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J Neurotrauma. 2015 Nov 15;32(22):1722-4. doi: 10.1089/neu.2015.3976. Epub 2015 Aug 31.

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

Author information

1
1 Department of Neurological Surgery, University of Washington , Seattle, Washington.
2
2 Department of Neurology, Rush University Medical Center , Chicago Illinois.
3
3 Department of Health Sciences, University of Milano-Bicocca , Milano, Italy .
4
4 Division of Critical Care Neurology and Comprehensive Epilepsy Center, Columbia University , New York, New York.
5
5 Department of Intensive Care, Alfred Hospital , Melbourne, VIC, Australia .
6
6 Neurosurgery Intensive Care, St. Anthony Hospital , Lakewood, Colorado.
7
7 Department of Neurology, Washington University School of Medicine , St. Louis, Missouri.
8
8 Anesthesiology and Intensive Care, University Hospital of Lund , Lund, Sweden .
9
9 Departments of Neurology and Neurological Surgery, University of California , San Francisco, San Francisco, California.
10
10 Division of Neurosurgery, Addenbrooke's Hospital and University of Cambridge , Cambridge, United Kingdom .
11
11 Neurosurgery, Lankenau Medical Center , Wynnewood, Pennsylvania.
12
12 Institute for Critical Care Medicine, Icahn School of Medicine at Mount Sinai , New York, New York.
13
13 Division of Anaesthesia, University of Cambridge , Cambridge, United Kingdom .
14
14 Department of Intensive Care Medicine, University of New South Wales and the George Institute for Global Health , Sydney, Australia .
15
15 Department of Neurological Surgery, University of Pittsburgh , Pittsburgh, Pennsylvania.
16
16 Department of Neurological Surgery, Baylor College of Medicine , Houston, Texas.
17
17 Department of Neurological Surgery, Vall d'Hebron University Hospital , Barcelona, Spain .
18
18 Department of Physiopathology and Transplant, Milan University and Neuro ICU Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico , Milan, Italy .
19
19 Department of Neurology, University of Southern California , Los Angeles, California.
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20 Department of Biostatistics, University of Washington , Seattle, Washington.
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21 Department of Neurology, University of California Los Angeles , Los Angeles, California.
22
22 Intensive Care Medicine, Hospital Nacional Professor Alejandro Posadas , Buenos Aires, Argentina .
23
23 Department of Neurological Surgery, University of New Mexico , Albuquerque, New Mexico .

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.

KEYWORDS:

BEST TRIP trial; Consensus Development Conference; intracranial pressure; neurocritical care; traumatic brain injury

PMID:
26061135
DOI:
10.1089/neu.2015.3976
[Indexed for MEDLINE]

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