Duclos A, Chollet F, Pascal L, Ormando H, Carty MJ, Polazzi S, Lifante JC; SHEWHART Trial Group.
Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial. BMJ. 2020 Nov 4;371:m3840. doi: 10.1136/bmj.m3840. PMID: 33148601.
Study question : What is the effect of introducing prospective monitoring of outcomes using control charts with regular feedback on indicators to surgical teams on major adverse events in patients?
Methods : A difference-in-differences analysis was embedded in a national, parallel, cluster randomised trial. After a baseline assessment in 40 surgical departments from hospitals across France were randomly allocated to implement a control chart based programme in 2017-2018. Among 20 hospitals randomised to the intervention group, a set of control charts was provided quarterly for monitoring surgical outcomes with feedback on indicators to surgical teams. The main outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery among 155 362 adults who underwent digestive tract procedures.
Study answer and limitations : A significant decrease in major adverse events (adjusted ratio of odds ratios 0.89, 95% confidence interval 0.83 to 0.96), patient death (0.84, 0.71 to 0.99), and intensive care stay (0.85, 0.76 to 0.94) was found in intervention compared with control hospitals. The feasibility and effect of implementing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients and in a different context remain unknown.
What this study adds: A statistically significant reduction in major adverse events and patient death after surgery was found after implementation of a programme using control charts with regular feedback on indicators to surgical teams. The findings support the routine use of control charts to monitor variations in surgical outcomes over time to improve patient safety.