The mandatory use of surgical safety checklists at hospitals across Ontario failed to improve operative mortality, surgical complications, readmissions, or emergency department visits within 30 days after hospital discharge, according to a report published March 12 in the New England Journal of Medicine.
In the 3 months following introduction of checklists at 101 hospitals, mortality remained the same across all subgroups studied, including high-risk groups such as elderly patients and those who required emergency procedures, said Dr. David R. Urbach of the Institute for Clinical Evaluative Sciences and the Institute of Health Policy, Management, and Evaluation, University of Toronto, and his associates.
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"There may be value in the use of surgical safety checklists, such as enhanced communication and teamwork, and the promotion of a hospital culture in which safety is a high priority; however, these potential benefits did not translate into meaningful improvements in the outcomes we analyzed," they reported.
The investigators studied about 200,000 surgical procedures performed at "virtually all hospitals providing surgical care for the population of Ontario, [allowing] us to obtain an estimate of the effectiveness of surgical safety checklists that is less susceptible to biases from selective reporting."
Of the 92 hospitals that furnished copies of their checklist, 79 used that of the Canadian Patient Safety Institute, 9 used customized lists, and 4 used the World Health Organization checklist.
A total of 97 hospitals reported that they used a special intervention or educational program to implement the checklist, and almost every hospital reported that it achieved nearly 100% compliance. "The lowest reported compliance by a large community hospital during this period was 91.6%," the investigators said.
The primary outcome measure – overall operative mortality – was 0.71% before introduction of the surgical safety checklist and 0.65% afterward, a nonsignificant difference.
The risk of an emergency department visit within 1 month of hospital discharge was 10.44% before the checklist and 10.55% afterward, and the risk of readmission within 1 month of hospital discharge was 3.11% before the checklist and 3.14% afterward. These differences too were nonsignificant.
When the data were analyzed according to individual hospitals, "no hospital had a significant change in operative mortality after checklist introduction. Within-hospital changes in other surgical outcomes were mixed. For example, 6 hospitals had significantly fewer complications after introduction of the checklist, whereas 3 had significantly more complications," the investigators reported (N. Engl. J. Med. 2014;370:1029-38).
When the data were further adjusted to account for other factors that might contribute to surgical outcomes, such as patient income, gender, and urban vs. rural residence, the results did not change appreciably. Subgroup analyses also failed to identify any particular group of surgical patients who benefited from implementation of the checklist.
The study was supported by the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences. Dr. Urbach and his associates reported no financial conflicts of interest.