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

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

The Journal of Head Trauma Rehabilitation: May/June 2018 - Volume 33 - Issue 3 - p 147–157
doi: 10.1097/HTR.0000000000000367
Original Articles

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.

Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston (Dr Bodien); Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Charlestown, Massachusetts (Drs Bodien and Giacino); Departments of Neurosurgery and Neurology, Medical College of Wisconsin, Milwaukee (Dr McCrea); Departments of Rehabilitation Medicine (Dr Dikmen and Mss Boase and Machamer) and Neurological Surgery and Biostatistics (Dr Temkin), University of Washington, Seattle; Department of Neurological Surgery, Brain and Spinal Injury Center (Dr Taylor), and Department of Neurology, Memory and Aging Center (Dr Kramer), University of California, San Francisco; TIRR Memorial Hermann, Houston, Texas (Dr Sherer); Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, Texas (Drs Sherer and Levin); Department of Physical Medicine & Rehabilitation, The Ohio State University, Columbus (Dr Corrigan); Department of Psychiatry, University of Indiana School of Medicine, Indianapolis (Dr McAllister); and Moss Rehabilitation Research Institute, Elkins Park, Pennsylvania (Dr Whyte).

Corresponding Author: Yelena G. Bodien, PhD, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, 175 Cambridge St, Boston, MA 02114 (ybodien@mgh.harvard.edu).

The TRACK-TBI Investigators: Ramon Diaz-Arrastia, MD, PhD, University of Pennsylvania; Pratik Mukherjee, MD, PhD, University of California, San Francisco; David Okonkwo, MD, PhD, University of Pittsburgh; and Claudia Robertson, MD, Baylor College of Medicine.

The authors thank the examiners at all TRACK-TBI sites who contributed their experience and knowledge to the observations and recommendations described in this article. The authors are particularly grateful to the patients and families who participated in the TRACK-TBI initiative.

This study was supported by the National Institute of Neurological Disorders and Stroke (grant no. U0-1NS086090) and the Department of Defense (grant no. DoD W81XWH-14-2-0176). The TRACK-TBI and TED initiatives also receive key support from One Mind and more than 25 industry and philanthropic partners.

Y.B.: US Department of Defense, James S. McDonnell Foundation; M.M.: US Department of Defense, National Collegiate Athletic Association, National Football League; S.D.: none; N.T.: National Institutes of Health (NIH), US Department of Defense, K.B.: none; J.M.: none; S.T.: None; M.S.: National Institute on Disability, Independent Living, and Rehabilitation Research, NIH; H.L.: CDMRP W8IXWH-13, TBI Endpoints Development, R21 NS086714, VA Merit Review B1320-I, and VA/DoD Chronic Effects of Neurotrauma; J.K.: none; J.C.: none; T.M.: none; J.W.: none; G.M.: Department of Defense, NIH, and other support from One Mind, Palantir, and Johnson & Johnson Family of Companies/DePuy Synthes/Codman Neuro; J.G.: NIH, US Department of Defense. 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..

The authors declare no conflicts of interest.

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