TY - JOUR
T1 - A Consensus-based Interpretation of the BEST TRIP ICP Trial.
AU - Chesnut, Randall
AU - Bleck, Thomas
AU - Citerio, Giuseppe
AU - Claassen, Jan
AU - Cooper, D James
AU - Coplin, William
AU - Diringer, Michael
AU - Grände, Per-Olof
AU - Hemphill, Claude M
AU - Hutchinson, Peter John
AU - LeRoux, Peter
AU - Mayer, Stephan
AU - Menon, David
AU - Myburgh, John
AU - Okonkwo, David O
AU - Robertson, Claudia S
AU - Sahuquillo, Juan
AU - Stocchetti, Nino
AU - Sung, Gene
AU - Temkin, Nancy
AU - Vespa, Paul M
AU - Videtta, Walter
AU - Yonas, Howard
PY - 2015
Y1 - 2015
N2 - Widely varying published and presented analyses of the BEST TRIP randomized controlled trial of intracranial pressure (ICP) monitoring have suggested denying trial generalizability, questioning the need for ICP monitoring in severe traumatic brain injury (sTBI), re-assessing current clinical approaches to monitored ICP, and initiating a general ICP-monitoring moratorium. In response to this dissonance, 23 clinically-active, international opinion leaders in acute-care sTBI management met to draft a consensus statement to interpret this study. A Delphi-method-based approach employed iterative pre-meeting polling to codify the groups general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of > 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83-100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that this study: 1) studied protocols, not ICP-monitoring per se; 2) applies only to those protocols and specific study groups and should not be generalized to other treatment approaches or patient groups; 3) strongly calls for further research on ICP interpretation and use; 4) should be applied cautiously to regions with much different treatment milieu; 5) did not investigate the utility of treating monitored ICP in the specific patient group with established intracranial hypertension; 6) should not change the practice of those currently monitoring ICP; and 7) provided a protocol, used in non-monitored study patients, that should be considered when treating without ICP monitoring. Consideration of these statements can clarify study interpretation and avoid "collateral damage".
AB - Widely varying published and presented analyses of the BEST TRIP randomized controlled trial of intracranial pressure (ICP) monitoring have suggested denying trial generalizability, questioning the need for ICP monitoring in severe traumatic brain injury (sTBI), re-assessing current clinical approaches to monitored ICP, and initiating a general ICP-monitoring moratorium. In response to this dissonance, 23 clinically-active, international opinion leaders in acute-care sTBI management met to draft a consensus statement to interpret this study. A Delphi-method-based approach employed iterative pre-meeting polling to codify the groups general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of > 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83-100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that this study: 1) studied protocols, not ICP-monitoring per se; 2) applies only to those protocols and specific study groups and should not be generalized to other treatment approaches or patient groups; 3) strongly calls for further research on ICP interpretation and use; 4) should be applied cautiously to regions with much different treatment milieu; 5) did not investigate the utility of treating monitored ICP in the specific patient group with established intracranial hypertension; 6) should not change the practice of those currently monitoring ICP; and 7) provided a protocol, used in non-monitored study patients, that should be considered when treating without ICP monitoring. Consideration of these statements can clarify study interpretation and avoid "collateral damage".
U2 - 10.1089/neu.2015.3976
DO - 10.1089/neu.2015.3976
M3 - Article
C2 - 26061135
SN - 1557-9042
VL - 32
SP - 1722
EP - 1724
JO - Journal of Neurotrauma
JF - Journal of Neurotrauma
IS - 22
ER -