The debunking of a standard protocol for treating sepsis should not mask the great progress hospitals and clinicians have made over the last dozen years—or reduce the focus on sepsis.
This week's plot twist in the story about how hospitals deal with patients diagnosed with sepsis and septic shock may seem to many clinicians like more bad news: A protocol embedded in a nationally endorsed practice guideline didn't work better at saving lives than letting physicians use their best judgment.
True, most agree that there are problems with parts of that protocol, and the National Quality Forum and the New York State Department of Health, which is enacting reporting regulations throughout that state's hospitals, will have to go back to the drawing board.
But this is hardly cause for gloom. In fact, it is actually great news because it starts to clear the air, enabling us to see a better pathway to manage this terrible form of infection, a syndrome so thoroughly awful that the 750,000 to 1.1 million patients in the U.S. who are diagnosed with it each year are often said to be "circling the drain" because of sepsis' rapid corkscrew cascade.
And, by the way, sepsis costs the healthcare system in this country an estimated $17 billion a year because of added stays in intensive care and multiple desperation strategies to salvage failing organs.
This study, published online in the New England Journal of Medicine on Tuesday, will surely help clinicians improve their recognition and management of sepsis, which is hard to see early and extremely difficult to manage late.
The study refocuses clinicians on what they need to do and how soon they need to do it, as much as it helps them avoid unnecessary and expensive processes like inserting central venous catheters to capture rates of oxygen saturation. We now know clinicians don't need to do this, although clearly many still are.
The study also reinforces the fact that care practices have gotten so much better in the last decade and that physicians' judgment is pretty darn good, even apart from the standard protocol. Like the impact of the Hawthorne effect, people are watching sepsis care much more closely; thus, care has improved because they do.
In addition to this news, another good thing happened in field of sepsis care this week.
Today, the Centers for Disease Control and Prevention, criticized by the Rory Staunton Foundation and others for not putting enough emphasis on sepsis in the past, is launching the first in a series of fact sheets about sepsis. The agency is, indeed, taking a more aggressive approach to researching the condition to help hospitals better treat their sepsis patients. It is working with states including New York on development of reporting regulations, as well.
The CDC estimates that not only have the numbers of people treated for sepsis in U.S. hospitals nearly doubled between 2000 and 2008, from 621,000 to 1.14 million, it also estimates that between 28% to 50% of those patients died. Those are much bigger numbers than what's usually quoted for sepsis, which is around 750,000 cases per year.
In addition, according to Clifford McDonald, MD, chief of the CDC's prevention and response branch, "We intend to pursue a large study on sepsis, probably on identification and processes for assessing treatment. We want to take what's already in the literature and the Surviving Sepsis Campaign and implement it on a larger scale."
Older people are especially susceptible to the syndrome, although a minor skin abrasion can result in sepsis in a young child, as it did in 12-year-old Rory Staunton in New York City two years ago. McDonald says that one mystery the CDC hopes to tackle is where community-acquired sepsis infections really come from, and why they can be lethal for one boy with a cut on his arm but leave another unharmed.
As further evidence the CDC is more engaged in the topic of sepsis, CDC director Tom Frieden, MD, met with Staunton's parents on February 10 and pledged to help improve treatment, and even Tweeted about it. He wrote that Rory Staunton's parents "commitment is inspiring. CDC will do whatever we can to help stop sepsis."
There was other good news on sepsis this week. A report in the Journal of the American Medical Association Tuesday studying sepsis patients in Australia and New Zealand found that mortality of those diagnosed with sepsis in the hospital decreased from 35% to 18.4% between 2000 and 2012.
So how do we assess the latest sepsis news?
J. Christopher Farmer, MD, president of the Society of Critical Care Medicine and chair of the Mayo Clinic's department of critical care medicine in Scottsdale, AZ, has several plausible explanations. He ought to know because he lives and breathes sepsis care.
Hospitals and physicians are just better at diagnosing and treating sepsis today, even after a few fumbles and wrong directions over the last 12 years, he says.
The protocol, developed by Emanuel (Manny) Rivers, MD, of Henry Ford Hospital in Detroit in 2001, that was debunked by this week's New England Journal of Medicine, actually resulted in great leaps of improvement over the past few years.
"Pre-Manny Rivers, it was very common that a patient would come in to the ED with sepsis and our ability to recognize it early was limited," Farmer says. The criteria that were used were not specific to sepsis, but mainly informed that there was an inflammatory condition. "A patient could come in with a pulmonary embolism and, by the books and by the list, look like they have sepsis."
Second, he says, few hospitals had a team-based approach to treating sepsis, which requires interaction by a pharmacist, an ED nurse, an ICU nurse, an ED physician, an ICU doctor, and a respiratory therapist—practices that are now in place in many hospitals.
Third, the Rivers protocol and many others that have come along since in hospitals throughout the nation have stressed the importance of getting appropriate antibiotics into patients suspected of having sepsis as soon as possible, within three hours. That also was not done before 2001 in many hospital organizations, Farmer says.
Fourth, the Institute for Healthcare Improvement's 100,000 Lives Campaign in the middle part of the last decade pushed the team approach.
"The fact that—as the Australia paper showed—mortality has gone down in the last decade, these are the kinds of things that take the credit for that," he says.
So even though the Rivers protocol has aspects that the new report found did not help, other elements about that protocol we now know to be essential. They've been implemented in hospitals over the past decade, such as prompting hospitals to "resuscitate" patients by giving them adequate levels of fluid.
"In the days before the Rivers protocol, these patients didn't get two liters of fluid. They didn't get resuscitated," Farmer says.
Hospitals have many reasons to worry about sepsis. For starters, it's not good for their mortality stats. And it's also not good for hospital morale or use of resources when staff can't stop patients from circling the drain.
It's nice to have some good news about sepsis.