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Seeking a Sharper Focus on Sepsis

Stephen Claypool, MD, Medical Director, Innovation Lab, Wolters Kluwer
Stephen Claypool, MD, Medical Director, POC Advisor, Wolters Kluwer

It’s been just a few weeks since boxing legend and activist Mohamand Ali died of sepsis, a condition that still remains greatly a mystery to many outside and inside healthcare. 

In our previous worked focusing upon sepsis, we learned several discrepancies exist in incidence and mortality reporting due to the host of definitions and terminologies used for sepsis in the field.

Formally, sepsis definitions have been largely unchanged for more than two decades, that is, until the recent publication of “Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)“.

There are now only two identified stages of sepsis: Sepsis and septic shock, as the new sepsis-3 definitions are designed to apply only to patients with life-threatening organ dysfunction caused by a dysregulated host response to infection. “Severe” sepsis is no longer used in the terminology and the milder stage of sepsis that was identified as “sepsis” by SIRS+ (Systemic Inflammatory Response Syndrome) criteria is no longer recognized. With this new definition, “sepsis” now best correlates with the old version’s status of severe sepsis.

Seeking clarification, we decided to contact Dr. Claypool, MD, Medical Director, POC Advisor, Wolters Kluwer for his thoughts on these recent definition changes and how they may impact physicians and the patients.

(Editor’s note: To hear audio excerpts of this interview, click on the media player buttons that run throughout this article.)

I. The long, ongoing debate around sepsis

Claypool traces the early history of the formal definition of sepsis. He also outlines some of the difficulties in arriving at a consensus among physicians on the identification of the condition.  

Notable quote: “There is no test for sepsis. There is no lab test that you can just order, and if it is positive [a patient has] sepsis and if it is negative, they don’t. So, it takes an evaluation of symptoms and signs and findings and then saying, ‘Yes, okay. This person has sepsis.’ That, therefore, requires agreement [on a definition].”


II. Sepsis-2

Continuing his historical background of the first formal definition of sepsis, Claypool provides details behind the creation of the 2001 sepsis-2 definition and how it was linked to SIRS+ criteria. (Interestingly, Claypool notes the ICD-9 codes of the time revealed a wide gap in physicians’ agreement of diagnosing sepsis.)  

Notable quote: “Some of the early screening evaluations done about 15 years ago focused on trying to identify and catch patients [who] were not yet at that dire state of being very, very ill. That effort led the group that created the sepsis-2 definition to define sepsis as the state where patients are not quite so ill, but they are clearly having some inflammatory changes.”


III. Sepsis-3 

Claypool details some of the limitations of the sepsis-2 definition, especially those relative to its sensitivity and the resulting false positives. He goes on to describe how the new sepsis-3 definition is very specific, yet it may not be as sensitive as the sepsis-2 definition, which could lead to patients not being identified as having sepsis earlier in their care.   

Notable quote: “The second definition [of sepsis] is very sensitive … but it has very, very poor specificity. The problem with the sepsis-2 definition from the physicians’ perspective is, ‘Yes, a lot of people meet the criteria, but unfortunately, tons of people who don’t have sepsis meet the criteria and you get a lot of false positives.” 


IV. “Rule out”

Claypool makes the suggestion that physicians ought not be pedantic in terms of applying the new definitions within their work. Like the approach many care providers take with congestive heart failure patients, Claypool believes patients could be designated “sepsis rule out” prior to a formal sepsis diagnosis. 

Notable quote: “What we really should do is still identify people [who] are SIRS+ due to infection and we ought to start acting on that, but let’s not call them sepsis because we know some of those SIRS+ patients will not end up actually having sepsis. What we should use is what the Sepsis Alliance is proposing which is we ought to call those people ‘rule out sepsis’.”


V.  Ambiguity remains 

Claypool states that even with the new sepsis-3 definition, physicians must recognize the often chaotic progression patients sometimes make toward sepsis and act immediately.  

Notable quote: “Sepsis doesn’t always progress from, ‘I’m sick. I’m a little bit more sick. I’m getting more sick. I’m starting to have evidence of hyperperfusion. I’m getting a little bit of organ failure, and now I have a lot of organ failure.'”