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ObjectiveTo 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.DesignNational, parallel, cluster randomised trial embedding a difference-in-differences analysis.Setting40 surgical departments of hospitals across France.Participants155 362 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).InterventionsProspective 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 measuresThe 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.Results75 047 patients were analysed in the intervention hospitals (37 579 before and 37 468 after programme implementation) versus 80 315 in the control hospitals (41 548 and 38 767). 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).ConclusionsThe 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.Trial registrationClinicalTrials.gov NCT02569450.

Lison Huet a obtenu le 2ème prix du meilleur poster; Obesity is associated with a greater prevalence of neuropsychiatric disorders, including depression. Recent data support the notion that adiposity-driven inflammation contributes to this effect, given the notorious role of inflammatory processes in the pathophysiology of depressive symptoms. Moreover, it has been recently suggested that this effect may be potentiated by metabolic abnormalities associated with obesity. The objective of the present study was to determine the relative contribution of systemic inflammation and metabolic abnormalities to depressive symptomatology in subjects afflicted with severe obesity.The study was conducted in a large sample of severely or morbidly obese patients eligible for bariatric surgery and recruited from the units of digestive and bariatric surgery at the Tivoli (Bordeaux, France) and Jean Villar (Bruges, France) clinics. A group of age- and gender-matched lean healthy subjects were included as control participants. Depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) during a semi-structured clinical interview with a trained rater. Metabolic data, including high density lipoprotein cholesterol, triglycerides, fasting glucose and blood pressure, were collected from the patients' clinical charts. Information on the use of antihypertensive and antidiabetic medication was also obtained. Fasting blood samples were collected in all subjects for the measurement of serum concentrations of inflammatory markers by ELISA. These markers included the acute phase protein, high sensitive C-reactive protein (hs-CRP), the pro-inflammatory cytokines, interleukin-6 (IL-6) and tumor necrosis factor α (TNF-α) and the adipokine, leptin.Results indicate higher levels of circulating inflammatory markers, especially hs-CRP, and greater MADRS scores in obese subjects compared to lean controls. Furthermore, multiple linear regression analyses adjusted for age and gender revealed that hs-CRP contributed significantly to the relationship between obesity and depressive symptoms. Interestingly, this relationship was not modulated by metabolic abnormalities, which did not explain depressive symptoms.Taken together these data support the hypothesis that chronic low-grade inflammation is a key determinant of depressive symptoms in obesity and that this effect does not rely on metabolic abnormalities.