development of quality of life tool for tbi

Conditions: Traumatic Brain Injury

Summary: 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 furthermore, this approach is consistent with the fda's draft guidance on patient reported outcome (pro) measures development.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). \[objectives #3 \& 4\]

Eligibility criteria:
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

Keywords: traumatic brain injury quality of life