Developing Evidence-Based Sepsis Time Zero Criteria and Quality Metrics Using Electronic Health Record Data

项目摘要 败血症是导致死亡的主要原因。它也是抗生素使用的主要驱动力，在很大程度上是因为 目前的指导方针和要求迫使临床医生立即为所有患有 可能是脓毒症，即使最初怀疑有脓毒症的患者中有超过三分之一的人后来发现 病毒感染或非传染性疾病。医疗保险和医疗补助服务中心(CMS)“SEP-1”措施，用于 例如，要求医院在3小时内给所有疑似患者服用广谱抗生素 脓毒症，以及测量乳酸水平，抽取血培养，并给予至少30cc/kg的液体治疗 低血压。更新的指南正在推动更快的抗生素管理和捆绑完成。 因此，积极、僵硬和反射性的脓毒症护理可能会使一些患者受益，但也会带来不必要的风险。 促进抗生素耐药性、药物不良事件、艰难梭菌感染和其他人的液体超载。 为合适的患者提供适当的脓毒症护理的一个主要障碍是我们对 哪些具体的临床表现最有可能立即从抗生素中受益，哪些可以安全地 被更保守地管理。同样，我们对哪些具体的过程也没有完全的理解 护理对优化结果至关重要，而哪些不是。为了解决这些差距，我们需要一种更好的方式来 将脓毒症定义为“时间零”，这个概念包含了引发立即干预的两个标准 怀疑感染的时间以及衡量护理及时性的起点。当前的定义是 脓毒症包括各种不同的临床症状，其中一些明显是紧急的，另一些则可能 在使用抗生素之前，允许有更多的时间进行调查。这一事实使问题变得更加复杂 SEP-1的S时间零点定义主观而费力地抽象，破坏了其可信度和可信度 用于对医院的护理质量进行基准评估的效用。 在这个项目中，我们建议利用来自数百万次接触的详细电子健康记录数据 从167家医院的两个数据集制定出更多循证的脓毒症时间零标准和质量 指标。这些目标反映了我们的具体目标：1)发展循证的、客观的和电子化的 通过使用电子健康记录数据识别临床体征来计算脓毒症时间零的定义 当抗生素被推迟时与更高的死亡率相关的，2)系统地评估 每个败血症束组分与死亡率之间的关系，并将全束与更简单的比较， 简化的版本，以及3)评估最优治疗策略是否以及如何在常见的 根据感染部位、合并症和临床表现，遇到和容易识别的脓毒症表型 有征兆。这项建议直接解决了AHRQ HAI预防组合中抗生素管理的重点 AHRQ的使命是通过提供新的见解来识别和提高医疗保健的安全和质量 治疗败血症，告知更合理的抗生素使用，并促进更好地衡量护理质量。 1

PROJECT ABSTRACT Sepsis is a leading cause of death. It is also a major driver of antibiotic utilization, in large part because current guidelines and mandates compel clinicians to administer antibiotics immediately for all patients with possible sepsis even though more than a third of patients initially suspected to have sepsis turn out to have viral or non-infectious conditions. The Centers for Medicare & Medicaid Services (CMS) “SEP-1” measure, for example, requires hospitals to give broad-spectrum antibiotics within 3 hours of to all patients with suspected sepsis as well as measure lactate levels, draw blood cultures, and administer at least 30cc/kg of fluids for hypotension. Newer guidelines are pushing for even faster antibiotic administration and bundle completion. Aggressive, rigid, and reflexive sepsis care may therefore benefit some patients but also unnecessarily risks promoting antibiotic resistance, drug adverse events, C.difficile infections, and fluid overload in others. A major barrier to providing appropriate sepsis care to the right patients is our limited understanding of which specific clinical presentations are most likely to benefit from immediate antibiotics and which can safely be managed more conservatively. Similarly, we have imperfect understanding of which specific processes of care are critical to optimize outcomes and which are not. To address these gaps, we need a better way to define sepsis “time zero,” a concept that embodies both the criteria that should trigger immediate interventions when infection is suspected and the point from which timeliness of care is measured. The current definition of sepsis includes a heterogeneous mix of clinical signs, some of which are clearly urgent and some that may tolerate more time for investigation before administering antibiotics. The problem is compounded by the fact that SEP-1's time zero definition is subjective and labor-intensive to abstract, undermining its credibility and utility for benchmarking hospitals' quality of care. In this project, we propose to leverage detailed electronic health record data from millions of encounters from 167 hospitals in two datasets to develop more evidence-based sepsis time zero criteria and quality metrics. These goals are reflected our Specific Aims: 1) Develop evidence-based, objective, and electronically computable definitions of sepsis time zero by using electronic health record data to identify the clinical signs that are associated with higher mortality when antibiotics are delayed, 2) Systematically evaluate the associations between each sepsis bundle component and mortality and compare the full bundle to simpler, streamlined versions, and 3) Assess whether and how optimal treatment strategies differ for commonly encountered and easily recognizable sepsis phenotypes based on infection site, comorbidities, and clinical signs. This proposal directly addresses the antibiotic stewardship focus of AHRQ's HAI Prevention Portfolio and AHRQ's mission to improve health care safety and quality by providing new insights into identifying and treating sepsis, informing more rational antibiotic use, and facilitating better measurement of quality-of-care. 1