Traumatic Brain Injury Clinical Trial
Official title:
Development of a Quality of Life Tool for Deployment Related TBI
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with the FDA's draft guidance on patient reported outcome (PRO) measures development.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]
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
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