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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| University of Michigan | OTHER |
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Objectives: The ultimate goal of this research program is to promote seamless, comprehensive care for Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) veterans. The purpose of this study is to develop a psychometrically sound tool to measure health-related quality of life (HRQOL) applicable to wounded warriors with TBI (deployment-related TBI).
Specific short-term objectives for this study include:
O1: Identify a parsimonious set of domains that capture HRQOL in deployment-related TBI.
O2: Construct and refine clinically-relevant HRQOL of life item banks for deployment-related TBI, in order to supplement the TBI-QOL and generic Neuro-QOL banks and extend the TBI/Neuro-QOL projects to address the unique issues facing wounded warriors with TBI.
O3:Utilize Item Response Theory methodology to refine and calibrate targeted and generic item banks for use with deployment-related TBI.
O4:Develop a short form, refining item sets and developing algorithms for future development of a computerized adaptive test.
Research Design: The proposed three-year prospective study will employ a mixed methods research design in three stages. Combining qualitative and quantitative methods maximizes the ability of the study team to design and validate a clinically sensitive HRQOL measure for wounded warriors with deployment-related TBI. Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.
Phase 1: Qualitative data obtained from focus groups of veterans and VA providers will be used to (a) evaluate the generic Neuro-QOL domains and items for relevance and appropriateness for use in deployment-related TBI and (b) identify new HRQOL domains and items specific to deployment-related TBI. [Objective #1] Phase 2: The generic and specific item banks will be field tested in a large sample of veterans with deployment-related TBI recruited from all 4 VA Polytrauma Rehabilitation Centers (PRCs). [Objective #2] Phase 3: Psychometric analyses, including item response theory (IRT) of field test data will be completed. The psychometric properties of the scale will be evaluated empirically. A short form will be developed, refining item sets and developing algorithms for future development of a computerized adaptive test (CAT). [Objectives #3 & 4]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Item Development | Individuals with TBI to provide input to relevant questions for quality of life measure in TBI | ||
| Group 2: Item Development | Clinicians who treat those with deployment related TBI to obtain their feedback on relevant questions pertaining to quality of life measures in TBI. | ||
| Group 3: Instrument Development | Individuals with deployment TBI who will complete the Beta version of the TBI QOL measure. |
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| Measure | Description | Time Frame |
|---|---|---|
| development of an outcomes measure | one time |
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Inclusion Criteria:
Clinicians Inclusion Criteria:
Clinicians, including:
Exclusion Criteria:
Veterans Exclusion criteria include:
No exclusion criteria for the clinicians
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Individuals with deployment related traumatic brain injury and clinicians who treat those veterans.
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| Name | Affiliation | Role |
|---|---|---|
| Rodney D Vanderploeg, PhD | James A. Haley Veterans' Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States | ||
| James A. Haley Veterans' Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25310294 | Result | Toyinbo PA, Vanderploeg RD, Donnell AJ, Mutolo SA, Cook KF, Kisala PA, Tulsky DS. Development and Initial Validation of Military Deployment-Related TBI Quality-of-Life Item Banks. J Head Trauma Rehabil. 2016 Jan-Feb;31(1):52-61. doi: 10.1097/HTR.0000000000000089. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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None retained
| Tampa |
| Florida |
| 33612-4745 |
| United States |
| VA Medical Center, Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |