild, moderate, or severe TBI within the previous 6 months were evaluated. The majority of the sample was male, white, and non-Hispanic. The participants were 18-92 years of age and were first evaluated from 0 to 5 months post-injury. Eighty participants completed the 1-year follow-up assessment. Results show acceptable standard response mean values (0.47-0.51) for all measures and minimal detectable change values ranging from 8.2 to 8.8 T-score points for Cognition-General Concerns and Executive Functioning measures. Anchor rating analysis revealed that changes in scores on the Executive Function item bank and the Cognitive Health Composite were meaningfully associated with participant-reported changes in the areas of attention, multitasking, and memory. Evaluation of change score differences by a variety of clinical indicators demonstrated a small but significant difference in the three TBI-QOL change scores by TBI injury severity grouping. These results support the responsiveness of the TBI-QOL cognition measures in newly injured individuals and provides information on the minimal important differences for the TBI-QOL cognition measures, which can be used for score interpretation by clinicians and researchers seeking patient-reported outcome measures of self-reported cognitive QOL after TBI.
PMCID:8931768
PMID: 35308618
ISSN: 1662-5161
CID: 5220282

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

Carlozzi, Noelle E; Lange, Rael T; Kallen, Michael A; Boileau, Nicholas R; Sander, Angelle M; Massengale, Jill P; Nakase-Richardson, Risa; Tulsky, David S; French, Louis M; Hahn, Elizabeth A; Ianni, Phillip A; Miner, Jennifer A; Hanks, Robin; Brickell, Tracey A
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/METHODS:= 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:≤ .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).
PMID: 31971432
ISSN: 1939-1544
CID: 4273242

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

Carlozzi, Noelle E; Boileau, Nicholas R; Kallen, Michael A; Nakase-Richardson, Risa; Hahn, Elizabeth A; Tulsky, David S; Miner, Jennifer A; Hanks, Robin A; Massengale, Jill P; Lange, Rael T; Brickell, Tracey A; French, Louis M; Ianni, Phillip A; Sander, Angelle M
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/METHODS: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) 2019 APA, all rights reserved).
PMID: 31829641
ISSN: 1939-1544
CID: 4234742

TBI-CareQOL family disruption: Family disruption in caregivers of persons with TBI

Carlozzi, Noelle E; Lange, Rael T; Boileau, Nicholas R; Kallen, Michael A; Sander, Angelle M; Hanks, Robin A; Nakase-Richardson, Risa; Tulsky, David S; Massengale, Jill P; French, Louis M; Brickell, Tracey A
PURPOSE/OBJECTIVE:Family disruption is often an indirect consequence of providing care for a person with traumatic brain injury (TBI). This article describes the development and preliminary validation of a Family Disruption scale designed for inclusion within the TBI-CareQOL measurement system. METHOD/DESIGN/METHODS:= 218) completed the Family Disruption scale, alongside several other measures of caregiver strain and health-related quality of life. Classical test theory and item response theory (IRT)-based analyses were conducted to develop, and establish reliability and validity of, this scale. RESULTS:= 10); higher scores are indicative of more family disruption. Reliability (internal consistency; test-retest stability) was supported for both caregiver groups, and average administration times were under 10 s. Convergent and discriminant validity were supported by strong correlations between Family Disruption and measures of caregiver burden, and smaller correlations with positive aspects of caregiving. As evidence of known-groups validity, caregivers of lower-functioning persons with TBI experienced more family disruption than caregivers of higher functioning individuals. CONCLUSIONS:The TBI-CareQOL Family Disruption scale is a brief, reliable, and valid assessment of caregiver perceptions of how caring for an individual with a TBI interferes with family life. This measure is well-suited for inclusion in studies seeking to support family functioning in persons with TBI. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
PMID: 31841019
ISSN: 1939-1544
CID: 4242122

Reproductive Health in Women with Physical Disability: A Conceptual Framework for the Development of New Patient-Reported Outcome Measures

Kalpakjian, Claire Z; Kreschmer, Jodi M; Slavin, Mary D; Kisala, Pamela A; Quint, Elisabeth H; Chiaravalloti, Nancy D; Jenkins, Natalie; Bushnik, Tamara; Amtmann, Dagmar; Tulsky, David S; Madrid, Roxanne; Parten, Rebecca; Evitts, Michael; Grawi, Carolyn L
PMID: 32429740
ISSN: 1931-843x
CID: 4444232

Establishing the Factor Structure of a Health-Related Quality of Life Measurement System for Caregivers of Persons Living With Traumatic Brain Injury

Raad, Jason H; Tulsky, David S; Lange, Rael T; Brickell, Tracey A; Sander, Angelle M; Hanks, Robin A; French, Louis; Miner, Jennifer A; Kisala, Pamela A; Carlozzi, Noelle E
OBJECTIVES/OBJECTIVE:To understand the factor structure of health-related quality of life specific to caregivers of people living with traumatic brain injury (TBI). DESIGN/METHODS:Prospective, cross-sectional data collection. SETTING/METHODS:Three TBI Model Systems rehabilitation hospitals, an academic medical center, and a military medical treatment facility. PARTICIPANTS/METHODS:Caregivers (N=558) of people who have sustained a TBI (344 caregivers of civilians and 214 caregivers of service members or veterans; 85% women; 58% spouses; mean age, 46.12±14.07y) who have provided care for an average of 5.82±5.40 years. INTERVENTIONS/METHODS:Not applicable. MAIN OUTCOMES MEASURES/METHODS:The Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) measurement system including 10 Patient-Reported Outcomes Measurement Information System item banks (anger, anxiety, depression, social isolation, sleep disturbance, fatigue, ability to participate in social roles and activities, satisfaction with social roles and activities, emotional support, informational support) and 5 TBI-CareQOL banks (feelings of loss-self, feelings of loss-person with TBI, feeling trapped, caregiver-specific anxiety, caregiver strain). RESULTS:Confirmatory factor analysis model fit indices were compared for 14 empirically derived and 5 theoretically derived models. Confirmatory factor analysis results indicated that the best model fit was for a 6-factor model with dimensions that included mental health, social support, social participation, social isolation, physical health, and caregiver emotion. CONCLUSIONS:Results indicated that a 6-factor model provided the best model fit for health-related quality of life in caregivers of individuals with TBI. These results have utility for both research and clinical applications. Establishing the TBI-CareQOL's factor structure provides preliminary evidence of the measurement system's construct validity, helps inform the selection of measures for specific research or clinical interventions, and informs the development of composite scores.
PMID: 32315649
ISSN: 1532-821x
CID: 4477452

Emotional Suppression and Hypervigilance in Military Caregivers: Relationship to Negative and Positive Affect

Sander, Angelle M; Boileau, Nicholas R; Hanks, Robin A; Tulsky, David S; Carlozzi, Noelle E
OBJECTIVE:To investigate the relationship of 2 health-related quality-of-life (QOL) item banks (Emotional Suppression and Caregiver Vigilance), developed for caregivers of service members/veterans with traumatic brain injury (TBI), to caregivers' positive and negative affect. SETTING/METHODS:Community. PARTICIPANTS/METHODS:One hundred sixty-five caregivers of service members/veterans with TBI. DESIGN/METHODS:Retrospective database analysis. MAIN MEASURES/METHODS:TBI-CareQOL Emotional Suppression; TBI-CareQOL Caregiver Vigilance; measures of negative (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, PROMIS Anger, TBI-CareQOL Caregiver-Specific Anxiety, National Institutes of Health Toolbox [NIHTB] Perceived Stress, GAD-7) and positive affect (Neuro-QOL Positive Affect and Well-being, NIHTB Self-efficacy, NIHTB General Life Satisfaction, Family Resilience Scale for Veterans, TBI-QOL Resilience). RESULTS:When considered separately, linear regression showed that higher levels of Emotional Suppression and greater Caregiver Vigilance were individually associated with more negative affect and less positive affect. When considered together, the pattern of findings was generally consistent for both Emotional Suppression and Caregiver Vigilance with regard to negative affect and for Emotional Suppression with regard to positive affect. However, when considered together, Caregiver Vigilance was no longer related to positive affect. CONCLUSIONS:Caregivers with high emotional suppression and/or vigilance are more likely to show emotional distress and less likely to have positive affect than caregivers with lower levels of emotional suppression and vigilance. A combination of education and individual counseling targeting coping with negative emotions and TBI-related problems may be beneficial.
PMID: 31365438
ISSN: 1550-509x
CID: 4011092