In the JournalsPerspective

Rory’s Regulations: State-mandated sepsis care decreases mortality

Jeremy M. Kahn, MD, MS
Jeremy M. Kahn

State-mandated sepsis care in New York was associated with a greater decrease in mortality in adults hospitalized with sepsis compared with states that do not have similar protocols, according to findings from a retrospective cohort study published in JAMA.

“Sepsis is a public health crisis affecting millions of patients each year,” Jeremy M. Kahn, MD, MS, professor of critical care medicine and health policy management and vice chair for academic affairs in the department of critical care medicine at the University of Pittsburgh, told Infectious Disease News. “Early recognition and treatment save lives, but unfortunately, many patients don’t receive high-quality care. Although mandating the use of evidence-based practices is controversial, we show that at least in this case, it appears to have worked.”

In 2013, New York state mandated that all acute-care hospitals adopt evidence-based protocols for sepsis recognition and treatment. Previous research found that rapid care and delivery of antibiotics in accordance with the mandate — called Rory’s Regulations — resulted in decreased mortality risk.

For their study, Kahn and colleagues included 1,012,410 sepsis admissions between January 2011 and March 2013 using all-payer hospital discharge data from 509 hospitals in New York and four control states — Florida, Maryland, Massachusetts and New Jersey. The primary outcome was 30-day in-hospital mortality, they wrote.

Before the passing of the regulations in 2013, the unadjusted 30-day in-hospital mortality among patients diagnosed with sepsis in New York was 26.3%, compared with 22% in the control states, Kahn and colleagues reported. Following the regulations, New York’s sepsis mortality rate dropped 4.3% to 22%. In the control states, the rate decreased 2.9% to 19.1%.

According to the researchers, New York state’s adjusted absolute mortality was 3.2% (95% CI, 1% to 5.4%) lower than expected by the 10th quarter after implementation of the regulations compared with the control states (P = .004).

The regulations also were associated with significant relative decreases in hospital length of stay (P = .04) and Clostridioides difficile infection rate (P < .001), as well as a significant relative increase in central venous catheter use (P = .02). They were associated with no significant differences in ICU admission (P = .09), according to the study.

Kahn said the data strongly suggest that the regulations effectively reduced sepsis death rates.

“Right now, about 12 states are actively considering these regulations, and many others are considering them,” Kahn said. “Our data clearly show that these regulations work in New York and they are likely to work elsewhere. However, given that New York is unique in many ways, states should consider looking at their own sepsis outcomes before fully adopting sepsis mandates.”

If a state’s sepsis outcomes are already favorable because of regional quality improvement efforts or other initiatives, “they may not see as strong an effect as we saw in New York,” Kahn said. – by Joe Gramigna

Disclosures: Kahn reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

Jeremy M. Kahn, MD, MS
Jeremy M. Kahn

State-mandated sepsis care in New York was associated with a greater decrease in mortality in adults hospitalized with sepsis compared with states that do not have similar protocols, according to findings from a retrospective cohort study published in JAMA.

“Sepsis is a public health crisis affecting millions of patients each year,” Jeremy M. Kahn, MD, MS, professor of critical care medicine and health policy management and vice chair for academic affairs in the department of critical care medicine at the University of Pittsburgh, told Infectious Disease News. “Early recognition and treatment save lives, but unfortunately, many patients don’t receive high-quality care. Although mandating the use of evidence-based practices is controversial, we show that at least in this case, it appears to have worked.”

In 2013, New York state mandated that all acute-care hospitals adopt evidence-based protocols for sepsis recognition and treatment. Previous research found that rapid care and delivery of antibiotics in accordance with the mandate — called Rory’s Regulations — resulted in decreased mortality risk.

For their study, Kahn and colleagues included 1,012,410 sepsis admissions between January 2011 and March 2013 using all-payer hospital discharge data from 509 hospitals in New York and four control states — Florida, Maryland, Massachusetts and New Jersey. The primary outcome was 30-day in-hospital mortality, they wrote.

Before the passing of the regulations in 2013, the unadjusted 30-day in-hospital mortality among patients diagnosed with sepsis in New York was 26.3%, compared with 22% in the control states, Kahn and colleagues reported. Following the regulations, New York’s sepsis mortality rate dropped 4.3% to 22%. In the control states, the rate decreased 2.9% to 19.1%.

According to the researchers, New York state’s adjusted absolute mortality was 3.2% (95% CI, 1% to 5.4%) lower than expected by the 10th quarter after implementation of the regulations compared with the control states (P = .004).

The regulations also were associated with significant relative decreases in hospital length of stay (P = .04) and Clostridioides difficile infection rate (P < .001), as well as a significant relative increase in central venous catheter use (P = .02). They were associated with no significant differences in ICU admission (P = .09), according to the study.

Kahn said the data strongly suggest that the regulations effectively reduced sepsis death rates.

“Right now, about 12 states are actively considering these regulations, and many others are considering them,” Kahn said. “Our data clearly show that these regulations work in New York and they are likely to work elsewhere. However, given that New York is unique in many ways, states should consider looking at their own sepsis outcomes before fully adopting sepsis mandates.”

If a state’s sepsis outcomes are already favorable because of regional quality improvement efforts or other initiatives, “they may not see as strong an effect as we saw in New York,” Kahn said. – by Joe Gramigna

Disclosures: Kahn reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

    Perspective

    In essence, this large comparative retrospective study confirms that which would appear to be intuitively true and obvious. Patients with conditions that are associated with increased rates of mortality have an improved chance of survival if the condition is recognized, acted upon and successfully reversed or halted earlier rather than later. However, almost certainly the definition of sepsis as applied in hospitals throughout the United States, both then and to this day, is based on satisfying two of four relatively overly sensitive and nonspecific criteria defined as the systemic inflammatory response syndrome. Undoubtedly, many patients deemed to be septic but never proven to have an active infection (historically, culture-positive sepsis is observed in only 30% to 40% of cases) increases the institution's number of sepsis cases (denominator), which has a direct effect on decreasing the mortality rate even if the number of deaths (numerator) were the same. Having voiced that concern, there are clear data proving that earlier initiation of adequate antimicrobial therapy provides a significant advantage for survival in those who are truly septic with associated hypotension and organ dysfunction. It was this determination that led to the 2018 Surviving Sepsis Campaign bundle update, which combined the 3- and 6-hour bundles employed with the Rory's Regulations-mandated protocol into a now 1-hour bundle of care. Unfortunately, to this day, the definition of time zero or time of presentation remains nebulous, to the point of suggesting that sepsis is in the eye of the beholder.

    In large part, the Infectious Diseases Society of America has not endorsed these surviving sepsis campaign guidelines, rightfully fearful of treating many uninfected individuals and leading to a potential array of unintentional, unwarranted consequences of which we are all familiar and deal with on a daily basis.

    Perhaps a similar study using the 2016 third international consensus definitions for sepsis (SOFA and qSOFA) and septic shock would prove to be more valuable. Until that time, it is hoped that we will continue to practice evidence-based medicine while keeping in mind the age-old adages: Base decisions on each individual clinical scenario, and first, do no harm.

    • Larry M. Bush, MD, FACP
    • Affiliate professor of clinical medicine
      Charles E. Schmidt College of Medicine
      Florida Atlantic University
      Affiliate associate professor of medicine
      University of Miami Miller School of Medicine
      Palm Beach County Regional Campus

    Disclosures: Bush reports no relevant financial disclosures.