Can serum biomarkers be used to rule out significant intracranial pathology in emergency department patients with mild traumatic brain injury? A Systemic Review &amp; Meta-Analysis

Rogan, Alice; O'Sullivan, Morgane Brunton; Holley, A.; McQuade, David; Larsen, Peter

doi:10.1016/j.injury.2021.10.015

Cited by 16 publications

(16 citation statements)

References 25 publications

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“…Regarding the optimal timing of S100B measurement, this study demonstrates that within 6-hours of head injury is superior to within 24-hours of injury. The 6-hour data in this study is consistent with international data 12 demonstrating the diagnostic ability of S100B to exclude intracranial pathology within 6-hours was between 83-99% sensitivity with a NPV of 87.5-100%. While a 3-hour time limit was noted to be superior with sensitivity of 98-100% and NPV of 97-100%, we did not view a 3-hour window to be long enough for clinical practice.…”

Section: Discussionsupporting

confidence: 90%

“…The lower limit of detection is <0.005ug/L. The reference standard for S100B to rule out S100B has been clinically validated at 0.1ug/ml, 12,27 and is documented in the S100B Cobas pack insert available from Roche Diagnostics. Patients with S100B >0.1ug/ml were recorded as a positive test and those <0.1ug/ml recorded as a negative test.…”

Section: Blood Samplingmentioning

confidence: 99%

“…We are reassured these results are still of value given our sample size is above the median for studies of this type and our key results have narrow con dence intervals that are within similar ranges of other published studies. 12 However, positive CT heads are the critical factor when determining the diagnostic performance of the test, so ideally a larger sample with higher positive CT rates is required to rigorously test S100B in a variety of clinical settings. It should also be noted that the NICE guidelines were not developed to exclude non-depressed fractures.…”

Section: Limitationsmentioning

confidence: 99%

“…11 Despite this, S100B has been shown to be a sensitive marker for predicting intracranial pathology on CT-head scans in patients that present to ED with a head injury. 12 Although GFAP is potentially more accurate diagnostically, 13 and the combination of GFAP & UCH-L1 as a panel has recently being approved by the Food and Drug Agency in the USA, 14 S100B remains the only biomarker with a validated clinical platform and pre-speci ed threshold for intracranial injury; making it the current biomarker of choice for use in ED. 4,15 The use of S100B as a rule out test in a clinical guideline for TBI has demonstrated that this is feasible and potentially cost saving, reducing CT-head rates by a third.…”

Section: Introductionmentioning

confidence: 99%

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Diagnostic performance of S100B as a rule out test for intracranial pathology in head injured patients presenting to the Emergency Department who meet NICE CT-head criteria- A BRAIN Project Study

Rogan

Sik

Dickinson

et al. 2022

Preprint

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Background: Traumatic brain injury (TBI) is a common Emergency Department (ED) presentation. CT-head utilisation is escalating, exacerbating resource pressure in ED. The biomarker S100B could assist clinicians with CT-head decisions by excluding intracranial pathology. Diagnostic performance of S100B was assessed in patients meeting NICE CT-head criteria within 6 and 24-hours of injury. Methods: This multi-centre prospective observational study included adult patients presenting to ED with mild TBI who were able to give their own informed consent and had a CT-head scan performed as part of standard care. Patients were recruited using consecutive sampling methods. Informed consent was obtained prior to blood sampling. Serum was tested for S100B using a Cobas Elecsys S100 module; >0.1ug/ml is the validated threshold indicating a positive test. Diagnostic performance was assessed using ROC analysis as well as sensitivity, specificity, NPV and PPV calculations. Results: There were 265 included patients, and 35 (13.2%) had a positive CT-head. The sensitivity of S100B when performed within 24 hours of injury was 82.9% (95%CI 66.4-93.44) and specificity was 43.0% (95%CI 36.6–49.7%). NPV was 94.29% (95%CI 88.7–97.2). Within 6 hours sensitivity was 93.8% (95%CI 69.8–99.8%) and specificity was 30.8% (22.6–40.0%). NPV was 97.3% (95%CI 84.2–99.6%). Theoretically, use of S100B as a rule out test would have reduced CT scans by 37.4% within 24 hours and 27.1% within 6-hours. The risk of missing a significant injury with this approach would have been 2.3% within 24 hours and 0.75% within 6-hours. Conclusion Within 6-hours of injury, S100B performed well as a diagnostic test to exclude significant intracranial pathology in patients presenting with mild head injuries, with low risk of missed injury. In theory, if used in addition to NICE CT-head guidelines, CT-head request rates could reduce by one quarter and one fifth of patients could be discharged earlier from ED. What is already known on this topic S100B has shown promise diagnostically as an objective marker that can rule out intracranial injuries in head injured patients. S100B has a validated platform that could potentially be used to reduce CT head demand in ED. However, evidence testing the added value of biomarkers to existing clinical guidelines are limited. What this study adds This study demonstrates that S100B could theoretically reduce CT-head demand and enable earlier ED discharge in low-risk patients meeting NICE CT-head criteria. The included population were GCS 15, had no post traumatic amnesia and were able to consent for themselves. This low-risk population have a low yield of traumatic CT abnormalities and could be a suitable population to target biomarker use. How this study might affect research, practice or policy S100B has the potential to reduce CT-head demand, thereby benefitting EDs by reducing overcrowding, resource burden and healthcare costs; and from the patients’ perspective, enable shorter waits, earlier intervention and earlier discharge. Further research should focus on optimising the performance of S100B within the NICE CT-head guidelines in low-risk patients, and review real-time economic benefits.

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Section: Discussionsupporting

confidence: 90%

Section: Blood Samplingmentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Diagnostic performance of S100B as a rule out test for intracranial pathology in head injured patients presenting to the Emergency Department who meet NICE CT-head criteria- A BRAIN Project Study

Rogan

Sik

Dickinson

et al. 2022

Preprint

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“…The Scandinavian guidelines with S100B incorporated reduce CT usage and costs ( 67 ). A recent meta-analysis confirms this approach ( 68 ). Other studies have shown, however, the presence of peripheral trauma may impact serum values [e.g., ( 69 )].…”

Section: Clinical Studies and Current Use In Tbi (Including Injuries ...mentioning

confidence: 84%

GFAP and S100B: What You Always Wanted to Know and Never Dared to Ask

et al. 2022

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Traumatic brain injury (TBI) is a major global health issue, with outcomes spanning from intracranial bleeding, debilitating sequelae, and invalidity with consequences for individuals, families, and healthcare systems. Early diagnosis of TBI by testing peripheral fluids such as blood or saliva has been the focus of many research efforts, leading to FDA approval for a bench-top assay for blood GFAP and UCH-L1 and a plasma point-of-care test for GFAP. The biomarker S100B has been included in clinical guidelines for mTBI (mTBI) in Europe. Despite these successes, several unresolved issues have been recognized, including the robustness of prior data, the presence of biomarkers in tissues beyond the central nervous system, and the time course of biomarkers in peripheral body fluids. In this review article, we present some of these issues and provide a viewpoint derived from an analysis of existing literature. We focus on two astrocytic proteins, S100B and GFAP, the most commonly employed biomarkers used in mTBI. We also offer recommendations that may translate into a broader acceptance of these clinical tools.

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Management of traumatic brain injury in adult—A cross‐sectional national study

Modin,

Wickbom,

Kamis

et al. 2023

Health Science Reports

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BackgroundMild traumatic brain injury (mTBI) is a common cause for seeking care. Previous studies have shown considerable variations in TBI management. New guidelines may have influenced management routines.MethodsThis is a descriptive cross‐sectional study, collecting data through structured questionnaires. All Swedish emergency hospitals that manage and treat adult patients with mTBI (Reaction Level Scale [RLS] 1–3, Glasgow Coma Scale [GCS] 13–15, age > 18 years) for the initial 24 h after injury were included in this study.ResultsThe response rate among hospitals fulfilling the study criteria's was 61/67 (91%). We observed a distinct predominance of nonspecialists being responsible for the initial management of these patients, with general surgeons and ED‐physicians being the dominating specialties. A total of 45/61 (74%) of the hospitals use a guideline when managing TBI, with 12 hospitals (20%) stating that no guideline was used.ConclusionIn general, established guidelines are used for the management of TBI in Sweden. However, some of these are outdated and several hospitals used local guidelines not based upon reliable evidence‐based methodology. Most patients with TBI are managed by nonspecialist doctors, stressing the need of a reliable guideline.

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Can serum biomarkers be used to rule out significant intracranial pathology in emergency department patients with mild traumatic brain injury? A Systemic Review & Meta-Analysis

Cited by 16 publications

References 25 publications

Diagnostic performance of S100B as a rule out test for intracranial pathology in head injured patients presenting to the Emergency Department who meet NICE CT-head criteria- A BRAIN Project Study

Diagnostic performance of S100B as a rule out test for intracranial pathology in head injured patients presenting to the Emergency Department who meet NICE CT-head criteria- A BRAIN Project Study

GFAP and S100B: What You Always Wanted to Know and Never Dared to Ask

Management of traumatic brain injury in adult—A cross‐sectional national study

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