Holmes James F, Holubkov Richard, Kuppermann Nathan
Department of Emergency Medicine, UC Davis School of Medicine, Sacramento, CA, USA.
Acad Emerg Med. 2009 Jan;16(1):15-20. doi: 10.1111/j.1553-2712.2008.00293.x. Epub 2008 Nov 12.
Enrolling children in research studies in the emergency department (ED) is typically dependent on the presence of a guardian to provide written informed consent.
The objectives were to determine the rate of guardian availability during the initial ED evaluation of children with nontrivial blunt head trauma, to identify the reasons why a guardian is unavailable, and to compare clinical factors in patients with and without a guardian present during initial ED evaluation.
This was a prospective study of children (<18 years of age) presenting to a single Level 1 trauma center after nontrivial blunt head trauma over a 10-month period. Physicians documented patient history and physical examination findings onto a structured data form after initial evaluation. The data form contained data points regarding the presence or absence of the patient's guardian during the initial ED evaluation. For those children for whom the guardian was not available during the initial ED evaluation, the physicians completing the data forms documented the reasons for the absence.
The authors enrolled 602 patients, of whom 271 (45%, 95% confidence interval [CI] = 41% to 49%) did not have a guardian available during the initial ED evaluation. In these 271 patients, 261 had reasons documented for lack of guardian availability, 43 of whom had multiple reasons. The most common of these was that the guardian did not ride in the ambulance (51%). Those patients without a guardian available were more likely to be older (mean age, 11.4 years vs. 7.6 years; p < 0.001), be victims of a motor vehicle collision (MVC; 130/268 [49%] vs. 35/328 [11%]; p < 0.001), have a Glasgow Coma Scale (GCS) score <14 (21/269 [7.8%] vs. 11/331 [3.3%]; p = 0.02), and undergo cranial computed tomography (CT) scanning (224/271 [83%] vs. 213/331 [64%]; p < 0.001). Multivariate analysis identified similar independent risk factors for lack of guardian presence.
Nearly one-half of children with nontrivial blunt head trauma evaluated in the ED may not have a guardian available during their initial ED evaluation. Patients whose guardians are not available at the time of initial ED evaluation are older and have more severe mechanisms of injury and more serious head trauma. ED research studies of pediatric trauma patients that require written informed consent from a guardian at the time of initial ED evaluation and treatment may have difficulty enrolling targeted sample size numbers and will likely be limited by enrollment bias.
在急诊科(ED)招募儿童参与研究通常依赖监护人在场以提供书面知情同意书。
目的是确定在对非轻微钝性头部创伤儿童进行首次急诊科评估期间监护人在场的比例,找出监护人不在场的原因,并比较首次急诊科评估期间有监护人和无监护人在场患者的临床因素。
这是一项对在10个月期间因非轻微钝性头部创伤就诊于单一一级创伤中心的18岁以下儿童进行的前瞻性研究。医生在首次评估后将患者病史和体格检查结果记录在结构化数据表格上。该数据表格包含关于首次急诊科评估期间患者监护人是否在场的数据点。对于那些在首次急诊科评估期间监护人不在场的儿童,填写数据表格的医生记录了不在场的原因。
作者纳入了602例患者,其中271例(45%,95%置信区间[CI]=41%至49%)在首次急诊科评估期间没有监护人在场。在这271例患者中,261例记录了监护人不在场的原因,其中43例有多个原因。最常见的原因是监护人未乘坐救护车(51%)。那些没有监护人在场的患者更可能年龄较大(平均年龄11.4岁对7.6岁;p<0.001),是机动车碰撞(MVC)的受害者(130/268[49%]对35/328[11%];p<0.001),格拉斯哥昏迷量表(GCS)评分<14(21/269[7.8%]对11/331[3.3%];p=0.02),并接受头颅计算机断层扫描(CT)(224/271[83%]对213/331[64%];p<0.001)。多变量分析确定了类似的缺乏监护人在场的独立危险因素。
在急诊科接受评估的非轻微钝性头部创伤儿童中,近一半在首次急诊科评估期间可能没有监护人在场。在首次急诊科评估时监护人不在场的患者年龄较大,损伤机制更严重,头部创伤更严重。在首次急诊科评估和治疗时需要监护人书面知情同意的儿科创伤患者的急诊科研究可能难以招募到目标样本量,并且可能会受到入组偏倚的限制。