Optimizing outcome assessment in multicenter TBI trials: Perspectives from TRACK-TBI and the TBI endpoints development initiative

Model System:

TBI

Reference Type:

Journal article

Accession No.:

J78897

Journal:

Journal of Head Trauma Rehabilitation

Year, Volume, Issue, Page(s):

2018 , 33, 3, 147-157

Publication Website:

Abstract:

Article presents lessons learned from initiatives aimed at optimizing the validity of outcome assessment in traumatic brain injury (TBI). In stark contrast to the effective trials that have been conducted in other neurological diseases, nearly 30 studies of interventions employed during acute hospital care for TBI have failed to identify treatments that improve outcome. Many factors may confound the ability to detect true and meaningful treatment effects. One promising area for improving the precision of intervention studies is to optimize the validity of the outcome assessment battery by using well-designed tools and data collection strategies to reduce variability in the outcome data. The Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, conducted at 18 sites across the United States, implemented a multidimensional outcome assessment battery with 22 measures aimed at characterizing TBI outcome up to 1 year after injury. In parallel, through the TBI Endpoints Development (TED) Initiative, federal agencies and investigators have partnered to identify the most valid, reliable, and sensitive outcome assessments for TBI. Based on lessons learned through experience with TRACK-TBI and TED, the authors offer recommendations for optimizing outcome assessment in multi-center longitudinal TBI studies.

Author(s):