Abstract
The heterogeneity of traumatic brain injury (TBI) is considered one of the most significant barriers to finding effective therapeutic interventions. In October, 2007, the National Institute of Neurological Disorders and Stroke, with support from the Brain Injury Association of America, the Defense and Veterans Brain Injury Center, and the National Institute of Disability and Rehabilitation Research, convened a workshop to outline the steps needed to develop a reliable, efficient and valid classification system for TBI that could be used to link specific patterns of brain and neurovascular injury with appropriate therapeutic interventions. Currently, the Glasgow Coma Scale (GCS) is the primary selection criterion for inclusion in most TBI clinical trials. While the GCS is extremely useful in the clinical management and prognosis of TBI, it does not provide specific information about the pathophysiologic mechanisms which are responsible for neurological deficits and targeted by interventions. On the premise that brain injuries with similar pathoanatomic features are likely to share common pathophysiologic mechanisms, participants proposed that a new, multidimensional classification system should be developed for TBI clinical trials. It was agreed that preclinical models were vital in establishing pathophysiologic mechanisms relevant to specific pathoanatomic types of TBI and verifying that a given therapeutic approach improves outcome in these targeted TBI types. In a clinical trial, patients with the targeted pathoanatomic injury type would be selected using an initial diagnostic entry criterion, including their severity of injury. Coexisting brain injury types would be identified and multivariate prognostic modeling used for refinement of inclusion/exclusion criteria and patient stratification. Outcome assessment would utilize endpoints relevant to the targeted injury type. Advantages and disadvantages of currently available diagnostic, monitoring, and assessment tools were discussed. Recommendations were made for enhancing the utility of available or emerging tools in order to facilitate implementation of a pathoanatomic classification approach for clinical trials.
| Original language | English |
|---|---|
| Pages (from-to) | 719-738 |
| Number of pages | 20 |
| Journal | Journal of Neurotrauma |
| Volume | 25 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 1 2008 |
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Keywords
- Clinical trial
- Head injury
- Intervention
- Outcome
- Therapy
ASJC Scopus subject areas
- Clinical Neurology
- Neuroscience(all)
Cite this
Classification of traumatic brain injury for targeted therapies. / Saatman, Kathryn E.; Duhaime, Ann Christine; Bullock, Ross; Maas, Andrew I R; Valadka, Alex; Manley, Geoffrey T.; Brody, David; Contant, Charles; Dash, Pramod; Diaz-Arrastia, Ramon; Fertig, Stephanie; Gean, Alisa; Goodman, Clay; Gordon, Wayne; Hayes, Ronald; Hicks, Ramona; Langloi, Jean; Marmarou, Anthony; Moore, David; Murray, Gordon; Okonkwo, David; Papa, Linda; Phillips, Linda; Plesnila, Nikolaus; Robertson, Claudia; Robertson, Courtney; Sahuquillo, Juan; Silbergleit, Robert; Steyerberg, Ewout; Stocchetti, Nino; Teasdale, Evelyn; Teasdale, Graham; Temkin, Nancy; Thompson, Hilaire; Tong, Karen; Wilson, Lindsay; Wright, David.
In: Journal of Neurotrauma, Vol. 25, No. 7, 01.07.2008, p. 719-738.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Classification of traumatic brain injury for targeted therapies
AU - Saatman, Kathryn E.
AU - Duhaime, Ann Christine
AU - Bullock, Ross
AU - Maas, Andrew I R
AU - Valadka, Alex
AU - Manley, Geoffrey T.
AU - Brody, David
AU - Contant, Charles
AU - Dash, Pramod
AU - Diaz-Arrastia, Ramon
AU - Fertig, Stephanie
AU - Gean, Alisa
AU - Goodman, Clay
AU - Gordon, Wayne
AU - Hayes, Ronald
AU - Hicks, Ramona
AU - Langloi, Jean
AU - Marmarou, Anthony
AU - Moore, David
AU - Murray, Gordon
AU - Okonkwo, David
AU - Papa, Linda
AU - Phillips, Linda
AU - Plesnila, Nikolaus
AU - Robertson, Claudia
AU - Robertson, Courtney
AU - Sahuquillo, Juan
AU - Silbergleit, Robert
AU - Steyerberg, Ewout
AU - Stocchetti, Nino
AU - Teasdale, Evelyn
AU - Teasdale, Graham
AU - Temkin, Nancy
AU - Thompson, Hilaire
AU - Tong, Karen
AU - Wilson, Lindsay
AU - Wright, David
PY - 2008/7/1
Y1 - 2008/7/1
N2 - The heterogeneity of traumatic brain injury (TBI) is considered one of the most significant barriers to finding effective therapeutic interventions. In October, 2007, the National Institute of Neurological Disorders and Stroke, with support from the Brain Injury Association of America, the Defense and Veterans Brain Injury Center, and the National Institute of Disability and Rehabilitation Research, convened a workshop to outline the steps needed to develop a reliable, efficient and valid classification system for TBI that could be used to link specific patterns of brain and neurovascular injury with appropriate therapeutic interventions. Currently, the Glasgow Coma Scale (GCS) is the primary selection criterion for inclusion in most TBI clinical trials. While the GCS is extremely useful in the clinical management and prognosis of TBI, it does not provide specific information about the pathophysiologic mechanisms which are responsible for neurological deficits and targeted by interventions. On the premise that brain injuries with similar pathoanatomic features are likely to share common pathophysiologic mechanisms, participants proposed that a new, multidimensional classification system should be developed for TBI clinical trials. It was agreed that preclinical models were vital in establishing pathophysiologic mechanisms relevant to specific pathoanatomic types of TBI and verifying that a given therapeutic approach improves outcome in these targeted TBI types. In a clinical trial, patients with the targeted pathoanatomic injury type would be selected using an initial diagnostic entry criterion, including their severity of injury. Coexisting brain injury types would be identified and multivariate prognostic modeling used for refinement of inclusion/exclusion criteria and patient stratification. Outcome assessment would utilize endpoints relevant to the targeted injury type. Advantages and disadvantages of currently available diagnostic, monitoring, and assessment tools were discussed. Recommendations were made for enhancing the utility of available or emerging tools in order to facilitate implementation of a pathoanatomic classification approach for clinical trials.
AB - The heterogeneity of traumatic brain injury (TBI) is considered one of the most significant barriers to finding effective therapeutic interventions. In October, 2007, the National Institute of Neurological Disorders and Stroke, with support from the Brain Injury Association of America, the Defense and Veterans Brain Injury Center, and the National Institute of Disability and Rehabilitation Research, convened a workshop to outline the steps needed to develop a reliable, efficient and valid classification system for TBI that could be used to link specific patterns of brain and neurovascular injury with appropriate therapeutic interventions. Currently, the Glasgow Coma Scale (GCS) is the primary selection criterion for inclusion in most TBI clinical trials. While the GCS is extremely useful in the clinical management and prognosis of TBI, it does not provide specific information about the pathophysiologic mechanisms which are responsible for neurological deficits and targeted by interventions. On the premise that brain injuries with similar pathoanatomic features are likely to share common pathophysiologic mechanisms, participants proposed that a new, multidimensional classification system should be developed for TBI clinical trials. It was agreed that preclinical models were vital in establishing pathophysiologic mechanisms relevant to specific pathoanatomic types of TBI and verifying that a given therapeutic approach improves outcome in these targeted TBI types. In a clinical trial, patients with the targeted pathoanatomic injury type would be selected using an initial diagnostic entry criterion, including their severity of injury. Coexisting brain injury types would be identified and multivariate prognostic modeling used for refinement of inclusion/exclusion criteria and patient stratification. Outcome assessment would utilize endpoints relevant to the targeted injury type. Advantages and disadvantages of currently available diagnostic, monitoring, and assessment tools were discussed. Recommendations were made for enhancing the utility of available or emerging tools in order to facilitate implementation of a pathoanatomic classification approach for clinical trials.
KW - Clinical trial
KW - Head injury
KW - Intervention
KW - Outcome
KW - Therapy
UR - http://www.scopus.com/inward/record.url?scp=48249108682&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=48249108682&partnerID=8YFLogxK
U2 - 10.1089/neu.2008.0586
DO - 10.1089/neu.2008.0586
M3 - Article
C2 - 18627252
AN - SCOPUS:48249108682
VL - 25
SP - 719
EP - 738
JO - Journal of Neurotrauma
JF - Journal of Neurotrauma
SN - 0897-7151
IS - 7
ER -