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，这在很大程度上是因为 目前的指南和要求迫使临床医生立即为所有患有 尽管超过三分之一的最初怀疑患有败血症的患者最终证实患有败血症， 病毒或非感染性疾病。医疗保险和医疗补助服务中心（CMS）“SEP-1”措施， 例如，要求医院在3小时内给予所有疑似患者广谱抗生素， 败血症以及测量乳酸水平，抽取血液培养物，并给予至少30 cc/kg的液体， 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、严格和反射性的脓毒症护理可能使一些患者受益，但也存在不必要的风险。 促进抗生素耐药性、药物不良事件、艰难梭菌感染和其他体液过多。 为正确的患者提供适当的脓毒症护理的一个主要障碍是我们对以下方面的了解有限： 哪些特定的临床表现最有可能从立即使用抗生素中获益，哪些可以安全地 更保守地管理。同样，我们也不完全了解哪些特定的过程， 护理对优化结果至关重要，而哪些不是。为了弥补这些差距，我们需要一种更好的方式， 将脓毒症定义为“时间零点”，这一概念既体现了应立即采取干预措施的标准， 当怀疑感染时，以及从何时开始衡量护理的及时性。目前的定义 脓毒症包括多种多样的临床体征，其中一些明显紧急，而另一些可能 在使用抗生素之前，需要更多的时间进行检查。问题因以下事实而变得复杂 SEP-1的时间零点定义是主观的和劳动密集型的抽象，破坏了它的可信度， 用于基准医院护理质量的实用程序。 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， 来自167家医院的两个数据集，以制定更多基于证据的脓毒症零时标准和质量 指标.这些目标反映了我们的具体目标：1）发展基于证据的，客观的，电子化的 通过使用电子健康记录数据识别临床体征的脓毒症时间零点的可计算定义 当抗生素延迟使用时，与较高的死亡率相关，2）系统地评估 每个脓毒症束成分与死亡率之间的关联，并将完整束与简单束进行比较， 简化版本，以及3）评估最佳治疗策略是否以及如何与常见的 根据感染部位、合并症和临床表现， 信号装置.该提案直接涉及AHRQ HAI预防组合的抗生素管理重点 和AHRQ的使命，以提高医疗保健安全和质量，提供新的见解，以确定和 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