RESEARCH—HUMAN—CLINICAL STUDIES

Intracranial Pressure Monitoring in Patients With

Severe Traumatic Brain Injury: Extension of the
Recommendations and the Effect on Outcome by
Propensity Score Matching
Ana M. Castaño-Leon, PhD,
MD
Pedro A. Gomez, PhD, MD
Luı́s Jimenez-Roldan, PhD, MD
Igor Paredes, PhD, MD
Pablo M. Munarriz, MD
Irene Panero Perez, MD
Carla Eiriz Fernandez, MD
Daniel Garcı́a-Pérez, PhD, MD
Luis Miguel Moreno Gomez,
MD
Olga Esteban Sinovas, MD
Guillermo Garcia Posadas, MD
Alfonso Lagares, PhD, MD
Department of Neurosurgery, Research
Institute i+12-CIBERESP, Hospital Uni-
versitario 12 de Octubre, Universidad
Complutense de Madrid, Madrid, Spain
A summary of the Methods and the
Results sections of the manuscript were
presented at the European Association of
Neurosurgical Societies (EANS) virtual
congress on October 6, 2021.
BACKGROUND: Intracranial pressure (ICP) monitoring is recommended for patients with
traumatic brain injury (TBI) with a Glasgow Coma Scale (GCS) <9 on admission and re-
vealing space-occupying lesions or swelling on computed tomography. However, pre-
vious studies that have evaluated its effect on outcome have shown conflicting results.
OBJECTIVE: To study the effect of ICP monitoring on outcome after adjustment of patient’s
characteristics imbalance and determine the potential benefit on patients with higher GCS that
deteriorates early or in the absence of computed tomography results suggesting high ICP.
METHODS: We searched for adult patients with TBI admitted between 1996 and 2020 with a
GCS <9 on admission or deterioration from higher scores within 24 hours after TBI. Patients
were divided into groups if they fulfilled strict (Brain Trauma Foundation guidelines) or extended
criteria (patients who worsened after admission or without space-occupying lesions) for ICP
monitoring. Propensity score analyses based on nearest neighbor matching was performed.
RESULTS: After matching, we analyzed data from 454 patients and 184 patients who
fulfilled strict criteria or extended criteria for ICP monitoring, respectively. A decreased on
in-hospital mortality was detected in monitored patients following strict and extended
criteria. Those patients with a higher baseline risk of poor outcome showed higher odds of
favorable outcome if they were monitored.
CONCLUSION: ICP monitoring in patients with severe TBI within 24 hours after injury
following strict and extended criteria was associated with a decreased in-hospital mortality.
The identification of patients with a higher risk of an unfavorable outcome might be useful
to better select cases that would benefit more from ICP monitoring.
KEY WORDS: Traumatic brain injury, Intracranial pressure, Monitoring, Propensity score, Matching, Outcome
Neurosurgery 91:437–449, 2022 https://doi.org/10.1227/neu.0000000000002044

Correspondence:
Ana M. Castaño-Leon, PhD, MD,
Department of Neurosurgery,
Research Institute i+12-CIBERESP,
Hospital Universitario 12 de Octubre,
Universidad Complutense de Madrid,
Avda Cordoba, SN,
Madrid 28041, Spain.
Email: ana.maria.castano.leon@gmail.com
Received, August 30, 2021.
Accepted, April 4, 2022.
Published Online, July 14, 2022.
© Congress of Neurological Surgeons
2022. All rights reserved.
O
ne of the main goals in the management
of patients with traumatic brain injury
(TBI) consists of the early identification and
treatment of secondary insults.1 Specifically, the
increase of intracranial pressure (ICP) secondary to
ABBREVIATIONS: BTF, Brain Trauma Foundation; DC,
Decompressive craniectomy; EDH, epidural hematoma;
EVD, external ventricular drainage; ISS, Injury Severity
Score; IVH, intraventricular hemorrhage; MEI, major
extracranial injury; MLS, midline shift; PS, propensity
score; RCT, randomized control trial; SBP, systolic blood
pressure; SDH, subdural hematoma; TBI, traumatic brain
injury.
Supplemental digital content is available for this article at
neurosurgery-online.com.
swelling or space-occupying lesions may lead to
hypoxic-ischemic injury and result in death by brain
herniation. The level and duration of increased ICP
have been associated to mortality and disability.2,3
In 1996, the Brain Trauma Foundation (BTF)
published the first edition4 of the guidelines to
manage severe head injury including the recom-
mendation to monitor patients with severe TBI as
defined by a Glasgow Coma Scale (GCS) <9 after
cardiopulmonary resuscitation on admission and an
abnormal computed tomography (CT). An ab-
normal CT was considered only if it revealed he-
matomas, contusions, edema, or compressed basal
cisterns. It is not clear whether to monitor patients
who experienced deterioration after admission or
those cases with subarachnoid hemorrhage,

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CASTAÑO-LEON ET AL

FIGURE 1. Flow chart of patients recruited and excluded for the final analysis. *Brain Trauma Foundation guidelines (first-third editions) advised to monitor patients with a
normal CT if 2 or more of the following criteria were noted at admission: age >40 years, motor posturing, or SBP <90 mmHg. CT, computed tomography; GCS, Glasgow Coma
Scale; ICP, intracranial pressure; IVH, intraventricular hemorrhage; SAH, subarachnoid hemorrhage; SBP, systolic blood pressure; TBI, traumatic brain injury.

intraventricular hemorrhage, or petechia in the absence of additional
lesions because there is no certainty that these findings would be
sufficient to warrant a situation of high ICP.
Thus, ICP monitoring has been widely used in the manage-
ment of severe TBI, but the reported compliance to the guidelines
on this issue varied among centres,5-8 and a temporary trend to
reduce the use of ICP monitoring has been noticed.9,10 This
variation in practice can be partially explained by controversies
regarding the efficacy of ICP monitoring yielded by observational
studies11-21 and 2 randomized controlled trials (RCTs)22,23
characterized by differences in therapeutic regimes and pre-
hospital management that leads to their results being difficult to
generalize.24 Consequently, in the last edition of BTF guidelines,25
recommendations from prior editions were not supported by evi-
dence meeting their current standards.
The development of further RCT is challenging because of the
wide use of ICP monitoring and the definitive effect of raised ICP on
outcomes, but another approach known as propensity score (PS)
analysis was developed to balance out confounding factors between
treatment modalities in observational studies to decrease the vari-
ability that may have arisen because of the lack of randomization.26
The aims of this study were (1) to investigate the effect of ICP
monitoring on in-hospital mortality and 1-year Glasgow Outcome
Score (GOS) after adjustment of patient’s differences by PS matching,
(2) to study whether the effect is the same in subgroups of patients with
severe TBI regarding their fulfilment of BTF criteria (strict criteria) or
not (extended criteria), and (3) to evaluate if there is a subset of patients
who would benefit more according to patient’s baseline risk.
METHODS
Study Design and Timeline
We performed a 24-year (1996-2020) retrospective analysis of our
prospectively maintained registry of patients with TBI admitted to our level I
trauma center since the publication of the first edition of the BTF guidelines.
This study was approved by our Institutional Review Board. Informed
consent was waived because of its observational retrospective design.
Inclusion Criteria
We selected all adult patients (>15 years) admitted with severe TBI
(GCS <9) within 24 hours after trauma. Then, we split our cohort into 2
groups if they fulfilled strict (Brain Trauma Foundation guidelines) or
extended criteria (patients who worsened after admission or without space-
occupying lesions) for ICP monitoring (Figure 1).
Exclusion Criteria
Patients were excluded if they experienced a penetrating missile TBI,
CT acquisition was delayed >24 hours after TBI or recovered with a
GCS ≥9 after sedation cessation or the effects of central nervous system
depressors at a second evaluation performed within 24 hours after TBI.
Patients with an early (<48-hours) mortality risk >80% (unsalvageable patients)
calculated by an externally validated prognostic score27 were also excluded.

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 EXTENDED CRITERIA FOR ICP MONITORING IN TBI

TABLE 1. Patient’s Demographics

Strict criteria Extended criteria

Not ICP ICP Not ICP ICP

monitored monitored P value monitored monitored P value

N 371 723 198 177

Year
1996-2004 107 (28.8%) 318 (44%) 42 (21.2%) 56 (31.6%)
2005-2012 123 (33.2%) 210 (29%) 52 (26.3%) 56 (31.5%)
2013-2020 141 (38%) 195 (27%) <.001 104 (52.5%) 65 (36.7%) .007
Age (median, IQR) 48 (41) 34 (24) <.001 44 (40) 34 (22) <.001
Sex
Male 279 (75.2%) 602 (83.3%) 142 (71.7%) 140 (79.1%)
Female 92 (24.8%) 121 (16.7%) .001 56 (28.3%) 37 (20.9%) NS
Mechanism
Traffic 75 (20.2%) 227 (31.4%) 38 (19.2%) 53 (29.9%)
Pedestrian 68 (18.3%) 102 (14.1%) 26 (13.1%) 23 (13%)
Bike 10 (2.7%) 20 (2.8%) 10 (5.1%) 16 (9%)
Motorbike 33 (8.9%) 114 (15.8%) 17 (8.6%) 36 (20.3%)
Falls <2 m 84 (22.6%) 45 (6.2%) 63 (31.8%) 16 (9%)
Falls from heights 69 (18.6%) 160 (22.1%) 30 (15.2%) 26 (14.7%)
Blow to head 31 (8.4%) 52 (7.2%) 12 (6.1%) 4 (2.3%)
Others 1 (0.3%) 3 (0.4%) <.001 2 (1%) 3 (1.7%) <.001
Estimated time from TBI to hospital admission 80 (110) 80 (110) NS 70 (120) 70 (90) NS
(min) (median, IQR)
ISS (median, IQR) 29 (13) 34 (18) <.001 25 (9) 33 (13) <.001
MEI 169 (45.6%) 417 (57.7%) <.001 80 (40.4%) 96 (54.2%) .007
Shock 148 (39.9%) 264 (36.5%) NS 34 (17.2%) 39 (22%) NS
Hypoxia 94 (25.3%) 179 (24.8%) NS 15 (7.6%) 32 (18.1%) .002
Pupillary abnormalities
Both reactive 211 (56.9%) 544 (75.2%) 191 (96.5%) 159 (45.4%)
One reactive 68 (18.3%) 140 (19.4%) 5 (2.5%) 16 (9%)
None reactive 92 (24.8%) 39 (5.4%) <.001 2 (1%) 2 (1.1%) .023
Deterioration to GCS ≤8 between on-field 117 (31.5%) 166 (23%) .002 43 (21.7%) 14 (7.9%) <.001
examination to hospital admission
Admission GCS
3 236 (63.6%) 378 (52.3%) 69 (34.8%) 72 (40.7%)
4 25 (6.7%) 55 (7.6%) 5 (2.5%) 8 (4.5%)
5 20 (5.4%) 57 (7.9%) 5 (2.5%) 2 (1.1%)
6 39 (10.5%) 90 (12.4%) 12 (6.1%) 22 (12.6%)
7 35 (9.4%) 110 (15.2%) 15 (7.6%) 20 (11.3%)
8 16 (4.3%) 33 (4.6%) 9 (4.5%) 2 (1.1%)
9-12 0 0 39 (19.7%) 36 (20.3%)
13-15 0 0 .010 44 (22.3%) 15 (8.6%) .015
Admission motor score
1 92 (24.8%) 75 (10.4%) 6 (3%) 9 (5.1%)
2 25 (6.7%) 56 (7.7%) 6 (3%) 8 (4.5%)
3 24 (6.5%) 59 (8.2%) 5 (2.5%) 4 (2.3%)
4 43 (11.6%) 98 (13.6%) 15 (7.6%) 24 (13.6%)
5 44 (11.9%) 131 (18.1%) 49 (24.7%) 47 (26.6%)
6 0 0 54 (27.3%) 22 (12.4%)
Nontestable 143 (38.5%) 304 (42%) <.001 63 (31.8%) 63 (35.6%) .017
Deterioration to GCS ≤8 after hospital admission
GCS 13-15 at admission NA NA NA
Deterioration ≤6 h 28 (14.1%) 8 (4.5%)
Deterioration 6-24 h 16 (8.1%) 7 (4%)
GCS 9-12 at admission
Deterioration ≤6 h 31 (15.7%) 35 (19.8%)
Deterioration 6-24 h 8 (4%) 1 (0.6%) <.001

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CASTAÑO-LEON ET AL

TABLE 1. Continued.

Strict criteria Extended criteria

Not ICP ICP Not ICP ICP

monitored monitored P value monitored monitored P value
a
Admission CT Marshall classification
I 4 (1.1%) 2 (0.3%) 0 1 (0.6%)
II 145 (39.1%) 349 (48.3%) 151 (76.3%) 151 (85.3%)
III 57 (15.4%) 104 (14.4%) 0 5 (2.8%)
IV 20 (5.4%) 14 (1.9%) 2 (1%) 0
V 55 (14.8%) 241 (33.3%) 21 (10.6%) 19 (10.7%)
VI 90 (24.3%) 13 (1.8%) <.001 24 (12.1%) 1 (0.6%) <.001
IVH 169 (45.6%) 313 (43.3%) NS 78 (39.4%) 97 (54.8%) .003
SAH
Mild 129 (34.8%) 248 (34.3%) 87 (43.9%) 81 (45.8%)
Moderate 88 (23.7%) 194 (26.8%) 42 (21.2%) 48 (27.1%)
Severe 107 (28.8%) 176 (24.3%) NS 25 (12.6%) 25 (14.1%) NS
Petechia 120 (32.3%) 304 (42%) .002 78 (39.4%) 105 (59.3%) <.001
Basal cistern effacement 196 (52.8%) 335 (46.3%) .042 39 (19.7%) 20 (11.3%) .026
MLS (mm) (median, IQR) 0 (10) 0 (5) NS 0 (2) 0 (0) .023
Swelling 218 (58.8%) 438 (60.6%) NS 44 (22.2%) 27 (15.3%) NS
SDH 221 (59.6%) 375 (51.9%) .015 62 (31.3%) 37 (20.9%) .022
SDH volume (cc) (median, IQR) 15 (39) 9 (15) NS 30 (43) 7 (6) .030
ICH 160 (43.1%) 423 (58.5%) <.001 42 (21.2%) 56 (25.4%) NS
ICH volume (cc) (median, IQR) 6 (9) 6 (7) <.001 5 (7) 0 (5) NS
EDH 71 (19.1%) 184 (25.4%) .019 15 (7.6%) 13 (7.3%) NS
EDH volume (cc) (median. IQR) 10 (20) 10 (17) .024 8 (65) 16 (25) NS
Early surgery 66 (17.8%) 312 (43.3%) .015 25 (12.6%) 32 (18.1%)
Depressed fracture 2 5 1 2
ICH evacuation 2 9 1 0
EDH/SDH evacuation 35 98 14 13
Primary DC 26 193 9 16
Secondary DC 1 2 0 0
EVD 0 5 0 1 .142
14 d mortality risk by CRASH-CT 77% (30) 48% (49) <.001 56% (55) 25% (38) .002
prediction (%) (median, IQR)
Overall in-hospital mortality 236 (63.6%) 152 (21%) <.001 62 (31.3%) 17 (9.6%) <.001
In-hospital mortality directly TBI-related 181 (48.8%) 82 (11.3%) <.001 49 (24.7%) 4 (2.3%) <.001
1-y GOS
Deadb 6 (4.4%) 16 (2.8%) <.001 6 (4.4%) 3 (1.9%) .009
Vegetative state 2 (1.5%) 24 (4.2%) 1 (0.7%) 4 (2.5%)
Severe disability 23 (17%) 200 (35%) 17 (12.5%) 36 (22.5%)
Moderate disability 33 (24.4%) 158 (27.7%) 33 (24.3%) 54 (33.8%)
Good recovery 69 (51.1%) 172 (30.1%) 76 (55.9%) 62 (38.8%)
CRASH, Corticosteroid Randomisation After Significant Head Injury; CT, computed tomography; DC, decompressive craniectomy; EDH, epidural hematoma; EVD, external ventricular
drainage; GCS, Glasgow Coma Scale; GOS, Glasgow Outcome Scale; ICH, intracranial hematoma; ICP, intracranial pressure; ISS, Injury Severity Score; IVH, intraventricular hem-
orrhage; MEI, major extracranial injury; MLS, midline shift; SAH, subarachnoid hemorrhage; SDH, subdural hematoma; TBI, traumatic brain injury.
a
Brain Trauma Foundation guidelines (first-third editions) advised to monitor patients with a normal CT if 2 or more of the following criteria were noted at admission: age >40 years,
motor posturing, or systolic blood pressure (SBP) <90 mm Hg.
b
Deaths after hospital discharge.
Clinical, radiological and outcome features. Comparisons between ICP-monitored and not ICP-monitored groups for each criteria.

Patient Management intensivist. At our institution, we used a parenchymal fibreoptic

All patients were admitted to the intensive care unit and were probe.
managed uniformly according to international guidelines. 28-31
Regarding the indication to ICP monitoring, BTF guideline rec- Outcome Measures
ommendations were usually followed, but the ultimate decision was Overall in-hospital mortality (all causes) and in-hospital mortality
made at the discretion of the attending neurosurgeon and directly related to TBI (brain herniation) was recorded. In addition,

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6-month and 1-year GOS was assessed by means of an in-person or
telephone interview.
Statistical Analysis
Descriptive Analysis
Patient characteristics are presented as the absolute frequency with a
relative percentage for qualitative measures and medians and the IQR for
quantitative measures. The χ 2 or Fisher exact test and the Kruskal–Wallis test
were performed to analyze differences between ICP-monitoring groups.
PS Analysis
We calculated the probability of ICP monitor placement for each patient
through a generalized linear model using the following variables: age,
mechanism, hypoxia (oxygen saturation <90% during the first day), shock
(systolic blood pressure <90 mmHg during the first day), pupillary ab-
normalities, Injury Severity Score, major extracranial injury, admission GCS,
motor response, worsening to GCS <9 within 24 hours after TBI, presence
and volume of epidural hematoma, subdural hematoma and contusion,
midline shift, basal cistern effacement, swelling, intraventricular hemorrhage,
petechia, subarachnoid hemorrhage, CT Marshall classification, <24 hours
surgery, decompressive craniectomy, and the Corticosteroid Randomisation
After Significant Head Injury (CRASH)-CT model32 risk of 14-day mor-
tality. Because of the long period of data collection and the possible effect of
advances in the management of patients with severe TBI, the period in which
the patients had been treated was also considered a variable for matching.
A 1:1 nearest neighbor matching was performed on the basis of the
logit of the PS by using calipers of a width equal to 0.2 of the standard
deviation of the logit of the PS (MatchIt package33). We examined
graphically the balance of all covariates achieved after matching using the
Cobalt package34 with the standardized mean difference (continuous
variables) or difference in proportion (categorical variables) being <0.2.
FIGURE 2. Density plots of propensity scores before and after matching. Distribution of propensity scores after matching
overlaps satisfying the assumption of balanced. ICP, intracranial pressure.
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EXTENDED CRITERIA FOR ICP MONITORING IN TBI
McNemar and Wilcoxon tests were applied to analyze differences be-
tween ICP-monitoring groups after matching.
Finally, we evaluated the effect of ICP monitoring on in-hospital mortality
and 1-year GOS in the matched data sets for each subgroup of patients (strict
and extended criteria) using conditional logistic regression and ordinal re-
gression analysis,35 respectively, including ICP monitoring as a single variable.
Sensitivity Analysis
To assess the potential effect of unobserved confounders that could
also have influenced the decision to use ICP monitoring, we performed a
sensitivity analysis according to the Rosenbaum method.36
Sliding Dichotomy
The estimated baseline risk of 6-month unfavorable outcome of each
patient was calculated by the International Mission for Prognosis and
Clinical Trials in Traumatic Brain Injury (IMPACT) model.37 After-
ward, matched patients were divided into prognostic bands of equal size
for the best, intermediate, and poor prognosis. Then, a different split was
used for the dichotomization of the 6-month observed GOS for each
band according to their expected outcomes. The effect of ICP monitoring
on this newly constructed dichotomous outcome was then estimated with
logistic regression, with stratification by prognostic band.38
There were no missing values except for 1-year GOS for 48 patients
(2.8%) who were lost before that point, so their outcome in the last
follow-up was used. Any imputation was used. The data sets analyzed are
available from the corresponding author on reasonable request.
All P values were 2-sided, and a value of P < .05 was considered
significant. Statistical analyses were performed using the computing
environment R (R Core Team [2015], which is a language and envi-
ronment for statistical computing, R Foundation for Statistical Com-
puting; http://www.R-project.org/).
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CASTAÑO-LEON ET AL

FIGURE 3. Assessment of covariate balanced after matching. A, Covariate balanced after PS matching for strict criteria and B, covariate balanced after PS matching for
extended criteria. Balance between ICP-monitored and not ICP-monitored groups was confirmed as standardized, and the mean values were found to be within 0.2. EDH,
epidural hematoma; GCS-M, Glasgow Coma Scale motor response; ICH, intracranial hematoma; ISS, Injury Severity Score; IVH, intraventricular hemorrhage; MEI, major
extracranial injury; PS, propensity score; SAH, subarachnoid hemorrhage; SDH, subdural hematoma.

RESULTS
Patients’ Characteristics
During the period of study, 1689 patients with a GCS <9 within
24 hours after TBI were admitted (Figure 1). 186 patients were ex-
cluded because they were assessed to have a risk of early mortality >80%
(unsalvageable patients). Among 1503 of the included patients, 1094
patients met the BTF criteria for ICP monitoring (strict criteria), but
another 375 patients were at risk of high ICP (extended criteria).
Patient characteristics and comparison between groups are
detailed in Table 1.
PS Matching
After matching, 454 and 184 patients remained as matched
data sets for strict and extended criteria, respectively. Distri-
bution summary of PS is shown in Figure 2 and Supplemental
File 1, http://links.lww.com/NEU/D207. The condition of
balance after matching was found to be within 0.2 standard-
ized means (Figure 3). Univariate comparisons between
matched monitored and nonmonitored patients are described
in Table 2. Finally, we compared the matched cases with the
whole cohort in Supplemental File 2, http://links.lww.com/
NEU/D208.

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 EXTENDED CRITERIA FOR ICP MONITORING IN TBI

TABLE 2. Comparisons Between ICP-Monitored and Not ICP-Monitored Groups for Each Criteria After Matching

Strict criteria Extended criteria

Not ICP ICP P Not ICP ICP P

monitored monitored value monitored monitored value

N 227 227 92 92
Year
1996-2004 77 (33.9%) 87 (38.3%) .174 29 (31.5%) 31 (33.7%) .891
2005-2012 67 (29.5%) 75 (33%) .695 27 (29.3%) 29 (31.5%) .587
2013-2020 83 (36.6%) 65 (28.6%) .350 36 (39.1%) 32 (34.8%) .806
Age (median, IQR) 41 (31) 41 (25) .616 38 (30) 37 (27) .651
Sex
Male 181 (79.7%) 189 (81.5%) 69 (75%) 75 (81.5%)
Female 46 (20.3%) 38 (16.7%) .383 23 (25%) 17 (18.5%) .622
Mechanism
Traffic 57 (25.1%) 63 (27.8%) .478 29 (31.5%) 27 (29.3%) .476
Pedestrian 40 (17.6%) 36 (15.9%) .579 8 (8.7%) 12 (13%) .374
Bike 7 (3.1%) 7 (3.1%) .566 7 (7.6%) 5 (5.4%) .410
Motorbike 27 (11.9%) 28 (12.3%) .127 12 (13%) 14 (15.2%) .549
Falls <2 m 26 (11.5%) 29 (12.8%) .768 17 (18.5%) 11 (12%) .683
Falls from heights 50 (22%) 43 (18.9%) .623 14 (15.2%) 19 (20.7%) .602
Blow to head 19 (8.4%) 20 (8.8%) .857 3 (3.3%) 3 (3.3%) .341
Others 1 (0.4%) 1 (0.4%) .610 2 (2.2%) 1 (1.1%) .571
ISS (median, IQR) 33 (18) 34 (17) .598 29.5 (16) 33 (13) .695
MEI 122 (53.7%) 120 (52.9%) .845 47 (51.1%) 52 (56.5%) .478
Shock 98 (43.2%) 106 (46.7%) .438 23 (25%) 25 (27.2%) .886
Hypoxia 57 (25.1%) 54 (23.8%) .770 12 (13%) 11 (12%) .835
Pupillary abnormalities
Both reactive 159 (70%) 155 (68.3%) .668 86 (93.5%) 85 (92.4%) .999
One reactive 38 (16.7%) 43 (18.9%) .811 5 (5.4%) 6 (6.5%) .530
None reactive 30 (13.2%) 29 (12.8%) .866 1 (1.1%) 1 (1.1%) .999
Deterioration to GCS ≤8 between on field examination to 71 (31.3%) 58 (25.6%) .279 51 (55.4%) 52 (56.5%) .999
hospital admission
Admission GCS
3 134 (59%) 123 (54.2%) .620 35 (38%) 36 (39.1%) .806
4 13 (5.7%) 23 (10.1%) .065 1 (1.1%) 3 (3.3%) .341
5 14 (6.2%) 13 (5.7%) .396 1 (1.1%) 0 .610
6 28 (12.3%) 33 (14.5%) .467 10 (10.5%) 14 (15.2%) .655
7 26 (11.5%) 27 (11.9%) .631 12 (13%) 14 (15.2%) .695
8 12 (5.3%) 8 (3.5%) .372 6 (6.5%) 1 (1.1%) .097
9-12 0 0 17 (18.5%) 16 (17.4%) .999
13-15 0 0 11 (12%) 8 (8.7%) .808
Admission motor score
1 35 (15.4%) 29 (12.8%) .891 4 (4.3%) 5 (5.4%) .999
2 13 (5.7%) 23 (10.1%) .065 2 (2.2%) 3 (3.3%) .341
3 17 (7.5%) 13 (5.7%) .321 1 (1.1%) 1 (1.1%) .999
4 32 (14.1%) 37 (16.3%) .493 12 (13%) 14 (15.2%) .835
5 32 (14.1%) 30 (13.2%) .882 26 (28.3%) 28 (30.4%) .786
6 0 0 NA 15 (16.3%) 10 (10.9%) .670
Nontestable 98 (43.2%) 95 (41.9%) .502 32 (34.8%) 31 (33.7%) .895
Deterioration to GCS ≤8 after hospital admission
GCS 13-15 at admission
Deterioration ≤6 h 0 0 5 (5.4%) 5 (5.4%) .763
Deterioration 6-24 h 0 0 6 (6.5%) 3 (3.2 %) .372
GCS 9-12 at admission
Deterioration ≤6 h 0 0 10 (11%) 15 (16.3%) .724
Deterioration 6-24 h 0 0 NA 1 (1.1%) 1 (1.1%) .999
Admission CT Marshall classificationa
I 2 (0.9%) 1 (0.4%) .999 0 0

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CASTAÑO-LEON ET AL

TABLE 2. Continued.

Strict criteria Extended criteria

Not ICP ICP P Not ICP ICP P

monitored monitored value monitored monitored value

II 125 (55.1%) 116 (51.1%) .603 81 (88%) 82 (89.1%) .999

III 41 (18.1%) 43 (18.9%) .896 0 0
IV 6 (2.6%) 6 (2.6%) .999 0 0
V 44 (19.4%) 53 (23.3%) .282 11 (12%) 9 (9.8%) .819
VI 9 (4%) 8 (3.5%) .372 0 1 (1.1%) .610
IVH 102 (44.9%) 97 (42.7%) .671 40 (43.5%) 44 (47.8%) .745
SAH
Mild 84 (37%) 74 (32.6%) .328 42 (45.7%) 44 (47.8%) .912
Moderate 54 (23.8%) 58 (25.6%) .596 22 (23.9%) 26 (28.3%) .378
Severe 63 (27.8%) 62 (27.3%) .841 12 (13%) 8 (8.7%) .493
Petechia 89 (39.2%) 87 (38.3%) .880 55 (59.8%) 55 (59.8%) .772
Basal cistern effacement 87 (38.3%) 101 (44.5%) .384 7 (7.6%) 7 (7.6%) .999
MLS (mm) (median, IQR) 0 (3) 0 (3) .889 0 (0) 0 (0) .673
Swelling 104 (45.8%) 120 (52.9%) .352 9 (9.8%) 10 (10.9%) .819
SDH 109 (48%) 121 (53.3%) .601 22 (23.9%) 20 (21.7%) .999
SDH volume (cc) (median, IQR) 0 (5) 3 (8) .529 0 (0) 0 (0) .772
ICH 104 (45.8%) 112 (49.3%) .685 22 (23.9%) 21 (22.8%) .999
ICH volume (cc) (median, IQR) 0 (5) 0 (5) .383 0 (0) 0 (0) .828
EDH 54 (23.8%) 52 (22.9%) .999 6 (6.5%) 4 (4.3%) .372
EDH volume (cc) (median, IQR) 0 (0) 0 (0) .369 0 (0) 0 (0) .789
Early surgery 54 (23.8%) 70 (30.8%) .381 15 (16.3%) 13 (14.1%) .999
Early DC 24 (44.4%) 43 (61.4%) .071 7 (46.7%) 6 (46.2%) .999
14-d mortality risk by CRASH-CT prediction (%) (median, IQR) 64.16% (47) 61.7% (41) .651 25.14% (55) 25.14% (39) .931
CRASH, Corticosteroid Randomisation After Significant Head Injury; CT, computed tomography; DC, decompressive craniectomy; EDH, epidural hematoma; EVD, external ventricular
drainage; GCS, Glasgow Coma Scale; ICH, intracranial hematoma; ICP, intracranial pressure; ISS, Injury Severity Score; IVH, intraventricular hemorrhage; MEI, major extracranial injury;
MLS, midline shift; SAH, subarachnoid hemorrhage; SDH, subdural hematoma.
a
Brain Trauma Foundation guidelines (first-third editions) advised to monitor patients with a normal CT if 2 or more of the following criteria were noted at admission: age >40 years,
motor posturing, or systolic blood pressure (SBP) <90 mm Hg.

Effect of ICP Monitoring on Patient’s Outcome
The odds ratios of death were 0.62 (95% CI 0.46-0.84,
P = .002) for monitored patients following strict criteria and 0.33
(95% CI 0.14-0.78, P = .012) for those monitored following
extended criteria. Then, we assessed the effect on in-hospital
mortality directly related to TBI (brain herniation), and we
found that the odds ratio of death was 0.53 (95% CI 0.36-0.78,
P = .001) for monitored patients following strict criteria.
We found a detrimental effect of ICP monitoring following
strict criteria on 1-year GOS. The odds ratio of higher 1-year GOS
categories (better recovery) was 2.5 (95% CI 1.60-3.90) times
more in nonmonitored patients compared with monitored pa-
tients. The test of parallel lines was 0.448, so we could uphold the
proportional odds assumption.
In the case of extended criteria, no statistically significant as-
sociation was detected (P = .362).
criteria. Gamma is the log odds of differential assignment because of
an unobserved factor because the odds of a patient being ICP
monitored can vary according to the values on an unobserved co-
variate despite being identical on the matched covariates. According
to the coefficients of the factors included in the strongest prognostic
models,32,39 gammas indicate that our PS model is robust.
Sliding Dichotomy
For patients in the poor prognostic band, we found that the odds
ratio of having a favorable outcome was 3.76 (95% CI 1.659-8.529,
P = .001) if they were monitored following strict criteria and 14.50
(95% CI 2.92-71.94, P < .001) if they were monitored following
extended criteria. However, a deleterious effect was observed for
patients in the best band if they were monitored following strict
criteria. The results are detailed in Table 3 and Figures 4 and 5.

DISCUSSION
Sensitivity Analysis
The sensitivity analysis revealed, with a significance of 0.05, a The main finding of the present study is that a clear benefit on
gamma of 2.1 for strict criteria and a gamma of 1.7 for extended in-hospital mortality of ICP monitoring in patients with severe

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 EXTENDED CRITERIA FOR ICP MONITORING IN TBI

TABLE 3. Analysis of the Glasgow Outcome Scale With the Sliding Dichotomy Approach for Each Criteria

IMPACT- Odds ratio of favorable

extended Split for Unfavorable Favorable outcome if ICP was P
prognostic bands dichotomization Treatment condition outcome outcome monitored (95%CI) value

Strict Poor prognostic Death vs survival ICP monitoring 47 (40.9%) 26 (72.2%) 3.762 (1.659-8.529) .001
criteriaa band (T3) Not ICP monitoring 68 (59.1%) 10 (27.8%)
Intermediate Unfavorable vs ICP monitoring 53 (51.5%) 27 (55.1%) 1.158 (0.585-2.292) .674
prognostic band favorable outcome Not ICP monitoring 50 (48.5%) 22 (44.9%)
(T2)
Best prognostic Less than good vs ICP monitoring 50 (57.5%) 24 (37.5%) 0.444 (0.229-0.860) .015
band (T1) good recovery Not ICP monitoring 37 (42.5%) 40 (62.5%)
Extended Poor prognostic Death vs survival ICP monitoring 2 (11.8%) 29 (65.9%) 14.50 (2.923-71.94) <.001
criteriab band (T3) Not ICP monitoring 15 (88.2%) 15 (34.1%)
Intermediate Unfavorable vs ICP monitoring 14 (66.7%) 19 (46.3%) 0.432 (0.144-1.291) .129
prognostic band favorable outcome Not ICP monitoring 7 (33.3%) 22 (53.7%)
(T2)
Best prognostic Less than good vs ICP monitoring 16 (53.3%) 12 (38.7%) 0.553 (0.200-1.530) .252
band (T1) good recovery Not ICP monitoring 14 (46.7%) 19 (61.3%)
GOS, Glasgow Outcome Score; IMPACT, International Mission for Prognosis and Clinical Trials in Traumatic Brain Injury; MD, moderate disability; VS, vegetative state.
a
Terciles IMPACT extended model for the prediction of unfavorable outcome at 6 months after TBI: T1 means a risk <46.9%; T2 risk between 46.9% and 70.9%; and T3 risk >70.9%.
b
Terciles IMPACT-extended model for the prediction of unfavorable outcome at 6 months after TBI: T1 means a risk <31.1%; T2 risk between 31.1% and 46.7%; and T3 risk >46.7%.
The sliding dichotomy approach dichotomizes the GOS into a binary variable, but the point of dichotomy is customized according to each individual patient’s baseline risk. First, the
baseline prognostic risk of each patient was defined by calculating the probability of 6-month unfavorable outcome with the IMPACT model. Therefore, patients were divided into 3
prognostic bands (best, intermediate, and worst prognosis) based on the terciles of the risk calculated. For each band, a different point of dichotomy in the GOS was defined for
unfavorable and favorable outcomes. Specifically, in the “best prognosis” band, the split was taken at good recovery (GOS 5) vs worse than good recovery (GOS 1-4), in the
“intermediate prognosis” band at moderate disability (GOS 4-5 vs GOS 1-3), and in the “worst prognosis” band between death and survival (GOS 1 vs 2-5).38 The effect of ICP
monitoring on this newly created dichotomous outcome was then calculated with binary logistic regression, and odds ratios were determined for each prognostic band.

TBI following strict criteria (BTF criteria) was confirmed after
adjustment of the patient’s baseline characteristics, and this effect
was independent of the cause of death. Secondary but for the first
time,17,40-43 we also demonstrated the same benefit in those
patients who worsened within 24 hours after hospital admission or
those who were at risk of increased ICP in the absence of mass-
occupying lesions or swelling (extended criteria).
Our results corroborate the need for adequate correction of case-
mix effect by the inclusion of a wide number of covariates inde-
pendently of their association with outcomes. We recommend the
use of matching strategies because it seems to overcome weighted
regression analyses for a better adjustment of confounders.
The main limitation of previous observational studies12,13,15-19
is the insufficient approach to deal with an imbalance in the
baseline characteristics because patients undergoing ICP moni-
toring sustained more severe injuries. To deal with this problem,
we found 6 studies that have performed adjusted logistic re-
gression with the inclusion of the PS of receiving ICP monitoring
into the model6,40-42,44,45 and 6 additional studies8,17,43,46-49
that have used PS matching. Even after these adjustments, the
beneficial,8,17,41-45,47,49 null,6,46 or detrimental effect40,48 of ICP
monitoring on the outcome measure of interest varied between
studies. We noticed some limitations as to their epidemiological
basis with the selection of patients being based on International
Classification of Diseases coding or AIShead and so omitting
important clinical and radiological information that could have
compromised the adequate balance of confounding factors. In
addition, the study design can be controversial because of dif-
ferences in prehospital care45 and low rate of compliance with
guidelines41,42,45,46 along with the exclusion of specific patients
such as those with extracranial injuries41,48,49 or those monitored
after craniotomy.42 The key strengths of our study include the
large number of patients and covariates recorded, the evaluation of
extended indications, and the use of PS matching.
The association between long-term outcome and ICP moni-
toring has seldom been studied before. We found only 4 ob-
servational studies6,8,43,45 and 1 RCT22 that recorded 6-months
GOS. In contrast with our study, GOS categories were divided
into favorable and unfavorable outcomes, and sometimes patients
who did not survive hospital discharge were also included as
unfavorable outcomes in the long term. Except for one, these
studies did not detect a significant association between ICP
monitoring and GOS. Robba et al8 detected a 1.67 odds ratio for
unfavorable outcome in the cohort of patients with TBI, and no
pupillary abnormalities that were monitored, but the effect was
beneficial for those patients with at least one unreactive pupil.
The detrimental effect of ICP monitoring on 1-year GOS in
our data set is more difficult to interpret. It must be associated
with a clear effect on reducing mortality due to brain herniation
and limited action on underlying primary injury. However, we
found a clear benefit on 6-month GOS in those patients with the
highest risk of poor outcome because they had 3 times more odds

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CASTAÑO-LEON ET AL

FIGURE 4. Analysis of the Glasgow Outcome Scale with the sliding dichotomy approach
for strict criteria. The number of patients who achieved a favorable outcome was sig-
nificantly higher (72.2% vs 27.8%) if they were ICP monitored for those patients with
the highest baseline risk of 6-month unfavorable outcome. On the other hand, a del-
eterious effect was observed for patients with the lowest baseline risk of 6-month un-
favorable outcome if they were monitored (37.5% vs 62.5%). ICP, intracranial pressure.

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 EXTENDED CRITERIA FOR ICP MONITORING IN TBI

FIGURE 5. Analysis of the Glasgow Outcome Scale with the sliding dichotomy approach
for extended criteria. The number of patients who achieved a favourable outcome was
significantly higher (65.9% vs 34.1%) if they were ICP monitored for those patients with
the highest baseline risk of 6-month unfavorable outcome. ICP, intracranial pressure.

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CASTAÑO-LEON ET AL
of favorable outcome if they were monitored. On the contrary,
patients with the lower baseline risk had a 55% reduction in the
odds of favorable outcome if they were monitored. Therefore, we
suggest that the baseline risk of poor outcome should be assessed
before placing an ICP monitor to better discriminate from the
outset those patients that would benefit more from ICP-guided
therapies. After an overall interpretation of our results, we
recommend monitoring patients with intermediate or high
baseline risk of unfavorable outcome, but it could be sensible to
manage those patients with the lowest risk with early sedation
withdrawal and not to install from the beginning a monitor
even if they fulfil BTF guideline criteria. Then, if the neuro-
logical response is poor, ICP monitoring would be recom-
mended and is associated with a reduced risk of in-hospital
mortality.
Our results represent the experience of a single trauma center
with a 66% adherence to BTF criteria for ICP monitoring.
However, there is a large variability for the indication of ICP
monitoring among centers,8 so the external validation of our
results cannot be guaranteed. Additionally, our recommendations
to ICP monitoring imply that the prognostic models must be
externally validated before their application, and the physicians
must be aware of the limitations to predict individual risk until
new models can be developed.
Limitations
Our study has some limitations. First, we did not evaluate the
differences in the intensity of therapy and its complications.
Nevertheless, the number of external ventricular drainage was not
significantly different between groups of patients, and the number
of decompressive craniectomy and early surgeries was balanced by
PS. The potential harmful effect of intensive treatments might be
overcome by the benefit of ICP monitoring–guided treatment
because we found a reduced mortality in monitored patients.
Second, although our model has higher explained variances of
monitor placement compared with previous studies, it suggests
that there could be other residual and complex factors41,44 that
have influenced this decision which have not been adjusted for,
and reasons for not monitoring were not recorded. Finally, al-
though we appropriately used the PS method,50 limitations in-
herent to the method can misrepresent the average treatment
effect in an observational study.
CONCLUSION
After balancing differences in patient’s baseline characteristics,
ICP monitoring in patients with severe TBI following strict and
extended criteria was associated with a reduced risk of in-hospital
mortality. The identification of patients with a higher risk of
unfavorable outcome might be useful to better select patients who
would benefit more from ICP monitoring.
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Funding
This research was jointly funded by the ISCIII and FEDER European insti-
tutions with FIS project number PI18/01387 and Mutua Madrileña with project
number 2019/0133. The sponsors had no role in the design or conduct of this
research.
Disclosures
The authors have no personal, financial, or institutional interest in any of the
drugs, materials, or devices described in this article.
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Supplemental digital content is available for this article at neurosurgery-online.com.
Supplemental File 1. Graphic summary of distribution of PS before and after
matching for strict criteria (left) and extended criteria (right).
Supplemental File 2. Comparisons between unmatched and matched data sets for
each criteria.
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