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.

Length of Stay Prediction With Standardized Hospital Data From Acute and Emergency Care Using a Deep Neural Network.

OBJECTIVE: Length of stay (LOS) is an important metric for the organization and scheduling of care activities. This study sought to propose a LOS prediction method based on deep learning using widely available administrative data from acute and emergency care and compare it with other methods. PATIENTS AND METHODS: All admissions between January 1, 2011 and December 31, 2019, at 6 university hospitals of the Hospices Civils de Lyon metropolis were included, leading to a cohort of 1,140,100 stays of 515,199 patients. Data included demographics, primary and associated diagnoses, medical procedures, the medical unit, the admission type, socio-economic factors, and temporal information. A model based on embeddings and a Feed-Forward Neural Network (FFNN) was developed to provide fine-grained LOS predictions per hospitalization step. Performances were compared with random forest and logistic regression, with the accuracy, Cohen kappa, and a Bland-Altman plot, through a 5-fold cross-validation. RESULTS: The FFNN achieved an accuracy of 0.944 (CI: 0.937, 0.950) and a kappa of 0.943 (CI: 0.935, 0.950). For the same metrics, random forest yielded 0.574 (CI: 0.573, 0.575) and 0.602 (CI: 0.601, 0.603), respectively, and 0.352 (CI: 0.346, 0.358) and 0.414 (CI: 0.408, 0.422) for the logistic regression. The FFNN had a limit of agreement ranging from -2.73 to 2.67, which was better than random forest (-6.72 to 6.83) or logistic regression (-7.60 to 9.20). CONCLUSION: The FFNN was better at predicting LOS than random forest or logistic regression. Implementing the FFNN model for routine acute care could be useful for improving the quality of patients' care.

Combining the Hospital Frailty Risk Score With the Charlson and Elixhauser Multimorbidity Indices to Identify Older Patients at Risk of Poor Outcomes in Acute Care.

OBJECTIVE: The Hospital Frailty Risk Score (HFRS) can be applied to medico-administrative datasets to determine the risks of 30-day mortality and long length of stay (LOS) in hospitalized older patients. The objective of this study was to compare the HFRS with Charlson and Elixhauser comorbidity indices, used separately or combined. DESIGN: A retrospective analysis of the French medical information database. The HFRS, Charlson index, and Elixhauser index were calculated for each patient based on the index stay and hospitalizations over the preceding 2 years. Different constructions of the HFRS were considered based on overlapping diagnostic codes with either Charlson or Elixhauser indices. We used mixed logistic regression models to investigate the association between outcomes, different constructions of HFRS, and associations with comorbidity indices. SETTING: 743 hospitals in France. PARTICIPANTS: All patients aged 75 years or older hospitalized as an emergency in 2017 (n=1,042,234).Main outcome measures: 30-day inpatient mortality and LOS >10 days. RESULTS: The HFRS, Charlson, and Elixhauser indices were comparably associated with an increased risk of 30-day inpatient mortality and long LOS. The combined model with the highest c-statistic was obtained when associating the HFRS with standard adjustment and Charlson for 30-day inpatient mortality (adjusted c-statistics: HFRS=0.654; HFRS + Charlson = 0.676) and with Elixhauser for long LOS (adjusted c-statistics: HFRS= 0.672; HFRS + Elixhauser =0.698). CONCLUSIONS: Combining comorbidity indices and HFRS may improve discrimination for predicting long LOS in hospitalized older people, but adds little to Charlson's 30-day inpatient mortality risk.

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.

The increasing age of respiratory syncytial virus-related hospitalisation during COVID-19 pandemic in Lyon was associated with reduced hospitalisation costs.

BACKGROUND: Preventive measures applied during the COVID-19 pandemic have modified the age distribution, the clinical severity and the incidence of Respiratory Syncytial Virus (RSV) hospitalisations during the 2020/21 RSV season. The aim of the present study was to estimate the impact of these aspects on RSV-associated hospitalisations (RSVH) costs stratified by age group between pre-COVID-19 seasons and 2020/21 RSV season. METHODS: We compared the incidence, the median costs, and total RSVH costs from the national health insurance perspective in children < 24 months of age during the COVID-19 period (2020/21 RSV season) with a pre-COVID-19 period (2014/17 RSV seasons). Children were born and hospitalised in the Lyon metropolitan area. RSVH costs were extracted from the French medical information system (Programme de Médicalisation des Systémes d'Information). RESULTS: The RSVH-incidence rate per 1000 infants aged < 3 months decreased significantly from 4.6 (95 % CI [4.1; 5.2]) to 3.1 (95 % CI [2.4; 4.0]), and increased in older infants and children up to 24 months of age during the 2020/21 RSV season. Overall, RSVH costs for RSVH cases aged below 2 years old decreased by €201,770 (31 %) during 2020/21 RSV season compared to the mean pre-COVID-19 costs. CONCLUSIONS: The sharp reduction in costs of RSVH in infants aged < 3 months outweighed the modest increase in costs observed in the 3-24 months age group. Therefore, conferring a temporal protection through passive immunisation to infants aged < 3 months should have a major impact on RSVH costs even if it results in an increase of RSVH in older children infected later in life. Nevertheless, stakeholders should be aware of this potential increase of RSVH in older age groups presenting with a wider range of disease to avoid any bias in estimating the cost-effectiveness of passive immunisation strategies.

The Economic Cost of Thyroid Cancer in France and the Corresponding Share Associated With Treatment of Overdiagnosed Cases.

OBJECTIVES: Thyroid cancer incidence in France has increased rapidly in recent decades. Most of this increase has been attributed to overdiagnosis, the major consequence of which is overtreatment. We aimed to estimate the cost of thyroid cancer management in France and the corresponding cost proportion attributable to the treatment of overdiagnosed cases. METHODS: Multiple data sources were integrated: the mean cost per patient with thyroid cancer was estimated by using the Echantillon Généraliste des Bénéficiaires data set; thyroid cancer cases attributable to overdiagnosis were estimated for 21 departments using data from the French network of cancer registries and extrapolated to the whole country; medical records from 6 departments were used to refine the diagnosis and care pathway. RESULTS: Between 2011 and 2015, 33 911 women and 10 846 men in France were estimated to be diagnosed of thyroid cancer, with mean cost per capita of €6248. Among those treated, 8114 to 14 925 women and 1465 to 3626 men were due to overdiagnosis. The total cost of thyroid cancer patient management was €203.5 million (€154.3 million for women and €49.3 million for men), of which between €59.9 million (or 29.4% of the total cost, lower bound) and €115.9 million (or 56.9% of the total cost, upper bound) attributable to treatment of overdiagnosed cases. CONCLUSIONS: The management of thyroid cancer represents not only a relevant clinical and public health problem in France but also a potentially important economic burden. Overdiagnosis and corresponding associated treatments play an important role on the total costs of thyroid cancer management.

Veno-arterial extracorporeal membrane oxygenation for cardiogenic shock after acute myocardial infarction: Insights from a French nationwide database.

BACKGROUND: We aimed to analyze the impact of timing of implantation (strategy-outcome relationship) and volume of procedures (volume-outcome relationship) on survival of veno-arterial extracorporeal membrane oxygenation (VA ECMO) for cardiogenic shock complicating acute myocardial infarction (AMI). METHODS: We conducted an observational retrospective study through two propensity score-based analyses using a nationwide database between January 2013 and December 2019. We classified patients into early implantation (VA ECMO on the day of primary percutaneous coronary intervention [PCI]) and delayed implantation (VA ECMO beyond the day of PCI) groups. We classified patients into low- or high-volume groups based on the median hospital volume. RESULTS: During the study period 649 VA ECMO were implanted across 20 French hospitals. Mean age was 57.1 ± 10.4 years, 80% were male. Overall, 90-day mortality was 64.3%. Patients in the early implantation group (n = 479, 73.8%) did not show a statistical difference in 90-day mortality than in the delayed group (n = 170, 26.2%) (HR: 1.18; 95% CI 0.94-1.48; p = 0.153). The mean number of VA ECMO implanted during the study period by low-volume centers was 21.3 ± 5.4 as compared to 43.6 ± 11.8 in high-volume centers. There was no significant difference in 90-day mortality between high-volume and low-volume centers (HR: 1.00; 95% CI: 0.82-1.23; p = 0.995). CONCLUSIONS: In this real-world nationwide study, we did not find a significant association between early VA ECMO implantation as well as high-volume centers and lower mortality in AMI-related refractory cardiogenic shock.

Excess mortality among non-COVID-19 surgical patients attributable to the exposure of French intensive and intermediate care units to the pandemic.

PURPOSE: The mobilization of most available hospital resources to manage coronavirus disease 2019 (COVID-19) may have affected the safety of care for non-COVID-19 surgical patients due to restricted access to intensive or intermediate care units (ICU/IMCUs). We estimated excess surgical mortality potentially attributable to ICU/IMCUs overwhelmed by COVID-19, and any hospital learning effects between two successive pandemic waves. METHODS: This nationwide observational study included all patients without COVID-19 who underwent surgery in France from 01/01/2019 to 31/12/2020. We determined pandemic exposure of each operated patient based on the daily proportion of COVID-19 patients among all patients treated within the ICU/IMCU beds of the same hospital during his/her stay. Multilevel models, with an embedded triple-difference analysis, estimated standardized in-hospital mortality and compared mortality between years, pandemic exposure groups, and semesters, distinguishing deaths inside or outside the ICU/IMCUs. RESULTS: Of 1,870,515 non-COVID-19 patients admitted for surgery in 655 hospitals, 2% died. Compared to 2019, standardized mortality increased by 1% (95% CI 0.6-1.4%) and 0.4% (0-1%) during the first and second semesters of 2020, among patients operated in hospitals highly exposed to pandemic. Compared to the low-or-no exposure group, this corresponded to a higher risk of death during the first semester (adjusted ratio of odds-ratios 1.56, 95% CI 1.34-1.81) both inside (1.27, 1.02-1.58) and outside the ICU/IMCU (1.98, 1.57-2.5), with a significant learning effect during the second semester compared to the first (0.76, 0.58-0.99). CONCLUSION: Significant excess mortality essentially occurred outside of the ICU/IMCU, suggesting that access of surgical patients to critical care was limited.

Nurse-to-Nurse Familiarity and Mortality in the Critically Ill: A Multicenter Observational Study.

Rationale: Nurse-to-nurse familiarity at work should strengthen the components of teamwork and enhance its efficiency. However, its impact on patient outcomes in critical care remains poorly investigated. Objectives: To explore the role of nurse-to-nurse familiarity on inpatient deaths during ICU stay. Methods: This was a retrospective observational study in eight adult academic ICUs between January 1, 2011 and December 31, 2016. Measurements and Main Results: Nurse-to-nurse familiarity was measured across day and night 12-hour daily shifts as the mean number of previous collaborations between each nursing team member during previous shifts within the given ICU (suboptimal if <50). Primary outcome was a shift with at least one inpatient death, excluding death of patients with a decision to forego life-sustaining therapy. A multiple modified Poisson regression was computed to identify the determinants of mortality per shift, taking into account ICU, patient characteristics, patient-to-nurse and patient-to-assistant nurse ratios, nurse experience length, and workload. A total of 43,479 patients were admitted, of whom 3,311 (8%) died. The adjusted model showed a lower risk of a shift with mortality when nurse-to-nurse familiarity increased in the shift (relative risk, 0.90; 95% confidence interval per 10 shifts, 0.82-0.98; P = 0.012). Low nurse-to-nurse familiarity during the shift combined with suboptimal patient-to-nurse and patient-to-assistant nurse ratios (suboptimal if >2.5 and >4, respectively) were associated with increased risk of shift with mortality (relative risk, 1.84; 95% confidence interval, 1.15-2.96; P < 0.001). Conclusions: Shifts with low nurse-to-nurse familiarity were associated with an increased risk of patient deaths.

Healthcare cost by primary tumour, functioning status and treatment among patients with metastatic neuroendocrine tumours: The LyREMeNET study.

The annual prevalence of metastatic neuroendocrine tumours (mNETs) is rising, leading to significant healthcare costs. The present study aimed to describe healthcare resource use (HRU) and the corresponding costs among patients with mNETs, according to primary tumour location, functioning status and type of treatments. The LyREMeNET study included consecutive mNET patients with a diagnosis performed between January 2010 and December 2017, who were seen at least once in the ENETS center of excellence in Lyon. The median HRU and costs per patient were estimated, up to 3 years before and after the diagnosis. The Cancer database of the center was linked to the French national health data system. HRU and related costs were described per person per month (PPPM). Among 316 patients presenting with a mNET, 48.4% had a small-intestinal mNET, 32.3% had a pancreatic mNET and 39.2% had carcinoid syndrome. The mean overall cost increased from €615 to €2875 PPPM between the years preceding and following the diagnosis, and remained above €2500 in the two subsequent years. The two main cost drivers of total healthcare expenditure were drugs (€1161) and hospital stay (€662). Median costs of mNETs arising from pancreas and small intestine were €2325 and €2540 PPPM, respectively. Costs were higher in patients with a functional mNET (€2807 PPPM for carcinoid syndrome) and during peptide receptor radionuclide therapy (PRRT) (€8835 PPPM). The highest overall cost was found during the first year following the diagnosis. Cost of care was higher for small intestine mNETs, for functional mNETs and during peptide receptor radionuclide therapy.

Association of Hospital Bed Turnover With Patient Outcomes in Digestive Surgery.

To determine the influence of hospital bed turnover rate (BTR) on the occurrence of complications following minor or major digestive surgery. Background: Performance improvement in surgery aims at increasing productivity while preventing complications. It is unknown whether this relationship can be influenced by the complexity of surgery. Methods: A nationwide retrospective cohort study was conducted, based on generalized estimating equation modeling to determine the effect of hospital BTR on surgical outcomes, adjusting for patient mix and clustering within 631 public and private French hospitals. All patients who underwent minor or major digestive surgery between January 1, 2013 and December 31, 2018 were included. Hospital BTR was defined as the annual number of stays per bed for digestive surgery and categorized into tertiles. The primary endpoint was a composite measurement of events occurring within 30 days after surgery: inpatient death, extended intensive care unit (ICU) admission, and reoperation. Results: Rate of adverse events was 2.51% in low BTR hospitals versus 2.25% in high BTR hospitals for minor surgery, and 16.79% versus 16.83% for major surgery. Patients who underwent minor surgery in high BTR hospitals experienced lower complications (odds ratio [OR], 0.89; 95% confidence interval [CI], 0.81-0.97; P = 0.009), mortality (OR, 0.87; 95% CI, 0.78-0.98, P = 0.02), ICU admission (OR, 0.83; 95% CI, 0.70-0.99; P = 0.03), and reoperation (OR, 0.91; 95% CI, 0.85-0.97; P = 0.002) compared to those in low BTR hospitals. Such differences were not consistently observed among patients admitted for major surgery. Conclusions: High turnover of patients in beds is beneficial for minor procedures, but questionable for major surgeries.

Mortality Among Noncoronavirus Disease 2019 Critically Ill Patients Attributable to the Pandemic in France.

OBJECTIVES: We investigated whether the risk of death among noncoronavirus disease 2019 critically ill patients increased when numerous coronavirus disease 2019 cases were admitted concomitantly to the same hospital units. DESIGN: We performed a nationwide observational study based on the medical information system from all public and private hospitals in France. SETTING: Information pertaining to every adult admitted to ICUs or intermediate care units from 641 hospitals between January 1, 2020, and June 30, 2020 was analyzed. PATIENTS: A total of 454,502 patients (428,687 noncoronavirus disease 2019 and 25,815 coronavirus disease 2019 patients) were included. INTERVENTIONS: For each noncoronavirus disease 2019 patient, pandemic exposure during their stay was calculated per day using the proportion of coronavirus disease 2019 patients among all patients treated in ICU. MEASUREMENTS AND MAIN RESULTS: We computed a multivariable logistic regression model to estimate the influence of pandemic exposure (low, moderate, and high exposure) on noncoronavirus disease 2019 patient mortality during ICU stay. We adjusted on patient and hospital confounders. The risk of death among noncoronavirus disease 2019 critically ill patients increased in case of moderate (adjusted odds ratio, 1.12; 95% CI, 1.05-1.19; p < 0.001) and high pandemic exposures (1.52; 95% CI, 1.33-1.74; p < 0.001). CONCLUSIONS: In hospital units with moderate or high levels of coronavirus disease 2019 critically ill patients, noncoronavirus disease deaths were at higher levels.

External validation of the Hospital Frailty Risk Score in France.

BACKGROUND: The Hospital Frailty Risk Score (HFRS) has made it possible internationally to identify subgroups of patients with characteristics of frailty from routinely collected hospital data. OBJECTIVE: To externally validate the HFRS in France. DESIGN: A retrospective analysis of the French medical information database. SETTING: 743 hospitals in Metropolitan France. SUBJECTS: All patients aged 75 years or older hospitalised as an emergency in 2017 (n = 1,042,234). METHODS: The HFRS was calculated for each patient based on the index stay and hospitalisations over the preceding 2 years. Main outcome measures were 30-day in-patient mortality, length of stay (LOS) >10 days and 30-day readmissions. Mixed logistic regression models were used to investigate the association between outcomes and HFRS score. RESULTS: Patients with high HFRS risk were associated with increased risk of mortality and prolonged LOS (adjusted odds ratio [aOR] = 1.38 [1.35-1.42] and 3.27 [3.22-3.32], c-statistics = 0.676 and 0.684, respectively), while it appeared less predictive of readmissions (aOR = 1.00 [0.98-1.02], c-statistic = 0.600). Model calibration was excellent. Restricting the score to data prior to index admission reduced discrimination of HFRS substantially. CONCLUSIONS: HFRS can be used in France to determine risks of 30-day in-patient mortality and prolonged LOS, but not 30-day readmissions. Trial registration: Reference ID on clinicaltrials.gov: ID: NCT03905629.

Temporal and geographical variations of thyroid cancer incidence and mortality in France during 1986-2015: The impact of overdiagnosis.

BACKGROUND: France is among the countries showing fastest growth of thyroid cancer (TC) incidence and highest incidence rates in Europe. This study aimed to clarify the temporal and geographical variations of TC in France and to quantify the impact of overdiagnosis. METHODS: We obtained TC incidence data in 1986-2015, and mortality data in 1976-2015, for eight French departments covering 8% of the national population, and calculated the age-standardised rates (ASR). We estimated the average annual percent changes (AAPC) of TC incidence, overall and by department and histological subtype. Numbers and proportions of TC cases attributable to overdiagnosis were estimated by department and period, based on the comparison between the shape of the age-specific curves with that observed prior to changes in diagnostic practice. RESULTS: During 1986-2015, there were 13,557 TC cases aged 15-84 years. Large variations of TC incidence were observed across departments, with the highest ASR and the fastest increase in Isère. Papillary subtype accounted for 82.8% of the cases, and presented an AAPC of 7.0% and 7.6% in women and men, respectively. Anaplastic TC incidence decreased annually 3.0% in women and 0.8% in men. Mortality rates declined consistently for all departments. The absolute number (and proportion) of TC cases attributable to overdiagnosis grew from 1074 (66%) in 1986-1995 to 3830 (72%) in 2006-2015 in women, and varied substantially across departments. CONCLUSIONS: Overdiagnosis plays an important role in the temporal and regional variations of TC incidence in France. Monitoring the time trends and regulating the regional healthcare practice are needed to reduce its impact.

High-dimensional propensity scores improved the control of indication bias in surgical comparative effectiveness studies.

OBJECTIVES: The objective of the study is to evaluate the performance of high-dimensional propensity scores (hdPSs) for controlling indication bias as compared with propensity scores (PSs) in surgical comparative effectiveness studies. STUDY DESIGN AND SETTING: Patients who underwent interventional transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) between 2013 and 2017 were included from the French nationwide hospitals. At each hospital level, matched pairs of patients who underwent TAVI and SAVR were formed using PSs, considering 20 patient baseline characteristics, and hdPSs, considering the same patient characteristics and 300 additional variables from procedure and diagnosis codes the year before surgery. We compared death, reoperation, and stroke up to 3 years between TAVI and SAVR using Cox or Fine and Gray models. RESULTS: Before matching, 12 of 20 patient characteristics were imbalanced between the included patients who underwent TAVI and SAVR. No significant imbalance persisted after matching with both methods. Hazard ratio of 1-year death, reoperation, and stroke was 1.3 [1.1; 1.4], 1.6 [1.1; 2.4], and 1.4 [1.2; 1.7] for TAVI relative to SAVR with PSs (n = 9,498 pairs) and 1.1 [1.0; 1.3], 1.3 [0.8; 2.0], and 1.3 [1.0; 1.6] with hdPSs (n = 7,157). CONCLUSION: HdPS estimations were more consistent with results seen in randomized controlled trials. The HdPS is a promising alternative for the PS to control indication bias in comparative studies of surgical procedures.

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.

Influence of Care Pathway on Thyroid Nodule Surgery Relevance: A Historical Cohort Study.

BACKGROUND: Guidelines recommend using fine-needle aspiration cytology (FNAC) to guide thyroid nodule surgical indication. However, the extent to which these guidelines are followed remains unclear. This study aimed to analyze the quality of the preoperative care pathway and to evaluate whether compliance with the recommended care pathway influenced the relevance of surgical indications. METHODS: Nationwide historical cohort study based on data from a sample (1/97th) of French health insurance beneficiaries. Evaluation of the care pathway of adult patients operated on between 2012 and 2015 during the year preceding thyroid nodule surgery. The pathway containing only FNAC was called "FNAC", the pathway including an endocrinology consultation (ENDO) with FNAC was called "FNAC+ENDO", whereas the no FNAC pathway was called "NO FNAC". The main outcome was the malignant nature of the nodule. RESULTS: Among the 1080 patients included in the study, "FNAC+ENDO" was found in 197 (18.2%), "FNAC" in 207 (19.2%), and "NO FNAC" in 676 (62.6%) patients. Cancer diagnosis was recorded in 72 (36.5%) "FNAC+ENDO" patients and 66 (31.9%) "FNAC" patients, against 119 (17.6%) "NO FNAC" patients. As compared to "NO FNAC", the "FNAC+ENDO" care pathway was associated with thyroid cancer diagnosis (OR 2.67, 1.88-3.81), as was "FNAC" (OR 2.09, 1.46-2.98). Surgeries performed in university hospitals were also associated with thyroid cancer diagnosis (OR 1.61, 1.19-2.17). Increasing the year for surgery was associated with optimal care pathway (2015 vs. 2012, OR 1.52, 1.06-2.18). CONCLUSIONS: The recommended care pathway was associated with more relevant surgical indications. While clinical guidelines were insufficiently followed, compliance improved over the years.

Reoperation Incidence and Severity Within 6 Months After Bariatric Surgery: a Propensity-Matched Study from Nationwide Data.

BACKGROUND: Data about incidence and severity of reoperations up to 6 months after bariatric surgery are currently limited. The aim of this cohort study was to evaluate the incidence and severity of reoperations after initial bariatric surgical procedures and to compare this between the 3 most frequent current surgical procedures (sleeve, gastric bypass, gastric banding). STUDY DESIGN: Nationwide observational cohort study using data from French Hospital Information System (2013-2015) to evaluate incidence and severity of reoperations within 6 months after bariatric surgery. Hazard ratios (HR) of longitudinal comparison between historical propensity-matched cohorts were estimated from a Fine and Gray's model using competing risk of death. RESULTS: Cumulative reoperation rates increased from postoperative day-30 to day-180. Consequently, 31.1 to 90.0% of procedures would have been missed if the reoperation rate was based solely on a 30-day follow-up. Reoperation rate at 6 months was significantly higher after gastric bypass than after sleeve (HR 0.64; IC 95% [0.53-0.77]) and corresponded to moderate-risk reoperations (HR 0.65; IC 95% [0.53-0.78]). Reoperation rate at 6 months was significantly higher after gastric banding than after sleeve (HR 0.08; IC 95% [0.07-0.09]) and corresponded to moderate-risk reoperations (HR 0.08; IC 95% [0.07-0.10]). CONCLUSION: Cumulative incidence of reoperations increased from 30 days to 6 months after sleeve, gastric bypass, or gastric banding and corresponded to moderate-risk surgical procedures. Consequently, 30-day reoperation rate should no longer be considered when evaluating complications and surgical performance after bariatric surgery.

Influence of trends in hospital volume over time on patient outcomes for high-risk surgery.

BACKGROUND: The "practice makes perfect" concept considers the more frequent a hospital performs a procedure, the better the outcome of the procedure. We aimed to study this concept by investigating whether patient outcomes improve in hospitals with a significantly increased volume of high-risk surgery over time and whether a learning effect existed at the individual hospital level. METHODS: We included all patients who underwent one of 10 digestive, cardiovascular and orthopaedic procedures between 2010 and 2014 from the French nationwide hospitals database. For each procedure, we identified three groups of hospitals according to volume trend (increased, decreased, or no change). In-hospital mortality, reoperation, and unplanned hospital readmission within 30 days were compared between groups using Cox regressions, taking into account clustering of patients within hospitals and potential confounders. Individual hospital learning effect was investigated by considering the interaction between hospital groups and procedure year. RESULTS: Over 5 years, 759,928 patients from 694 hospitals were analysed. Patients' mortality in hospitals with procedure volume increase or decrease over time did not clearly differ from those in hospitals with unchanged volume across the studied procedures (e.g., Hazard Ratios [95%] of 1.04 [0.93-1.17] and 1.08 [0.97-1.21] respectively for colectomy). Furthermore, patient outcomes did not improve or deteriorate in hospitals with increased or decreased volume of procedures over time (e.g., 1.01 [0.95-1.08] and 0.99 [0.92-1.05] respectively for colectomy). CONCLUSIONS: Trend in hospital volume over time did not appear to influence patient outcomes based on real-world data. TRIAL REGISTRATION: NCT02788331, June 2, 2016.