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: 10441695
• 负责人: Julie C. Leonard
• 金额: $ 2.24万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10441695
• 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; Dissemination and Implementation; 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，但在儿童中很少发生，相反，使用脊柱。 急诊科 (ED) 创伤转运和 CSI 放射学评估的预防措施 因此，数百万没有 CSI 的儿童受到了影响。 国家的 EMS 系统需要一个儿科 CSI 风险评估工具。 可用于减少在运输过程中采取脊柱预防措施和受到辐射的儿童数量 Leonard 等人和儿科紧急护理应用研究网络 (PECARN) 我们回顾性地确定了预测儿童 CSI 的 8 个风险因素。 前瞻性地从 EMS 和 ED 提供商那里收集配对观察结果，并确定测试的准确性 PECARN CSI 风险因素 目标：我们建议开发并测试儿童 CSI 风险评估工具。 EMS 和 ED 提供者可以使用它来确定哪些儿童需要采取脊柱预防措施， 钝性创伤后颈椎成像的具体目标：使用前瞻性观察数据和 来自主题专家和相关最终人员进行的认知任务分析（ACTA）的信息 用户，我们将采用以用户为中心的设计方法来 1) 开发儿科 CSI 风险评估工具 患有钝性创伤的儿童，以及 2) 在单独的儿童群体中验证儿科 CSI 风险评估工具 患有钝性创伤的儿童；以及 3) 通过 EMS 观察结果验证儿科 CSI 风险评估工具 来自开发和验证队列的协调：我们将在 15 PECARN 进行这项工作。 方法：我们将从 EMS 和 ED 提供商收集前瞻性观察数据。 关于钝性创伤后接受紧急评估并随访的儿童的 CSI 危险因素 招募受试者为期 28 天以确定 CSI 状态 该研究将分两个阶段进行： 开发。 （13,333 名儿童；240 名患有 CSI 的儿童）和验证（8,889 名儿童；160 名患有 CSI 的儿童）。 利用研究基础设施进行 ACTA 和工具原型测试，为 迭代工具设计，以确保该工具可供 EMS 和 ED 提供商使用。 评估：使用来自的数据。 在开发队列中，将构建一个可用的临床决策支持工具，实现 >95% CSI 预测的敏感性和足够的特异性 (>40%) 随后，我们将确定 CSI 的预测。 该工具在独立验证队列和具有 EMS 的队列中的性能特征 该项目的最终输出将是一套儿科 CSI 规范。 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：准确、经过验证并最终经过现场测试。 儿科 CSI 风险评估工具将安全地限制不必要的脊柱预防措施和放射线检查 为数百万儿童提供帮助，同时帮助识别那些真正面临 CSI 风险的儿童。