Evaluation of VA's Traumatic Brain Injury (TBI) Clinical Reminder and Comprehensive TBI Evaluation (CTBIE)
The purpose of the proposed study is to determine the clinical validity and reliability of the VA's Traumatic Brain Injury (TBI) Clinical Reminder and the Comprehensive TBI Evaluation used to screen for mild traumatic brain injury. Examining the reliability of the two screens will determine whether they are dependable. Verifying the clinical validity is important because valid screening and evaluation of mild TBI leads to accurate diagnosis and timely treatment. Accurate screening also 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 of a mild TBI event.
Mild Traumatic Brain Injury
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of VA's TBI Clinical Reminder And Secondary Level Evaluation|
- VA TBI Clinical Reminder [ Time Frame: All OEF/OIF Veterans to receive upon enrollment in VA ] [ Designated as safety issue: No ]The mandatory 4-items screen addresses events that may increase the risk of TBI, immediate symptoms following the event, new or worsening symptoms following the event and current symptoms.
- VA Comprehensive TBI Evaluation (CTE) [ Time Frame: Within 30-days of a positive screen on the TBI Clinical Reminder ] [ Designated as safety issue: No ]The CTE documents a historical event and the immediate sequelae including any period of loss or a decreased level of consciousness, post-traumatic amnesia, alteration in mental state at the time of the injury, or neurological deficits that may/may not be transient.
- Historical TBI Scale [ Time Frame: Following the TCR and CTE ] [ Designated as safety issue: No ]The HTS is a comprehensive assessment battery used to diagnose a historical mild TBI. It is used as a criterion for the CTE.
|Study Start Date:||July 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852527
|United States, Arizona|
|Southern AZ VA Health Care System (Tucson)|
|Tucson, Arizona, United States, 85723|
|United States, Illinois|
|Edward Hines, Jr. VA Hospital|
|Hines, Illinois, United States, 60141-5000|
|United States, Kentucky|
|VA Medical Center, Lexington|
|Lexington, Kentucky, United States, 40502|
|Principal Investigator:||Judi L Babcock-Parziale, PhD||Southern AZ VA Health Care System (Tucson)|