Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

儿童颈椎损伤风险评估工具的开发和测试

• 批准号: 10165905
• 负责人: Julie C. Leonard
• 金额: $ 3.96万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165905
• 关键词: Accident and Emergency department; Adverse effects; Applied Research; Assessment tool; Blunt Trauma; Case-Control Studies; Cervical; Cervical spine; Characteristics; Child; Child Care; Childhood; Childhood Injury; Clinical; Cohort Studies; Data; Development; Diagnostic radiologic examination; Diving; Emergency Care; Emergency Situation; Emergency medical service; Enrollment; Ensure; Evaluation; Event; Exposure to; Focal Neurologic Deficits; Funding; Goals; Health Personnel; Image; Immobilization; Infrastructure; Injury; Ionizing radiation; Methodology; Methods; Multicenter Studies; National Institute of Child Health and Human Development; Neck; Neck Pain; Observational Study; Output; Pain; Patient Self-Report; Performance; Phase; Pilot Projects; Population; Pre-hospital setting; Predictive Factor; Procedures; Process; Provider; Radiation; Recommendation; Research; Research Infrastructure; Risk; Risk Assessment; Risk Factors; Sampling; Specificity; Spinal; Spinal Injuries; Statistical Models; System; Testing; Torticollis; Trauma; Validation; Vehicle crash; Work; cancer risk; case control; clinical care; clinical decision support; cognitive task; cohort; design; experience; field study; high risk; improved; irradiation; lifetime risk; mental state; pediatric emergency; prospective; prototype; screening; service providers; support tools; task analysis; tool; trauma care; trauma centers; user centered design

Problem: Cervical spine injuries (CSI) are serious, but rare events in children. In contrast, use of spinal precautions for trauma transport and radiographic evaluation for CSI in the emergency department (ED) are common and associated with adverse effects. As a result, millions of children who have no CSI are exposed to harm with no demonstrable benefit. The nation’s EMS systems need a Pediatric CSI Risk Assessment Tool that can be used to reduce the number of children who are transported in spinal precautions and irradiated unnecessarily. Leonard et al. and the Pediatric Emergency Care Applied Research Network (PECARN) retrospectively identified 8 risk factors that predict CSI in children. We also established the infrastructure to prospectively collect paired observations from EMS and ED providers and determined the test accuracies of the PECARN CSI risk factors. Goal: We propose to develop and test a Pediatric CSI Risk Assessment Tool that can be used by EMS and ED providers to determine which children warrant spinal precautions and cervical spine imaging after blunt trauma. Specific Aims: Using prospective observational data and information from a cognitive task analysis (ACTA) conducted with subject matter experts and relevant end- users, we will use a user-centered design approach to 1) Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma and 2) Validate the Pediatric CSI Risk Assessment Tool in a separate population of children with blunt trauma; and 3) Validate the Pediatric CSI Risk Assessment Tool with EMS observations from both the development and validation cohorts. Coordination: We will conduct this work at 15 PECARN trauma centers. Methodology: We will collect prospective observational data from EMS and ED providers regarding CSI risk factors for children who undergo emergency evaluation after blunt trauma and follow enrolled subjects for 28 days to determine CSI status. The study will occur in two phases: development (13,333 children; 240 children with CSI) and validation (8,889 children; 160 children with CSI). We will also capitalize on the research infrastructure to conduct an ACTA and tool prototype testing that will inform the iterative tool design to ensure that the tool is useable by EMS and ED providers. Evaluation: With data from the development cohort, a useable clinical decision support tool will be constructed that achieves >95% sensitivity, as well as adequate specificity (>40%) in the prediction of CSI. Subsequently, we will determine the performance characteristics of the tool in the independent validation cohort and in a cohort that has EMS provider observations. The ultimate output from this project will be a set of specifications for the Pediatric CSI Risk Assessment Tool that will include a validated clinical decision rule, validated tool designs and functions, and recommendations for implementation. Significance: An accurate, validated, and ultimately field-tested Pediatric CSI Risk Assessment Tool will safely limit unnecessary spinal precautions and radiographic testing for millions of children while helping identify those children who are truly at risk for CSI.

问题：颈椎损伤（CSI）是严重的，但在儿童中很少见。相反，使用脊柱 急诊科（ED）中CSI的创伤运输和射线照相评估的预防措施是 常见并与不良反应有关。结果，数以百万计的没有CSI的孩子接触 危害没有明显的好处。国家的EMS系统需要儿科CSI风险评估工具 可以用来减少在脊柱预防措施中运输并辐照的儿童数量 不必要。伦纳德等。以及小儿急诊应用研究网络（PECARN） 回顾性地确定了5种预测儿童CSI的风险因素。我们还建立了基础设施 前瞻性地收集来自EMS和ED提供商的配对观察结果，并确定了测试准确性 Pecarn CSI风险因素。目标：我们建议开发和测试儿科CSI风险评估工具 EMS和ED提供者可以使用哪些孩子来确定哪些孩子应采取脊柱预防措施和 钝性创伤后的颈椎成像。具体目的：使用前瞻性观察数据和 来自主题专家进行的认知任务分析（ACTA）的信息和相关的终点 用户，我们将使用以用户为中心的设计方法1）在 钝创伤的儿童和2）在另外人群中验证儿科CSI风险评估工具 钝创伤的孩子； 3）用EMS观察验证小儿CSI风险评估工具 从开发和验证人群中。协调：我们将在15 Pecarn进行这项工作 创伤中心。方法论：我们将从EMS和ED提供商那里收集前瞻性观察数据 考虑到钝创伤后接受紧急评估的儿童的CSI危险因素并关注 注册受试者28天以确定CSI状态。该研究将分为两个阶段：发展 （13,333名儿童； 240名CSI儿童）和验证（8889名儿童； 160名CSI儿童）。我们也会 利用研究基础架构进行ACTA和工具原型测试，以告知 迭代工具设计，以确保该工具可由EMS和ED提供商使用。评估：带有来自的数据 开发队列将构建可用的临床决策支持工具，达到95％ 在CSI的预测中，灵敏度以及适当的特异性（> 40％）。随后，我们将确定 该工具在独立验证队列中的性能特征和具有EMS的队列中 提供者观察。该项目的最终输出将是小儿CSI的一组规格 风险评估工具将包括经过验证的临床决策规则，经过验证的工具设计和功能， 和实施建议。意义：精确，经过验证且最终进行现场测试 小儿CSI风险评估工具将安全限制不必要的脊柱预防措施和XoRogrica学测试 对于数百万儿童而言，同时帮助确定那些真正有CSI风险的孩子。