Brain Injuries, Traumatic
Conditions
Keywords
brain injuries, traumatic, military personnel, classification, diagnosis, instrumentation
Brief summary
The current study will evaluate the initial reliability and validity of a new instrument, the INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) veterans. The SAFE-TBI is a relatively brief measure developed by INTRuST consortium investigators and designed to be given by a trained administrator. It allows for a determination of the level of evidence for exposure to a mild traumatic brain injury (TBI) using the following categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The first objective is to determine the reliability (both test-retest and inter-rater) in a sample of 100 veterans recently returned from deployment at Joint Base Lewis-McChord and Fort Bragg (Cohort 1), who have screened positive for TBI on the Post-Deployment Health Assessment. The second objective is to determine the concordance between the SAFE-TBI and the VA TBI Screen in 100 OEF/OIF/OND veterans within the Northern New England VA Research Consortium (Cohort 2). The third objective, to be carried out in a sample of 200 Walter Reed National Military Medical Center (WRNMMC) and Fort Belvoir Community Hospital OEF/OIF/OND patients (Cohort 3), is to determine the sensitivity and specificity of the SAFE-TBI using the INTRuST study Brain Indices of Risk for Posttraumatic Stress Disorder after Mild Traumatic Brain Injury initial evaluation as the gold standard for TBI assessment.
Interventions
None listed
Sponsors
U.S. Army Medical Research and Development Command
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Cohort 1: 1. Military personnel returning to Joint Base Lewis-McChord and Fort Bragg from deployment in support of OEF/OIF/OND between the ages of 18-60. 2. Screen positive on the PDHA TBI screen and referred to the Madigan Army Medical Center TBI clinic and Womack Army Medical Center. 3. Capable of giving informed consent. Cohort 2: 1. Veterans of OEF/OIF/OND between the ages of 18-60, receiving care at any of the three VAMCs that comprise the Northern New England VA Research Consortium (White River Junction, VT; Manchester, NH; Togus, ME). 2. Screen positive on the VA Level 1 TBI screen. 3. Capable of giving informed consent. Cohort 3: Military Personnel participating in the INTRuST Consortium Brain Indices Study at Walter Reed National Military Medical Center and Fort Belvoir Community Hospital. This study has the following Inclusion Criteria: 1. Must be a patient at WRNMMC or FBCH 2. Must be Defense Enrollment Eligibility Reporting System (DEERS) eligible. 3. Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria 4. For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale 5. Aged 18-60
Exclusion criteria
Cohort 1: 1. Speech/language deficit of sufficient severity to preclude answering interview questions 2. Unable or unwilling to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA)authorization (unable includes cases in which the potential subject cannot read and understand English well enough to provide informed consent). Cohort 2: 1. Speech/language deficit of sufficient severity to preclude answering interview questions. 2. Unable or unwilling to provide informed consent and HIPAA authorization (unable includes cases in which the potential subject cannot read and understand English well enough to provide informed consent). 3. Second level in-depth TBI evaluation done prior to SAFE TBI interview Cohort 3:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test-retest Reliability SAFE-TBI | Up to 6 weeks | Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1) Cohort 1: The primary endpoints for this sub-study (cohort) are the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks) as well as the two rater types TRC vs. TBIC. (Specific Aim 1). |
| Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. | baseline | Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2) Cohort 2: The primary endpoint for this sub-study is the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen. (Specific Aim 2). |
| Sensitivity and Specificity of the SAFE-TBI | 6-months after medical evacuation | Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI |
Countries
United States
Participant flow
Pre-assignment details
This difference is due to screened patients who were enrolled, but then found ineligible,were unreachable, or withdrew from study.
Participants by arm
| Arm | Count |
|---|---|
| Test-Retest Reliability of SAFE-TBI 100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen | 98 |
| Comparison of SAFE-TBI and VA Screen 100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen | 115 |
| Sensitivity and Specificity of SAFE-TBI 200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI). | 55 |
| Total | 268 |
Baseline characteristics
| Characteristic | Test-Retest Reliability of SAFE-TBI | Comparison of SAFE-TBI and VA Screen | Sensitivity and Specificity of SAFE-TBI | Total |
|---|---|---|---|---|
| Age, Continuous | 32.29 years STANDARD_DEVIATION 9.3 | 33.03 years STANDARD_DEVIATION 8.68 | 29.20 years STANDARD_DEVIATION 8.56 | 31.33 years STANDARD_DEVIATION 8.5 |
| Presence of TBI | 91 participants | 115 participants | 55 participants | 261 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Male | 91 Participants | 109 Participants | 49 Participants | 249 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 98 | 0 / 115 | 0 / 55 |
| serious Total, serious adverse events | 0 / 98 | 0 / 115 | 0 / 55 |
Outcome results
Primary
Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2) Cohort 2: The primary endpoint for this sub-study is the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen. (Specific Aim 2).
Time frame: baseline
Population: Analyses done for Cohort 2 only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test-Retest Reliability of SAFE-TBI | Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. | Strong Evidence | 64.35 percentage of participants |
| Test-Retest Reliability of SAFE-TBI | Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. | Moderate Evidence | 11.3 percentage of participants |
| Test-Retest Reliability of SAFE-TBI | Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. | Weak Evidence | 14.78 percentage of participants |
| Test-Retest Reliability of SAFE-TBI | Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. | No Evidence | 9.57 percentage of participants |
Primary
Sensitivity and Specificity of the SAFE-TBI
Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI
Time frame: 6-months after medical evacuation
Population: Data were only collected for cohort 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test-Retest Reliability of SAFE-TBI | Sensitivity and Specificity of the SAFE-TBI | Sensitivity for Cutoff 2 | 93 percentage |
| Test-Retest Reliability of SAFE-TBI | Sensitivity and Specificity of the SAFE-TBI | Specificity for Cutoff 2 | 50 percentage |
Primary
Test-retest Reliability SAFE-TBI
Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1) Cohort 1: The primary endpoints for this sub-study (cohort) are the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks) as well as the two rater types TRC vs. TBIC. (Specific Aim 1).
Time frame: Up to 6 weeks
Population: Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test-Retest Reliability of SAFE-TBI | Test-retest Reliability SAFE-TBI | Cutoff 1 (no vs. at least weak evidence) | 0.372 kappa (reliability) |
| Test-Retest Reliability of SAFE-TBI | Test-retest Reliability SAFE-TBI | Cutoff 2 (no or weak vs. at least moderate evid) | 0.504 kappa (reliability) |
| Test-Retest Reliability of SAFE-TBI | Test-retest Reliability SAFE-TBI | Cutoff (no, weak, moderate vs. strong) | 0.581 kappa (reliability) |