Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure

Abstract

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.

Monocyte Distribution Widths for Early Sepsis Detection in Emergency Department and Comparison with C-reactive Protein and Procalcitonin

“…Hence, there is no perfect standard for sepsis diagnosis and there is always a risk of misdiagnosis. Considering the risk of overdiagnosis (24), the biomarker of sepsis needs to be sensitive because of poor clinical outcomes of delayed diagnosis. As earlier intervention (antibiotics and uid resuscitation) results in better outcome in sepsis management, rapid and easily available screening tools are highly bene cial for patients with sepsis.…”

Recommended Revisions to the National SEP‐1 Sepsis Quality Measure: A commentary by the Society of Infectious Diseases Pharmacists on the Infectious Diseases Society of America Position Paper

“…The SIDP agrees that the revisions suggested by IDSA are important improvements to the SEP‐1 measure, and readers are encouraged to review the entire recommendation and rationale 1 . Important highlights of the recommendations from IDSA are as follows.…”

Empiric Antibiotic Prescribing for Suspected Sepsis: A Stewardship Balancing Act

“…stable) be guided by the treating clinician with support from evidence based guidelines. 3 This approach would enable ED clinicians to first focus on source identification and control, when applicable, in stable patients. The brief delay needed to obtain a comprehensive history and physical exam, review previous culture data, and obtain necessary diagnostic tests (e.g.…”

“…The optimal approach to empiric antibiotic prescribing for suspected sepsis in the emergency department (ED), specifically timing and spectrum of therapy, is a matter of significant ongoing controversy. 1 , 2 , 3 The debate hinges on interpretation of the ratio between benefit from prompt, active antibiotic therapy for patients with bacterial sepsis and the established societal (e.g. selective pressure towards bacterial resistance) and patient level harms associated with unnecessary antibiotic therapy (e.g.…”

“… 12 Both the Hour-1 bundle and SEP-1 metric have generated significant opposition from those who accurately point out that they exert pressure on ED clinicians to initiate broad-spectrum antibiotics for clinically stable patients who meet non-specific sepsis criteria that often result in overdiagnosis. 3 , 13 Also, it is important to note that other analyses, including a meta-analysis, examining time to antibiotics in sepsis have yielded conflicting results and there are ongoing concerns about potential biases in the available observational studies (e.g. varying definitions of time zero).…”