Little Evidence for Government-Mandated Performance Measure for Sepsis

Marcia Frellick

February 21, 2018

A hospital performance measure for sepsis that requires physicians to perform up to 141 tasks for each patient lacks rigorous evidence to show it improves survival in adults, according to a systematic review. Experts say the results are concerning and should trigger a discussion with the Centers for Medicare & Medicaid Services (CMS).

CMS introduced the performance measure Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) in 2015. The bundle requires that physicians perform up to 5 hemodynamic interventions and up to 141 tasks and complete 3 hours of documentation for a single patient.

However, after contacting CMS, reviewing the available literature, and reviewing the CMS specifications manual for SEP-1, researchers conclude that "[n]o high- or moderate-level evidence shows that SEP-1 or its hemodynamic interventions improve survival in adults with sepsis."

Dominique J. Pepper, MBChB, MD, from the National Institutes of Health in Bethesda, Maryland, and colleagues published their findings online February 20 in the Annals of Internal Medicine, and they point out far-reaching consequences.

At this time, hospitals must fully adopt this performance measure or risk accreditation status and reimbursements. Yet, tying SEP-1 performance to accreditation and payment will "transform unproven practices into universal care," the authors write.

"Not only does no high- or moderate-level evidence support the benefit of SEP-1's hemodynamic interventions, neither the SEP-1 specifications manual nor this systematic review contains evidence that mandating their use is actually safe," they add.

Requiring these measures also means valuable time is being used that could be more effectively used on therapies with strong evidence for septic patients.

Reviewing the Evidence

Pepper and colleagues found 18 published studies that addressed SEP-1's effect on survival in septic adults.

They considered studies that compared the effect on survival of one or more of the nonantibiotic hemodynamic SEP-1 interventions vs survival in a control group: "serial lactate measurements alone (5 articles), a 30-mL/kg fluid infusion alone (5 articles), serial lactate measurements and a 30-mL/kg fluid infusion (4 articles), a component of the volume status and tissue perfusion assessment (3 articles), and SEP-1 in its entirety (1 article)."

Fifteen of the studies were observational and subject to selection bias. Only one single-center, observational study found lower in-hospital mortality after the SEP-1 bundle was put in place.

None of the studies was free of confounders or had a low risk for bias, the authors write.

The authors note that their findings do not mean the hemodynamic interventions in SEP-1 are contraindicated, but that no solid evidence shows a positive benefit on survival or supports mandated use for all septic patients.

Findings Raise "Great Concern"

The work should "raise great concern" and should prompt talks with CMS to reconsider SEP-1, write John P. Kress, MD, and Jesse B. Hall, MD, from the University of Chicago in Illinois, in an accompanying editorial.

"Even if we put aside the issue of publication bias for positive trials, this literature, although supportive of sepsis treatment that includes early antibiotics, is underwhelming in its support of various hemodynamic management elements, including early fluid therapy that may adversely affect some patients," the editorialists write.

They note that early administration of crystalloid fluids (30 mL/kg of body weight), part of the SEP-1 bundle, has in some studies even been linked to poor outcomes.

Kress and Hall write, "Enforcing a cookbook approach to management of a syndrome as complex as sepsis is unwise because it may shackle thoughtful consideration of each case's nuances. It would be unfortunate if government mandates like SEP-1 fostered mediocrity at the cost of excellence."

The authors and editorialists have disclosed no relevant financial relationships.

Ann Intern Med. Published online February 20, 2018. Article abstract, Editorial extract

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