Jan 092019

In an unusual turn, the Society for Critical Care Medicine (SCCM) is advising against implementation of the one-hour sepsis bundle originally advocated in Spring 2018 by committee members of its Surviving Sepsis Campaign.

SCCM and American College of Emergency Physicians (ACEP) issued a joint statement in which they acknowledged “concerns expressed about the recently released Surviving Sepsis Campaign (SSC) Hour-1 bundle and the appropriateness of implementation in the United States. The organizations recommend that hospitals do not implement the Hour-1 bundle in its present form.”

The Surviving Sepsis Campaign is a collaboration between SCCM and its European counterpart, so SCCM’s advising delaying implementation of the guidelines is surprising and significant.

The societies planned a meeting to discuss things further, but haven’t issued additional statements since.

The concerns acknowledged may have included an online petition to retract the guidelines, which has so far garnered more than 6,000 signatures from physicians and other providers worldwide. Commentary from this and other online sources was outspoken against the SSC's recommendations.

That was followed by an editorial published in Chest as the con side of a pro/con debate, in which Drs. Paul Marik, Josh Farkas, Scott Weingart, and Rory Spiegel were invited to critique the sepsis guidelines and the one-hour bundle directly to the SSC authors, pointing out:

No evidence seems to exist supporting the 1-h cutoff recommended in the 2018 revised SSC bundle ... No data are provided to show that implementing a 1-h bundle is either feasible or beneficial."

(The SSC did cite some observational data from New York that suggested that earlier delivery of antibiotics was beneficial in general -- but this did not support a one-hour timeframe for antibiotics or any other bundle element.)

Emergency physicians in particular have voiced concerns that the requirements of a one-hour bundle would lead to indiscriminate antibiotic use and distort operations and care in unpredictable, wasteful and potentially harmful ways.

But the larger issue -- triggering the emotional backlash from physicians -- was the perceived presumptuousness of SSC’s unilateral move to dictate health care policy and the behavior of tens of thousands of physicians, without adequate basis.

Guideline-writing committees and practicing physicians have a symbiotic relationship. Individual physicians (and the practice of medicine itself) depend on consensus, and guidelines provide this. The physicians get outsourced expert analysis of the best research, gaining confidence in their own decisions and shelter from liability.

In return, doctors concede some autonomy and independent judgment, along with their time and cognitive energy spent on whatever operational changes eventually result (think "sepsis alerts").

For their part, guideline-writers get prestige and significant power over health care delivery. It’s that last item that can become a problem.

Physicians’ acquiescence to the deal -- their compliance -- depends not just on the authority, but on some degree of humility on the part of the guideline authors. Medical research evolves and frequently generates mistaken conclusions. Changing system-based care in tens of thousands of health systems is costly and hard, and diverts resources away from other important efforts. New guidelines can expose physicians to liability or other consequences for non-compliance. Added documentation burdens and fear of "dings" for the use of independent clinical judgment add to the risk of physician burnout. Regulators are increasingly eager to turn guidelines into de facto legal mandates, further raising the stakes.

For these reasons, guideline authors are duty-bound to be conservative, generally making strong recommendations only when they are strongly supported by evidence, or the consensus among physicians is already high.

With its advocacy of the one-hour sepsis bundle, the SSC veered from these norms and weakened its bonds of trust and credibility with practicing physicians. There was insufficient basis to advocate for this disruption to the practice of emergency medicine and the operations of U.S. hospitals. SCCM was prudent in recommending against implementation of the one-hour sepsis bundle across the U.S.

(In making its decision, SCCM did not say whose concerns it was acknowledging, but those who support the outcome may wish to thank the petition organizers and Chest authors Drs. Marik, Farkas, Weingart and Spiegel, and their collaborating authors including Drs. Jon-Emile Kenny, Scott Aberegg, Philippe Rola et al).

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Hospitals should not implement one-hour sepsis bundles, say SCCM and ACEP