Faculty Collaboration Database

Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative. J Head Trauma Rehabil 2018;33(3):147-157

Date

02/01/2018

Pubmed ID

29385010

Pubmed Central ID

PMC5940527

DOI

10.1097/HTR.0000000000000367

Scopus ID

2-s2.0-85047979359 (requires institutional sign-in at Scopus site)   35 Citations

Abstract

Traumatic brain injury (TBI) is a global public health problem that affects the long-term cognitive, physical, and psychological health of patients, while also having a major impact on family and caregivers. 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 postinjury. 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. Here, we present lessons learned from the TRACK-TBI and TED initiatives aimed at optimizing the validity of outcome assessment in TBI.

Author List

Bodien YG, McCrea M, Dikmen S, Temkin N, Boase K, Machamer J, Taylor SR, Sherer M, Levin H, Kramer JH, Corrigan JD, McAllister TW, Whyte J, Manley GT, Giacino JT, TRACK-TBI Investigators

Author

Michael McCrea PhD Professor in the Neurosurgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Brain Injuries, Traumatic
Clinical Trials as Topic
Combined Modality Therapy
Female
Glasgow Coma Scale
Humans
Incidence
Injury Severity Score
Male
Multicenter Studies as Topic
Needs Assessment
Program Evaluation
Risk Assessment
Treatment Outcome
United States