Effect of the World Health Organization Checklist on Patient Outcomes A Stepped Wedge Cluster Randomized Controlled Trial

Objectives: We hypothesized reduction of 30 days' in-hospital morbidity, mortality, and length of stay postimplementation of the World Health Organization's Surgical Safety Checklist (SSC). Background: Reductions of morbidity and mortality have been reported after SSC implementation in pre-/postdesigned studies without controls. Here, we report a randomized controlled trial of the SSC. Methods: A stepped wedge cluster randomized controlled trial was conducted in 2 hospitals. We examined effects on in-hospital complications registered by International Classification of Diseases, Tenth Revision codes, length of stay, and mortality. The SSC intervention was sequentially rolled out in a random order until all 5 clusters-cardiothoracic, neurosurgery, orthopedic, general, and urologic surgery had received the Checklist. Data were prospectively recorded in control and intervention stages during a 10-month period in 2009-2010. Results: A total of 2212 control procedures were compared with 2263 SCC procedures. The complication rates decreased from 19.9% to 11.5% (P < 0.001), with absolute risk reduction 8.4 (95% confidence interval, 6.3-10.5) from the control to the SSC stages. Adjusted for possible confounding factors, the SSC effect on complications remained significant with odds ratio 1.95 (95% confidence interval, 1.59-2.40). Mean length of stay decreased by 0.8 days with SCC utilization (95% confidence interval, 0.11-1.43). In-hospital mortality decreased significantly from 1.9% to 0.2% in 1 of the 2 hospitals post-SSC implementation, but the overall reduction (1.6%-1.0%) across hospitals was not significant. Conclusions: Implementation of the WHO SSC was associated with robust reduction in morbidity and length of in-hospital stay and some reduction in mortality.