Search

OBJECTIVES: In preparation for a clinical trial of therapeutic agents for children with moderate-to-severe blunt traumatic brain injuries (TBIs) in emergency departments (EDs), we conducted this feasibility study to 1) determine the number and clinical characteristics of eligible children, 2) determine the timing of patient and guardian arrival to the ED, and 3) describe the heterogeneity of TBIs on computed tomography (CT) scans. METHODS: We conducted a prospective observational study at 16 EDs of children ≤ 18 years of age presenting with blunt head trauma and Glasgow Coma Scale (GCS) scores of 3-12. We documented the number of potentially eligible patients, timing of patient and guardian arrival, patient demographics and clinical characteristics, severity of injuries, and cranial CT findings. RESULTS: We enrolled 295 eligible children at the 16 sites over 6 consecutive months. Cardiac arrest and non-survivable injuries were the most common characteristics that would exclude patients from a future trial. Most children arrived within 2 hours of injury, but most guardians did not arrive until 2-3 hours after the injury. There was a substantial range in types of TBIs, with subdural hemorrhages being the most common. CONCLUSION: Enrolling children with moderate-to-severe TBI into time sensitive clinical trials will require large numbers of sites, meticulous preparation and coordination, and will prove challenging to obtain informed consent given the timing of patient and guardian arrival. The Federal Exception from Informed Consent for Emergency Research will be an important consideration for enrolling these children. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved. Language: en

ACADEMIC EMERGENCY MEDICINE 2012; 19:161–173 © 2012 by the Society for Academic Emergency Medicine Abstract Objectives: Recent efforts to increase emergency medical services (EMS) prehospital research productivity by focusing on reducing systems-related barriers to research participation have had limited effect. The objective of this study was to explore the barriers and motivators to participating in research at the agency and provider levels and to solicit suggestions for improving the success of prehospital research projects. Methods: The authors conducted a qualitative exploratory study of EMS personnel using focus group and focused interview methodology. EMS personnel affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) hospitals were selected for participation using a purposive sampling plan. Exploratory questioning identified identified factors that influence participation in research and suggestions for ensuring successful research partnerships. Through iterative coding and analysis, the factors and suggestions that emerged from the data were organized into a behavioral change planning model. Results: Fourteen focus groups were conducted, involving 88 EMS prehospital providers from 11 agencies. Thirty-five in-depth interviews with EMS administrators and researchers were also conducted. This sample was representative of prehospital personnel servicing the PECARN catchment area and was sufficient for analytical saturation. From the transcripts, the authors identified 17 barriers and 12 motivators to EMS personnel participation in research. Central to these data were patient safety, clarity of research purpose, benefits, liability, professionalism, research training, communication with the research team, reputation, administrators’ support, and organizational culture. Interviewees also made 29 suggestions for increasing EMS personnel participation in research. During data analysis, the PRECEDE/PROCEED planning model was chosen for behavioral change to organize the data. Important to this model, factors and suggestions were mapped into those that predispose (knowledge, attitudes, and beliefs), reinforce (social support and norms), and/or enable (organizational) the participation in prehospital research. Conclusions: This study identified factors that influence the participation of EMS personnel in research and gathered suggestions for improvement. These findings were organized into the PRECEDE/PROCEED planning model that may help researchers successfully plan, implement, and complete prehospital research projects. The authors provide guidance to improve the research process including directly involving EMS providers throughout, a strong theme that emerged from the data. Future work is needed to determine the validity of this model and to assess if these findings are generalizable across prehospital settings other than those affiliated with PECARN.

The emergency management of cerebral concussion typically centers on the decision to perform a head computed tomography (CT) scan, which only rarely detects hemorrhagic lesions requiring neurosurgery. The absence of hemorrhage on CT scan often is equated with a lack of brain injury. However, observational studies revealing poor long-term cognitive outcome after concussion suggest that brain injury may be present despite a normal CT scan. To explore this idea further, the authors reviewed the evidence for objective neurologic injury in humans after concussion, with particular emphasis on those with a normal brain CT. This evidence comes from studies involving brain tissue pathology, CT scanning, magnetic resonance image (MRI) scanning, serum biomarkers, formal cognitive and balance tests, functional MRI, positron emission tomography, and single-photon emission computed tomography scanning. Each section is accompanied by technical information to help the reader understand what these tests are, not to endorse their use clinically. The authors discuss the strengths and weaknesses of the evidence in each case. These reports make a compelling case for the existence of concussion as a clinically relevant disease with demonstrable neurologic pathology. Areas for future emergency medicine research are suggested.