title: A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial.
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.
authors.affiliation: 1 Department of Neurological Surgery, University of Washington , Seattle, Washington.
authors.forename: Randall M
authors.initials: RM
authors.lastname: Chesnut
authors.affiliation: 2 Department of Neurology, Rush University Medical Center , Chicago Illinois.
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Bleck
authors.affiliation: 3 Department of Health Sciences, University of Milano-Bicocca , Milano, Italy .
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Citerio
authors.affiliation: 4 Division of Critical Care Neurology and Comprehensive Epilepsy Center, Columbia University , New York, New York.
authors.forename: Jan
authors.initials: J
authors.lastname: Classen
authors.affiliation: 5 Department of Intensive Care, Alfred Hospital , Melbourne, VIC, Australia .
authors.forename: D James
authors.initials: DJ
authors.lastname: Cooper
authors.affiliation: 6 Neurosurgery Intensive Care, St. Anthony Hospital , Lakewood, Colorado.
authors.forename: William M
authors.initials: WM
authors.lastname: Coplin
authors.affiliation: 7 Department of Neurology, Washington University School of Medicine , St. Louis, Missouri.
authors.forename: Michael N
authors.initials: MN
authors.lastname: Diringer
authors.affiliation: 8 Anesthesiology and Intensive Care, University Hospital of Lund , Lund, Sweden .
authors.forename: Per-Olof
authors.initials: PO
authors.lastname: Grände
authors.affiliation: 9 Departments of Neurology and Neurological Surgery, University of California , San Francisco, San Francisco, California.
authors.forename: J Claude
authors.initials: JC
authors.lastname: Hemphill
authors.affiliation: 10 Division of Neurosurgery, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Hutchinson
authors.affiliation: 11 Neurosurgery, Lankenau Medical Center , Wynnewood, Pennsylvania.
authors.forename: Peter
authors.initials: P
authors.lastname: Le Roux
authors.affiliation: 12 Institute for Critical Care Medicine, Icahn School of Medicine at Mount Sinai , New York, New York.
authors.forename: Stephan A
authors.initials: SA
authors.lastname: Mayer
authors.affiliation: 13 Division of Anaesthesia, University of Cambridge , Cambridge, United Kingdom .
authors.forename: David K
authors.initials: DK
authors.lastname: Menon
authors.affiliation: 14 Department of Intensive Care Medicine, University of New South Wales and the George Institute for Global Health , Sydney, Australia .
authors.forename: John A
authors.initials: JA
authors.lastname: Myburgh
authors.affiliation: 15 Department of Neurological Surgery, University of Pittsburgh , Pittsburgh, Pennsylvania.
authors.forename: David O
authors.initials: DO
authors.lastname: Okonkwo
authors.affiliation: 16 Department of Neurological Surgery, Baylor College of Medicine , Houston, Texas.
authors.forename: Claudia S
authors.initials: CS
authors.lastname: Robertson
authors.affiliation: 17 Department of Neurological Surgery, Vall d'Hebron University Hospital , Barcelona, Spain .
authors.forename: Juan
authors.initials: J
authors.lastname: Sahuquillo
authors.affiliation: 18 Department of Physiopathology and Transplant, Milan University and Neuro ICU Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy .
authors.forename: Nino
authors.initials: N
authors.lastname: Stocchetti
authors.affiliation: 19 Department of Neurology, University of Southern California , Los Angeles, California.
authors.forename: Gene
authors.initials: G
authors.lastname: Sung
authors.affiliation: 1 Department of Neurological Surgery, University of Washington , Seattle, Washington.|20 Department of Biostatistics, University of Washington , Seattle, Washington.
authors.forename: Nancy
authors.initials: N
authors.lastname: Temkin
authors.affiliation: 21 Department of Neurology, University of California Los Angeles , Los Angeles, California.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Vespa
authors.affiliation: 22 Intensive Care Medicine, Hospital Nacional Professor Alejandro Posadas , Buenos Aires, Argentina .
authors.forename: Walter
authors.initials: W
authors.lastname: Videtta
authors.affiliation: 23 Department of Neurological Surgery, University of New Mexico , Albuquerque, New Mexico .
authors.forename: Howard
authors.initials: H
authors.lastname: Yonas
mesh_terms: D019985:Benchmarking; D001930:Brain Injuries / Q000503:physiopathology / Q000628:therapy*; D002985:Clinical Protocols; D032921:Consensus; D003422:Critical Care / Q000592:standards; D019317:Evidence-Based Medicine; D006801:Humans; D019586:Intracranial Hypertension / Q000503:physiopathology; D007427:Intracranial Pressure; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D013020:South America
keywords: BEST TRIP trial; Consensus Development Conference; intracranial pressure; neurocritical care; traumatic brain injury