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

描述（由申请人提供）：颈椎损伤（CSI）是严重的，但在儿童中罕见的事件。相比之下，在急诊科（ED）进行脊柱固定后运送儿科创伤患者是常见的，并且已知与不良反应有关。结果，超过99%的无法活动的儿童没有CSI，暴露在伤害中却没有明显的益处。国家的EMS系统需要一套CSI筛选标准，可以应用于院前和急诊科设置，以减少不必要的固定和照射儿童的数量。Leonard等人和儿科急诊应用研究网络（PECARN）已经确定了8个预测儿童颈椎损伤的敏感危险因素。作为决策支持工具，在实施之前需要对这些风险因素进行前瞻性评估。为这项大型多中心研究做准备的合乎逻辑的下一步是建立从EMS提供者和急诊医生那里收集CSI危险因素成对观察的可行性，并前瞻性地验证PECARN模型。目标：开发和测试从护理钝性创伤儿童的EMS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，作为开展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。具体目的：1)构建钝性创伤患儿院前及急诊医师观察数据收集系统；2)确定院前服务提供者和急诊医师用于儿童CSI评估的变量的可观察性和量表间信度；3)前瞻性验证先前确定的儿童CSI预测模型，以作为预测工具。协调：这项工作将在中西部紧急研究节点PECARN医院（HOMERUN）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、辛辛那提儿童医疗中心和威斯康星州儿童医院。方法：每个研究点将组成一个研究小组，由EMS人员参与开发必要的研究材料和方法，从EMS院前提供者和急诊医生那里收集关于儿童颈椎损伤危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试点测试这些材料和方法，这些儿童在钝性创伤后被送往HOMERUN急诊科进行评估。评估：我们将跟踪错过的符合条件的患者，并报告EMS提供者和急诊医生观察的捕获率。我们还将比较入选患者和未入选患者的特征。我们将报告所有配对的EMS提供者和医生观察的评分者之间的一致性。我们将报告一个建议的预测模型对儿童CSI的预测价值，并将该模型纳入电子儿科CSI风险评估工具。

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.