Department of Population Medicine, Harvard Medical School/Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Clin Infect Dis. 2021 Feb 16;72(4):541-552. doi: 10.1093/cid/ciaa059.
The Centers for Medicare & Medicaid Services' Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) measure has appropriately established sepsis as a national priority. However, the Infectious Diseases Society of America (IDSA and five additional endorsing societies) is concerned about SEP-1's potential to drive antibiotic overuse because it does not account for the high rate of sepsis overdiagnosis and encourages aggressive antibiotics for all patients with possible sepsis, regardless of the certainty of diagnosis or severity of illness. IDSA is also concerned that SEP-1's complex "time zero" definition is not evidence-based and is prone to inter-observer variation. In this position paper, IDSA outlines several recommendations aimed at reducing the risk of unintended consequences of SEP-1 while maintaining focus on its evidence-based elements. IDSA's core recommendation is to limit SEP-1 to septic shock, for which the evidence supporting the benefit of immediate antibiotics is greatest. Prompt empiric antibiotics are often appropriate for suspected sepsis without shock, but IDSA believes there is too much heterogeneity and difficulty defining this population, uncertainty about the presence of infection, and insufficient data on the necessity of immediate antibiotics to support a mandatory treatment standard for all patients in this category. IDSA believes guidance on managing possible sepsis without shock is more appropriate for guidelines that can delineate the strengths and limitations of supporting evidence and allow clinicians discretion in applying specific recommendations to individual patients. Removing sepsis without shock from SEP-1 will mitigate the risk of unnecessary antibiotic prescribing for noninfectious syndromes, simplify data abstraction, increase measure reliability, and focus attention on the population most likely to benefit from immediate empiric broad-spectrum antibiotics.
医疗保险和医疗补助服务中心的严重脓毒症和脓毒性休克早期管理捆绑包（SEP-1）措施恰当地将脓毒症确立为国家优先事项。然而，美国传染病学会（IDSA）和另外五个支持的学会担心 SEP-1 有可能导致抗生素过度使用，因为它没有考虑到脓毒症过度诊断的高发生率，并鼓励对所有可能患有脓毒症的患者使用积极的抗生素，而不管诊断的确定性或疾病的严重程度如何。IDSA 还担心 SEP-1 的复杂“时间零”定义没有证据基础，并且容易受到观察者之间的差异的影响。在这份立场文件中，IDSA 提出了几项建议，旨在降低 SEP-1 的意外后果的风险，同时保持对其基于证据的要素的关注。IDSA 的核心建议是将 SEP-1 限制用于脓毒性休克，因为支持立即使用抗生素的证据对其最有利。对于没有休克的疑似脓毒症，立即使用经验性抗生素通常是合适的，但 IDSA 认为，这种人群存在太多的异质性和难以定义的问题，对感染的存在存在不确定性，并且没有足够的数据支持对所有此类患者立即使用抗生素的必要性，因此无法支持对所有此类患者的强制性治疗标准。IDSA 认为，关于管理没有休克的疑似脓毒症的指南更适合，因为这些指南可以阐明支持证据的优势和局限性，并允许临床医生在将具体建议应用于个别患者时行使自由裁量权。将没有休克的脓毒症从 SEP-1 中剔除，将降低对非传染性综合征不必要的抗生素处方的风险，简化数据提取，提高衡量标准的可靠性，并将注意力集中在最有可能从立即使用广谱经验性抗生素中受益的人群上。
