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.

Severe traumatic brain injury: targeted management in the intensive care unit

“…However, in a multicentre trial from South America (BEST:TRIP), 57 ICU management based on repeated clinical examination and CT scans was not inferior to management including continuous measure ment of ICP. It would be entirely inappropriate to discard the role of ICP monitoring on the basis of the findings of this study, 58 but it does highlight the difficulties with postulating a direct link between monitoring and improvement of outcome, which can be too simplistic when considered in isolation.…”

Rethinking Neuroprotection in Severe Traumatic Brain Injury: Toward Bedside Neuroprotection

“…A recent South-American trial (44) on severe TBI, using a treatment strategy based on ICP monitoring compared with a clinical and CT-based strategy, failed to show better outcomes in the ICP group; nevertheless, the value of ICP monitoring still stands (45). Recent guidelines (46) have incorporated this trial, but still suggest ICP monitoring for reducing early mortality after TBI.…”

Intracranial pressure thresholds in severe traumatic brain injury: Pro

“…However, evidence of adverse outcomes, specifically extracranial complications, associated with aggressive targeting of ICP and CPP thresholds emerged, prompting a reassessment of treatment thresholds. The initial treatment algorithm was removed from subsequent editions of the BTF guidelines, pending high-quality randomised controlled trials (RCTs) and consensus statements to inform the revision of treatment thresholds and therapies [11,12].…”