As I’ve written before, I have to confess I’ve never been a huge fan of pathways and protocols. They often struck me as rigid and insensitive to the nuances of differences between patients. There are also times when they are just absurd when physicians, especially mid-level providers, implement them when analysis of the clinical situation clearly shows them to be inappropriate.

I suppose part of me feels rigid protocols and pathways diminish medicine’s art, especially for physicians like me who have been practicing for decades. But more and more evidence is emerging that these things help patient care by ensuring nothing falls through the cracks. I find myself noticing as I enter protocol-driven orders that they can remind me of how to proceed.

I can always uncheck a pre-filled order box in the electronic medical record if it is inappropriate for a particular patient.

Now we have more data about the topic. The clinical situation that has been extensively studied with protocols is sepsis, a series of life-threatening systemic events that can be provoked by various things, but most commonly a serious infection.

A key reason for sepsis being highly appropriate for protocols and pathways is that outcome, odds of survival, is highly influenced by early recognition and treatment. Moreover, the immediate treatment is simple, relatively safe, and available in any hospital. This is why virtually all hospitals now have what are called “sepsis bundles.” These are measures taken for suspected sepsis early in the course before the diagnosis is confirmed.

Because it’s common, researchers have looked at how implementing sepsis bundles has affected outcomes. Bear in mind these comparisons are generally not randomized trials because the ethics of that would be questionable. Historical controls, what happened before implementing the bundle, are often used. This approach carries the possibility of a Hawthorne Effect: the phenomenon that can happen when people know they are being observed and change their behavior.

Of the many investigations reporting an improvement in sepsis outcomes, this one and this one are representatives. The latter is part of the Surviving Sepsis program, an initiative of the Society of Critical Care Medicine. The bottom line is that such bundles of strongly recommended actions improve outcomes.

Sepsis is a bit of an unusual case, though, because, in sepsis, early and immediate action is important, something not the case in many other conditions in which we have time to ponder things.

New York State offers an interesting test case of bundle effectiveness since it has a state law that mandates them. The above studies were in adults. There have been several recent studies of sepsis bundles in children, such as here and here, and they also show benefit. New York provided the comparison before and after implementing the mandate (“Rory’s Regulations”).

I still believe slavish, unthinking adherence to pathways and protocols is bad because they can get in the way of clear thinking. And we don’t need protocols for everything. Yet with more and more acute care being delivered by mid-level, non-physician providers, people who do not have extensive training in the pathophysiology of disease, these things provide a safety net of care. I’ve become cautiously reconciled to them, especially things like sepsis and stroke, in which early and prompt action matters a great deal.

Christopher Johnson is a pediatric intensive care physician and author of Keeping Your Kids Out of the Emergency Room: A Guide to Childhood Injuries and Illnesses, Your Critically Ill Child: Life and Death Choices Parents Must Face, How to Talk to Your Child’s Doctor: A Handbook for Parents, and How Your Child Heals: An Inside Look At Common Childhood Ailments. He blogs at his self-titled site, Christopher Johnson, MD.

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