BACKGROUND/RATIONALE:
Traumatic brain injury (TBI) is a leading injury among military personnel serving in the Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) combat theaters due largely to improvised explosive devices. Since symptoms of mild TBI (mTBI) are reported many months after combat exposures, and reported symptoms may be indicative of mental health conditions, mild TBI is difficult to identify and diagnose. In order to identify OEF/OIF Veterans at risk for mTBI, in 2007 the VA implemented a national TBI Clinical Reminder (TCR) to screen Veterans for mTBI. Veterans who screen positive are referred for the secondary, Comprehensive TBI Evaluation (CTBIE). Given the urgent clinical needs of these Veterans, both instruments were implemented prior to scientific evaluation. The purpose of this study was to evaluate the diagnostic validity and reliability of the TCR and the CTBIE.

OBJECTIVE(S):
Objectives for the diagnostic accuracy study included:
(1) To develop an mTBI Expert-Derived Assessment Battery (EDAB) and a corresponding Diagnostic Algorithm to serve as the criterion standard. This was developed using evidence derived from (a) a systematic review of published diagnostic accuracy studies using the STARD (Standards for Reporting of Diagnostic Accuracy) criteria; and (b) a Delphi survey of mTBI experts regarding the diagnostic issues that continue to lack expert consensus.
(2) To evaluate the diagnostic validity of the TCR and the CTBIE through an examination of: (a) sensitivity, specificity, false negatives and positives, and positive/negative predictive values of the TCR relative to a standardized mTBI Structured Interview (MSI), and the CTBIE relative to the EDAB; (b) concordance between measures of functional impairment and the TCR and CTBIE; (c) the concurrent validity between the clinical symptoms consistent with a diagnosis of TBI on the criterion standard (EDAB) and measures of functional impairment; and (d) the test/retest reliability for the TCR and the CTBIE.


METHODS:
The mixed methods project recruited OEF/OIF Veterans over 12-months at three VA Polytrauma Network Sites (PNS) including Southern Arizona/Tucson, Hines and Lexington. The sample was recruited through PNS clinics (1/3) and via OEF/OIF VA registries of personnel returning to VISN 18, 12, and 9 following deployment. Enrolled subjects were initially screened in the VA with the TCR. Regardless of TCR screen results, all subjects were evaluated on the CTBIE by VA or research clinicians. Research clinicians administered specified EDAB tests to all subjects. Two neuropsychologists then completed independent and blinded reviews using the Diagnostic Algorithm and were not privy to TCR and CTBIE results. Subjects were diagnosed with or without history of mTBI and categorized as being healthy controls, having symptoms resolved, or having current symptoms consistent with mTBI, PTSD, or mTBI + PTSD. (This parallels the diagnostic scoring used for the CTBIE.) To address reliability, subjects from Hines also participated in a one-week test /retest of the TCR and CTBIE.

FINDINGS/RESULTS:
A sample of 438 OEF/OIF Veterans enrolled across the three sites (Tucson = 131; Hines = 134; Lexington = 173) and included largely Caucasian (77%) males (90%). Prior to deployment, the majority of subjects were employed full-time by the military (61%) with 22% employed on a full-time basis in a non-military job, 13% full-time students, and 4% employed in a part-time, non-military job.

Forty-five percent of subjects screened positive for mTBI on the TCR, and 69% of this group were diagnosed with PTSD using the CAPS "moderate" scoring criteria (F1/I2 plus total severity > 45). In comparison, using the criterion or MSI, 47% screened positive for mTBI and 71% of this group were diagnosed with PTSD using the CAPS "moderate" scoring criteria.

Evaluating the TCR with the criterion standard indicates a Sensitivity (Se) of 79% (95%CI: 73-85), Specificity (Sp) of 85% (95% CI: 81-90), False Negatives (FN) of 15%, False Positives (FP) of 21%, Positive Predictive Value (PPV) of 49% and Negative Predictive Value (NPV) of 96%. Using a conservative mTBI prevalence rate of 15%, the accuracy of these indices is 84%.

Evaluation of the Comprehensive TBI Evaluation (CTBIE) with the criterion standard was conducted after excluding 104 subjects who failed tests of effort. Findings indicate that the CTBIE identified mTBI with 74% Se (95%CI: 66-81), 87% Sp (95%CI: 82-92), 26% FN, 13% FP, 13% PPV, and 95% NPV. Using the 15% prevalence rate, the accuracy is 85%.

The test/retest reliability of the TCR and CTBIE was assessed using a G-Theory analysis (n=87). The TCR and selected CTBIE items were stable and performed well regardless of the time of administration (TCR: ICC=0.91; CTBIE: ICC=0.98).

IMPACT:
The TBI Clinical Reminder, used to screen for mTBI in returning Veterans, demonstrates adequate diagnostic validity and reliability. The high negative predictive value for both the TCR and CTBIE indicate that Veterans diagnosed as negative for mTBI can be assured that they do not have the condition. The EDAB Diagnostic Algorithm may improve the diagnostic accuracy of the CTBIE (i.e., increase sensitivity) by providing clinicians with a standardized method of distinguishing between cognitive, affective, and somatic symptoms commonly shared by mTBI and PTSD.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Herrold AA, Jordan N, High WM, Babcock-Parziale JL, Chambers RA, Smith BM, Evans CT, Li X, Mallinson T, Jenkins S, Pape TL. Alcohol use and craving among Veterans with mental health disorders and mild traumatic brain injury. Journal of rehabilitation research and development. 2014 Dec 1; 51(9):1397-1410. [view]
2. Pape TLB, Smith B, Babcock-Parziale J, Evans CT, Herrold AA, Phipps Maieritsch K, High WM. Diagnostic Accuracy of the Veteran Affairs' Traumatic Brain Injury Screen. Archives of physical medicine and rehabilitation. 2018 Jul 1; 99(7):1370-1382. [view]
3. Pape TL, High WM, St Andre J, Evans C, Smith B, Shandera-Ochsner AL, Wingo J, Moallem I, Baldassarre M, Babcock-Parziale J. Diagnostic accuracy studies in mild traumatic brain injury: a systematic review and descriptive analysis of published evidence. PM & R : the journal of injury, function, and rehabilitation. 2013 Oct 1; 5(10):856-81. [view]
4. Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM. Neuropsychological effects of self-reported deployment-related mild TBI and current PTSD in OIF/OEF veterans. The Clinical Neuropsychologist. 2013 Jun 11; 27(6):881-907. [view]
5. Herrold AA, Kletzel SL, Mallinson T, Pape TLB, Weaver JA, Guernon A, Smith B, Babcock-Parziale J, High WM, Sesso-Osburn F, Vis L. Psychometric measurement properties of the world health organization disability assessment schedule 2.0 (WHODAS) evaluated among veterans with mild traumatic brain injury and behavioral health conditions. Disability and rehabilitation. 2021 May 1; 43(9):1313-1322. [view]
6. Combs HL, Berry DT, Pape T, Babcock-Parziale J, Smith B, Schleenbaker R, Shandera-Ochsner A, Harp JP, High WM. The Effects of Mild Traumatic Brain Injury, Post-Traumatic Stress Disorder, and Combined Mild Traumatic Brain Injury/Post-Traumatic Stress Disorder on Returning Veterans. Journal of Neurotrauma. 2015 Jul 1; 32(13):956-66. [view]

Conference Presentations

1. Wingo J, St. Andre J, Moallem I, Evans C, Smith B, Urban B, Pape TL. An Evidence-Based Review of Neuropsychological Assessment for Diagnosis of Mild TBI. Poster session presented at: International Neuropsychological Society Annual Meeting; 2012 Feb 15; Montréal, Canada. [view]
2. Babcock-Parziale JL. Development of a Mild TBI Diagnostic Reference Standard. Paper presented at: Federal Interagency Conference on Traumatic Brain Injury; 2011 Jun 13; Washington, DC. [view]
3. High WM. Diagnostic Algorithm for Symptom Attribution Following Possible Mild TBI. Paper presented at: Federal Interagency Conference on Traumatic Brain Injury; 2011 Jun 13; Washington, DC. [view]
4. Mason LH, Shandera-Ochsner AL, Harp JP, Williamson K, High WM, Berry DT. Differential Sensitivity of the MMPI-2-RF Validity Scales to Random Responding and Over Reporting of PTSD Symptoms. Poster session presented at: International Neuropsychological Society Annual Meeting; 2012 Feb 15; Montréal, Canada. [view]
5. Herrold AA, High WM, Smith BM, Evans (Mayfield) C, Urban A, Noblett K, Pape TL, Babcock-Parziale JL. Effects Of Alcohol Use On Patient Outcomes In Veterans With Mild TBI and/or Behavioral Health Symptoms. Paper presented at: Federal Interagency Conference on Traumatic Brain Injury; 2011 Jun 13; Washington, DC. [view]
6. Babcock-Parziale JL, McKnight PE. Experts’ Diagnostic Criterion for Mild Traumatic Brain Injury Identified through an Online Delphi Process. Paper presented at: Force Health Protection Annual Conference; 2010 Aug 11; Phoenix, AZ. [view]
7. Baldassare M, Pape TL, Smith BM, Herrold AA, Babcock-Parziale J, High W. Exploring the Relationship between mTBI Exposure in OIF/OEF Veterans and the Presence and Severity of Persistent Postconcussive Symptoms. Poster session presented at: American Academy of Clinical Neuropsychology Annual Meeting; 2013 Jun 20; Chicago, IL. [view]
8. Herrold AA, Babcock-Parziale J, High WM, Smith BM, Evans (Mayfield) C, Urban A, Noblett K, Harton B, Parrish T, Wang X, Jordan N, Pape TL. Neuroimaging correlates of alcohol craving in Veterans with mild traumatic brain injury and mental health disorders. Poster session presented at: Society for Neuroscience Annual Meeting; 2013 Nov 9; Chicago, IL. [view]
9. Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM. Outcome in OIF/OEF Veterans with PTSD and History of Concussion. Paper presented at: International Neuropsychological Society Annual Meeting; 2011 Feb 15; Montréal, Canada. [view]
10. Harp JP, Shandera-Ochsner AL, Edmundson MS, Berry DT, Pape TL, Babcock-Parziale JL, Schleenbaker RE, High WM. Reported Symptom Onset and Symptom Validity in Evaluation of Veterans for Mild TBI. Paper presented at: American Academy of Clinical Neuropsychology Annual Meeting; 2013 Jun 19; Chicago, IL. [view]
11. Harp JP, Shandera-Ochsner AL, Edmundson MS, Berry DT, Pape TL, Babcock-Parziale JL, Schleenbaker RE, High WM. Symptom Validity Effects in Neuropsychological Evaluation of Veterans. Poster session presented at: International Neuropsychological Society Annual Meeting; 2013 Feb 7; Waikoloa, HI. [view]
12. Combs HL, Berry DT, High WM. The Effects of Posttraumatic Stress Disorder, Mild Traumatic Brain Injury, and Combined PTSD/mTBI on Returning Veterans. Paper presented at: American Academy of Clinical Neuropsychology Annual Meeting; 2013 Jun 19; Chicago, IL. [view]

DRA: Military and Environmental Exposures, Health Systems Science, Acute and Combat-Related Injury, Brain and Spinal Cord Injuries and Disorders
DRE: Diagnosis, Prevention
Keywords: PTSD, Traumatic Brain Injury
MeSH Terms: none