Development of Quality of Life Tool for 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with the FDA's draft guidance on patient reported outcome (PRO) measures development.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]

Inclusion Criteria:

- enrolled in VA and diagnosed with a deployment-related TBI documented in computerized
patient record system (CPRS)

- at least one year post injury

- greater than 18 years of age

- able to follow two step commands and

- English speaking

Clinicians Inclusion Criteria:

- Clinicians, including:

- physicians

- psychologists

- nurses

- social workers

- therapists who have provided care to wounded warriors with deployment-related
TBI for at least three years

Exclusion Criteria:

Veterans Exclusion criteria include:

- those veterans who are not yet discharged from initial rehabilitation (want patients
to experience community based living environment)

- living in the community less than three months post initial rehabilitation, including
residential care or long term care living environments

No exclusion criteria for the clinicians