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Observational Study
. 2021 Aug 1;78(8):982-992.
doi: 10.1001/jamaneurol.2021.2043.

Functional Outcomes Over the First Year After Moderate to Severe Traumatic Brain Injury in the Prospective, Longitudinal TRACK-TBI Study

Michael A McCrea  1 , Joseph T Giacino  2   3   4 , Jason Barber  5 , Nancy R Temkin  5 , Lindsay D Nelson  1 , Harvey S Levin  6 , Sureyya Dikmen  5 , Murray Stein  7 , Yelena G Bodien  2   3   4 , Kim Boase  5 , Sabrina R Taylor  8 , Mary Vassar  8 , Pratik Mukherjee  8 , Claudia Robertson  6 , Ramon Diaz-Arrastia  9 , David O Okonkwo  10 , Amy J Markowitz  8 , Geoffrey T Manley  8 ; TRACK-TBI Investigators; Opeolu Adeoye  11 , Neeraj Badjatia  12 , M Ross Bullock  13 , Randall Chesnut  14 , John D Corrigan  15 , Karen Crawford  16 , Ann-Christine Duhaime  17 , Richard Ellenbogen  14 , V Ramana Feeser  18 , Adam R Ferguson  19 , Brandon Foreman  11 , Raquel Gardner  19 , Etienne Gaudette  16 , Dana Goldman  16 , Luis Gonzalez  20 , Shankar Gopinath  21 , Rao Gullapalli  12 , J Claude Hemphill  19 , Gillian Hotz  13 , Sonia Jain  22 , C Dirk Keene  14 , Frederick K Korley  23 , Joel Kramer  19 , Natalie Kreitzer  11 , Chris Lindsell  24 , Joan Machamer  14 , Christopher Madden  25 , Alastair Martin  19 , Thomas McAllister  26 , Randall Merchant  18 , Laura B Ngwenya  11 , Florence Noel  21 , Amber Nolan  19 , Eva Palacios  19 , Daniel Perl  27 , Ava Puccio  28 , Miri Rabinowitz  28 , Jonathan Rosand  29 , Angelle Sander  21 , Gabriella Satris  19 , David Schnyer  30 , Seth Seabury  16 , Mark Sherer  20 , Arthur Toga  16 , Alex Valadka  18 , Kevin Wang  31 , John K Yue  19 , Esther Yuh  19 , Ross Zafonte  32
Affiliations
Observational Study

Functional Outcomes Over the First Year After Moderate to Severe Traumatic Brain Injury in the Prospective, Longitudinal TRACK-TBI Study

Michael A McCrea et al. JAMA Neurol. .

Abstract

Importance: Moderate to severe traumatic brain injury (msTBI) is a major cause of death and disability in the US and worldwide. Few studies have enabled prospective, longitudinal outcome data collection from the acute to chronic phases of recovery after msTBI.

Objective: To prospectively assess outcomes in major areas of life function at 2 weeks and 3, 6, and 12 months after msTBI.

Design, setting, and participants: This cohort study, as part of the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, was conducted at 18 level 1 trauma centers in the US from February 2014 to August 2018 and prospectively assessed longitudinal outcomes, with follow-up to 12 months postinjury. Participants were patients with msTBI (Glasgow Coma Scale scores 3-12) extracted from a larger group of patients with mild, moderate, or severe TBI who were enrolled in TRACK-TBI. Data analysis took place from October 2019 to April 2021.

Exposures: Moderate or severe TBI.

Main outcomes and measures: The Glasgow Outcome Scale-Extended (GOSE) and Disability Rating Scale (DRS) were used to assess global functional status 2 weeks and 3, 6, and 12 months postinjury. Scores on the GOSE were dichotomized to determine favorable (scores 4-8) vs unfavorable (scores 1-3) outcomes. Neurocognitive testing and patient reported outcomes at 12 months postinjury were analyzed.

Results: A total of 484 eligible patients were included from the 2679 individuals in the TRACK-TBI study. Participants with severe TBI (n = 362; 283 men [78.2%]; median [interquartile range] age, 35.5 [25-53] years) and moderate TBI (n = 122; 98 men [80.3%]; median [interquartile range] age, 38 [25-53] years) were comparable on demographic and premorbid variables. At 2 weeks postinjury, 36 of 290 participants with severe TBI (12.4%) and 38 of 93 participants with moderate TBI (41%) had favorable outcomes (GOSE scores 4-8); 301 of 322 in the severe TBI group (93.5%) and 81 of 103 in the moderate TBI group (78.6%) had moderate disability or worse on the DRS (total score ≥4). By 12 months postinjury, 142 of 271 with severe TBI (52.4%) and 54 of 72 with moderate TBI (75%) achieved favorable outcomes. Nearly 1 in 5 participants with severe TBI (52 of 270 [19.3%]) and 1 in 3 with moderate TBI (23 of 71 [32%]) reported no disability (DRS score 0) at 12 months. Among participants in a vegetative state at 2 weeks, 62 of 79 (78%) regained consciousness and 14 of 56 with available data (25%) regained orientation by 12 months.

Conclusions and relevance: In this study, patients with msTBI frequently demonstrated major functional gains, including recovery of independence, between 2 weeks and 12 months postinjury. Severe impairment in the short term did not portend poor outcomes in a substantial minority of patients with msTBI. When discussing prognosis during the first 2 weeks after injury, clinicians should be particularly cautious about making early, definitive prognostic statements suggesting poor outcomes and withdrawal of life-sustaining treatment in patients with msTBI.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr McCrea reported grants from the National Institutes of Health during the conduct of the study and grants from the National Institutes of Health, Department of Defense, US Centers for Disease Control and Prevention, National Collegiate Athletics Association, and the National Football League outside the submitted work. Dr Giacino reported grants from National Institute on Disability, Independent Living, and Rehabilitation Research (grant 90DPTB0011) and the National Football League during the conduct of the study. Dr Temkin reported grants from the US federal government during the conduct of the study. Dr Nelson reported grants from National Institutes of Health during the conduct of the study and grants from National Institute of Neurological Disorders and Stroke Grant funding, Department of Defense, Advancing a Healthier Wisconsin (Endowment Grant), and the US Centers for Disease Control and Prevention outside the submitted work. Dr Dikmen reported grants from the US federal government during the conduct of the study. Dr Stein reported biopharmaceutical stock options from Oxeia outside the submitted work. Dr Bodien reported grants from the National Institute of Neurological Disorders and Stroke and grants from the National Institute on Disability, Independent Living, and Rehabilitation Research during the conduct of the study. Dr Boase reported grants from the US federal government during the conduct of the study and outside the submitted work. Dr Robertson reported grants from the National Institutes of Health during the conduct of the study. Dr Diaz-Arrastia reported grants from the National Institutes of Health and the Department of Defense during the conduct of the study; stock options from BrainBox Solutions; personal fees from Pinteon Therapeutics, MesoScale Discoveries, and Ischemix; and nonfinancial support from Quanterix outside the submitted work. Dr Manley reported grants and a contract from the US Department of Defense (grants W81XWH-14-2-0176 and W81XWH-18-2-0042 and contract W81XWH-15-9-0001), grants from National Institute of Neurological Disorders and Stroke (grant U01NS086090), support for a precision medicine collaboration from the US Department of Energy, funding for stipends for patients in the TRACK-TBI study and support to clinical sites from One Mind, and support for TRACK-TBI data curation efforts from NeuroTrauma Sciences LLC during the conduct of the study. Ms Markowitz reported grants from the US Department of Defense (grant W81XWH-14-2-0176), a contract with the US Department of Defense (contract W81XWH-15-9-0001), and personal fees from One Mind during the conduct of the study. Dr Adeoye reported being a founder and equity holder from Sense Diagnostics Inc outside the submitted work; in addition, Dr Adeoye has a patent for US13/977,689 issued for Sense Diagnostics work. Dr Corrigan reported grants from Ohio State University during the conduct of the study. Dr Duhaime reported grants from the National Institutes of Health during the conduct of the study. Dr Ferguson reported grants from the National Institutes of Health (NS106899 and NS088475), Department of Veterans Affairs (grants I01RX002245 and I01RX002787), Department of Defense (grant W81XWH-14-2-0176), DARPA (grant N660012024046), Department of Energy, Wings for Life Foundation, and the Craig H. Nielson Foundation during the conduct of the study. Dr Foreman reported personal fees for speaking and consulting from UCB Pharma Inc; grants from the National Institutes of Health, Department of Defense, and National Science Foundation; and personal fees for consulting from Minnetronix Inc outside the submitted work. Dr Goldman reported grants from the National Institute of Neurological Disorders and Stroke (grant U01NS086090) during the conduct of the study; personal fees for advisory board participation from Biogen, Grail, Acadia Pharmaceuticals, and Precision Medicine Group outside the submitted work. Dr Lindsell reported grants from the National Institutes of Health during the conduct of the study; grants from the National Institutes of Health, US Centers for Disease Control and Prevention, Department of Defense, and Marcus Foundation; research contracts to his institution from Entegrion Inc, Endpoint Health, and bioMerieux; stock options from Bioscape Digital; and a patent for risk stratification in pediatric septic shock issued to Cincinnati Children's Hospital Medical Center, outside the submitted work. Dr Machamer reported grants from the US federal government during the conduct of the study. Dr Madden reported grants from the National Institutes of Health during the conduct of the study. Dr McAllister reported grants (a research subaward for Indiana University School of Medicine for TRACK-TBI) from University of California, San Francisco, during the conduct of the study. Dr Rosand reported grants from the National Institutes of Health and One Mind for Research during the conduct of the study and consulting fees from Boehringer Ingelheim. Dr Sander reported grants from the National Institutes of Health during the conduct of the study. Dr Schnyer reported grants from the National Institutes of Health during the conduct of the study. Dr Sherer reported grants from the National Institute of Neurological Disorders and Stroke during the conduct of the study. Dr Toga reported grants from the National Institutes of Health during the conduct of the study. Dr Yuh reported grants from the National Institutes of Health and the Department of Defense during the conduct of the study. Dr Zafonte reported receiving royalties for the textbook Brain Injury Medicine from Springer/Demos and serves on scientific advisory boards for Biodirection, ElMinda, Oxeia Biopharma, and Myomo. Abbott Laboratories provides research support to the TRACK-TBI Network under a collaborative research agreement for an unrelated study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Glasgow Outcome Scale–Extended (GOSE) Total Score Distribution for Patients With Severe Traumatic Brain Injury at 2 Weeks and 3, 6, and 12 Months Postinjury
Table 2 indicates 1 participant from the severe traumatic brain injury group (0.3%) was in a vegetative state (GOSE score, 2) at 12 months postinjury.
Figure 2.
Figure 2.. Glasgow Outcome Scale–Extended (GOSE) Total Score Distribution for Patients With Moderate Traumatic Brain Injury at 2 Weeks and 3, 6, and 12 Months Postinjury
Figure 3.
Figure 3.. Disability Rating Scale (DRS) Total Score Distribution for Patients With Moderate or Severe Traumatic Brain Injury at 2 Weeks and 3, 6, and 12 Months Postinjury
Numbers in parentheses in the key indicate DRS score ranges.
See this image and copyright information in PMC

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