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Goal: The ultimate goal of this research program is to improve the health and quality of life for wounded warriors from Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) through screening, risk assessment, and outcome measurement.
Purpose: The purpose of this study is to evaluate the reliability and validity of the existing Traumatic Brain Injury (TBI) Clinical Reminder Screen for OEF/OIF Veterans.
Objectives: To meet a VA-wide need for early diagnosis of mild traumatic brain injuries (TBI) in returning soldiers, in April 2007 VA established policy and procedures for screening and evaluation of possible TBI in OEF and OIF veterans. Although the screening process has been in effect for over a year, the validity, reliability, false positive rates, and false negative rates of the TBI Clinical Reminder are unknown. The purpose of this research is to develop a gold standard and then assess the validity/reliability of the TBI Clinical Reminder screen. Specific short-term objectives for this study include:
Research Design: Methodologies for this study include both prospective and retrospective approaches. Experts will convene in Tampa to operationalize a gold standard for TBI identification (Objective 1). Retrospective, population-based cohort analyses of extant databases will provide insight into current practices and findings to address Objective 2. The gold standard developed in Objective1 will be implemented with a small time-limited prospective cohort so that psychometric analysis of the TBI screen can be conducted (Objective 3). Findings from these analyses will help identify potential improvement in the TBI Screening process to address Objective 4.
Collaboration: This study is responsive to the RFP (#410127, TBI Screen, 8/7/2008). The Tampa HSR&D REAP is partnering with investigators at the Boston VAMC; Tampa investigators are taking the lead on the psychometric evaluation of the TBI screen, while Boston investigators will use the same cohort to evaluate the Second Level TBI Evaluation. Researchers from both sites are co-investigators on each of the proposals to enhance collaboration and linkage of findings.
Anticipated Impact: Traumatic brain injury (TBI), and particularly mild TBI, is said to be the "signature injury" of the current conflicts. These injuries are currently a focus of post-deployment assessment and treatment within the VA and are likely to continue to be the focus of treatment for many years to come. To ensure that OEF/OIF veterans with TBI are identified and treated, the VA TBI Clinical Reminder was instituted in the form of a four-item screening tool for use in VA. While the VA-TBI screening reminder rolled out on April 2, 2007, the utility and psychometric properties of this screening are unknown. The proposed project will address these gaps by operationalizing a gold standard for TBI identification and then using that gold standard to evaluate the reliability and validity of the current TBI screen. By completing this project, we propose to identify specific improvements to the TBI protocol instrument and screening process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities. |
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| Measure | Description | Time Frame |
|---|---|---|
| Responses From the TBI Clinical Reminder | The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview. | April 2007 January 2012 |
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Inclusion Criteria:
Exclusion Criteria:
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All those who have served in OEF/OIF who have been or need to be screened using the TBI Clinical Reminder
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| Name | Affiliation | Role |
|---|---|---|
| Rodney D. Vanderploeg, PhD | James A. Haley Veterans' Hospital, Tampa, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22426242 | Result | Belanger HG, Vanderploeg RD, Soble JR, Richardson M, Groer S. Validity of the Veterans Health Administration's traumatic brain injury screen. Arch Phys Med Rehabil. 2012 Jul;93(7):1234-9. doi: 10.1016/j.apmr.2012.03.003. Epub 2012 Mar 15. | |
| 22773258 | Result | Vanderploeg RD, Groer S, Belanger HG. Initial developmental process of a VA semistructured clinical interview for TBI identification. J Rehabil Res Dev. 2012;49(4):545-56. doi: 10.1682/jrrd.2011.04.0069. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Convenience Sample | A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responses From the TBI Clinical Reminder | The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview. | Posted | Number | percentage of participants | April 2007 January 2012 |
|
Overall study: April 2007 to present
Data collection was paper-and-pencil demographic and TBI Screening followed by a semi-structured TBI Identification Clinical Interview.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Convenience Sample | A convenience sample of 97 VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rodney Vanderploeg, Ph.D | Tampa VAMC | (813) 972-2000 | 6728 | Rodney.Vanderploeg@va.gov |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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As there are no biospecimans, there is no biospeciman description.
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 97 |
| 0 |
| 97 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |