Evidence-Based Guidelines for Fatigue Risk Management in EMS: Formulating Research Questions and Selecting Outcomes

<b>Background</b>: Greater than half of Emergency Medical Services (EMS) personnel report work-related fatigue, yet there are no guidelines for the management of fatigue in EMS. A novel process has been established for evidence-based guideline (EBG) development germane to clinical EMS questions. This process has not yet been applied to operational EMS questions like fatigue risk management. The objective of this study was to develop content valid research questions in the Population, Intervention, Comparison, and Outcome (PICO) framework, and select outcomes to guide systematic reviews and development of EBGs for EMS fatigue risk management. <b>Methods</b>: We adopted the National Prehospital EBG Model Process and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework for developing, implementing, and evaluating EBGs in the prehospital care setting. In accordance with steps one and two of the Model Process, we searched for existing EBGs, developed a multi-disciplinary expert panel and received external input. Panelists completed an iterative process to formulate research questions. We used the Content Validity Index (CVI) to score relevance and clarity of candidate PICO questions. The panel completed multiple rounds of question editing and used a CVI benchmark of ≥0.78 to indicate acceptable levels of clarity and relevance. Outcomes for each PICO question were rated from 1 = less important to 9 = critical. <b>Results</b>: Panelists formulated 13 candidate PICO questions, of which 6 were eliminated or merged with other questions. Panelists reached consensus on seven PICO questions (<i>n</i> = 1 diagnosis and <i>n</i> = 6 intervention). Final CVI scores of relevance ranged from 0.81 to 1.00. Final CVI scores of clarity ranged from 0.88 to 1.00. The mean number of outcomes rated as critical, important, and less important by PICO question was 0.7 (SD 0.7), 5.4 (SD 1.4), and 3.6 (SD 1.9), respectively. Patient and personnel safety were rated as critical for most PICO questions. PICO questions and outcomes were registered with PROSPERO, an international database of prospectively registered systematic reviews. <b>Conclusions</b>: We describe formulating and refining research questions and selection of outcomes to guide systematic reviews germane to EMS fatigue risk management. We outline a protocol for applying the Model Process and GRADE framework to create evidence-based guidelines

**背景**：超过半数的急诊医疗服务（Emergency Medical Services，EMS）从业人员报告存在职业相关性疲劳，但目前尚无针对EMS领域疲劳管理的相关指南。目前已建立一套适用于临床EMS相关问题的循证指南（Evidence-Based Guideline，EBG）制定新流程，但该流程尚未被应用于诸如疲劳风险管理这类EMS运营相关问题。本研究的目标是基于人群、干预、对照、结局（Population, Intervention, Comparison, and Outcome，PICO）框架构建具有内容效度的研究问题，并遴选结局指标，以指导EMS疲劳风险管理相关的系统评价及循证指南制定。
**方法**：本研究采用国家院前EBG模型流程以及推荐分级、评估、制定与评价（Grading of Recommendations Assessment, Development, and Evaluation，GRADE）框架，用于院前急救场景下EBG的制定、实施与评价。遵循该模型流程的第一步与第二步，研究团队检索了现有EBG，组建了多学科专家小组，并收集外部意见。专家小组通过迭代流程构建研究问题。研究采用内容效度指数（Content Validity Index，CVI）对候选PICO问题的相关性与清晰度进行评分。专家小组完成多轮问题修订，并以CVI得分≥0.78作为清晰度与相关性可接受的判定标准。每个PICO问题对应的结局指标按重要性进行评分，1分为极不重要，9分为至关重要。
**结果**：专家小组共构建13个候选PICO问题，其中6个被剔除或与其他问题合并。专家小组最终就7个PICO问题达成共识（其中1个为诊断类问题，6个为干预类问题）。相关性维度的最终CVI得分范围为0.81至1.00，清晰度维度的最终CVI得分范围为0.88至1.00。每个PICO问题对应的结局指标中，被评为至关重要、重要及极不重要的平均数量分别为0.7（标准差SD=0.7）、5.4（SD=1.4）及3.6（SD=1.9）。多数PICO问题均将患者与从业人员安全评为至关重要的结局指标。所有PICO问题及结局指标均已在PROSPERO（国际系统评价前瞻注册数据库）完成注册。
**结论**：本研究阐述了如何构建并优化研究问题，以及遴选结局指标，以指导EMS疲劳风险管理相关的系统评价工作。本研究还提出了一套应用该模型流程与GRADE框架制定循证指南的方案。