Sunday, June 1, 2014

For sepsis, protocol-driven care is not superior to clinical judgment

- Kenny Lin, MD, MPH

Unwarranted variations in medical care contribute to poor health outcomes in the United States. In many cases, following a standard management protocol is likely to produce as good or better results than clinical judgment alone. For example, American Family Physician's Point-of-Care Guides provide high-quality clinical decision rules and tools designed to improve quality of care for problems encountered by family physicians in outpatient and inpatient settings.

Similar principles have guided the management of patients presenting to emergency departments with severe sepsis and septic shock since a 2001 randomized trial found that early goal-directed therapy, or EGDT (including central venous catheterization, intravenous fluids, vasopressors, inotropes, and blood transfusions) improved mortality compared to usual care. A 2013 AFP review, "Early Recognition and Management of Sepsis in Adults: The First Six Hours," recommended using the EGDT protocol and concluded that "timely initiation of evidence-based protocols should improve sepsis outcomes."

This conclusion was recently put to the test in a multicenter trial published in The New England Journal of Medicine. 1,341 patients presenting to 31 emergency departments in the U.S. were randomly assigned to protocol-based EGDT, procotol-based standard therapy, or usual care. Surprisingly, the trial found no statistically significant differences between the three groups in 60-day mortality, longer-term mortality, or the need for organ support. An accompanying perspective cautioned policymakers against rushing to implement regulatory mandates to adhere to sepsis protocols in light of the increasing incidence of this diagnosis and potential harms of protocol-based care:

Protocols that force physician behavior risk promoting inappropriate prescribing of broad-spectrum antibiotics for noninfectious conditions, unnecessary testing, overuse of invasive catheters, diversion of scarce ICU capacity, and delayed identification of nonsepsis diagnoses.

Two lessons from this study for the management of sepsis and other areas of family medicine are that decision rules and protocols should be derived from replicable studies conducted in multiple settings; and that these tools can sometimes enhance, but should not supplant, best clinical judgment.

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