Abstract

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.

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