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. 2018 May/Jun;33(3):147-157.
doi: 10.1097/HTR.0000000000000367.

Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative

Yelena G Bodien  1 , Michael McCrea, Sureyya Dikmen, Nancy Temkin, Kim Boase, Joan Machamer, Sabrina R Taylor, Mark Sherer, Harvey Levin, Joel H Kramer, John D Corrigan, Thomas W McAllister, John Whyte, Geoffrey T Manley, Joseph T Giacino; TRACK-TBI Investigators
Collaborators, Affiliations

Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative

Yelena G Bodien et al. J Head Trauma Rehabil. 2018 May/Jun.

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.

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Conflict of interest statement

Conflicts of Interest:

YB: None

MM: None

SD:None

NT: None

KB: None

JM: None

ST: None

MS: None

HL: None

JK: None

JC: None

TM: None

JW: None

GM: Dr. Manley reports grants from NIH, Department of Defense, and other support from One Mind, Abbott, General Electric, Pfizer, and Johnson & Johnson Family of Companies/DePuy Synthes/Codman Neuro during the conduct of the study.

JG: None

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