BACKGROUND: The Centers for Medicare & Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) is now included in the Hospital Value-Based Purchasing (VBP) Program.
PURPOSE: To assess the evidence supporting SEP-1 compliance or SEP-1 implementation in improving sepsis mortality.
DATA SOURCES: PubMed, Web of Science, EMBASE, CINAHL Complete, and Cochrane Library from inception to 26 November 2024.
STUDY SELECTION: Studies of adults with sepsis that included 3- or 6-hour sepsis bundles defined by SEP-1 specifications.
DATA EXTRACTION: Article screening, full-text review, data extraction, and risk-of-bias assessment were independently performed by 2 authors. Level of evidence was determined using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria and National Quality Forum criteria.
DATA SYNTHESIS: A total of 4403 unique references were screened, and 17 studies were included. Twelve studies assessed the relationship between SEP-1 compliance and mortality; 5 showed statistically significant benefit, whereas 7 did not. Among studies showing benefit, 1 did not adjust for confounders, 1 found benefit only among patients with severe sepsis, 1 included only patients with septic shock, and 1 included only Medicare beneficiaries. Five studies assessed the relationship between SEP-1 implementation and sepsis mortality; only 1 showed significant benefit, but it did not adjust for mortality trends before SEP-1 implementation. All 17 studies were observational, and none had low risk of bias.
LIMITATIONS: The conclusions are limited by the underlying quality of the available studies, as all were observational. Because there was considerable methodologic heterogeneity among the included studies, a meta-analysis was not performed as the results could have been misleading.
CONCLUSION: This review found no moderate- or high-level evidence to support that compliance with or implementation of SEP-1 was associated with sepsis mortality. CMS should reconsider the addition of SEP-1 to the Hospital VBP Program.
PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42023482787).
| Discipline Area | Score |
|---|---|
| Infectious Disease |  |
| Hospital Doctor/Hospitalists | |
| Internal Medicine | |
| Intensivist/Critical Care |  |
| Emergency Medicine |  |
Although the systematic review is well conducted, the poor quality of the underlying studies makes the study much less newsworthy.
Although some of the most transformative sepsis research over the past 25 years originated in the emergency department setting using approaches that had been less successful downstream in the ICU environment (https://emergencymedicine.wustl.edu/items/sepsis-early-goal-directed-therapy/), the question of which specialty "owns" sepsis is legitimate (http://pmid.us/31986525). Emergency Medicine has lacked a seat at the table when measures like SEP-1 were proposed and despite early evidence pointing towards a reduced mortality with SEP-1 (http://pmid.us/32317604), this systematic review raises questions about such effectiveness. I believe this systematic review of biased observational studies provides sufficient equipoise to justify RCTs to more definitely understand the impact of SEP-1 on sepsis mortality.
The early identification of sepsis and using bundles to guide a standardized approach to the diagnosis and treatment of sepsis has been a major focus of the care of hospitalized patients. This article describes the authors systematic review of the available evidence that using bundles and early treatment can improve sepsis mortality. Unfortunately, the evidence available is of poor quality (i.e. based on observational studies), and does not show a consistent and clear improvement in mortality.
This systematic review did not detect good evidence for a sepsis mortality benefit of the sepsis bundle promulgated by the Center for Medicare and Medicaid Services. Infectious disease specialists have questioned the appropriateness of the bundle. There is a possibility that the Center may reconsider continued use of the bundle based on this review. This could have a major impact on hospital practice, including quality improvement activities.
Interesting but not new information and ++ heterogeneity impacts uptake (in fact, precluded meta-analysis).
This is a timely high-quality study demonstrating the lack of evidence to support using SEP-1.