World Sepsis Day: The CDC's new guidance on the life-threatening condition looks like progress.
September 13th is World Sepsis Day, and September is Sepsis Awareness Month. Sepsis is a dangerous medical condition in which the body’s immune response to infection causes it to attack itself.
Think of it like a scorched Earth scenario: Our immune system’s war on a pathogen wreaks havoc on the battlefield itself, our own body, which can cause organ damage ranging from mild to life-threatening.
Sepsis can happen to anyone, but for the most part, serious cases occur in medically vulnerable individuals with complex medical problems. Over the years, various definitions of sepsis have become more liberal and inclusive. This has pluses (identifying cases early) and minuses (overtreating patients with powerful medications leading to further problems). Moreover, the debate on how to treat sepsis has been raging for decades.
There is, however, broad agreement in one key area of this: Screening patients for possible sepsis is essential. Identifying patients who might have sepsis is the absolute, undisputed, most important component of any strategy to improve sepsis outcomes. Once a good sepsis screen is in place, better outcomes are possible.
The government got into the sepsis game in the 2010s, with mixed results.
Somewhat infamously, the CDC didn’t even mention sepsis on its website until Ciaran and Orlaith Staunton—advocates whose young son Rory tragically died of sepsis a decade ago in New York—proverbially pounded their fists on the desk of then-director Dr. Tom Frieden. However, it was not until recently that the CDC heartily chimed in with concrete guidance on what hospitals and clinicians might do to improve sepsis outcomes. Just last month, the CDC came out with a sepsis toolkit for hospitals. The Stauntons believe that Rory might be alive today had this toolkit been around ten years ago, and they may very well be right.
The federal government was already in the sepsis game by the mid-2010s, but not at the CDC. Rather, Medicare (i.e., the Centers for Medicare and Medicaid Services, within HHS) started requiring hospitals to screen and treat sepsis in a highly specific way. There were massive problems with this—a federal regulation called “SEP-1”—although updates to the protocol have improved things somewhat. Still, the Medicare sepsis regime is riddled with problems, is deeply unpopular in the medical profession, and seems to accomplish almost nothing. (Government largesse, incarnate.)
Meanwhile, there are alternatives. In fact, New York was the first state to enact a sepsis regulation that guides hospital-based sepsis care—an action literally known as the Rory Regulation. Unlike many other sepsis protocols, the Rory Regulation has actually been associated with decreases in mortality, with data appearing in high-quality medical journals conducted by respected researchers.
I’ve interviewed Ciaran and Orlaith a couple of times. My heart goes out to them. Also, they are, in many ways, ideal patient advocates. What I mean by that is that they truly do believe in medicine, and they believe in the medical field. Despite their tragedy, they aren’t haters of our profession—though one couldn’t blame them if they were. They aren’t looking to undermine physician expertise and “burn it all down.” Rather, they want to augment and improve what we do. And they have been unusually effective.
Not all sepsis protocols are created equal.
What makes the New York sepsis regulation successful, in my view, hinges on three things.
Good screening. You don’t want a sepsis screen that cries wolf, nor one that misses key cases. Hospitals are permitted to create their own screening protocols that reflect the particular patient population they serve. The one we used at Elmhurst Hospital in Queens perfectly balanced those needs.
Flexible framework. The guideline outlines the best evidence we have, but allows for physician judgment (which has always been a problem with the Medicare regulation, albeit this has improved over time).
More is not always better. Requiring clinicians to do more than necessary can distract from the actions that are actually needed.
The new CDC toolkit outlines key actions that hospitals should take to improve outcomes. That does not mean treating all patients with possible sepsis the exact same way. But it does mean having an evidence-based protocol, tracking and reporting outcomes, and building and maintaining sepsis leadership teams with the multi-disciplinary expertise needed to make things work in practice, not just in theory and on paper.
While the CDC’s sepsis toolkit does not explicitly highlight this fact, there are a few aspects which could be read as discreetly contradicting the Medicare standards. I’ve never been a fan of the Medicare standards, so I tend to be sympathetic to the CDC’s new view on this. In fact, I’ve often called on the Centers for Medicare and Medicaid Services to retire and replace its now-dinosaur regulation on sepsis.
If something that encompasses the CDC’s new approach to sepsis care can be aligned with Medicare’s complicated regulatory requirements—thereby replacing the current regulation that drives clinicians like me crazy and does not improve patient outcomes—that would be much-needed and welcome progress.
Something to think about on World Sepsis Day.
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