A time-adjusted control chart for monitoring surgical outcome variations.

BACKGROUND: Statistical Process Control (SPC) tools providing feedback to surgical teams can improve patient outcomes over time. However, the quality of routinely available hospital data used to build these tools does not permit full capture of the influence of patient case-mix. We aimed to demonstrate the value of considering time-related variables in addition to patient case-mix for detection of special cause variations when monitoring surgical outcomes with control charts. METHODS: A retrospective analysis from the French nationwide hospital database of 151,588 patients aged 18 and older admitted for colorectal surgery between January 1st, 2014, and December 31st, 2018. GEE multilevel logistic regression models were fitted from the training dataset to predict surgical outcomes (in-patient mortality, intensive care stay and reoperation within 30-day of procedure) and applied on the testing dataset to build control charts. Surgical outcomes were adjusted on patient case-mix only for the classical chart, and additionally on secular (yearly) and seasonal (quarterly) trends for the enhanced control chart. The detection of special cause variations was compared between those charts using the Cohen's Kappa agreement statistic, as well as sensitivity and positive predictive value with the enhanced chart as the reference. RESULTS: Within the 5-years monitoring period, 18.9% (28/148) of hospitals detected at least one special cause variation using the classical chart and 19.6% (29/148) using the enhanced chart. 59 special cause variations were detected overall, among which 19 (32.2%) discordances were observed between classical and enhanced charts. The observed Kappa agreement between those charts was 0.89 (95% Confidence Interval [95% CI], 0.78 to 1.00) for detecting mortality variations, 0.83 (95% CI, 0.70 to 0.96) for intensive care stay and 0.67 (95% CI, 0.46 to 0.87) for reoperation. Depending on surgical outcomes, the sensitivity of classical versus enhanced charts in detecting special causes variations ranged from 0.75 to 0.89 and the positive predictive value from 0.60 to 0.89. CONCLUSION: Seasonal and secular trends can be controlled as potential confounders to improve signal detection in surgical outcomes monitoring over time.

Economic analysis of surgical outcome monitoring using control charts: the SHEWHART cluster randomised trial.

IMPORTANCE: Surgical complications represent a considerable proportion of hospital expenses. Therefore, interventions that improve surgical outcomes could reduce healthcare costs. OBJECTIVE: Evaluate the effects of implementing surgical outcome monitoring using control charts to reduce hospital bed-days within 30 days following surgery, and hospital costs reimbursed for this care by the insurer. DESIGN: National, parallel, cluster-randomised SHEWHART trial using a difference-in-difference approach. SETTING: 40 surgical departments from distinct hospitals across France. PARTICIPANTS: 155 362 patients over the age of 18 years, who underwent hernia repair, cholecystectomy, appendectomy, bariatric, colorectal, hepatopancreatic or oesophageal and gastric surgery were included in analyses. INTERVENTION: After the baseline assessment period (2014-2015), hospitals were randomly allocated to the intervention or control groups. In 2017-2018, the 20 hospitals assigned to the intervention were provided quarterly with control charts for monitoring their surgical outcomes (inpatient death, intensive care stay, reoperation and severe complications). At each site, pairs, consisting of one surgeon and a collaborator (surgeon, anaesthesiologist or nurse), were trained to conduct control chart team meetings, display posters in operating rooms, maintain logbooks and design improvement plans. MAIN OUTCOMES: Number of hospital bed-days per patient within 30 days following surgery, including the index stay and any acute care readmissions related to the occurrence of major adverse events, and hospital costs reimbursed for this care per patient by the insurer. RESULTS: Postintervention, hospital bed-days per patient within 30 days following surgery decreased at an adjusted ratio of rate ratio (RRR) of 0.97 (95% CI 0.95 to 0.98; p<0.001), corresponding to a 3.3% reduction (95% CI 2.1% to 4.6%) for intervention hospitals versus control hospitals. Hospital costs reimbursed for this care per patient by the insurer significantly decreased at an adjusted ratio of cost ratio (RCR) of 0.99 (95% CI 0.98 to 1.00; p=0.01), corresponding to a 1.3% decrease (95% CI 0.0% to 2.6%). The consumption of a total of 8910 hospital bed-days (95% CI 5611 to 12 634 bed-days) and €2 615 524 (95% CI €32 366 to €5 405 528) was avoided in the intervention hospitals postintervention. CONCLUSIONS: Using control charts paired with indicator feedback to surgical teams was associated with significant reductions in hospital bed-days within 30 days following surgery, and hospital costs reimbursed for this care by the insurer. TRIAL REGISTRATION NUMBER: NCT02569450.

Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial.

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: 155 362 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). 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: 75 047 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). 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02569450.

Hospital Length of Stay Reduction Over Time and Patient Readmission for Severe Adverse Events Following Surgery.

OBJECTIVE: The aim of the study was to investigate whether patients who undergo surgery in hospitals experiencing significant length of stay (LOS) reductions over time are exposed to a higher risk of severe adverse events in the postoperative period. SUMMARY BACKGROUND DATA: Surgical care innovation has encouraged hospitals to shorten LOS under financial pressures with uncertain impact on patient outcomes. METHODS: We selected all patients who underwent elective colectomy or urgent hip fracture repair in French hospitals between 2013 and 2016. For each procedure, hospitals were categorized into 3 groups according to variations in their median LOS as follows: major decrease, moderate decrease, and no decrease. These groups were matched using propensity scores based on patients' and hospitals' potential confounders. Potentially avoidable readmission for severe adverse events and death at 6 months were compared between groups using Cox regressions. RESULTS: We considered 98,713 patients in 540 hospitals for colectomy and 206,812 patients in 414 hospitals for hip fracture repair before matching. After colectomy, patient outcomes were not negatively impacted when hospitals reduced their LOS [hazard ratio (95% confidence interval): 0.93 (0.78-1.10)]. After hip fracture repair, patients in hospitals with major decreases in LOS had a higher risk of severe adverse events [1.22 (1.11-1.34)] and death [1.17 (1.04-1.32)]. CONCLUSIONS: Patients who underwent surgical procedures in hospitals experiencing major decreases in LOS were demonstrated worse postoperative outcomes after urgent hip fracture repair and not after elective colectomy. Development of care bundles to enhance recovery after emergency surgeries may allow better control of LOS reduction and patient outcomes.

Enlarged perivascular spaces and florbetapir uptake in patients with intracerebral hemorrhage.

PURPOSE: Enlarged perivascular spaces in the centrum semiovale (CSO-EPVS) have been linked to cerebral amyloid angiopathy (CAA). To get insight into the underlying mechanisms of this association, we investigated the relationship between amyloid-ß deposition assessed by 18F-florbetapir PET and CSO-EPVS in patients with acute intracerebral hemorrhage (ICH). METHODS: We prospectively enrolled 18 patients with lobar ICH (suggesting CAA) and 20 with deep ICH (suggesting hypertensive angiopathy), who underwent brain MRI and 18F-florbetapir PET. EPVS were assessed on MRI using a validated 4-point visual rating scale in the centrum semiovale and the basal ganglia (BG-EPVS). PET images were visually assessed, blind to clinical and MRI data. We evaluated the association between florbetapir PET positivity and high degree (score> 2) of CSO-EPVS and BG-EPVS. RESULTS: High CSO-EPVS degree was more common in patients with lobar ICH than deep ICH (55.6% vs. 20.0%; p = 0.02). Eight (57.1%) patients with high CSO-EPVS degree had a positive florbetapir PET compared with 4 (16.7%) with low CSO-EPVS degree (p = 0.01). In contrast, prevalence of florbetapir PET positivity was similar between patients with high vs. low BG-EPVS. In multivariable analysis adjusted for age, hypertension, and MRI markers of CAA, florbetapir PET positivity (odds ratio (OR) 6.44, 95% confidence interval (CI) 1.32-38.93; p = 0.03) was independently associated with high CSO-EPVS degree. CONCLUSIONS: Among patients with spontaneous ICH, high degree of CSO-EPVS but not BG-EPVS is associated with amyloid PET positivity. The findings provide further evidence that CSO-EPVS are markers of vascular amyloid burden that may be useful in diagnosing CAA.

Surgical risks associated with winter sport tourism.

BACKGROUND: Mass tourism during winter in mountain areas may cause significant clustering of body injuries leading to increasing emergency admissions at hospital. We aimed at assessing if surgical safety and efficiency was maintained in this particular context. METHODS: We selected all emergency admissions of open surgery performed in French hospitals between 2010 and 2012. After identifying mountain areas with increasing volume of surgical stays during winter, we considered seasonal variations in surgical outcomes using a difference-in-differences study design. We computed multilevel regressions to evaluate whether significant increase in emergency cases had an effect on surgical mortality, complications and length of stay. Clustering effect of patients within hospitals was integrated in analysis and surgical outcomes were adjusted for both patient and hospital characteristics. RESULTS: A total of 381 hospitals had 559,052 inpatient stays related to emergency open surgery over 3 years. Compared to other geographical areas, a significant peak of activity was noted during winter in mountainous hospitals (Alps, Pyrenees, Vosges), ranging 6-77% volume increase. Peak was mainly explained by tourists' influx (+124.5%, 4,351/3,496) and increased need for orthopaedic procedures (+36.8%, 4,731/12,873). After controlling for potential confounders, patients did not experience increased risk for postoperative death (ratio of OR 1.01, 95%CI 0.89-1.14, p = 0.891), thromboembolism (0.95, 0.77-1.17, p = 0.621) or sepsis (0.98, 0.85-1.12, p = 0.748). Length of stay was unaltered (1.00, 0.99-1.02, p = 0.716). CONCLUSION: Surgical outcomes are not compromised during winter in French mountain areas despite a substantial influx of major emergencies.

MR, (18)F-FDG, and (18)F-AV45 PET correlate with AD PSEN1 original phenotype.

We report the case of a 37-year-old man suffering from insidious visual agnosia and spastic paraparesis due to a PSEN1 mutation. His mother was diagnosed with Alzheimer disease after a biopsy. He was assessed by multimodal neuroimaging, including new in vivo positron emission tomography amyloid imaging (F-AV45). His data were compared with those from healthy participants and patients with sporadic predemential Alzheimer disease. He exhibited posterior cortical thickness reduction, posterior hypometabolism, and increased amyloid ligand uptake in the posterior cortex and the striatum. We show that F-AV45 positron emission tomography allows visualization of the unusual pattern of amyloid deposits that co-localize with cortical atrophy in this genetic form of Alzheimer disease.

Writing, calculating, and finger recognition in the region of the angular gyrus: a cortical stimulation study of Gerstmann syndrome.

OBJECT: In an attempt to gain a better understanding of the cerebral functions represented in the angular gyrus and to spare them during surgery, the authors studied patients with brain tumors located close to the angular gyrus and mapped cortical sites by using electrostimulation. METHODS: Before undergoing tumor removal, six right-handed patients (five with left and one with right hemisphere tumors) were studied using cortical mapping with the aid of calculating, writing, finger-recognition, and color-naming tasks in addition to standard reading and object-naming tasks (for a total of 36 brain mapping studies). Strict conditions of functional site validation were applied to include only those cortical sites that produced repetitive interferences in the function tested. Preoperatively, four of the patients exhibited discrete symptoms related to Gerstmann syndrome while performing very specific tasks, whereas the other two patients presented with no symptoms of the syndrome. No patient had significant language or apraxic deficits. Distinct or shared cortical sites producing interferences in calculating, finger recognition, and writing were repeatedly found in the angular gyrus. Object- or color-naming sites and reading-interference sites were also found in or close to the angular gyrus; although frequently demonstrated, these latter results were variable and unpredictable in the group of patients studied. Finger agnosia and acalculia sites were also found elsewhere, such as in the supramarginal gyrus or close to the intraparietal sulcus. Mechanisms involved in acalculia, agraphia, or finger agnosia (either complete interferences or hesitations) during stimulation were various, from an aphasia-like form (for instance, the patient did not understand the numbers or words given for calculating or writing tasks) to an apparently pure interference in the function tested (patients understood the numbers, but were unable to perform a simple addition). CONCLUSIONS: Symptoms of Gerstmann syndrome can be found during direct brain mapping in the angular gyrus region. In this series of patients, sites producing interferences in writing, calculating, and finger recognition were demonstrated in the angular gyrus, which may or may not have been associated with object-naming, color-naming, or reading sites.