TY - JOUR
T1 - A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials
T2 - Treatment of Intracranial Pressure Trial
AU - Chesnut, Randall M.
AU - Bleck, Thomas P.
AU - Citerio, Giuseppe
AU - Classen, Jan
AU - Cooper, D. James
AU - Coplin, William M.
AU - Diringer, Michael N.
AU - Grände, Per Olof
AU - Hemphill, J. Claude
AU - Hutchinson, Peter J.
AU - Le Roux, Peter
AU - Mayer, Stephan A.
AU - Menon, David K.
AU - Myburgh, John A.
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 - 2015/11/15
Y1 - 2015/11/15
N2 - Widely-varying published and presented analyses of the Benchmark Evidence From South American Trials: Treatment of Intracranial Pressure (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 group's general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of more than 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83% to 100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that the BEST TRIP trial: 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.
AB - Widely-varying published and presented analyses of the Benchmark Evidence From South American Trials: Treatment of Intracranial Pressure (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 group's general opinions, followed by an in-person meeting wherein individual statements were refined. Statements required an agreement threshold of more than 70% by blinded voting for approval. Seven precisely-worded statements resulted, with agreement levels of 83% to 100%. These statements, which should be read in toto to properly reflect the group's consensus positions, conclude that the BEST TRIP trial: 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.
KW - BEST TRIP trial
KW - Consensus Development Conference
KW - intracranial pressure
KW - neurocritical care
KW - traumatic brain injury
UR - http://www.scopus.com/inward/record.url?scp=84947079301&partnerID=8YFLogxK
U2 - 10.1089/neu.2015.3976
DO - 10.1089/neu.2015.3976
M3 - Article
AN - SCOPUS:84947079301
SN - 0897-7151
VL - 32
SP - 1722
EP - 1724
JO - Journal of Neurotrauma
JF - Journal of Neurotrauma
IS - 22
ER -