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

开发小儿颈椎损伤风险评估工具的试点研究

• 批准号: 8638236
• 负责人: Julie C. Leonard
• 金额: $ 24.46万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-24 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8638236
• 关键词: Accident and Emergency department; Adult; Adverse effects; Aftercare; Agreement; Applied Research; Blunt Trauma; Case-Control Studies; Cervical spine; Characteristics; Child; Child Care; Childhood; Childhood Injury; Data; Data Collection; Development; Electronics; Emergency Care; Emergency Situation; Enrollment; Evaluation; Event; Future; Goals; Hospitals; Human Resources; Immobilization; Injury; Malignant Neoplasms; Measures; Medical; Medical center; Methodology; Methods; Modeling; Neck; Nervous System Trauma; Observational Study; Pain; Patients; Pediatric Hospitals; Physicians; Pilot Projects; Population; Predictive Value; Preparation; Procedures; Process; Prospective Studies; Provider; Reporting; Research; Research Infrastructure; Risk; Risk Assessment; Risk Factors; Sampling; Site; Spinal; Spinal Injuries; System; Testing; Trauma; Validation; Vertebral column; Wisconsin; Work; X-Ray Computed Tomography; base; cost; experience; improved; injured; irradiation; lifetime risk; network models; pediatric trauma; prospective; public health relevance; screening; thyroid neoplasm; tool; trauma centers; trend

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.

描述（由申请人提供）：颈椎损伤（CSI）是严重的，但罕见的儿童事件。相比之下，在急诊室（艾德）进行影像学检查后，儿科创伤患者的脊柱固定是常见的，并且已知与不良反应相关。因此，超过99%的瘫痪儿童没有CSI，并暴露于伤害，没有明显的好处。国家的EMS系统需要一套CSI筛查标准，可以应用于院前和艾德设置，以减少儿童谁是固定和不必要的辐射的数量。伦纳德等人和儿科急救应用研究网络（PECARN）已经确定了8个预测儿童颈椎损伤的敏感风险因素。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。在准备这项大型多中心研究的过程中，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风险因素配对观察结果的可行性，并前瞻性地验证PECARN模型。目标：开发和测试必要的基础设施，以收集来自EMS提供者和急诊医生的前瞻性观察数据，这些医生负责钝性创伤儿童，这是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）建立一个数据收集系统，用于院前提供者和急诊医生对钝性创伤后接受医疗护理的儿童进行观察; 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分者间可靠性; 3）前瞻性验证先前确定的儿童CSI预测模型，以用作预测工具。协调：这项工作将在中西部紧急研究节点（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、辛辛那提儿童医疗中心和威斯康星州儿童医院。方法学：每家临床试验机构将组成一个研究小组，由EMS人员开发必要的研究材料和方法，以收集EMS院前提供者和急诊医生关于儿童颈椎损伤风险因素的前瞻性观察数据。我们将对4，500名受伤儿童的样本进行试点测试，这些儿童在钝伤后被运送到HOMERUN急诊室进行评估。评价：我们将跟踪错过的合格患者，并报告EMS提供者和急诊医生观察的捕获率。我们还将比较入组患者与缺失的合格患者的特征。我们将报告所有配对EMS提供者和医生观察结果的评估者间一致性的测量结果。我们将报告一个建议的预测模型CSI在儿童中的预测价值，并将该模型纳入电子儿科CSI风险评估工具。