Review of Studies Finds SEP-1 Protocol for Sepsis Shock Was Not Associated With Mortality Benefit

A review and meta-analysis found “no evidence that compliance with a protocol aimed at improving sepsis care was associated with a mortality benefit.” CIDRAP has the news.

Researchers at several University of California locations “reviewed literature assessing the relationship between the Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock Management Bundle (SEP-1) and mortality. Implemented in 2015 by CMS, SEP-1 is a bundle of measures that includes administration of broad-spectrum antibiotics within 3 hours of sepsis onset.”

SEP-1 was announced by CMS as a “pay-for-performance measure” to be incorporated into the Hospital Value-Based Purchasing (VBP) program. CMS “based its decision on data that indicated that antibiotic and fluid-focused sepsis bundles were associated with improved patient outcomes.” The authors of this study note, however, that “the evidence that the bundle is associated with a mortality benefit is limited. There has also been concern that SEP-1 leads to overuse of broad-spectrum antibiotics.”

Of twelve studies analyzed in this review, “five showed a statistically significant benefit on mortality in at least one subgroup, but seven showed no benefit.” Among the five that showed a benefit, “only one showed significant benefit. Among the four others, one didn't adjust for confounders, one found benefit only among patients with severe sepsis, one included only patients with septic shock, and one included only Medicare beneficiaries.” The authors concluded that “until higher-quality evidence supporting SEP-1 is available, the addition of SEP-1 into the Hospital VBP Program should be reconsidered.”