Abstract：
BACKGROUND: Traumatic brain injury is a common ED presentation. CT-head utilisation is escalating, exacerbating resource pressure in the ED. The biomarker S100B could assist clinicians with CT-head decisions by excluding intracranial pathology. Diagnostic performance of S100B was assessed in patients meeting National Institute of Health and Clinical Excellence Head Injury Guideline (NICE HIG) criteria for CT-head within 6 and 24 hours of injury.
METHODS: This multicentre prospective observational study included adult patients presenting to the ED with head injuries between May 2020 and June 2021. Informed consent was obtained from patients meeting NICE HIG CT-head criteria. A venous blood sample was collected and serum was tested for S100B using a Cobas Elecsys-S100 module; >0.1 µg/mL was the threshold used to indicate a positive test. Intracranial pathology reported on CT-head scan by the duty radiologist was used as the reference standard to review diagnostic performance.
RESULTS: This study included 265 patients of whom 35 (13.2%) had positive CT-head findings. Within 6 hours of injury, sensitivity of S100B was 93.8% (95% CI 69.8% to 99.8%) and specificity was 30.8% (22.6% to 40.0%). Negative predictive value (NPV) was 97.3% (95% CI 84.2% to 99.6%) and area under the curve (AUC) was 0.73 (95% CI 0.61 to 0.85; p=0.003). Within 24 hours of injury, sensitivity was 82.9% (95% CI 66.4% to 93.44%) and specificity was 43.0% (95% CI 36.6% to 49.7%). NPV was 94.29% (95% CI 88.7% to 97.2%) and AUC was 0.65 (95% CI 0.56 to 0.74; p=0.046). Theoretically, use of S100B as a rule-out test would have reduced CT-head scans by 27.1% (95% CI 18.9% to 36.8%) within 6 hours and 37.4% (95% CI 32.0% to 47.2%) within 24 hours. The risk of missing a significant injury with this approach would have been 0.75% (95% CI 0.0% to 2.2%) within 6 hours and 2.3% (95% CI 0.5% to 4.1%) within 24 hours.
CONCLUSIONS: Within 6 hours of injury, S100B performed well as a diagnostic test to exclude significant intracranial pathology in low-risk patients presenting with head injury. In theory, if used in addition to NICE HIGs, CT-head rates could reduce by one-quarter with a potential miss rate of <1%.
METHODS: This multicentre prospective observational study included adult patients presenting to the ED with head injuries between May 2020 and June 2021. Informed consent was obtained from patients meeting NICE HIG CT-head criteria. A venous blood sample was collected and serum was tested for S100B using a Cobas Elecsys-S100 module; >0.1 µg/mL was the threshold used to indicate a positive test. Intracranial pathology reported on CT-head scan by the duty radiologist was used as the reference standard to review diagnostic performance.
RESULTS: This study included 265 patients of whom 35 (13.2%) had positive CT-head findings. Within 6 hours of injury, sensitivity of S100B was 93.8% (95% CI 69.8% to 99.8%) and specificity was 30.8% (22.6% to 40.0%). Negative predictive value (NPV) was 97.3% (95% CI 84.2% to 99.6%) and area under the curve (AUC) was 0.73 (95% CI 0.61 to 0.85; p=0.003). Within 24 hours of injury, sensitivity was 82.9% (95% CI 66.4% to 93.44%) and specificity was 43.0% (95% CI 36.6% to 49.7%). NPV was 94.29% (95% CI 88.7% to 97.2%) and AUC was 0.65 (95% CI 0.56 to 0.74; p=0.046). Theoretically, use of S100B as a rule-out test would have reduced CT-head scans by 27.1% (95% CI 18.9% to 36.8%) within 6 hours and 37.4% (95% CI 32.0% to 47.2%) within 24 hours. The risk of missing a significant injury with this approach would have been 0.75% (95% CI 0.0% to 2.2%) within 6 hours and 2.3% (95% CI 0.5% to 4.1%) within 24 hours.
CONCLUSIONS: Within 6 hours of injury, S100B performed well as a diagnostic test to exclude significant intracranial pathology in low-risk patients presenting with head injury. In theory, if used in addition to NICE HIGs, CT-head rates could reduce by one-quarter with a potential miss rate of <1%.
摘要：
背景：创伤性脑损伤是常见的ED表现。CT头的使用率正在上升，加剧了ED的资源压力。生物标志物S100B可以通过排除颅内病理学来帮助临床医生进行CT-头部决策。S100B的诊断性能在受伤后6和24小时内符合美国国立卫生与临床卓越研究院头部损伤指南（NICEHIG）CT头部标准的患者中进行了评估。
方法：这项多中心前瞻性观察性研究包括2020年5月至2021年6月期间因头部受伤而出现ED的成年患者。从符合NICEHIGCT头标准的患者获得知情同意。收集静脉血样品，并使用CobasElecsys-S100模块测试血清的S100B；>0.1µg/mL是用于指示阳性测试的阈值。值班放射科医生在CT头颅扫描中报告的颅内病理被用作参考标准来审查诊断性能。
结果：本研究纳入了265例患者，其中35例（13.2%）的头颅CT表现为阳性。受伤后6小时内,S100B的敏感性为93.8%(95%CI69.8%~99.8%),特异性为30.8%(22.6%~40.0%).阴性预测值（NPV）为97.3%（95%CI84.2%至99.6%），曲线下面积（AUC）为0.73（95%CI0.61至0.85；p=0.003）。受伤后24小时内,敏感性为82.9%(95%CI为66.4%~93.44%),特异性为43.0%(95%CI为36.6%~49.7%).NPV为94.29%（95%CI为88.7%至97.2%），AUC为0.65（95%CI为0.56至0.74；p=0.046）。理论上,使用S100B作为排除性检查,6小时内的CT头颅扫描将减少27.1%(95%CI18.9%~36.8%),24小时内减少37.4%(95%CI32.0%~47.2%).这种方法在6小时内错过重大伤害的风险为0.75％（95％CI0.0％至2.2％），在24小时内为2.3％（95％CI0.5％至4.1％）。
结论：受伤后6小时内，S100B表现良好，作为诊断测试，以排除低危的颅脑损伤患者的重要颅内病理。理论上,如果除了NICEHIGS之外还使用，CT头颅率可减少四分之一，潜在的漏检率<1%。
方法：这项多中心前瞻性观察性研究包括2020年5月至2021年6月期间因头部受伤而出现ED的成年患者。
结果：本研究纳入了265例患者，其中35例（13.2%）的头颅CT表现为阳性。
结论：受伤后6小时内，
