@article{ref1,
title="The roles of protocols and protocolization in improving outcome from severe traumatic brain injury",
journal="Neurosurgery",
year="2023",
author="Chesnut, Randall M. and Temkin, Nancy and Videtta, Walter and Lujan, Silvia and Petroni, Gustavo and Pridgeon, Jim and Dikmen, Sureyya and Chaddock, Kelley and Hendrix, Terence and Barber, Jason and Machamer, Joan and Guadagnoli, Nahuel and Hendrickson, Peter and Alanis, Victor and La Fuente, Gustavo and Lavadenz, Arturo and Merida, Roberto and Sandi Lora, Freddy and Romero, Ricardo and Pinillos, Oscar and Urbina, Zulma and Figueroa, Jairo and Ochoa, Marcelo and Davila, Rafael and Mora, Jacobo and Bustamante, Luis and Perez, Carlos and Leiva, Jorge and Carricondo, Carlos and Mazzola, Ana Maria and Guerra, Juan",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="BACKGROUND AND OBJECTIVES: Our Phase-I parallel-cohort study suggested that managing severe traumatic brain injury (sTBI) in the absence of intracranial pressure (ICP) monitoring using an ad hoc Imaging and Clinical Examination (ICE) treatment protocol was associated with superior outcome vs nonprotocolized management but could not differentiate the influence of protocolization from that of the specific protocol. Phase II investigates whether adopting the Consensus REVised Imaging and Clinical Examination (CREVICE) protocol improved outcome directly or indirectly via protocolization. <br><br>METHODS: We performed a Phase-II sequential parallel-cohort study examining adoption of the CREVICE protocol from no protocol vs a previous protocol in patients with sTBI older than 13 years presenting ≤24 hours after injury. Primary outcome was prespecified 6-month recovery. The study was done mostly at public South American centers managing sTBI without ICP monitoring. Fourteen Phase-I nonprotocol centers and 5 Phase-I protocol centers adopted CREVICE. Data were analyzed using generalized estimating equation regression adjusting for demographic imbalances. <br><br>RESULTS: A total of 501 patients (86% male, mean age 35.4 years) enrolled; 81% had 6 months of follow-up. Adopting CREVICE from no protocol was associated with significantly superior results for overall 6-month extended Glasgow Outcome Score (GOSE) (protocol effect = 0.53 [0.11, 0.95], P =.013), mortality (36% vs 21%, HR = 0.59 [0.46, 0.76], P <.001), and orientation (Galveston Orientation and Amnesia Test discharge protocol effect = 10.9 [6.0, 15.8], P <.001, 6-month protocol effect = 11.4 [4.1, 18.6], P <.005). Adopting CREVICE from ICE was associated with significant benefits to GOSE (protocol effect = 0.51 [0.04, 0.98], P =.033), 6-month mortality (25% vs 18%, HR = 0.55 [0.39, 0.77], P <.001), and orientation (Galveston Orientation and Amnesia Test 6-month protocol effect = 9.2 [3.6, 14.7], P =.004). Comparing both groups using CREVICE, those who had used ICE previously had significantly better GOSE (protocol effect = 1.15 [0.09, 2.20], P =.033). <br><br>CONCLUSION: Centers managing adult sTBI without ICP monitoring should strongly consider protocolization through adopting/adapting the CREVICE protocol. Protocolization is indirectly supported at sTBI centers regardless of resource availability.<p /> <p>Language: en</p>",
language="en",
issn="0148-396X",
doi="10.1227/neu.0000000000002777",
url="http://dx.doi.org/10.1227/neu.0000000000002777"
}