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1. Feasibility and Utility of a Flexible Outcome Assessment Battery for Longitudinal Traumatic Brain Injury Research: A TRACK-TBI Study.

Author

Bodien, Yelena, Barber, Jason, Taylor, Sabrina, Boase, Kim, Corrigan, John, Dikmen, Sureyya, Gardner, Raquel, Kramer, Joel, Levin, Harvey, Machamer, Joan, McAllister, Thomas, Nelson, Lindsay, Ngwenya, Laura, Sherer, Mark, Stein, Murray, Vassar, Mary, Whyte, John, Temkin, Nancy, Giacino, Joseph, Markowitz, Amy, McCrea, Michael, Manley, Geoff, and Yue, John

Subjects
assessment, feasibility, outcome assessment, traumatic brain injury, Humans, Longitudinal Studies, Feasibility Studies, Brain Injuries, Traumatic, Outcome Assessment, Health Care, Glasgow Outcome Scale
Abstract

The effects of traumatic brain injury (TBI) are difficult to measure in longitudinal cohort studies, because disparate pre-injury characteristics and injury mechanisms produce variable impairment profiles and recovery trajectories. In preparation for the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, which followed patients with injuries ranging from uncomplicated mild TBI to coma, we designed a multi-dimensional Flexible outcome Assessment Battery (FAB). The FAB relies on a decision-making algorithm that assigns participants to a Comprehensive (CAB) or Abbreviated Assessment Battery (AAB) and guides test selection across all phases of recovery. To assess feasibility of the FAB, we calculated the proportion of participants followed at 2 weeks (2w) and at 3, 6, and 12 months (3m, 6m, 12m) post-injury who completed the FAB and received valid scores. We evaluated utility of the FAB by examining differences in 6m and 12m Glasgow Outcome Scale-Extended (GOSE) scores between participant subgroups derived from the FAB-enabled versus traditional approach to outcome assessment applied at 2w. Among participants followed at 2w (n = 2094), 3m (n = 1871), 6m (n = 1736), and 12m (n = 1607) post-injury, 95-99% received valid completion scores on the FAB, in full or in part, either in person or by telephone. Level of function assessed by the FAB-enabled approach at 2w was associated with 6m and 12m GOSE scores (proportional odds p

Published
2023

2. Genetic vulnerability and adverse mental health outcomes following mild traumatic brain injury: a meta-analysis of CENTER-TBI and TRACK-TBI cohorts

Author

Ackerlund, Cecilia, Adams, Hadie, Amrein, Krisztina, Andelic, Nada, Andreassen, Lasse, Anke, Audny, Antoni, Anna, Audibert, Gérard, Azouvi, Philippe, Azzolini, Maria Luisa, Bartels, Ronald, Barzó, Pál, Beauvais, Romuald, Beer, Ronny, Bellander, Bo-Michael, Belli, Antonio, Benali, Habib, Berardino, Maurizio, Beretta, Luigi, Blaabjerg, Morten, Bragge, Peter, Brazinova, Alexandra, Brinck, Vibeke, Brooker, Joanne, Brorsson, Camilla, Buki, Andras, Bullinger, Monika, Cabeleira, Manuel, Caccioppola, Alessio, Calappi, Emiliana, Calvi, Maria Rosa, Cameron, Peter, Lozano, Guillermo Carbayo, Carbonara, Marco, Castaño-León, Ana M., Cavallo, Simona, Chevallard, Giorgio, Chieregato, Arturo, Citerio, Giuseppe, Clusmann, Hans, Coburn, Mark Steven, Coles, Jonathan, Cooper, Jamie D., Correia, Marta, Čović, Amra, Curry, Nicola, Czeiter, Endre, Czosnyka, Marek, Dahyot-Fizelier, Claire, Dark, Paul, Dawes, Helen, De Keyser, Véronique, Degos, Vincent, Della Corte, Francesco, Boogert, Hugo den, Depreitere, Bart, Đilvesi, Đula, Dixit, Abhishek, Donoghue, Emma, Dreier, Jens, Dulière, Guy-Loup, Ercole, Ari, Esser, Patrick, Ezer, Erzsébet, Fabricius, Martin, Feigin, Valery L., Foks, Kelly, Frisvold, Shirin, Furmanov, Alex, Gagliardo, Pablo, Galanaud, Damien, Gantner, Dashiell, Gao, Guoyi, George, Pradeep, Ghuysen, Alexandre, Giga, Lelde, Glocker, Ben, Golubović, Jagoš, Gomez, Pedro A., Gratz, Johannes, Gravesteijn, Benjamin, Grossi, Francesca, Gruen, Russell L., Gupta, Deepak, Haagsma, Juanita A., Haitsma, Iain, Helbok, Raimund, Helseth, Eirik, Horton, Lindsay, Huijben, Jilske, Hutchinson, Peter J., Jacobs, Bram, Jankowski, Stefan, Jarrett, Mike, Jiang, Ji-yao, Johnson, Faye, Jones, Kelly, Karan, Mladen, Kolias, Angelos G., Kompanje, Erwin, Kondziella, Daniel, Koskinen, Lars-Owe, Kovács, Noémi, Kowark, Ana, Lagares, Alfonso, Lanyon, Linda, Laureys, Steven, Lecky, Fiona, Ledoux, Didier, Lefering, Rolf, Legrand, Valerie, Lejeune, Aurelie, Levi, Leon, Lightfoot, Roger, Lingsma, Hester, Maegele, Marc, Majdan, Marek, Manara, Alex, Maréchal, Hugues, Martino, Costanza, Mattern, Julia, McFadyen, Charles, McMahon, Catherine, Melegh, Béla, Menovsky, Tomas, Mikolic, Ana, Misset, Benoit, Muraleedharan, Visakh, Murray, Lynnette, Negru, Ancuta, Nelson, David, Newcombe, Virginia, Nieboer, Daan, Nyirádi, József, Oresic, Matej, Ortolano, Fabrizio, Otesile, Olubukola, Parizel, Paul M., Payen, Jean-François, Perera, Natascha, Perlbarg, Vincent, Persona, Paolo, Peul, Wilco, Piippo-Karjalainen, Anna, Pirinen, Matti, Pisica, Dana, Ples, Horia, Polinder, Suzanne, Pomposo, Inigo, Posti, Jussi P., Puybasset, Louis, Rădoi, Andreea, Ragauskas, Arminas, Raj, Rahul, Rambadagalla, Malinka, Rehorčíková, Veronika, Helmrich, Isabel Retel, Rhodes, Jonathan, Richter, Sophie, Rocka, Saulius, Roe, Cecilie, Roise, Olav, Rosenfeld, Jeffrey, Rosenlund, Christina, Rosenthal, Guy, Rossaint, Rolf, Rossi, Sandra, Rueckert, Daniel, Rusnák, Martin, Sahuquillo, Juan, Sakowitz, Oliver, Sanchez-Porras, Renan, Sandor, Janos, Schäfer, Nadine, Schmidt, Silke, Schoechl, Herbert, Schoonman, Guus, Schou, Rico Frederik, Schwendenwein, Elisabeth, Sewalt, Charlie, Singh, Ranjit D., Skandsen, Toril, Smielewski, Peter, Sorinola, Abayomi, Stamatakis, Emmanuel, Stanworth, Simon, Stevens, Robert, Stewart, William, Stocchetti, Nino, Sundström, Nina, Takala, Riikka, Tamás, Viktória, Tamosuitis, Tomas, Taylor, Mark Steven, Te Ao, Braden, Tenovuo, Olli, Theadom, Alice, Thibaut, Aurore, Thomas, Matt, Tibboel, Dick, Timmers, Marjolijn, Tolias, Christos, Trapani, Tony, Tudora, Cristina Maria, Unterberg, Andreas, Vajkoczy, Peter, Valeinis, Egils, Vallance, Shirley, Vámos, Zoltán, van der Jagt, Mathieu, van der Naalt, Joukje, Van der Steen, Gregory, van Dijck, Jeroen T.J.M., van Erp, Inge A., van Essen, Thomas A., Van Hecke, Wim, van Heugten, Caroline, Van Praag, Dominique, van Veen, Ernest, van Wijk, Roel, Vyvere, Thijs Vande, Vargiolu, Alessia, Vega, Emmanuel, Velt, Kimberley, Verheyden, Jan, Vespa, Paul M., Vik, Anne, Vilcinis, Rimantas, Volovici, Victor, von Steinbüchel, Nicole, Voormolen, Daphne, Vulekovic, Peter, Whitehouse, Daniel, Wiegers, Eveline, Williams, Guy, Wolf, Stefan, Yang, Zhihui, Ylén, Peter, Younsi, Alexander, Zeiler, Frederick A., Ziverte, Agate, Zoerle, Tommaso, Adeoye, Opeolu, Badjatia, Neeraj, Barber, Jason, Bergin, Michael, Boase, Kim, Bodien, Yelena, Chesnut, Randall, Corrigan, John, Crawford, Karen, Diaz-Arrastia, Ramon, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, Venkata, Ferguson, Adam R., Foreman, Brandon, Gaudette, Etienne, Giacino, Joseph, Gonzalez, Luis, Gopinath, Shankar, Grandhi, Ramesh, Gullapalli, Rao, Hemphill, Claude, Hotz, Gillian, Huie, Russell, Jha, Ruchira, Keene, Dirk C., Kitagawa, Ryan, Korley, Frederick, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Martin, Alastair, McAllister, Thomas, McCrea, Michael, Merchant, Randall, Mukherjee, Pratik, Nelson, Lindsay, Ngwenya, Laura B., Noel, Florence, Nolan, Amber, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Ben Rodgers, Richard, Rosenthal, Eric, Sander, Angelle, Sandsmark, Danielle, Schneider, Andrea, Schnyer, David, Seabury, Seth, Sherer, Mark, Sugar, Gabriella, Temkin, Nancy, Toga, Arthur, Torres-Espin, Abel, Valadka, Alex, Vassar, Mary, Wang, Kevin, Wang, Vincent, Yue, John K., Yuh, Esther, Zafonte, Ross, Kals, Mart, Wilson, Lindsay, Levey, Daniel F., Parodi, Livia, Steyerberg, Ewout W., Richardson, Sylvia, He, Feng, Sun, Xiaoying, Jain, Sonia, Palotie, Aarno, Ripatti, Samuli, Rosand, Jonathan, Manley, Geoff T., Maas, Andrew I.R., Stein, Murray B., and Menon, David K.

Published
2024
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4. Diffusion Tensor Imaging Reveals Elevated Diffusivity of White Matter Microstructure that Is Independently Associated with Long-Term Outcome after Mild Traumatic Brain Injury: A TRACK-TBI Study

Author

Palacios, Eva M, Yuh, Esther L, Donald, Christine L Mac, Bourla, Ioanna, Wren-Jarvis, Jamie, Sun, Xiaoying, Vassar, Mary J, Diaz-Arrastia, Ramon, Giacino, Joseph T, Okonkwo, David O, Robertson, Claudia S, Stein, Murray B, Temkin, Nancy, McCrea, Michael A, Levin, Harvey S, Markowitz, Amy J, Jain, Sonia, Manley, Geoffrey T, Mukherjee, Pratik, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Barber, Jason, Bodien, Yelena, Bullock, M Ross, Chesnut, Randall, Corrigan, John D, Crawford, Karen, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, V Ramana, Ferguson, Adam R, Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Goldman, Dana, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, J Claude, Hotz, Gillian, Keene, C Dirk, Korley, Frederick K, Kramer, Joel, Kreitzer, Natalie, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Martin, Alastair, McAllister, Thomas, Merchant, Randall, Nelson, Lindsay, Ngwenya, Laura B, Noel, Florence, Nolan, Amber, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Seabury, Seth, Sherer, Mark, Taylor, Sabrina, Toga, Arthur, Valadka, Alex, Vespa, Paul, Wang, Kevin, Yue, John K, and Zafonte, Ross

Subjects
Traumatic Head and Spine Injury, Neurosciences, Clinical Research, Traumatic Brain Injury (TBI), Physical Injury - Accidents and Adverse Effects, Brain Disorders, Biomedical Imaging, Injuries and accidents, Neurological, Adolescent, Adult, Brain, Brain Concussion, Brain Injuries, Traumatic, Cohort Studies, Diffusion Magnetic Resonance Imaging, Diffusion Tensor Imaging, Humans, Middle Aged, White Matter, Young Adult, concussion, diffusion tensor imaging, Glasgow Outcome Scale, MRI, traumatic brain injury, TRACK-TBI Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

Diffusion tensor imaging (DTI) literature on single-center studies contains conflicting results regarding acute effects of mild traumatic brain injury (mTBI) on white matter (WM) microstructure and the prognostic significance. This larger-scale multi-center DTI study aimed to determine how acute mTBI affects WM microstructure over time and how early WM changes affect long-term outcome. From Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), a cohort study at 11 United States level 1 trauma centers, a total of 391 patients with acute mTBI ages 17 to 60 years were included and studied at two weeks and six months post-injury. Demographically matched friends or family of the participants were the control group (n = 148). Axial diffusivity (AD), fractional anisotropy (FA), mean diffusivity (MD), and radial diffusivity (RD) were the measures of WM microstructure. The primary outcome was the Glasgow Outcome Scale Extended (GOSE) score of injury-related functional limitations across broad life domains at six months post-injury. The AD, MD, and RD were higher and FA was lower in mTBI versus friend control (FC) at both two weeks and six months post-injury throughout most major WM tracts of the cerebral hemispheres. In the mTBI group, AD and, to a lesser extent, MD decreased in WM from two weeks to six months post-injury. At two weeks post-injury, global WM AD and MD were both independently associated with six-month incomplete recovery (GOSE

Published
2022

5. Comparing the Quality of Life after Brain Injury-Overall Scale and Satisfaction with Life Scale as Outcome Measures for Traumatic Brain Injury Research

Author

Kreitzer, Natalie, Jain, Sonia, Young, Jacob S, Sun, Xiaoying, Stein, Murray B, McCrea, Michael A, Levin, Harvey S, Giacino, Joseph T, Markowitz, Amy J, Manley, Geoffrey T, Nelson, Lindsay D, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Barber, Jason, Bodien, Yelena, Bullock, M Ross, Corrigan, John D, Crawford, Karen, Diaz-Arrastia, Ramon, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, V Ramana, Ferguson, Adam R, Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Goldman, Dana, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, J Claude, Hotz, Gillian, Keene, C Dirk, Korley, Frederick K, Kramer, Joel, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Martin, Alastair, McAllister, Thomas, Merchant, Randall, Mukherjee, Pratik, Ngwenya, Laura B, Noel, Florence, Nolan, Amber, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Seabury, Seth, Sherer, Mark, Taylor, Sabrina, Temkin, Nancy, Toga, Arthur, Valadka, Alex, Vassar, Mary, Wang, Kevin, Yue, John K, Yuh, Esther, and Zafonte, Ross

Subjects
Pediatric, Traumatic Head and Spine Injury, Clinical Research, Physical Injury - Accidents and Adverse Effects, Traumatic Brain Injury (TBI), Neurosciences, Brain Disorders, Childhood Injury, Injuries and accidents, Adult, Brain Injuries, Traumatic, Female, Humans, Male, Outcome Assessment, Health Care, Patient Acuity, Personal Satisfaction, Psychometrics, Quality of Life, common data elements, friend controls, Glasgow Coma Scale, health related quality of life, orthopedic trauma controls, Quality of Life after Brain Injury Overall Score, Satisfaction with Life Survey, traumatic brain injury, Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

It is important to measure quality of life (QoL) after traumatic brain injury (TBI), yet limited studies have compared QoL inventories. In 2579 TBI patients, orthopedic trauma controls, and healthy friend control participants, we compared the Quality of Life After Brain Injury-Overall Scale (QOLIBRI-OS), developed for TBI patients, to the Satisfaction with Life Scale (SWLS), an index of generic life satisfaction. We tested the hypothesis that group differences (TBI and orthopedic trauma vs. healthy friend controls) would be larger for the QOLIBRI-OS than the SWLS and that the QOLIBRI-OS would manifest more substantial changes over time in the injured groups, demonstrating more relevance of the QOLIBRI-OS to traumatic injury recovery. (1) We compared the group differences (TBI vs. orthopedic trauma control vs. friend control) in QoL as indexed by the SWLS versus the QOLIBRI-OS and (2) characterized changes across time in these two inventories across 1 year in these three groups. Our secondary objective was to characterize the relationship between TBI severity and QoL. As compared with healthy friend controls, the QOLIBRI reflected greater reductions in QoL than the SWLS for both the TBI group (all time points) and the orthopedic trauma control group (2 weeks and 3 months). The QOLIBRI-OS better captured expected improvements in QoL during the injury recovery course in injured groups than the SWLS, which demonstrated smaller changes over time. TBI severity was not consistently or robustly associated with self-reported QoL. The findings imply that, as compared with the SWLS, the QOLIBRI-OS appears to identify QoL issues more specifically relevant to traumatically injured patients and may be a more appropriate primary QoL outcome measure for research focused on the sequelae of traumatic injuries.

Published
2021

6. Statistical Guidelines for Handling Missing Data in Traumatic Brain Injury Clinical Research

Author

Nielson, Jessica L, Cooper, Shelly R, Seabury, Seth A, Luciani, Davide, Fabio, Anthony, Temkin, Nancy R, Ferguson, Adam R, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Bodien, Yelena, Bullock, M Ross, Chesnut, Randall, Corrigan, John D, Crawford, Karen, Diaz-Arrastia, Ramon, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, V Ramana, Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Giacino, Joseph, Goldman, Dana, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, J Claude, Hotz, Gillian, Jain, Sonia, Korley, Frederick K, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Manley, Geoffrey T, Martin, Alastair, McAllister, Thomas, McCrea, Michael, Merchant, Randall, Mukherjee, Pratik, Nelson, Lindsay, Ngwenya, Laura B, Noel, Florence, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Sherer, Mark, Stein, Murray, Taylor, Sabrina, Toga, Arthur, Valadka, Alex, Vassar, Mary, Vespa, Paul, Wang, Kevin, Yue, John K, Yuh, Esther, and Zafonte, Ross

Subjects
Traumatic Head and Spine Injury, Neurosciences, Brain Disorders, Clinical Research, Traumatic Brain Injury (TBI), Clinical Trials and Supportive Activities, Physical Injury - Accidents and Adverse Effects, Neurological, Injuries and accidents, Good Health and Well Being, Brain Injuries, Traumatic, Child, Data Interpretation, Statistical, Databases, Factual, Guidelines as Topic, Humans, assessment tools, missing data, statistical guidelines, TBI, TRACK-TBI Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

Missing data is a persistent and unavoidable problem in even the most carefully designed traumatic brain injury (TBI) clinical research. Missing data patterns may result from participant dropout, non-compliance, technical issues, or even death. This review describes the types of missing data that are common in TBI research, and assesses the strengths and weaknesses of the statistical approaches used to draw conclusions and make clinical decisions from these data. We review recent innovations in missing values analysis (MVA), a relatively new branch of statistics, as applied to clinical TBI data. Our discussion focuses on studies from the International Traumatic Brain Injury Research (InTBIR) initiative project: Transforming Research and Clinical Knowledge in TBI (TRACK-TBI), Collaborative Research on Acute TBI in Intensive Care Medicine in Europe (CREACTIVE), and Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT). In addition, using data from the TRACK-TBI pilot study (n = 586) and the completed clinical trial assessing valproate (VPA) for the treatment of post-traumatic epilepsy (n = 379) we present real-world examples of typical missing data patterns and the application of statistical techniques to mitigate the impact of missing data in order to draw sound conclusions from ongoing clinical studies.

Published
2021

7. Central Curation of Glasgow Outcome Scale-Extended Data: Lessons Learned from TRACK-TBI

Author

Boase, Kim, Machamer, Joan, Temkin, Nancy R, Dikmen, Sureyya, Wilson, Lindsay, Nelson, Lindsay D, Barber, Jason, Bodien, Yelena G, Giacino, Joseph T, Markowitz, Amy J, McCrea, Michael A, Satris, Gabriela, Stein, Murray B, Taylor, Sabrina R, Manley, Geoffrey T, Adeoye, Opeolu, Bullock, M Ross, Corrigan, John D, Diaz-Arrastia, Ramon, Ellenbogen, Richard, Feeser, V Ramana, Ferguson, Adam R, Gardner, Raquel, Goldman, Dana, Gopinath, Shankar, Hemphill, J Claude, Keene, C Dirk, Korley, Frederick K, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Madden, Christopher, Martin, Alastair, McAllister, Thomas, Merchant, Randall, Mukherjee, Pratik, Ngwenya, Laura B, Noel, Florence, Nolan, Amber, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Schnyer, David, Seabury, Seth, Sherer, Mark, Toga, Arthur, Valadka, Alex, Vassar, Mary, MS, RN, Vespa, Paul, Wang, Kevin, Yue, John K, Yuh, Esther, and Zafonte, Ross

Subjects
Traumatic Head and Spine Injury, Traumatic Brain Injury (TBI), Neurosciences, Physical Injury - Accidents and Adverse Effects, Brain Disorders, Quality Education, Adult, Brain Injuries, Traumatic, Disability Evaluation, Female, Functional Status, Glasgow Outcome Scale, Humans, Longitudinal Studies, Male, Middle Aged, Outcome Assessment, Health Care, Recovery of Function, Reproducibility of Results, United States, Young Adult, central review, clinical outcome assessments, data curation, GOSE, traumatic brain injury, TRACK-TBI Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

The Glasgow Outcome Scale (GOS) in its original or extended (GOSE) form is the most widely used assessment of global disability in traumatic brain injury (TBI) research. Several publications have reported concerns about assessor scoring inconsistencies, but without documentation of contributing factors. We reviewed 6801 GOSE assessments collected longitudinally, across 18 sites in the 5-year, observational Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study. We recorded error rates (i.e., corrections to a section or an overall rating) based on site assessor documentation and categorized scoring issues, which then informed further training. In cohort 1 (n = 1261; February 2014 to May 2016), 24% of GOSEs had errors identified by central review. In cohort 2 (n = 1130; June 2016 to July 2018), acquired after curation of cohort 1 data, feedback, and further training of site assessors, the error rate was reduced to 10%. GOSE sections associated with the most frequent interpretation and scoring difficulties included whether current functioning represented a change from pre-injury (466 corrected ratings in cohort 1; 62 in cohort 2), defining dependency in the home and community (163 corrections in cohort 1; three in cohort 2) and return to work/school (72 corrections in cohort 1; 35 in cohort 2). These results highlight the importance of central review in improving consistency across sites and over time. Establishing clear scoring criteria, coupled with ongoing guidance and feedback to data collectors, is essential to avoid scoring errors and resultant misclassification, which carry potential to result in "failure" of clinical trials that rely on the GOSE as their primary outcome measure.

Published
2021

8. Invariance of the Bifactor Structure of Mild Traumatic Brain Injury (mTBI) Symptoms on the Rivermead Postconcussion Symptoms Questionnaire Across Time, Demographic Characteristics, and Clinical Groups: A TRACK-TBI Study

Author

Agtarap, Stephanie, Kramer, Mark D, Campbell-Sills, Laura, Yuh, Esther, Mukherjee, Pratik, Manley, Geoffrey T, McCrea, Michael A, Dikmen, Sureyya, Giacino, Joseph T, Stein, Murray B, Nelson, Lindsay D, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Bodien, Yelena, Bullock, M Ross, Chesnut, Randall, Corrigan, John D, Crawford, Karen, Diaz-Arrastia, Ramon, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, V Ramana, Ferguson, Adam R, Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Goldman, Dana, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, J Claude, Hotz, Gillian, Jain, Sonia, Korley, Frederick K, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Martin, Alastair, McAllister, Thomas, Merchant, Randall, Ngwenya, Laura B, Noel, Florence, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Seabury, Seth, Sherer, Mark, Taylor, Sabrina, Temkin, Nancy, Toga, Arthur, Valadka, Alex, Vassar, Mary, Vespa, Paul, Wang, Kevin, Yue, John K, and Zafonte, Ross

Subjects
Neurosciences, Traumatic Head and Spine Injury, Traumatic Brain Injury (TBI), Clinical Research, Brain Disorders, Physical Injury - Accidents and Adverse Effects, Brain Concussion, Demography, Emotions, Humans, Surveys and Questionnaires, mild TBI, bifactor, invariance, postconcussive symptoms, Rivermead Postconcussion Symptoms Questionnaire, traumatic brain injury, TRACK-TBI Investigators *, Psychology, Clinical Psychology
Abstract

This study aimed to elucidate the structure of the Rivermead Postconcussion Symptoms Questionnaire (RPQ) and evaluate its longitudinal and group variance. Factor structures were developed and compared in 1,011 patients with mild traumatic brain injury (mTBI; i.e., Glasgow Coma Scale score 13-15) from the Transforming Research and Clinical Knowledge in TBI study, using RPQ data collected at 2 weeks, and 3, 6, and 12 months postinjury. A bifactor model specifying a general factor and emotional, cognitive, and visual symptom factors best represented the latent structure of the RPQ. The model evinced strict measurement invariance over time and across sex, age, race, psychiatric history, and mTBI severity groups, indicating that differences in symptom endorsement were completely accounted for by these latent dimensions. While highly unidimensional, the RPQ has multidimensional features observable through a bifactor model, which may help differentiate symptom expression patterns in the future.

Published
2021

9. Tractography-Pathology Correlations in Traumatic Brain Injury: A TRACK-TBI Study

Author

Nolan, Amber L, Petersen, Cathrine, Iacono, Diego, Mac Donald, Christine L, Mukherjee, Pratik, van der Kouwe, Andre, Jain, Sonia, Stevens, Allison, Diamond, Bram R, Wang, Ruopeng, Markowitz, Amy J, Fischl, Bruce, Perl, Daniel P, Manley, Geoffrey T, Keene, C Dirk, Diaz-Arrastia, Ramon, Edlow, Brian L, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Barber, Jason, Bodien, Yelena, Bullock, M Ross, Chesnut, Randall, Corrigan, John D, Crawford, Karen, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, V Ramana, Ferguson, Adam R, Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Giacino, Joseph, Goldman, Dana, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, J Claude, Hotz, Gillian, Korley, Frederick K, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Martin, Alastair, McAllister, Thomas, McCrea, Michael, Merchant, Randall, Nelson, Lindsay, Ngwenya, Laura B, Noel, Florence, Okonkwo, David, Palacios, Eva, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Seabury, Seth, Sherer, Mark, Stein, Murray, Taylor, Sabrina, Temkin, Nancy, Toga, Arthur, Valadka, Alex, Vassar, Mary, Vespa, Paul, Wang, Kevin, Yue, John K, Yuh, Esther, and Zafonte, Ross

Subjects
Biomedical Imaging, Physical Injury - Accidents and Adverse Effects, Acquired Cognitive Impairment, Neurosciences, Traumatic Brain Injury (TBI), Traumatic Head and Spine Injury, Brain Disorders, Aetiology, 2.1 Biological and endogenous factors, Neurological, Brain Injuries, Traumatic, Connectome, Diffusion Tensor Imaging, Humans, Male, Middle Aged, Neural Pathways, contusion, MRI, neuropathology, tractography, traumatic axonal injury, traumatic brain injury, TRACK-TBI Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

Diffusion tractography magnetic resonance imaging (MRI) can infer changes in network connectivity in patients with traumatic brain injury (TBI), but the pathological substrates of disconnected tracts have not been well defined because of a lack of high-resolution imaging with histopathological validation. We developed an ex vivo MRI protocol to analyze tract terminations at 750-μm isotropic resolution, followed by histopathological evaluation of white matter pathology, and applied these methods to a 60-year-old man who died 26 days after TBI. Analysis of 74 cerebral hemispheric white matter regions revealed a heterogeneous distribution of tract disruptions. Associated histopathology identified variable white matter injury with patchy deposition of amyloid precursor protein (APP), loss of neurofilament-positive axonal processes, myelin dissolution, astrogliosis, microgliosis, and perivascular hemosiderin-laden macrophages. Multiple linear regression revealed that tract disruption strongly correlated with the density of APP-positive axonal swellings and neurofilament loss. Ex vivo diffusion MRI can detect tract disruptions in the human brain that reflect axonal injury.

Published
2021

10. Point-of-Care Platform Blood Biomarker Testing of Glial Fibrillary Acidic Protein versus S100 Calcium-Binding Protein B for Prediction of Traumatic Brain Injuries: A Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study

Author

Okonkwo, David O, Puffer, Ross C, Puccio, Ava M, Yuh, Esther L, Yue, John K, Diaz-Arrastia, Ramon, Korley, Frederick K, Wang, Kevin KW, Sun, Xiaoying, Taylor, Sabrina R, Mukherjee, Pratik, Markowitz, Amy J, Jain, Sonia, Manley, Geoffrey T, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Bodien, Yelena, Bullock, Ross, Chesnut, Randall, Corrigan, John, Crawford, Karen, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, Venkata, Ferguson, Adam R, Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Giacino, Joseph, Goldman, Dana, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, Claude, Hotz, Gillian, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Martin, Alastair, McAllister, Thomas, McCrea, Michael, Merchant, Randall, Nelson, Lindsay, Ngwenya, Laura B, Noel, Florence, Palacios, Eva, Perl, Daniel, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Seabury, Seth, Sherer, Mark, Stein, Murray, Temkin, Nancy, Toga, Arthur, Valadka, Alex, Vassar, Mary, Vespa, Paul, and Zafonte, Ross

Subjects
Brain Disorders, Clinical Research, Physical Injury - Accidents and Adverse Effects, Traumatic Brain Injury (TBI), Traumatic Head and Spine Injury, Neurosciences, Injuries and accidents, Good Health and Well Being, Adult, Aged, Biomarkers, Brain Injuries, Traumatic, Cohort Studies, Female, Glial Fibrillary Acidic Protein, Humans, Male, Middle Aged, Point-of-Care Systems, S100 Calcium Binding Protein beta Subunit, Sensitivity and Specificity, biomarkers, glial fibrillary acidic protein, S100 calcium-binding protein B, traumatic brain injury, Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

Glial fibrillary acidic protein (GFAP) is cleared by the Food and Drug Administration (FDA) to determine need for head computed tomography (CT) within 12 h after mild traumatic brain injury (TBI) (Glasgow Coma Score [GCS] 13-15); S100 calcium-binding protein B (S100B) serves this function in Europe. This phase 1 biomarker cohort analysis of the multi-center, observational Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study compares GFAP's diagnostic performance, measured on a rapid point-of-care platform, against protein S100B to predict intracranial abnormalities on CT within 24 h post-injury across the spectrum of TBI (GCS 3-15). Head CT scan performed in TBI subjects and blood was collected for all consenting subjects presenting to 18 United States level 1 trauma centers. Plasma was analyzed on a point-of-care device prototype assay for GFAP and serum was analyzed for S100B. In 1359 patients with TBI (GCS 3-15), mean (standard deviation [SD]) age = 40.1 (17.0) years; 68% were male. Plasma GFAP levels were significantly higher in CT+ TBI subjects (median = 1358 pg/mL, interquartile range [IQR]: 472-3803) than in CT- TBI subjects (median = 116 pg/mL, IQR: 26-397) or orthopedic trauma controls (n = 122; median = 13 pg/mL, IQR: 7-20), p

Published
2020

11. The Temporal Relationship of Mental Health Problems and Functional Limitations following mTBI: A TRACK-TBI and TED Study

Author

Zahniser, Evan, Nelson, Lindsay D, Dikmen, Sureyya S, Machamer, Joan E, Stein, Murray B, Yuh, Esther, Manley, Geoffrey T, Temkin, Nancy R, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Bodien, Yelena, Ross Bullock, M, Chesnut, Randall, Corrigan, John D, Crawford, Karen, Diaz-Arrastia, Ramon, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, V Ramana, Ferguson, Adam, Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Giacino, Joseph, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Claude Hemphill, J, Hotz, Gillian, Jain, Sonia, Korley, Frederick, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Madden, Christopher, Martin, Alastair, McAllister, Thomas, McCrea, Michael, Merchant, Randall, Mukherjee, Pratik, Noel, Florence, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Seabury, Seth, Sherer, Mark, Taylor, Sabrina, Toga, Arthur, Valadka, Alex, Vassar, Mary, Vespa, Paul, Wang, Kevin, Yue, John, and Zafonte, Ross

Subjects
Behavioral and Social Science, Depression, Mental Health, Biomedical Imaging, Physical Injury - Accidents and Adverse Effects, Brain Disorders, Traumatic Head and Spine Injury, Neurosciences, Traumatic Brain Injury (TBI), Clinical Research, 6.6 Psychological and behavioural, Evaluation of treatments and therapeutic interventions, Mental health, Injuries and accidents, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Anxiety, Brain Concussion, Female, Humans, Longitudinal Studies, Male, Middle Aged, Recovery of Function, Time Factors, Young Adult, brain injuries, mental health, patient outcome assessment, traumatic, TRACK-TBI Investigators, Clinical Sciences, Neurology & Neurosurgery
Abstract

Mental health problems, such as depression and anxiety, are often associated with functional limitations after traumatic brain injury (TBI), prompting researchers to explore which of these TBI-related sequelae tends to precede the other. Past studies among patients with injuries ranging in severity have predominantly reported that functional impairments predict subsequent psychological concerns, rather than the other way around; however, it remains unclear whether this directionality holds for individuals with mild TBI (mTBI). The present study utilized a cross-lagged panel design within a structural equation modeling analytical framework to explore the longitudinal relationships of symptoms of depression and anxiety to functional status among 717 adult mTBI patients, with assessments occurring at 2 weeks and 3 months post-injury. Symptoms of both depression and anxiety significantly predicted subsequent functional limitations (λs = -0.21 and -0.25), whereas the reverse effects were nonsignificant (λs = -0.05 and -0.03); thus, psychological concerns appeared to function as a precursor to functional impairment. This pattern was particularly pronounced among patients with normal head computed tomography (CT) results; however, results were less clear cut among those subjects whose injuries were accompanied by intracranial abnormalities detected on CT imaging, suggesting the possibility of a more reciprocal relationship in the case of CT-positive mTBI. These results may serve to partially explain the incidence of persistent functional limitations observed among subsets of mTBI patients in past studies. Findings likewise highlight the importance of assessment and treatment for mental health problems after mTBI as an important factor to promote psychological well-being and functional recovery.

Published
2019

13. Mood Tracker: A Randomized Controlled Trial of a Self-Monitoring Intervention for Emotional Distress After Traumatic Brain Injury.

Author

Sherer, Mark, Juengst, Shannon, Sander, Angelle M., Leon-Novelo, Luis, Liu, Xiangyi, Bogaards, Jay, Chua, Wilma, and Tran, Kim

Abstract

Objective: Persons with traumatic brain injury (TBI) frequently experience emotional distress (ED) manifested in anxiety and depression. However, they may not access mental health services due to external (eg, access, transportation, and cost) or internal (eg, stigma and discomfort with traditional counseling) barriers. Based on substantial literature indicating that self-monitoring can ameliorate several health conditions, we conducted a randomized, parallel group, wait-list control (WLC) trial of a self-monitoring intervention to decrease ED after TBI. Setting: Community in the southwestern United States. Participants: Persons with medically documented complicated mild, moderate, and severe TBI. Design: About 127 participants were randomized in blocks of 6 to an active treatment (AT) group, wherein they completed multiple assessments of ED each week over a 6-week period via a smartphone app, or a WLC group in a parallel group, controlled trial. Participants received weekly support calls to promote self-monitoring of ED using ecological momentary assessment. Main Measures: ED (Patient Health Questionnaire—9 and Generalized Anxiety Disorder—7), Satisfaction with Life Scale, and Participation Assessment with Recombined Tools—Objective. Results: Analysis of the primary study outcome at 6 weeks after initiation of treatment for the AT group did not demonstrate that self-monitoring was effective in decreasing ED as compared to the WLC group. Brief support calls made weekly to promote compliance with self-monitoring were effective in achieving the target number of self-assessments. About 80% of support calls lasted less than 5 minutes. Greater ED was associated with lower life satisfaction and lower participation indicating the importance of addressing ED in persons with TBI. Conclusion: Additional work is needed to develop nontraditional interventions to circumvent barriers that prevent persons with TBI from accessing care for ED. Brief support calls may be an effective, low-cost intervention to improve compliance with self-monitoring or self-management interventions. [ABSTRACT FROM AUTHOR]

Published
2025
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14. A genome-wide association study of outcome from traumatic brain injury

Author

Åkerlund, Cecilia, Amrein, Krisztina, Andelic, Nada, Andreassen, Lasse, Anke, Audny, Antoni, Anna, Audibert, Gérard, Azouvi, Philippe, Azzolini, Maria Luisa, Bartels, Ronald, Barzó, Pál, Beauvais, Romuald, Beer, Ronny, Bellander, Bo-Michael, Belli, Antonio, Benali, Habib, Berardino, Maurizio, Beretta, Luigi, Blaabjerg, Morten, Bragge, Peter, Brazinova, Alexandra, Brinck, Vibeke, Brooker, Joanne, Brorsson, Camilla, Buki, Andras, Bullinger, Monika, Cabeleira, Manuel, Caccioppola, Alessio, Calappi, Emiliana, Calvi, Maria Rosa, Cameron, Peter, Lozano, Guillermo Carbayo, Carbonara, Marco, Cavallo, Simona, Chevallard, Giorgio, Chieregato, Arturo, Citerio, Giuseppe, Clusmann, Hans, Coburn, Mark, Coles, Jonathan P., Cooper, Jamie D., Correia, Marta, Čović, Amra, Curry, Nicola, Czeiter, Endre, Czosnyka, Marek, DahyotFizelier, Claire, Dark, Paul, Dawes, Helen, De Keyser, Véronique, Degos, Vincent, Corte, Francesco Della, Boogert, Hugo den, Depreitere, Bart, Đilvesi, Đula, Dixit, Abhishek, Donoghue, Emma, Dreier, Jens, Dulière, GuyLoup, Ercole, Ari, Esser, Patrick, Ezer, Erzsébet, Fabricius, Martin, Feigin, Valery L., Foks, Kelly, Frisvold, Shirin, Furmanov, Alex, Gagliardo, Pablo, Galanaud, Damien, Gantner, Dashiell, Gao, Guoyi, George, Pradeep, Ghuysen, Alexandre, Giga, Lelde, Glocker, Ben, Golubovic, Jagoš, Gomez, Pedro A., Gratz, Johannes, Gravesteijn, Benjamin, Grossi, Francesca, Gruen, Russell L., Gupta, Deepak, Haagsma, Juanita A., Haitsma, Iain, Helbok, Raimund, Helseth, Eirik, Horton, Lindsay, Huijben, Jilske, Hutchinson, Peter J.A., Jacobs, Bram, Jankowski, Stefan, Jarrett, Mike, Jiang, Jiyao, Johnson, Faye, Jones, Kelly, Karan, Mladen, Kolias, Angelos G., Kompanje, Erwin, Kondziella, Daniel, Kornaropoulos, Evgenios, Koskinen, LarsOwe, Kovács, Noémi, Kowark, Ana, Lagares, Alfonso, Lanyon, Linda, Laureys, Steven, Lecky, Fiona, Ledoux, Didier, Lefering, Rolf, Legrand, Valerie, Lejeune, Aurelie, Levi, Leon, Lightfoot, Roger, Lingsma, Hester, Maas, Andrew I.R., CastañoLeón, Ana M., Maegele, Marc, Majdan, Marek, Manara, Alex, Martino, Costanza, Maréchal, Hugues, Mattern, Julia, McMahon, Catherine, Melegh, Béla, Menon, David K., Menovsky, Tomas, Mikolic, Ana, Misset, Benoit, Muraleedharan, Visakh, Murray, Lynnette, Negru, Ancuta, Nelson, David, Newcombe, Virginia F.J., Nieboer, Daan, Nyirádi, József, Olubukola, Otesile, Oresic, Matej, Ortolano, Fabrizio, Palotie, Aarno, Parizel, Paul M., Payen, JeanFrançois, Perera, Natascha, Perlbarg, Vincent, Persona, Paolo, Peul, Wilco, Piippo-Karjalainen, Anna, Pirinen, Matti, Pisica, Dana, Ples, Horia, Polinder, Suzanne, Pomposo, Inigo, Posti, Jussi P., Puybasset, Louis, Radoi, Andreea, Ragauskas, Arminas, Raj, Rahul, Rambadagalla, Malinka, Helmrich, Isabel Retel, Rhodes, Jonathan, Richardson, Sylvia, Richter, Sophie, Ripatti, Samuli, Rocka, Saulius, Roe, Cecilie, Roise, Olav, Rosenfeld, Jeffrey V., Rosenlund, Christina, Rosenthal, Guy, Rossaint, Rolf, Rossi, Sandra, Rueckert, Daniel, Rusnák, Martin, Sahuquillo, Juan, Sakowitz, Oliver, SanchezPorras, Renan, Sandor, Janos, Schäfer, Nadine, Schmidt, Silke, Schoechl, Herbert, Schoonman, Guus, Schou, Rico Frederik, Schwendenwein, Elisabeth, Sewalt, Charlie, Skandsen, Toril, Smielewski, Peter, Sorinola, Abayomi, Stamatakis, Emmanuel, Stanworth, Simon, Stevens, Robert, Stewart, William, Steyerberg, Ewout W., Stocchetti, Nino, Sundström, Nina, Takala, Riikka, Tamás, Viktória, Tamosuitis, Tomas, Taylor, Mark Steven, Ao, Braden Te, Tenovuo, Olli, Theadom, Alice, Thomas, Matt, Tibboel, Dick, Timmers, Marjolein, Tolias, Christos, Trapani, Tony, Tudora, Cristina Maria, Unterberg, Andreas, Vajkoczy, Peter, Vallance, Shirley, Valeinis, Egils, Vámos, Zoltán, van der Jagt, Mathieu, van der Steen, Gregory, van der Naalt, Joukje, van Dijck, Jeroen T.J.M., van Essen, Thomas A., Van Hecke, Wim, van Heugten, Caroline, Van Praag, Dominique, van Veen, Ernest, Vyvere, Thijs Vande, van Wijk, Roel P.J., Vargiolu, Alessia, Vega, Emmanuel, Velt, Kimberley, Verheyden, Jan, Vespa, Paul M., Vik, Anne, Vilcinis, Rimantas, Volovici, Victor, von Steinbüchel, Nicole, Voormolen, Daphne, Vulekovic, Petar, Wang, Kevin K.W., Wiegers, Eveline, Williams, Guy, Wilson, Lindsay, Winzeck, Stefan, Wolf, Stefan, Yang, Zhihui, Ylén, Peter, Younsi, Alexander, Zeiler, Frederick A., Zelinkova, Veronika, Ziverte, Agate, Zoerle, Tommaso, Izzy, Saef, Radmanesh, Farid, Frantzén, Janek, Katila, Ari, Maanpää, Henna-Rikka, Tallus, Jussi, Adeoye, Opeolu, Badjatia, Neeraj, Boase, Kim, Barber, Jason, Bodien, Yelena, Chesnut, Randall, Corrigan, John D., Crawford, Karen, Diaz-Arrastia, Ramon, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, Ramana, Ferguson, Adam R., Foreman, Brandon, Gardner, Raquel, Gaudette, Etienne, Giacino, Joseph, Goldman, Dana, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, Claude, Hotz, Gillian, Jain, Sonia, Keene, Dirk, Korley, Frederick K., Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Manley, Geoffrey T., Martin, Alastair, McAllister, Thomas, McCrea, Michael, Merchant, Randall, Mukherjee, Pratik, Nelson, Lindsay, Ngwenya, Laura B, Noel, Florence, Nolan, Amber, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rosand, Jonathan, Sander, Angelle, Satris, Gabriella, Schnyer, David, Seabury, Seth, Sherer, Mark, Stein, Murray, Taylor, Sabrina, Temkin, Nancy, Toga, Arthur, Valadka, Alex, Vassar, Mary, Yue, John K., Yuh, Esther, Zafonte, Ross, Kals, Mart, Kunzmann, Kevin, Parodi, Livia, Anderson, Christopher D., Puccio, Ava M., Okonkwo, David O., Stein, Murray B., and Manley, Geoff T.

Published
2022
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15. Effect of frailty on 6-month outcome after traumatic brain injury: a multicentre cohort study with external validation

Author

Ackerlund, Cecilia, Adams, Hadie, Amrein, Krisztina, Andelic, Nada, Andreassen, Lasse, Anke, Audny, Antoni, Anna, Audibert, Gérard, Azouvi, Philippe, Azzolini, Maria Luisa, Bartels, Ronald, Barzó, Pál, Beauvais, Romuald, Beer, Ronny, Bellander, Bo-Michael, Belli, Antonio, Benali, Habib, Berardino, Maurizio, Beretta, Luigi, Blaabjerg, Morten, Bragge, Peter, Brazinova, Alexandra, Brinck, Vibeke, Brooker, Joanne, Brorsson, Camilla, Buki, Andras, Bullinger, Monika, Cabeleira, Manuel, Caccioppola, Alessio, Calappi, Emiliana, Calvi, Maria Rosa, Cameron, Peter, Carbayo Lozano, Guillermo, Carbonara, Marco, Castaño-León, Ana M., Cavallo, Simona, Chevallard, Giorgio, Chieregato, Arturo, Clusmann, Hans, Coburn, Mark Steven, Coles, Jonathan, Cooper, Jamie D., Correia, Marta, Covic, Amra, Curry, Nicola, Czeiter, Endre, Czosnyka, Marek, Dahyot-Fizelier, Claire, Dark, Paul, Dawes, Helen, De Keyser, Véronique, Degos, Vincent, Della Corte, Francesco, den Boogert, Hugo, Depreitere, Bart, Đilvesi, Đula, Dixit, Abhishek, Donoghue, Emma, Dreier, Jens, Dulière, Guy-Loup, Ercole, Ari, Esser, Patrick, Ezer, Erzsébet, Fabricius, Martin, Feigin, Valery L., Foks, Kelly, Frisvold, Shirin, Furmanov, Alex, Gagliardo, Pablo, Galanaud, Damien, Gantner, Dashiell, Gao, Guoyi, George, Pradeep, Ghuysen, Alexandre, Giga, Lelde, Glocker, Ben, Golubovic, Jagoš, Gomez, Pedro A., Gratz, Johannes, Gravesteijn, Benjamin, Grossi, Francesca, Gruen, Russell L., Gupta, Deepak, Haagsma, Juanita A., Haitsma, Iain, Helbok, Raimund, Helseth, Eirik, Horton, Lindsay, Huijben, Jilske, Hutchinson, Peter J., Jacobs, Bram, Jankowski, Stefan, Jarrett, Mike, Jiang, Ji-yao, Johnson, Faye, Jones, Kelly, Karan, Mladen, Kolias, Angelos G., Kompanje, Erwin, Kondziella, Daniel, Koskinen, Lars-Owe, Kovács, Noémi, Kowark, Ana, Lagares, Alfonso, Lanyon, Linda, Laureys, Steven, Ledoux, Didier, Lefering, Rolf, Legrand, Valerie, Lejeune, Aurelie, Levi, Leon, Lightfoot, Roger, Lingsma, Hester, Maegele, Marc, Majdan, Marek, Manara, Alex, Maréchal, Hugues, Martino, Costanza, Mattern, Julia, McFadyen, Charles, McMahon, Catherine, Melegh, Béla, Menon, David, Menovsky, Tomas, Mikolic, Ana, Misset, Benoit, Muraleedharan, Visakh, Murray, Lynnette, Negru, Ancuta, Nelson, David, Newcombe, Virginia, Nieboer, Daan, Nyirádi, József, Oresic, Matej, Ortolano, Fabrizio, Otesile, Olubukola, Palotie, Aarno, Parizel, Paul M., Payen, Jean-François, Perera, Natascha, Perlbarg, Vincent, Persona, Paolo, Peul, Wilco, Piippo-Karjalainen, Anna, Pirinen, Matti, Pisica, Dana, Ples, Horia, Polinder, Suzanne, Pomposo, Inigo, Posti, Jussi P., Puybasset, Louis, Radoi, Andreea, Ragauskas, Arminas, Raj, Rahul, Rambadagalla, Malinka, Rehorčíková, Veronika, Retel Helmrich, Isabel, Rhodes, Jonathan, Richardson, Sylvia, Richter, Sophie, Ripatti, Samuli, Rocka, Saulius, Roe, Cecilie, Roise, Olav, Rosenfeld, Jeffrey, Rosenlund, Christina, Rosenthal, Guy, Rossaint, Rolf, Rossi, Sandra, Rueckert, Daniel, Rusnák, Martin, Sahuquillo, Juan, Sakowitz, Oliver, Sanchez-Porras, Renan, Sandor, Janos, Schäfer, Nadine, Schmidt, Silke, Schoechl, Herbert, Schoonman, Guus, Schou, Rico Frederik, Schwendenwein, Elisabeth, Sewalt, Charlie, Singh, Ranjit D., Skandsen, Toril, Smielewski, Peter, Sorinola, Abayomi, Stamatakis, Emmanuel, Stanworth, Simon, Stevens, Robert, Stewart, William, Steyerberg, Ewout W., Stocchetti, Nino, Sundström, Nina, Takala, Riikka, Tamás, Viktória, Tamosuitis, Tomas, Taylor, Mark Steven, Te Ao, Braden, Tenovuo, Olli, Theadom, Alice, Thomas, Matt, Tibboel, Dick, Timmers, Marjolijn, Tolias, Christos, Trapani, Tony, Tudora, Cristina Maria, Unterberg, Andreas, Vajkoczy, Peter, Valeinis, Egils, Vallance, Shirley, Vámos, Zoltán, van der Jagt, Mathieu, van der Naalt, Joukje, Van der Steen, Gregory, van Dijck, Jeroen T.J.M., van Erp, Inge A., van Essen, Thomas A., Van Hecke, Wim, van Heugten, Caroline, Van Praag, Dominique, van Veen, Ernest, van Wijk, Roel, Vande Vyvere, Thijs, Vargiolu, Alessia, Vega, Emmanuel, Velt, Kimberley, Verheyden, Jan, Vespa, Paul M., Vik, Anne, Vilcinis, Rimantas, Volovici, Victor, von Steinbüchel, Nicole, Voormolen, Daphne, Vulekovic, Peter, Wang, Kevin K.W., Wiegers, Eveline, Williams, Guy, Wilson, Lindsay, Wolf, Stefan, Yang, Zhihui, Ylén, Peter, Younsi, Alexander, Zeiler, Frederick A., Ziverte, Agate, Zoerle, Tommaso, Adeoye, Opeolu, Badjatia, Neeraj, Barber, Jason, Bergin, Michael, Boase, Kim, Bodien, Yelena, Chesnut, Randall, Corrigan, John, Crawford, Karen, Diaz-Arrastia, Ramon, Dikmen, Sureyya, Duhaime, Ann-Christine, Ellenbogen, Richard, Feeser, Venkata, Ferguson, Adam R, Foreman, Brandon, Gaudette, Etienne, Giacino, Joseph, Gonzalez, Luis, Gopinath, Shankar, Grandhi, Ramesh, Gullapalli, Rao, Hemphill, Claude, Hotz, Gillian, Huie, Russell, Jha, Ruchira, Keene, C. Dirk, Kitagawa, Ryan, Korley, Frederick, Kramer, Joel, Kreitzer, Natalie, Levin, Harvey, Lindsell, Chris, Machamer, Joan, Madden, Christopher, Martin, Alastair, McAllister, Thomas, McCrea, Michael, Merchant, Randall, Mukherjee, Pratik, Nelson, Lindsay, Ngwenya, Laura B., Noel, Florence, Nolan, Amber, Okonkwo, David, Palacios, Eva, Perl, Daniel, Puccio, Ava, Rabinowitz, Miri, Robertson, Claudia, Rodgers, Richard Ben, Rosand, Jonathan, Rosenthal, Eric, Sander, Angelle, Sandsmark, Danielle, Sugar, Gabriella, Schneider, Andrea, Schnyer, David, Seabury, Seth, Sherer, Mark, Stein, Murray, Temkin, Nancy, Toga, Arthur, Torres-Espin, Abel, Valadka, Alex, Vassar, Mary, Wang, Kevin, Wang, Vincent, Yue, John K., Yuh, Esther, Zafonte, Ross, Galimberti, Stefania, Graziano, Francesca, Maas, Andrew I R, Isernia, Giulia, Lecky, Fiona, Jain, Sonia, Sun, Xiaoying, Gardner, Raquel C, Taylor, Sabrina R, Markowitz, Amy J, Manley, Geoffrey T, Valsecchi, Maria Grazia, Bellelli, Giuseppe, and Citerio, Giuseppe

Published
2022
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16. Optimizing Outcome Assessment in Multicenter TBI Trials

Author

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

Subjects
Clinical and Health Psychology, Health Services and Systems, Health Sciences, Psychology, Physical Injury - Accidents and Adverse Effects, Clinical Research, Clinical Trials and Supportive Activities, Behavioral and Social Science, Traumatic Head and Spine Injury, Brain Disorders, Neurosciences, Traumatic Brain Injury (TBI), Evaluation of treatments and therapeutic interventions, 6.6 Psychological and behavioural, Good Health and Well Being, Brain Injuries, Traumatic, Clinical Trials as Topic, Combined Modality Therapy, Female, Glasgow Coma Scale, Humans, Incidence, Injury Severity Score, Male, Needs Assessment, Outcome Assessment, Health Care, Program Evaluation, Risk Assessment, Treatment Outcome, United States, common data elements, error, longitudinal studies, multicenter study, neuropsychological tests, outcome assessment, self-report, traumatic brain injury, validity, TRACK-TBI Investigators, Medical and Health Sciences, Psychology and Cognitive Sciences, Rehabilitation, Biomedical and clinical sciences, Health sciences
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.

Published
2018

19. Validity of the Telephone-Administered Coma Recovery Scale-Revised and Confusion Assessment Protocol for Standardized Remote Assessment of Persons with Disorders of Consciousness

Author

Sterling, Ally, primary, Bodien, Yelena, additional, Bergin, Michael, additional, Goostrey, Kelsey, additional, Hammond, Flora, additional, Kazis, Lewis, additional, Richardson, Risa, additional, Ni, Pengsheng, additional, O'Neil-Pirozzi, Therese, additional, O'Rourke, Justin, additional, Sanders, William, additional, Sherer, Mark, additional, Waters, Abigail, additional, and Giacino, Joseph, additional

Published
2024
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26. Association between plasma GFAP concentrations and MRI abnormalities in patients with CT-negative traumatic brain injury in the TRACK-TBI cohort: a prospective multicentre study

Author

Adeoye, Opeolu M, Badjatia, Neeraj, Boase, Kim, Bodien, Yelena G, Bullock, Malcom R, Chesnut, Randall M, Corrigan, John D, Crawford, Karen, Dikmen, Sureyya S, Duhaime, Ann-Christine, Ellenbogen, Richard G, Feeser, Venkata, Foreman, Brandon, Gardner, Raquel C, Gaudette, Etienne, Giacino, Joseph T, Goldman, Dana P, Gonzalez, Luis, Gopinath, Shankar, Gullapalli, Rao, Hemphill, J C, Hotz, Gillian, Kramer, Joel H, Kreitzer, Natalie P, Levin, Harvey S, Lindsell, Christopher J, Machamer, Joan, Madden, Christopher J, Martin, Alastair J, McAllister, Thomas W, McCrea, Michael, Merchant, Randall, Nelson, Lindsay D, Noel, Florence, Palacios, Eva M, Perl, Daniel P, Puccio, Ava M, Rabinowitz, Miri, Robertson, Claudia S, Rosand, Jonathan, Sander, Angelle M, Satris, Gabriela G, Schnyer, David M, Seabury, Seth A, Sherer, Mark, Stein, Murray B, Temkin, Nancy R, Toga, Arthur W, Valadka, Alex B, Vassar, Mary J, Vespa, Paul M, Yuh, Esther L, Zafonte, Ross, Yue, John K, Korley, Frederick K, Winkler, Ethan A, Sun, Xiaoying, Puffer, Ross C, Deng, Hansen, Choy, Winward, Chandra, Ankush, Taylor, Sabrina R, Ferguson, Adam R, Huie, J Russell, Mukherjee, Pratik, Wang, Kevin K W, Diaz-Arrastia, Ramon, Okonkwo, David O, Jain, Sonia, and Manley, Geoffrey T

Published
2019
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28. Assessing the benefits and risks of amantadine for irritability and aggression after traumatic brain injury.

Author

Hammond, Flora M., Zafonte, Ross D., Sherer, Mark, Bell, Kathleen R., Bogner, Jennifer, Malec, James F., Tang, Qing, and Jang, Jeong Hoon

Subjects
BRAIN injuries, AMANTADINE, RANDOMIZED controlled trials, CONFIDENCE intervals, SECONDARY analysis
Abstract

Objective: To quantify the benefits versus harms of amantadine in the treatment of irritability and aggression following traumatic brain injury. Methods: Secondary outcome data from a randomized controlled multisite trial of amantadine 100 mg twice daily were used to calculate number‐needed‐to‐treat (NNT). Given prior findings of positive clinician‐perceived effects and low incidence of adverse events, we hypothesized low number‐needed‐to‐treat for benefit (NNTB; high benefit) and high number‐needed‐to‐treat for harm (NNTH; low risk) based on the clinician ratings, supporting the use of amantadine in clinical practice. Specifically, NNTB values were calculated using number of individuals with improvement on the Clinician Global Impressions–Global Improvement scale (GI). NNTH values were computed using number of individuals with worsening on the GI and experiencing serious and any adverse events. Results: Based on clinician ratings, on average for every six patients treated with amantadine rather than placebo, one extra patient would be expected to improve (NNTB = 6.4; 95% confidence interval [CI]: [3.3–76.8]). More participants in the placebo group worsened than in the amantadine group, but the result was not statistically significant (NNTH = −92.4; 95% CI: [NNTB −32.9 to infinity to NNTH −19.2]). The amantadine and placebo groups did not differ on the numbers of adverse events experienced during the trial. Conclusion: Clinician ratings suggest modest benefit of amantadine 100 mg twice daily with low risk to appropriately selected patients with adequate renal clearance. Thus, amantadine should be considered a treatment option for the experienced brain injury clinician. These data may support treatment decisions when a pharmaceutical agent is being considered to control irritability/aggression. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Traumatic Brain Injury

Author

Sherer, Mark, Budd, Maggi A., editor, Hough, Sigmund, editor, Wegener, Stephen T., editor, and Stiers, William, editor

Published
2017
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34. Bedside Evaluations

Author

Sherer, Mark, Giacino, Joseph T., Doiron, Matthew J., LaRussa, Allison, Taylor, Sabrina R., Barr, William B., Series editor, Sherer, Mark, editor, and Sander, Angelle M., editor

Published
2014
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35. Variations in Inpatient Rehabilitation Functional Outcomes Across Centers in the Traumatic Brain Injury Model Systems Study and the Influence of Demographics and Injury Severity on Patient Outcomes

Author

Dahdah, Marie N., Barnes, Sunni, Buros, Amy, Dubiel, Rosemary, Dunklin, Cynthia, Callender, Librada, Harper, Caryn, Wilson, Amy, Diaz-Arrastia, Ramon, Bergquist, Thomas, Sherer, Mark, Whiteneck, Gale, Pretz, Christopher, Vanderploeg, Rodney D., and Shafi, Shahid

Published
2016
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