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A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial

Authors :
Per-Olof Grände
Nino Stocchetti
Walter Videtta
Juan Sahuquillo
Thomas P. Bleck
Randall M. Chesnut
Jan Classen
Peter J. Hutchinson
Michael N. Diringer
Peter D. Le Roux
Gene Sung
David K. Menon
D. James Cooper
Howard Yonas
Nancy R. Temkin
Paul M. Vespa
Stephan A. Mayer
William M. Coplin
J. Claude Hemphill
Giuseppe Citerio
Claudia S. Robertson
David O. Okonkwo
John Myburgh
Chesnut, R
Bleck, T
Citerio, G
Claassen, J
Cooper, D
Coplin, W
Diringer, M
Grande, P
Hemphill, J
Hutchinson, P
Leroux, P
Mayer, S
Menon, D
Myburgh, J
Okonkwo, D
Robertson, C
Sahuquillo, J
Stocchetti, N
Sung, G
Temkin, N
Vespa, P
Videtta, W
Yonas, H
Source :
Journal of Neurotrauma. 32:1722-1724
Publication Year :
2015
Publisher :
Mary Ann Liebert Inc, 2015.

Abstract

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.

Details

ISSN :
15579042 and 08977151
Volume :
32
Database :
OpenAIRE
Journal :
Journal of Neurotrauma
Accession number :
edsair.doi.dedup.....1afcebe774e65b873142a01f8184ad13