July 19, 2019

After 12-year-old Rory Staunton died of sepsis in 2012, New York imposed new regulations on how providers treat sepsis, and a recent study published in JAMA found those regulations appear to be working, Richard Harris writes for NPR's "Shots."

Background

In early 2013, New York Gov. Andrew Cuomo (D) announced new regulations requiring acute-care hospitals to adopt evidence-based practices to curb sepsis mortality rates.

The regulations were named "Rory's Regulations" after Staunton, who was misdiagnosed with the flu and then a stomach virus and sent home. He died three days later of severe septic shock in the ICU.

The regulations demand rapid diagnosis of sepsis, a prompt dosage of antibiotics, and careful management of fluids. New York hospitals were required to submit comprehensive sepsis protocols to the state's department of health and implement Rory's Regulations no later than Dec. 31, 2013.

Some of the regulations include granular requirements for clinical practice. For instance, the state provided "a formula regulating how much fluid to infuse and when," Harris reports.

Study finds sepsis regulations are working, but experts urge caution

According to Jeremy Kahn, a critical care physician at the University of Pittsburgh, many doctors objected to being told by the state how to treat their patients. For instance, "[t]here's a lot of concern in the clinical community that" the amount of fluid required by the New York regulations "can harm at least some patients with sepsis," Kahn said.

So Kahn and his colleagues decided to see if the state-imposed regulations led to faster improvements in sepsis death rates when compared with other states, Harris writes.

What they found, Kahn said, was that "these regulations had their intended effect of reducing mortality." For instance, the researchers found that over the first 10 quarters after the regulations took effect, New York's adjusted absolute mortality was 3.2% lower than expected based on the other states' experiences.

Even so, Kahn said there is still room for improvement in sepsis treatment, and regulations should be flexible enough to adapt to new treatment methods as they arrive. "The evidence changes all the time," Kahn said, "and when you enshrine [what is currently] 'best practice' into laws or regulations then you become less nimble."

Kahn also questioned whether the success in New York could be repeated in other states, since New York started off with much worse sepsis death rates than other states. "It does call into question what kind of impact these regulations will have in other states that may have better sepsis outcomes at baseline," he said.

Comments

Demetrios Kyriacou, an ED physician at Northwestern University, in an accompanying editorial published in JAMA was similarly cautious about how the findings should be interpreted. He wrote that "major public health interventions cannot be based on … [a] single observational study."

Kyriacou wrote, "Because demands on nurses and physicians to provide rapid intensive care to patients in critical settings can affect patient treatment, any strategy aimed toward reducing sepsis-related morbidity and mortality must be based on convincing evidence before being mandated by governmental regulations" (Harris, "Shots," NPR, 7/16).

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