Failure of an effective physiologic threshold compliance tool to demonstrate benefit in a clinical trial of traumatic brain injury patients.

Autor: Menacho S; Department of Neurosurgery, Clinical Neurosciences Center, Clinical Neurosciences Center, University of Utah, USA. Electronic address: neuropub@hsc.utah.edu., Hawryluk G; Section of Neurosurgery, University of Manitoba, Canada; Uniformed Services University, USA. Electronic address: ghawryluk@hsc.mb.ca.
Jazyk: angličtina
Zdroj: Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia [J Clin Neurosci] 2021 Jun; Vol. 88, pp. 113-119. Date of Electronic Publication: 2021 May 05.
DOI: 10.1016/j.jocn.2021.03.025
Abstrakt: Background: Better physiologic threshold compliance holds promise for improving outcomes in neurocritical care patients.
Methods: Our group developed a threshold compliance tool. This software computes and displays the proportion of values out of range in real time. We captured intracranial pressure (ICP) measures in our patients before and after implementation of this technology. Ten months after the threshold compliance tool was introduced we initiated a randomized controlled trial involving acute traumatic brain injury (TBI) patients to assess whether the tool was effective at reducing out-of-range ICP values.
Results: A total of 54 patients with ICP monitors were included in our analysis, 42 of whom sustained a TBI. Implementation of the threshold compliance tool was associated with an 85.3% reduction in ICP values exceeding 22 mmHg in neurocritical care patients (p = 0.004) and a 76.8% reduction in patients with TBI (p = 0.043). Out-of-range values in an area-under-the-curve analysis were reduced by 78.8% in all patients (p = 0.009) and in TBI patients by 77.9% (p = 0.051). Out-of-range values were not further reduced during our randomized controlled trial examining the threshold compliance tool, and a difference between treatment groups was not suggested.
Conclusions: Implementation of a threshold compliance tool was associated with a marked and significant reduction in out-of-range ICP values. Benefit was, however, not evident in a randomized controlled trial. Our analysis provides a unique perspective on our failure to detect an apparent true difference and may provide insights into other neurotrauma trial failures.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2021 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: