DY: I do think that with all three trials [ProCESS, ProMISe [Protocolised Management in Sepsis trial] and ARISE [Australasian Resuscitation in Sepsis Evaluation trial] showing the overall improvement in sepsis care, there was a pocket of people who wondered whether it was all true or whether maybe the improvement is really a bit more muted than what was shown.
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ACEP Now: Vol 35 – No 07 – July 2016KK: Tiffany, given your work with the Surviving Sepsis Campaign, how do you see these definitions now being applied, and what are some of the potential obstacles to applying them to the Surviving Sepsis Campaign or guidelines?
TO: Part of the issue is that you have two ICU groups that came together and said, “We want to redefine what sepsis is.” There was a lot of consternation about the use of SIRS [systemic inflammatory response syndrome] as a definition because if you walked up the stairs too fast and had a cough, you could probably screen positive for SIRS. That, in essence, increases the number of patients you have in your denominator; if you’re looking for really sick patients, you have to get a lot more patients to find that subset you’re looking for.
It wasn’t until I went back and listened to Morgan on Scott Weingart’s podcast [EMTcrit.org] that I made this connection: These definitions were never intended to be used in the management of patients. A direct quote from the podcast is, “As discussed later, the SOFA [sequential organ failure assessment] score is not intended to be used as a tool for patient management, but as a means to clinically categorize a septic patient.” However, listed in their paper in big red letters is, “Screening for Patients Likely to Have Sepsis.”
TS: Maybe the terminology was bad, but Tiffany is right; qSOFA isn’t really a screening tool. It’s something you use once you already know someone has an infection. The definition authors propose it as a way to look at organ dysfunction, what we would call severe sepsis. You don’t apply qSOFA to every comer into the ED. First, you have to figure out if they’re infected, and then apply SOFA, which is a really complicated way to look at organ failure. SOFA was done in 1996. It’s barely younger than SIRS. They did this massive data crunch, and they came up with qSOFA as a way to say, “In my infected patient population, these are the people I should worry about more.” But you still have to find the infected population first.
2 Responses to “A Marriage of Old Data and New Concepts: New Sepsis Definitions Raise Concerns about Accuracy, Usefulness in Emergency Medicine”
July 26, 2016
Lawrence LynnWe were encouraged that sepsis science was trying to move toward evidenced based crteria from the guessed SIRS of the past. The use of the guessed SIRS criteria in clinical trials was not scientific and was producing runaway inflation of the sepsis diagnosis, inflating the perceived benefit of intervention and rendering any positive benefit of RCT (in comparison with a control population) nonreproducible. SIRS had to be abandoned as the standard definition used in sepsis research.
However the needs of clinical medicine in a vacuum of objective data are different than the needs of scientists in that same vacuum. It is therefore not surprising that ER physcians have been disappointed with qSOFA which was derived from an effort to improve the scientific study of sepsis.
The problem is that there was no determination of when, on the timeline of the different dynamic relational patterns of common sepsis phenotypes, qSOFA criteria are met.
To illustrate this, consider the case of Rory Staunton. He was alert, non hypotensive, yet he had tachypnea, over 50% bands (evolving neutrophilic failure), a low platelet count (although not down to 100) and evidence of infection. Later (perhaps too late) he had hypotension and mental status changes.
When we called for a new sepsis definition we expected that the data from large trials would be reviewed to determine the dynamic relational patterns of the common sepsis phenotypes and then EARLY markers components of the patterns selected as a screening definition with the addition of the time patterns in the scientific definition. Alas, in the statistical search for correlates, time was, once again, overlooked. ER docs never overlook time as the essence of the word “emergency” is time.
The problem with setting up late criteria is the risk of a false sense of security. Altered mental state and hypotension are proven markers of all sepsis phenotypes but so is death. All three are often late findings and markers of diagnostic delay.
July 31, 2016
Mike GertzThe recommendations by the surviving sepsis campaign have always been to only screen patients who are “seriously ill appearing.” As a specialty, we know what that means. The problem is that we are trying to screen everyone with a lot of resultant noise. In the end, sepsis is like pornography, difficult to define but we all know it when we see it.