Title: Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial
Author: Antoine Duclos, Franois Chollet, Léa Pascal, Hector Ormando, Matthew J Carty, Stéphanie Polazzi, Jean-Christophe Lifante
Objective To determine the effect of introducing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients.
Design National, parallel, cluster randomised trial embedding a difference-in-differences analysis.
Setting 40 surgical departments of hospitals across France.
Participants 155362 adults who underwent digestive tract surgery. 20 of the surgical departments were randomised to prospective monitoring of outcomes using control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group).
Interventions Prospective monitoring of outcomes using control charts, provided in sets quarterly, with regular feedback on indicators (intervention hospitals). To facilitate implementation of the programme, study champion partnerships were established at each site, comprising a surgeon and another member of the surgical team (surgeon, anaesthetist, or nurse), and were trained to conduct team meetings, display posters in operating rooms, maintain a logbook, and devise an improvement plan.
Main outcome measures The primary outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery. Changes in surgical outcomes were compared before and after implementation of the programme between intervention and control hospitals, with adjustment for patient mix and clustering.
Results 75047 patients were analysed in the intervention hospitals (37579 before and 37468 after programme implementation) versus 80315 in the control hospitals (41548 and 38767). After introduction of the control chart, the absolute risk of a major adverse event was reduced by 0.9% (95% confidence interval 0.4% to 1.4%) in intervention compared with control hospitals, corresponding to 114 patients (70 to 280) who needed to receive the intervention to prevent one major adverse event. 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 same trend was observed for reoperation (0.91, 0.82 to 1.00), whereas severe complications remained unchanged (0.96, 0.87 to 1.07). Among the intervention hospitals, the effect size was proportional to the degree of control chart implementation witnessed. Highly compliant hospitals experienced a more important reduction in major adverse events (0.84, 0.77 to 0.92), patient death (0.78, 0.63 to 0.97), intensive care stay (0.76, 0.67 to 0.87), and reoperation (0.84, 0.74 to 0.96).
Conclusions The implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients. Understanding variations in surgical outcomes and how to provide safe surgery is imperative for improvements.