Re-Examining the Brain Injury Guidelines in Pediatric Traumatic Brain Injury: Can Simple Isolated Non-Displaced Skull Fractures be Treated as a BIG-1 Injury?

Abstract

Children with mild traumatic brain injury (TBI) often receive unnecessary imaging studies, hospital admissions, and interhospital transfers leading to avoidable burdens to patients, caregivers, and health systems. The Brain Injury Guidelines (BIG) consider a non-displaced skull fracture as a BIG-2 injury warranting hospitalization. In our clinical experience, patients with simple isolated non-displaced linear skull fractures seldom develop TBI-related complications. In this study, we evaluated the need for hospital admission for simple isolated linear skull fractures by examining the occurrence of clinically important TBI (ci-TBI) and patient outcome. We performed a retrospective study evaluating pediatric TBI admissions from 2018 to 2023 using an institutional registry of TBI patients requiring neurosurgery consultation. Patients included in our study cohort were 17 years and younger at injury, had a head computed tomography with an isolated skull fracture and a Glasgow Coma Scale (GCS) of 14 to 15. We excluded patients who had an intracranial injury (ICI), fractures extending into the skull base, or crossing the sagittal sinus. We reviewed medical records to identify the presence of ci-TBI: ICI resulting in death, neurosurgical intervention, intubation for more than 24 h, or hospital admission for at least 2 nights due to TBI. Repeat imaging studies obtained were reviewed to assess the progression of injury and association with clinical deterioration. Patient outcome was evaluated with the Glasgow Outcome Score Extended (GOS-E) 6 months after injury. Univariable statistics were calculated for continuous variables and 95% confidence intervals were calculated using the Clopper-Pearson exact method for proportions that were very close to 0 or 1 and the Wilson score interval for small-to-moderate proportions. A total of 804 subjects were analyzed, and 402 (50.0%) patients had a BIG-2 injury. A total of 247 of these BIG-2 patients (61.4%) had a simple, non-displaced fracture, and no associated ICI; 198 of these patients (80.2%) were transferred from referring hospitals. In both primary admissions and transfers, no significant injury progression on imaging was noted, no neurosurgical intervention occurred, and no patient had ci-TBI (0/247; 95% CI: 0% to 1.5%). Six-month GOS-E was available in a subset (53.8%) of patients: 98.5% were discharged home and had a favorable outcome (defined as GOS-E 5 to 7). ci-TBI rarely develops in children with simple isolated non-displaced skull fractures indicating that hospital admission and inpatient observation may not be necessary. In the context of the BIG, these patients can be considered for re-classification to a BIG-1 injury, which can reduce interhospital transfer and admission rates following implementation, while maintaining patient safety. A revised BIG classification for pediatric injuries is proposed.

Introduction

In the United States, traumatic brain injury (TBI) and intracranial injury (ICI) are leading causes of death and disability in children, resulting in approximately 600,000 emergency department (ED) visits and 51,000 hospitalizations each year.¹ For these patients, neurosurgical consultation is common practice, occurring in up to 40% of cases.² Recent studies support the claim that restructuring the medical guidelines regarding TBI and ICI consultations may improve the triaging and treatment process for this patient population.² Originally published in 2014, the Brain Injury Guidelines (BIG) provided a set of criteria that would indicate when an adult patient could be safely treated in the acute care setting without needing neurosurgical consultation, hospital admission, or repeat imaging.

The current literature only consists of three, mostly retrospective studies that examine the BIG in pediatric (age 0–21) populations. In total, between all three studies, 502 patients were assessed, and very low neurosurgical intervention rates were observed in both BIG-1 and BIG-2 groups.^3
–5 Although these studies present a limited sample size, they provide grounds for potential administrative adjustment in the utilization of neurosurgical consultation and repeat imaging. At our institution, we recently published the largest validation of the BIG classification among 804 pediatric patients and found similar results.

To optimize the BIG for pediatric populations, we aimed to examine if any variables should be recategorized based on patient outcomes.⁶ Several articles exist looking into this notion in general, but none have described it in the context of the BIG criteria for pediatric patients. One example of a potential benign pathology is the isolated skull fracture. In a study that included 7228 children with isolated skull fractures, only 1 child required neurosurgical intervention, and no deaths were reported.⁷ This is important to note, as non-displaced skull fractures currently fall under the BIG-2 category. This means that hospital guidelines would need to support the admission, observation, computed tomography (CT) imaging, and neurosurgical consultation of all 7228 children. Moreover, many of these patients are initially screened at hospitals without neurosurgical support. Thus, requiring them to be transported to a regional trauma center for further evaluation. This current approach can create a significant degree of travel and financial burden on families, as well as costing hospitals millions in unnecessary expenditures.

In our preceding validation study of BIG in pediatric patients with mild TBI, we identified a sizable cohort of patients with isolated skull fractures classified as BIG-2 injuries. In this study, we seek to understand if this cohort of patients could be reclassified to the BIG-1 injury group. We hypothesize that pediatric patients with simple isolated non-displaced skull fractures do not progress to develop clinically important TBI (ci-TBI) and have favorable, outcomes at 6-month follow-up, allowing for re-classification to a BIG-1 injury.

Methods

Study design

Patient data were obtained from our previous retrospective study titled “Validating the Brain Injury Guidelines in a Pediatric Population with Mild TBI and Intracranial Injury at a Level I Trauma Center.”⁸ All patient data were collected from our institutional TBI registry between January 2017 and August 2023. This registry captures data of all patients with TBI and ICI or skull fractures for whom neurosurgical consultation was obtained during ED or hospital admission and was developed for institutional quality improvement purposes. We defined ICI as the presence of epidural, subdural, intraparenchymal hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage on the initial head CT and only used this initial imaging study for BIG classification of our data. Any patient research utilizing the registry data requires IRB approval and was obtained for this study (IRB #2032348).

We included any patient 17 years and younger at the time of injury, a positive head CT (i.e., any intracranial finding and/or skull fracture), and a post-resuscitation Glasgow Coma Scale (GCS) score of 14 or higher in accordance with the original classification of mild TBI.³ Patients who first presented to our ED after injury and those who were transferred to our ED from other hospitals were also included in our original study.

We performed a post hoc analysis of this data, focusing on patients with simple isolated non-displaced skull fractures who fell into the BIG-2 category, and examined their rate of developing ciTBI⁹ as well as their 6-month outcomes post discharge from the hospital. Simple isolated skull fractures were defined as non-displaced fractures not crossing the sagittal sinus. Occipital non-displaced fractures with proximity to or crossing the transverse sinus were included. If these fractures extended into the mastoid or skull base, they were considered to be more complex and excluded from our analysis. We used the previously published and well-validated PECARN criteria to define ci-TBI as ICI resulting in death, neurosurgical intervention, intubation for more than 24 h, or hospital admission for at least 2 nights due to head-related injury.^10,11 The medical records (progress notes and discharge summary) of patients were queried individually to assess the occurrence of ci-TBI.

We used the Glasgow Outcome Score Extended (GOS-E) to assess outcome 6 months following injury.¹² The GOS-E was abstracted from the institutional TBI registry and collected by personnel specifically trained to obtain outcome data utilizing a structured telephone interview prior to this retrospective study. The study personnel entering outcome data into the registry were trained with standardized patient scenarios to achieve consistency in the outcome assessment, but the interobserver agreement was not formally evaluated. Informed consent to perform the outcome assessment was not specifically obtained and per our institutional policy was not deemed necessary for obtaining and including GOS-E outcome data in the registry. No separate patient contact was made for the purposes of this retrospective study of already collected registry data.

Data collection

Among patients meeting inclusion criteria, abstracted variables from the registry included age at injury, sex, mechanism of injury, comorbidities, medication use, post-resuscitation GCS, pupillary exam, cranial CT findings, neurological exam, routine laboratory parameters (glucose, INR/PTT, hemoglobin) admission to intensive care unit (ICU), and hospital length of stay. At the time of ED or hospital discharge, we also abstracted whether patients went home or if they required additional rehabilitation or supervision in a skilled care facility.

Cranial CT findings, which were interpreted by the on-call neurosurgeon and radiologist during admission were recorded. In the event of conflicting radiology readings, the neurosurgery assessment was prioritized. For transfers from referring hospitals, the initial cranial CT findings from the referring hospital were entered into our database after a formal secondary review of the CT scan at our institution.

Statistical analyses

Univariable statistics, including frequency, arithmetic mean, and standard deviation, were calculated for continuous variables. Frequency and percentage were calculated for categorical variables. Ninety-five percent confidence intervals were calculated using the Clopper-Pearson exact method for proportions that were very close to 0 or 1 and the Wilson score interval for small-to-moderate proportions. The Clopper-Pearson exact method was chosen due to its conservative nature and accuracy in estimating intervals for extreme proportions. Chi-square analyses were used to compare the observed values with the expected values for the frequency of ci-TBI and the frequency of injury progression on repeat imaging. For group comparisons of demographic data, a Mann-Whitney U test was conducted to compare age distributions. For categorical variables, including sex, race, ethnicity, and mechanism of injury chi-square tests of independence were used to assess differences in distribution between groups. All statistical analyses were conducted using Stata Statistical Software, version 15.

Results

Between January 2017 and August 2023, 1259 pediatric patients were evaluated in the ED for TBI with a positive CT scan. Of this group, 804 patients met inclusion criteria (a post-resuscitation GCS of 14–15 and were admitted to the hospital or ED) and remained after applying exclusion criteria. Among patients included in the analyses, most (551, 68.5%) were transferred to our institution’s ED from another hospital’s ED prior to hospital admission.

Clinically important TBI

In the final cohort of 804 patients, 64 (8.0%) had ci-TBI. Following categorization using the BIG criteria, ci-TBI most often occurred in the BIG-3 category (59 of 227 patients, 26.0%) and was rarely observed among those with BIG-2 category injuries (4 of 402, 1.0%) (p < 0.0001).

Characteristics of BIG-2 patients with isolated non-displaced skull fractures

Three hundred and seventy-one patients in the BIG-2 category had a non-displaced skull fracture. In 247 (66.6%) patients, these were simple isolated non-displaced skull fractures. One hundred and ninety-eight of these patients (80.2%) were transferred from referring hospitals. Fourteen patients with isolated fractures (5.7%) underwent additional cranial imaging studies for the following reasons: initial CT from referring hospital not available (6), rule out vascular injury (6), clinical symptoms deemed suspicious for developing ICI (2). No new or developing vessel injury, ICI, or cerebral swelling was noted in the follow-up imaging studies, and all patients remained neurologically stable. All vascular imaging studies were obtained in patients who had non-displaced occipital skull fractures and yielded no evidence of transverse sinus injury or venous thrombosis. In both primarily admitted and transferred patients, no neurosurgical intervention occurred, and no patient developed ci-TBI (Table 1).

Table 1.

Clinical Course of Patients with BIG-2 Simple Isolated Non-Displaced Skull Fractures

Simple isolated non-displaced skull fractures	OSH (n = 198)	Primary (n = 49)
Hospital course
LOS >48 h due to TBI, n (%)	0 (0.0%, CI: 0.0–1.9%)	0 (0.0%, CI: 0.0–7.3%)
Admitted to ICU, n (%)	12 (6.1%, CI: 3.5–10.3%)	9 (18.4%, CI: 10.0–31.4%)
Intubation >24 h, n (%)	0 (0.0%, CI: 0.0–1.9%)	0 (0.0%, CI: 0.0–7.3%)
Neurosurgical intervention, n (%)	0 (0.0%, CI: 0.0–1.9%)	0 (0.0%, CI: 0–7.3%)
Patients with ci-TBI, n (%)	0 (0.0%, CI: 0.0–1.9%)	0 (0.0%, CI: 0–7.3%)

Confidence intervals are calculated as 95% intervals.

CI, confidence interval; ci-TBI, clinically important TBI; ICU, intensive care unit; LOS, length of stay; OSH, outside hospital transfer.

Demographics of BIG-2 patients with isolated non-displaced skull fractures

Median age at injury was 2 years old (IQR 5.17). Males made up 157 (59.5%) number of patients and females 100 (40.5%). White race and non-Hispanic or Latino ethnicity made up the majority of patients, at 148 (59.9%) and 179 (72.5%), respectively. The most common mechanism of injury was a fall at 189 (76.5%) (Table 2).

Table 2.

Patient Demographics

Age at injury (years)
Median	2
Interquartile Range	5.17
Range	2 days–17 years
Sex, n (% of category)
Female	100 (40.5)
Male	147 (59.5)
Race, n (% of category)
African American	17 (6.9)
Asian	23 (9.3)
White	148 (59.9)
Other	59 (23.9)
Ethnicity, n (% of category)
Hispanic or Latino	65 (26.3)
Not Hispanic or Latino	179 (72.5)
Other	3 (1.2)
Mechanism of injury, n (% of category)
Assault	1 (0.4)
Auto vs. pedestrian	10 (4.0)
Fall	189 (76.5)
MVA	16 (6.5)
Object to the head	3 (1.2)
Recreational activity^a	16 (6.5)
Other/unknown	12 (4.9)

Patient demographics for the subset of 247 patients with BIG-2 injury and a simple, non-displaced skull fracture not crossing a venous sinus or associated with intracranial injury.

Recreational activity includes all-terrain vehicles, bicycles, horses, and sports.

MVA, motor vehicle accident.

Hospital discharge and clinical outcomes of simple isolated non-displaced skull fracture patients

Two hundred and forty-two patients with simple isolated non-displaced skull fractures were discharged home. Five were discharged to the care of a foster home or relative. Six-month outcome could only be collected in a subset of the patients (133/247, 53.8%). The GOS-E of these patients is recorded in Table 3. The majority of patients had a favorable outcome (131/133, 98.5%). Two patients were classified as severely disabled 6 months after injury. As this would be an unusual outcome after a simple skull fracture, the medical records of these patients were explored separately to better understand this outcome. One patient had a clavicular fracture which may have caused difficulty with grooming and dressing, which could explain the severe disability score on the GOS-E. In the other patient, no particular identifiable cause was noted in the EMR chart review. In the notes of the pediatrician 3 months after injury, normal recovery from injury was noted.

Table 3.

Discharge Status and Outcome for BIG-2 Simple Isolated Non-Displaced Skull Fractures

Discharge status (home/other)	242/5
Six-month GOS-E
UGR	110 (82.7%, CI: 75.4–88.2%)
LGR	14 (10.5%, CI: 6.4–16.9%)
UMD	5 (3.8%, CI: 1.2–8.6%)
LMD	2 (1.5%, CI: 0.2–5.3%)
USD	1 (0.8%, CI: 0.0–4.1%)
LSD	1 (0.8%, CI: 0.0–4.1%)
V	0 (0.0%, CI: 0.0–2.7%)
D	0 (0.0%, CI: 0.0–2.7%)
Known GOS-E score	133
Unknown GOS-E score	114

Percentages are calculated as number of patients within known GOS-E category relative to total number of available GOS-E scores. Confidence intervals are calculated as 95% intervals.

CI, confidence interval; D, dead; GOS-E, Glasgow Outcome Score Extended; LGR, lower good recovery; LMD, lower moderate disability; UGR, upper good recovery; UMD, upper moderate disability; USD, upper severe disability; V, vegetative state.

Because a significant portion of patients did not have available 6-month GOS-E scores, we assessed potential demographic differences between the subset of patients with available GOS-E scores (n = 133) with those that do not have available scores (n = 114). Notably, we found no differences in distributions for age (p = 0.85), sex (p = 0.76), race (p = 0.17), ethnicity (p = 0.79), or mechanism of injury (p = 0.13).

Discussion

Patients with isolated simple skull fractures are historically classified as BIG-2 injuries and like patients with small intracranial hematomas, are routinely admitted to the hospital for observation and neurosurgical consultation.¹³ To understand if this level of care would be routinely necessary for this specific cohort of patients, we examined in this study if they developed ci-TBI after injury: of 247 patients with simple skull fractures, no patients developed cTBI, none required intervention from neurosurgery and the overall outcome 6 months after injury was favorable.

Our findings are in line with a recent meta-analysis published in 2023, that looked at 25 studies including 7228 children with isolated skull fractures and found that no children died.⁶ The study defined an isolated skull fracture via CT imaging diagnosis and the absence of any additional intracranial findings, such as hemorrhage or contusions.⁶ They did not differentiate the isolated skull fractures based on whether they crossed a suture line. This meta-analysis stated in their review that only one child needed emergency neurosurgery, which consisted of repair of the cerebral meninges on the day of admission to prevent a growing skull fracture. No additional details were made available, and it is possible this could have been a minimally displaced skull fracture known to be associated with dural tear at a higher frequency than a non-displaced skull fracture.⁵ This, of course, is only a speculation. Nonetheless, given our findings upon classification of pediatric patients using the BIG and considering the meta-analysis of over ∼7000 children with isolated skull fractures, we argue that the re-classification of simple isolated non-displaced skull fractures from BIG-2 to BIG-1 may be reasonable.

To date, only one article has suggested re-classification of this pathology from BIG-2 to BIG-1.⁵ The BIG classification, originally devised for adults, was only recently validated for pediatric patients. Currently, three, mostly retrospective, studies have examined BIG in pediatric patients (age 0–21), but they are limited to a small number of patients, 502 in total.^3
–5 One of these pediatric studies examined BIG-1 injuries in 28 children over a 4-year period and included 9 patients with minor skull fractures. Similarly, none of their patients underwent neurosurgical intervention. The authors suggested that re-classification of simple skull fractures to BIG-1 injury could be considered but would require validation in a larger study. This is also in alignment with the work from Waseem et al. who recently reviewed their experience in 26 children with isolated skull fractures and suggested managing these children outside the confines of a major trauma center may be a safe strategy.²² Our study, having assessed 247 patients with simple isolated non-displaced skull fractures, and finding no evidence of ci-TBI in this group, is currently the largest study to date providing evidence that such a strategy may be a safe consideration.

Repeat imaging studies were obtained in a small number of children (5.7%) for various reasons. In our review, we found that none of the patients of interest showed progression on repeat imaging, and no further neurosurgical interventions were required as a result of the repeat imaging. Regardless, this finding is not out of line with the literature. An earlier meta-analysis identified that of the 6646 children across 21 studies with known ED disposition data, 4914 were hospitalized for observation, pooled estimate of the average hospitalization rate 83% (95% CI: 71–92%; I² = 99%).¹⁴ In trying to understand the outcome of repeated neuroimaging, and in an effort to account for a lack of precise data provided in a single study,¹⁵ they conducted a sensitivity analysis based on the minimum and maximum number of patients with an isolated non-displaced linear skull fracture who could have received a repeated CT scan. Based on these estimates, they found that the total denominator of patients who underwent repeated neuroimaging in the eight studies reporting on this outcome ranged between 510 and 569. They concluded that overall, only six patients had a new intracranial hemorrhage, with a pooled estimate ranging from 0.0% (95% CI: 0.0–8.9%; I² = 76% [6/510]) to 0.0% (95% CI: 0.0–9.0%; I² = 77% [6/569]) and finished by stating that none of the six children with new intracranial hemorrhage required neurosurgery,^16,17 consistent with our findings.

Our study is the only clinical series in which long-term outcomes (6 months) following discharge were assessed. In prior studies, only status after discharge was evaluated. Our patients had similar favorable discharge outcomes compared to these prior studies (i.e., they went home after their injuries), consistent with the expected outcome after mild TBI.^3
–5,18 In addition, we demonstrate the overall favorable outcome is sustained even though we were only able to have outcomes examined in a subset of patients, lending further support to the supposition that re-classification of simple isolated non-displaced skull fractures may not only be reasonable but is also safe.

In closing, considering our findings and review of the literature, we propose new management of simple isolated non-displaced skull fractures and recommendations for when to engage a neurosurgical consultant and consider repeat imaging illustrated by Table 4. Given their risk profile, we propose to reclassify them as BIG-1 injuries, indicating they can be observed and managed outside the confines of a level 1 trauma center and without the need for neurosurgery consultation, provided adequate ED experience and radiology support is available to support the care of these children. In a setting of many smaller rural hospitals surrounding a regional level 1 trauma center, this re-classification to a BIG-1 injury could significantly reduce the number of children transferred, put less strain on the parents to travel long distances to support their child, and use the resources of a level 1 trauma center more efficiently. In addition, the requirement for hospital admission and 24-h observation would no longer be necessary, and patients could be discharged after a 6–8 h observation in the ED, further reducing the demand for health care resources.

Table 4.

Proposed BIG Classification

VARIABLE	UCD-BIG-1 (estimated ci-TBI risk 0.6%)	UCD-BIG-2 (estimated ci-TBI risk 0.99%)	UCD-BIG-3 (estimated ci-TBI risk 26%)
Neurological exam	Normal	Normal	Abnormal
Intoxication	No	No/yes	No/yes
Skull fracture	Simple linear not crossing sutures	Other non-displaced	Displaced/depressed
EDH	No	No	Yes
SDH	≤4 mm	5–7 mm	≥8 mm
IPH	≤4 mm, 1 location	3–7 mm, 2 locations	≥ 8 mm, or multiple locations
IVH	No	No	Yes
SAH	Trace, 1–2 sulci	Localized, 3 or more sulci	Scattered
Therapeutic plan
Hospitalization	No, ED observation 6–8 h	Yes	Yes
Routine repeat imaging	No	No	Yes
NSG consultation	Yes/no^*	Yes	Yes

Indicates that Neurosurgery consultation is not necessary given adequate ED experience and radiology support, but can still be utilized if appropriate.

As previously outlined in the companion article reclassifying isolated skull fractures to a BIG-1 injury aligns with the PECARN definition of a low risk for ci-TBI (i.e., a predicted risk of 0.05–0.06%).¹⁹ In line with prior recommendations, and recognizing increasing injury severity represented by displaced, skull base and depressed fractures we propose for these fracture types to continue to be identified as BIG-2 and -3 injuries (Table 4).

Last, a separate note on patients with linear occipital skull fractures. It has been our clinical experience that these fractures may cross the transverse sinus, but if they are without extension into the skull base or mastoid, they typically are not associated with vascular injuries. Earlier in our experience, we obtained CT venograms in all patients with occipital fractures but abandoned that practice because we did not find significant venous injuries with occipital fractures unless patient had significant and protracted headaches, or if the fractures were displaced. For this reason, we have not excluded occipital skull from re-classification to BIG-1. A more detailed analysis may be necessary to fully evaluate this nuance and a prospective study evaluating our adaptations may be necessary to fully understand the implications and impact on pediatric patient care.

Strength and limitations

A strength of our study is the sample size: this is the largest pediatric study reported to date, examining patients in all BIG injury categories, and specifically the BIG-2 category. Furthermore, our data were meticulously collected in an institutional database within 24 h of patient admission, after medical record and imaging review by dedicated study personnel. Systematic data audits were completed to ensure the integrity of the data set and reduce data collection errors. Additionally, three individuals independently determined the BIG categorization and ci-TBI classification and met consensus, although no formal inter-rater reliability assessments were conducted (e.g., Cohen’s Kappa).²⁰

This study is subject to limitations consistent with retrospective single institution studies. That is, there is limited generalizability, thus multi-institutional studies may assist in widening the application of this guideline. Another limitation is that this study included polytrauma patients. While we considered this during data review and attempted to identify the patients with multisystem injuries by abbreviated injury score in our study, transfer ratios and outcomes may be skewed due to this patient population. It is also possible that race/ethnicity/socioeconomic status and age may be effect modifiers as they may affect patient outcomes and components of ci-TBI such as the length of hospital stay.^21,22 Given our sample size, we could not analyze these categories separately, thus socioeconomic data were not collected. Additionally, this study captured data through a time period when our institutional policy for ICU admission changed and this could have affected patient outcome, even though ICU admission was not a specific end-point of our study. Moreover, only a small proportion of our patients were admitted to the ICU, precluding meaningful analysis of outcome differences, that may have been very subtle to begin with. This may be an area for future research.

This study was also conducted at a major level 1 regional trauma center with an experienced trauma team, expert radiology support, and neurosurgery on site. It therefore remains to be determined if our findings can be extrapolated and implemented in a lower-resource environment. Lastly, the outcome data collected in this study were incomplete in a large proportion of patients, making it possible to miss outcome differences between BIG injury groups. We suspect we did not find an association between injury severity and GOS-E because all patients had a mild TBI with a GCS of 14–15 and were adequately managed for their injuries. Moreover, the GOS-E may not be able to pick up subtle outcome differences in these patients. Future larger prospective studies with sufficient patient follow-up may be able to determine if the BIG classification is able to predict more subtle outcome differences and recovery differences that can significantly affect the lives of the patients.

Conclusion

ci-TBI rarely develops in children with isolated simple skull fractures indicating that hospital admission and inpatient observation may not be necessary. In the context of the BIG, these patients can be considered for re-classification to a BIG-1 injury, which can reduce interhospital transfer and admission rates following implementation, while maintaining patient safety. A revised BIG classification for pediatric injuries is proposed.

Transparency, Rigor, and Reproducibility

The retrospective study was approved by the institutional review board (#2032348-1). The analysis plan was not formally pre-registered, however was further investigated upon submission and acceptance of a previous validation sent to the Neurotrauma journal under the same IRB. Therefore, the transparency, rigor, and reproducibility of this study are identical to that which proceeded it.

No experiments were performed on subjects, and randomization was not required for this study. Data were labeled using codes not linked to participant identifying information. Data were collected from our institutional Traumatic Brain Injury (TBI) Registry, which is an IRB-approved longitudinal database project. Those individuals who were tasked to collect data regarding this study were trained to chart review pediatric patients treated for TBI, screen for pre-defined variables, and navigate REDCap electronic data capture. A waiver of consent was used to enter all clinical and imaging data obtained in the acute care phase into this registry. Other study personnel, blinded to the acute phase of patient care, were trained to contact the care provider (i.e., parent, legal guardian) of each patient 6 months after injury. These individuals were trained separately by providing written case scenarios on how to determine GOS-E. These data were also stored in the registry using the REDCap electronic data capture tool and maintained separately from the acute care phase data. All equipment and software used to perform acquisition and analysis are widely available from Microsoft (i.e., Microsoft Word, Microsoft Excel) and Stata. Due to the retrospective nature of the study, investigators were not blinded. The study was developed by investigators with decades of medically licensed practice managing pediatric traumatic brain injuries in the hospital setting, in addition to experience in designing clinical trials and leadership in quality improvement initiatives. Statistical analysis was performed by Dr. James Marcin with qualifications including a Master of Public Health with a concentration in Biostatistics. No replication or external validation studies have been performed or are planned/ongoing to our knowledge. De-identified data from this study are not available in a public archive. There is no analytic code associated with this study. Materials used to conduct the study are not publicly available. The authors agree to provide the full content of the article on request by contacting Marike Zwienenberg, MD, or Dharminder S. Ojla (corresponding author).

Footnotes

Authors’ Contributions

J.C.: Data curation, writing—review and editing. J.T.M.: Data curation. D.S.O.: Writing—review and editing. N.Y. Data curation, writing—review and editing. J.E.K.: Writing—review and editing. J.P.M.: Writing—review and editing. D.K.N.: Writing—review and editing. K.S.: Writing—review and editing. M.Z.: Conceptualization, data curation, formal analysis, methodology, supervision, writing—original draft, writing—review and editing.

Author Disclosure Statement

There are no conflicts of interest to disclose.

Funding Information

There was no funding provided for this research.

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