A new study that demonstrated a significant positive impact of the WHO Surgical Safety Checklist on patient morbidity and mortality (Haugen 2015) seems to have touched off a debate on whether we are suffering from “checklist fatigue”. Haugen and colleagues, using a stepped wedge cluster randomized controlled trial at 2 Norwegian hospitals (one academic and one community), demonstrated that implementation of the Surgical Safety Checklist reduced complication rates from 19.9% to 11.5% (absolute risk reduction 8.4%). Moreover, mean hospital length of stay (LOS) was reduced by 0.8 days after the implementation. Mortality reduction from 1.6% to 1.0% overall did not reach statistical significance (though at the community hospital a mortality reduction from 1.9% to 0.2% was statistically significant).
The original introduction of the WHO Surgical Safety Checklist (Haynes 2009) was associated with striking reductions in both mortality and complication rates. However, that study and several others have come under some criticism because of their before-after study designs. And some studies, such as one done in Ontario, Canada (Urbach 2014) showed that implementation of surgical safety checklists was not associated with significant reductions in operative mortality or complications.
So the new study by Haugen and colleagues, using the new design (which is somewhat similar to crossover studies which you may be more familiar with in device or medication studies) should have been a welcome endorsement of the Surgical Safety Checklist. Indeed, in a commentary accompanying the study, several of the coauthors of the original WHO study were delighted that the new study showed support for use of the checklist (Haynes 2015). They pointed out that the Haugen study even showed a “dose effect” in that larger reductions in complications were seen when all portions of the checklist were followed.
But in a second commentary Stock and Sundt were less enthusiastic and raised the concern of “checklist fatigue” (Stock 2015). They note that checklists should be used judiciously, and are particularly useful to prevent memory lapses when a specific sequence of actions must be taken in order the same way each time. But they point out that such memory lapses actually are only involved in a small percentage of significant surgical incidents. They suggest we take a “timeout” before implementing any new checklist and see if it meets 3 criteria:
These are actually good criteria. We’ve done multiple columns on checklists (listed below) and described the ideal qualities of checklists in several of them.
The Haynes commentary also points out that the Norwegian study did several important things during its implementation. First, it modified the Surgical Safety Checklist to meet local needs. Second, they piloted it before widespread implementation, allowing for adjustments and for development of “champions” and “super users” who would be key players in further rollout. And, third, they did appropriate education for all disciplines affected when they did their widespread rollout.
We continue to be enthusiastic proponents of checklists. They need to be short and they don’t need to include a whole bunch of items that are seldom forgotten. And checklists are really good communication tools. So the wisdom of the criteria proposed by Stock and Sundt is well-grounded.
But perhaps a real lesson is that it is not simply enough to implement a checklist blindly based upon its successes in other venues. You actually need to measure after implementation to ensure it led to its intended effect and did not produce any unintended consequences.
Some of our prior columns on checklists:
Haugen AS, Søfteland E, Almeland SK, et al. Effect of the World Health Organization Checklist on Patient Outcomes: A Stepped Wedge Cluster Randomized Controlled Trial. Annals of Surgery 2015; 261(5): 821-828
Haynes A, Weiser T, Berry W, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009; 360(5): 491-499
Urbach DR, Govindarajan A, Saskin R, et al. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med 2014; 370(11): 1029-1038
Haynes AB, Berry WR, Gawande AA. What Do We Know About the Safe Surgery Checklist Now? Annals of Surgery 2015; 261(5): 829-830
Stock CT, Sundt T. Timeout for Checklists? Annals of Surgery 2015; 261(5): 841-842
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