U.S. Trends of ED Visits for Pediatric Traumatic Brain Injuries: Implications for Clinical Trials.
U.S. Trends of ED Visits for Pediatric Traumatic Brain Injuries: Implications for Clinical Trials.
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DOI：
10.3390/ijerph14040414
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发表时间：
2017-04-13
影响因子：
--
通讯作者：
Xiang H
中科院分区：
文献类型：
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作者：
Chen C;Shi J;Stanley RM;Sribnick EA;Groner JI;Xiang H
我们的目标是使用2006-2013年全国急诊科样本(NeDS)数据库来描述在美国急诊科(EDS)治疗的儿童创伤性脑损伤(TBI)的年度患者数量、患者人口统计学和医院特征的趋势；并使用相同的数据库来估计可用于各种儿科TBI病例临床试验的样本量。计算了国家对儿童脑外伤患者人口统计和医院特征的估计。模拟分析评估了在不同情况下随机选择的医院中纳入未来临床试验的儿科TBI病例的潜在数量。2006年至2013年，NeDS数据库估计，在去急诊室就诊的215,204,932名儿童中，6,089,930名(2.83%)被诊断为脑外伤。在美国急诊室的研究期间，儿童脑外伤患者增加了34.1%。模拟分析表明，每年有1,000次脑创伤急诊就诊的医院急诊室、I级和II级创伤中心、儿科医院和教学医院可能会为儿科脑损伤研究提供充足的病例。然而，由于样本量小，从有限数量的医院急救人员中招募严重的儿科脑损伤病例进行临床试验将是具有挑战性的。从2006年到2013年，美国与脑外伤相关的儿科急诊室就诊人数增加了30%以上。纳入ICD-9-CM代码为959.01的未指明的头部损伤病例将显著改变国家估计数和儿童脑外伤病例的人口统计模式。未来对脑外伤儿童的临床试验应该进行仔细的可行性评估，以估计他们在选定的研究地点的样本量和研究能力。
Our goal in this paper was to use the 2006–2013 Nationwide Emergency Department Sample (NEDS) database to describe trends of annual patient number, patient demographics and hospital characteristics of pediatric traumatic brain injuries (TBI) treated in U.S. emergency departments (EDs); and to use the same database to estimate the available sample sizes for various clinical trials of pediatric TBI cases. National estimates of patient demographics and hospital characteristics were calculated for pediatric TBI. Simulation analyses assessed the potential number of pediatric TBI cases from randomly selected hospitals for inclusion in future clinical trials under different scenarios. Between 2006 and 2013, the NEDS database estimated that of the 215,204,932 children who visited the ED, 6,089,930 (2.83%) had a TBI diagnosis. During the study period in the US EDs, pediatric TBI patients increased by 34.1%. Simulation analyses suggest that hospital EDs with annual TBI ED visits >1000, Levels I and II Trauma Centers, pediatric hospitals, and teaching hospitals will likely provide ample cases for pediatric TBI studies. However, recruiting severe pediatric TBI cases for clinical trials from a limited number of hospital EDs will be challenging due to small sample sizes. Pediatric TBI-related ED visits in the U.S. increased by over 30% from 2006 to 2013. Including unspecified head injury cases with ICD-9-CM code 959.01 would significantly change the national estimates and demographic patterns of pediatric TBI cases. Future clinical trials of children with TBI should conduct a careful feasibility assessment to estimate their sample size and study power in selected study sites.