SEP-1 sepsis management bundle not associated with improved mortality

1. In this systematic review, there was minimal evidence of improved sepsis mortality with implementation of the Severe Sepsis and Septic Shock Management Bundle.

2. Studies that found an association between sepsis bundle compliance and reduced mortality tended to have limited generalizability.

Evidence Rating Level: 1

Study Rundown: The Severe Sepsis and Septic Shock Management Bundle (SEP-1) was introduced by the Centers for Medicare and Medicaid Services (CMS) nearly one decade ago as a means for standardizing sepsis management.  In 2013, CMS announced it would be incorporating SEP-1 into the Hospital Value-Based Purchasing Program, which carried important implications for health care policy, economics, and clinical practice. However, the SEP-1 metric has been a subject of controversy due to concerns regarding overdiagnosis and inflexibility of treatment, especially given insufficient data on outcomes. This study aimed to determine if moderate- or high-level evidence could be found linking SEP-1 compliance or implementation to improved sepsis mortality. Out of a dozen studies focusing on SEP-1 compliance, the majority found no association with reduced mortality. Of the studies that did show improvement, however, many demonstrated a beneficial effect only among subgroups consisting of older, sicker patients. When examining studies that assessed mortality outcomes before and after SEP-1 implementation, it was found that only one study described a significant association although it did not adjust for trends in mortality prior to implementation. The generalizability of these results were limited by the observational nature of all included studies; the exclusion of other sepsis bundles; the inability to perform meta-analysis due to study heterogeneity; and the grouping of different versions of SEP-1 over time. Nevertheless, this study suggested that there was no high- or moderate-level evidence for mortality benefit from SEP-1.

Click to read this study in AIM

Relevant Reading: Evidence Underpinning the Centers for Medicare & Medicaid Services’ Severe Sepsis and Septic Shock Management Bundle (SEP-1): A Systematic Review

In-Depth [systematic review and meta-analysis]: This systematic review investigated the association between SEP-1 compliance or implementation and sepsis mortality. A total of 17 studies were included, 13 of which assessed both the 3-hour and 6-hour bundles and 4 of which only assessed the 3-hour bundle. Out of the 11 concurrent cohort studies and 1 case-control study that assessed the effect of SEP-1 compliance on mortality, 5 studies showed survival benefit in at least one subgroup while 7 studied showed no association. Sloan et al. showed an association between SEP-1 compliance and reduced mortality but only among patients with septic shock. In a study of patients with septic shock, Choi et al. showed that SEP-1 compliance was associated with reduced mortality (odds ratio [OR], 0.61 [95% CI, 0.40 to 0.91]). Bauer et al. found that SEP-1 compliance was linked to reduced mortality in patients without septic shock (adjusted OR, 0.44 [95% CI, 0.32 to 0.61]), while no association was found in patients with septic shock (adjusted OR, 0.93 [95% CI, 0.60 to 1.46]). Townsend et al. found a 5.7% (95% CI, 5.3% to 6.0%) absolute risk reduction among Medicare beneficiaries who complied with SEP-1, while Utariani et al. showed decreased mortality among patients who received the full bundle. Out of the 5 before-after cohort studies that assessed the effect of SEP-1 implementation on mortality, 1 study showed a survival benefit: Afshar et al. found a 1.2% reduction in mortality following implementation of SEP-1 along with a quality improvement program in a single-center study. Among the 4 studies that found no association between SEP-1 implementation and mortality, Barbash et al. conducted an interrupted time-series (ITS) analysis, with patient-level characteristics, hospital-level fixed effects, and seasonality controlled which showed no significant mortality difference before and after SEP-1 implementation (expected mortality difference, 0.1% [95% CI, -0.9% to 1.1%]). Overall, these results demonstrated that evidence associating SEP-1 compliance or implementation with reduced mortality was of a lower level.

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