PILOT STUDY TO DEVELOP A PEDIATRIC CERVICAL SPINE INJURY RISK ASSESSMENT TOOL

描述(申请人提供)：颈椎损伤(CSI)是严重的，但罕见的事件在儿童。相比之下，在急诊科(ED)进行脊柱固定以运送儿童创伤患者并随后进行放射检查是很常见的，并且已知与不良反应相关。因此，99%以上的被固定儿童没有CSI，并暴露在没有明显好处的伤害中。国家的EMS系统需要一套CSI筛查标准，该标准可以在院前和急诊室环境中应用，以减少被固定和不必要辐射的儿童数量。Leonard等人和儿科急救应用研究网络(PECARN)已经确定了预测儿童颈椎损伤的8个敏感危险因素。这些风险因素需要在作为决策支持工具实施之前进行前瞻性评估。准备这项大型多中心研究的合乎逻辑的下一步是确定从EMS提供者和急诊医生那里收集CSI风险因素的Pird观察的可行性，并展望验证PECARN模型的可行性。目标：开发和测试从急救服务提供者和急诊医生那里收集前瞻性观察数据所需的基础设施，这些数据是护理钝性创伤儿童的先决条件，作为进行大型前瞻性研究以完善、验证和实施儿科CSI风险评估工具的先决条件。具体目标：1)构建院前提供者和急诊医生对儿童钝性创伤后接受医疗护理的观察的数据收集系统；2)确定院前提供者和急诊医生用于评估儿童CSI的变量的可观察性和评价者间的可靠性；3)前瞻性地验证先前确定的儿童CSI预测模型作为预测工具。协调：这项工作将在中西部急救研究节点(HOMERUN)的PECARN医院内的3个一级儿科创伤中心及其附属EMS系统进行：圣路易斯儿童医院、辛辛那提儿童医学中心和威斯康星州儿童医院。研究方法：每个研究地点将组成一个研究团队，让EMS人员参与开发必要的研究材料和方法，以便从EMS院前提供者和急诊医生那里收集有关儿童颈椎损伤风险因素的前瞻性观察数据。我们将在4500名受伤儿童的样本上对材料和方法进行试点测试，这些儿童在钝性创伤后被送往家庭急诊科进行评估。评估：我们将跟踪遗漏的符合条件的患者，并报告EMS提供者和急诊医生观察的获取率。我们还将比较那些登记的患者和错过的合格患者的特征。我们将报告所有配对的EMS提供者和医生的观察结果的评价者之间的一致性度量。我们将报告拟议的儿童CSI预测模型的预测价值，并将该模型整合到电子儿科CSI风险评估工具中。

DESCRIPTION (provided by applicant): Cervical spine injuries (CSI) are serious, but rare events in children. In contrast, spinal immobilization for transport of pediatric trauma patients followed by radiographic clearance in the emergency department (ED) is common and known to be associated with adverse effects. As a result, more than 99% of immobilized children have no CSI and are exposed to harm with no demonstrable benefit. The nation's EMS systems need a set of CSI screening criteria that can be applied in both the prehospital and ED settings to reduce the number of children who are immobilized and irradiated unnecessarily. Leonard et al and the Pediatric Emergency Care Applied Research Network (PECARN) have identified 8 sensitive risk factors that predict cervical spine injury in children. These risk factors require prospective evaluation prior to implementation as a decision support tool. The logical next step in preparation for this large multi-center study is to establish the feasibility of collecting paird observations of CSI risk factors from EMS providers and emergency physicians and prospectivel validate the PECARN model. Goal: Develop and test the infrastructure necessary for collecting prospective observational data from EMS providers and emergency physicians who care for children with blunt trauma as a prerequisite for conducting a large prospective study to refine, validate and implement a Pediatric CSI Risk Assessment Tool. Specific Aims: 1) To construct a data collection system for prehospital provider and emergency physician observations of children who receive medical care after blunt trauma; 2) To determine the observability and inter-rater reliability of variables that are used by prehospital providers and emergency physicians for the assessment of CSI in children; 3) To prospectively validate a previously identified model for CSI prediction in children for use as a prediction tool. Coordination: This work will be conducted at 3 level-one pediatric trauma centers and their affiliated EMS-systems within the PECARN Hospitals of the Midwest Emergency Research Node (HOMERUN): St. Louis Children's Hospital, Cincinnati Children's Medical Center, and Children's Hospital of Wisconsin. Methodology: Each study site will form a research team that will engage EMS personnel in developing the necessary research materials and methods for collecting prospective observational data from EMS prehospital providers and emergency physicians regarding cervical spine injury risk factors in children. We will pilot test the materias and methods on a sample of 4,500 injured children who are transported to HOMERUN emergency departments for evaluation following blunt trauma. Evaluation: We will track missed eligible patients and report the capture rates for EMS provider and emergency physician observations. We will also compare the characteristics of those enrolled to the missed eligible patients. We will report measures of inter-rater agreement for all paired EMS provider and physician observations. We will report the predictive value of a proposed prediction model for CSI in children and incorporate the model into an electronic Pediatric CSI Risk Assessment Tool.