Chen Cheng, Shi Junxin, Stanley Rachel M, Sribnick Eric A, Groner Jonathan I, Xiang Henry
Center for Pediatric Trauma Research, The Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH 43205, USA.
Center for Injury Research and Policy, The Research Institute at Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH 43205, USA.
Int J Environ Res Public Health. 2017 Apr 13;14(4):414. doi: 10.3390/ijerph14040414.
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.
在本文中，我们的目标是利用2006 - 2013年全国急诊科样本（NEDS）数据库，描述美国急诊科治疗的小儿创伤性脑损伤（TBI）的年度患者数量、患者人口统计学特征和医院特征趋势；并使用同一数据库估计小儿TBI病例各种临床试验的可用样本量。计算了小儿TBI患者人口统计学特征和医院特征的全国估计值。模拟分析评估了在不同情况下，从随机选择的医院纳入未来临床试验的小儿TBI病例的潜在数量。2006年至2013年期间，NEDS数据库估计，在215,204,932名就诊于急诊科的儿童中，有6,089,930名（2.83%）被诊断为TBI。在美国急诊科的研究期间，小儿TBI患者增加了34.1%。模拟分析表明，每年TBI急诊就诊人数>1000的医院急诊科、一级和二级创伤中心、儿童医院和教学医院可能为小儿TBI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诊科招募严重小儿TBI病例进行临床试验将具有挑战性。2006年至2013年期间，美国与小儿TBI相关的急诊就诊人数增加了30%以上。将ICD - 9 - CM编码为959.01的未明确头部损伤病例纳入会显著改变小儿TBI病例的全国估计值和人口统计学模式。未来小儿TBI患儿的临床试验应进行仔细的可行性评估，以估计在选定研究地点的样本量和研究效能。
