Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder and Comprehensive TBI Evaluation

A. Anticipated Impacts on Veterans' Healthcare: Determining the clinical validity of the
VA's TBI Clinical Reminder and Comprehensive TBI Evaluation is critical because valid
screening and evaluation of mild traumatic brain injury (mTBI) leads to accurate diagnosis
and timely treatment. Accurate screening improves clinical efficiency and ensures that
resources are provided to those who need them most. The project findings are expected to
advance the science of screening and diagnosis by clarifying whether symptoms are consistent
with post-concussion syndrome due to an mTBI event. Findings are also expected to inform the
development of the next generation of VA screening instruments for mild TBI.

B. Project 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. While TBI severities
range from mild to severe, mTBI is particularly difficult to identify, diagnose and treat.
The VA modified a version of the Defense and Veterans Brain Injury Center (DVBIC) tool,
which is used to screen returning OEF/OIF service members. The VA's modified screen, the TBI
Clinical Reminder, is used to screen a slightly different population. Therefore, results of
the validity study for the DVBIC tool are not directly applicable. As a result, the General
Accountability Office (GAO) recommended the VA expeditiously evaluate the clinical validity
and reliability of its TBI screening tool.

C. Primary Study Objectives are: (1) Develop the Experts' Diagnostic Assessment Battery for
use as a proxy gold standard, and (2) Evaluate and compare the performance characteristics
of the TBI Clinical Reminder and the Comprehensive TBI Evaluation using the Experts'
Diagnostic Assessment Battery. These objectives will be realized via: (a) An examination
the performance characteristics (diagnostic validity) of the TBI Clinical Reminder and the
Comprehensive TBI Evaluation relative to the Experts' Diagnostic Assessment Battery to
determine sensitivity and specificity, (b) Determining whether false positives and/or false
negatives are related to Post Traumatic Stress Disorder (PTSD) and how the performance
characteristics of the tests differ for PTSD, (c) Ascertaining the concordance among
measures of functional impairment, the TBI Clinical Reminder and the Comprehensive TBI
Evaluation, (d) Establishing the concurrent validity between the diagnosis of presence or
absence of post-concussion syndrome due to mTBI and measures of functional impairment, (e)
Verifying the test/retest reliability for the TBI Clinical Reminder and the Comprehensive
TBI Evaluation and (f) Identifying whether clusters of symptoms or subjects reporting
similar patterns of symptoms correspond with clinical sub-groups (e.g., mTBI with PTSD, PTSD
alone).

D. Project Methods: An online Delphi process and will be conducted with mTBI experts to
inform the development of the Experts' Diagnostic Assessment Battery. A sample of 720
OEF/OIF veterans will be recruited over 12-months at three VA Polytrauma Network Sites. The
OEF/OIF veterans will have symptoms consistent with either a mild TBI event (True Positive)
or symptoms inconsistent with such an event (True Negative). All subjects will be assessed
by research clinicians using the TBI Clinical Reminder, the Comprehensive TBI Evaluation and
the Experts' Diagnostic Assessment Battery. Analysis will determine the sensitivity and
specificity as well as the test/retest reliability of the TBI Clinical Reminder and the
Comprehensive TBI Evaluation. The performance characteristics for the Experts' Diagnostic
Assessment Battery will be ascertained and used to further our understanding of how best to
distinguish mTBI symptoms from related and/or comorbid conditions (e.g., PTSD, anxiety, and
depression).