Epidemiological Study of Mild Traumatic Brain Injury Sequelae Caused by Blast Exposure During Operations Iraqi Freedom and Enduring Freedom
Abstract
Accomplishments include initial and ongoing IRB review & approval of all initial submissions, protocol amendments, recruitment advertisements, serious adverse events reporting, and completion of enrollment. We continue to submit to both McGuire and WRAMC IRBs. During Year-5, we completed enrollment, intensified data analysis efforts, and continued to work on follow-up evaluation data collection. Research assistant positions were reduced from 2 full time employees to 1 part-time employee by the end of year 4. Data management and analyses have been continued to be refined through meetings, reviews, quality checks, and consultations. At closure of enrollment, two hundred and thirty eight (238) participants passed eligibility pre-screen and consented for study procedures. Of these, twenty-two (22) participants either did not meet final eligibility or failed to complete Phase 1 (baseline) evaluations resulting in the final enrollment sample size of two hundred and sixteen (216). The overwhelming majority of these participants meet criteria for post-concussion syndrome (PCS). Conclusions to Date: Enrollment is completed. Study personnel continue to work on Phase 3 (longitudinal) follow-up data collection. The emphasis of the investigator work effort has shifted to data analysis and dissemination of findings. From the analyses to date we have achieved 2 publications, and have 2 other manuscripts under review, and have multiple pending manuscripts in varying stages of completion. Final conclusions regarding the primary study aims and hypotheses await further analyses and thus are pending at this time.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2013
- Accession Number
- ADA596636
Entities
People
- William C. Walker