No Improvement in Clinical Outcomes With Sepsis Performance Measure

By Megan Brooks

April 21, 2021

NEW YORK (Reuters Health) - The Medicare Sepsis Performance Measure (SEP-1) that requires U.S. hospitals to report adherence to a sepsis-management bundle has not led to meaningful improvement in clinical outcomes of sepsis patients, according to a new analysis.

In a report in Annals of Internal Medicine, researchers say policymakers could consider revisions to the SEP-1 bundle that "simplify the components, permitting clinicians some discretion on the basis of patient characteristics, and allowing clinicians to focus on the aspects of sepsis care that most directly drive improvements in patient outcomes."

The SEP-1 program was implemented in 2015 by the Centers for Medicare and Medicaid Services (CMS). It requires hospitals to collect and report data on their adherence to a multicomponent sepsis-treatment bundle that includes blood cultures, early antibiotics, serial lactate measurement, intravenous (IV) fluids, vasopressors for refractory hypotension, and documentation of a patient's response to treatment.

In its current form, SEP-1 is an "all-or-none" measure, meaning that treatment for a given patient is considered adherent only if all elements are completed. Whether or not SEP-1 improves patient outcomes has not been clear.

To investigate, researchers at the University of Pittsburgh School of Medicine and UPMC Health System analyzed data from electronic health records on more than 54,000 sepsis-patient encounters at 11 academic and community hospitals between 2013 and 2017. They evaluated changes in SEP-1-targeted processes using time-series analysis.

They found that two years after its rollout, SEP-1 was associated with substantial increases in lactate checks (70% observed vs. 47% expected if pre-SEP-1 trends had continued) and "small and clinically less important" increases in broad-spectrum antibiotic use (50% vs. 45%) and IV fluid administration within three hours (13% vs. 10%), with no marked change in vasopressor administration.

"Notably, these changes in process measures were not associated with meaningful changes in clinical outcomes," the authors report, including hospital mortality or the percentage of patients discharged home.

"I think one's perspective on the results depends a bit on pre-existing beliefs about the benefits of sepsis bundles as health policy," lead author Dr. Ian Barbash, UPMC intensivist and assistant professor in the University of Pittsburgh Division of Pulmonary, Allergy and Critical Care Medicine, told Reuters Health by email.

"I suspect that those who believe strongly in the widespread application of sepsis bundles found it surprising that the policy's impact on processes was modest, and that there was no detectable change in outcomes. Conversely, those who were more skeptical of the benefits of multicomponent sepsis bundles as policy will not be surprised by these findings," he said.

Going forward, Dr. Barbash said, "it might be beneficial to simplify the measure somewhat to allow physicians to focus on giving appropriate antibiotics, quickly, to the patients who need them most. Second, it will be important to incorporate measures of sepsis survival - either in conjunction with or in place of the process measures that are in SEP-1 - so that hospitals are accountable not just for the bundle elements but also for patient outcomes."

The authors of an editorial note that the SEP-1 program has been "controversial" and there are several possible explanations for SEP-1's failure to affect outcomes in this study.

Dr. Michael Klompas and Dr. Chanu Rhee of Harvard Medical School and Harvard Pilgrim Health Care Institute, in Boston, see two paths forward for SEP-1 "and the still critical goal of improving sepsis care."

"First, we need better diagnostics to detect infection, determine cause and antimicrobial susceptibilities, and inform antibiotic selection in near real-time. Such tools are needed to rapidly identify the subset of infected patients so that physicians can give appropriate antibiotics to those who stand to benefit and avoid collateral damage to those who do not," they write.

"This is not a pipe dream. We already have rapid and accurate molecular diagnostic tools for many respiratory viruses and selected bacterial pathogens. Fostering the development of improved diagnostics including susceptibilities, nurturing studies on their effects on outcomes, and facilitating their deployment are tangible ways that governments and foundations can advance sepsis care," Dr. Klompas and Dr. Rhee say.

"Second, it is time to shift sepsis reporting away from debatable process measures and onto objective outcomes using standardized, clinically meaningful, electronically definable, risk-adjusted indicators. This will help avoid the risk for therapeutic misdirection inherent in mandating overly rigid bundles; respect the physician's art in weighing diagnostic likelihoods with the risks and benefits of potential treatments; and allow clinicians and hospitals room to innovate new ways to improve sepsis recognition, tailor sepsis care, and improve outcomes," they conclude.

This study was funded by grants from the National Institutes of Health and the Agency for Healthcare Research and Quality.

SOURCE: and Annals of Internal Medicine, online April 19, 2021.