TY  - JOUR
PY  - 2023//
TI  - The roles of protocols and protocolization in improving outcome from severe traumatic brain injury
JO  - Neurosurgery
A1  - Chesnut, Randall M.
A1  - Temkin, Nancy
A1  - Videtta, Walter
A1  - Lujan, Silvia
A1  - Petroni, Gustavo
A1  - Pridgeon, Jim
A1  - Dikmen, Sureyya
A1  - Chaddock, Kelley
A1  - Hendrix, Terence
A1  - Barber, Jason
A1  - Machamer, Joan
A1  - Guadagnoli, Nahuel
A1  - Hendrickson, Peter
A1  - Alanis, Victor
A1  - La Fuente, Gustavo
A1  - Lavadenz, Arturo
A1  - Merida, Roberto
A1  - Sandi Lora, Freddy
A1  - Romero, Ricardo
A1  - Pinillos, Oscar
A1  - Urbina, Zulma
A1  - Figueroa, Jairo
A1  - Ochoa, Marcelo
A1  - Davila, Rafael
A1  - Mora, Jacobo
A1  - Bustamante, Luis
A1  - Perez, Carlos
A1  - Leiva, Jorge
A1  - Carricondo, Carlos
A1  - Mazzola, Ana Maria
A1  - Guerra, Juan
SP  - ePub
EP  - ePub
VL  - ePub
IS  - ePub
N2  - 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>
LA  - en
SN  - 0148-396X
UR  - http://dx.doi.org/10.1227/neu.0000000000002777
ID  - ref1
ER  -