Identifying individual and organizational predictors of accidental exposure to blood (AEB) among hospital healthcare workers: A longitudinal study.

BACKGROUND: Accidental exposure to blood (AEB) poses a risk of bloodborne infections for healthcare workers (HCWs) during hospital activities. In this study, we identified individual behavioral and organizational predictors of AEB among HCWs. METHODS: The study was a prospective, 1-year follow-up cohort study conducted in university hospitals in Paris, France. Data were collected from the Stress at Work and Infectious Risk in Patients and Caregivers (STRIPPS) study. Eligible participants included nurses, nursing assistants, midwives, and physicians from 32 randomly selected wards in 4 hospitals. AEB occurrences were reported at baseline, 4 months, 8 months, and 12 months, and descriptive statistical and multilevel risk-factor analyses were performed. RESULTS: The study included 730 HCWs from 32 wards, predominantly nurses (52.6%), nursing assistants (41.1%), physicians (4.8%), and midwives (1.5%). The incidence rate of AEB remained stable across the 4 visits. The multilevel longitudinal analysis identified several significant predictors of AEB occurrence. Individual-level predictors included younger age, occupation as nurses or midwives, irregular work schedule, rotating shifts, and lack of support from supervisors. The use of external nurses was the most significant ward-level predictor associated with AEB occurrence. CONCLUSIONS: AEBs among HCWs are strongly associated with organizational predictors, highlighting the importance of complementing infection control policies with improved staff management and targeted training. This approach can help reduce AEB occurrences and enhance workplace safety for HCWs.

Comorbidities directly extracted from the hospital database for adjusting SSI risk in the new national semiautomated surveillance system in France: The SPICMI network.

OBJECTIVE: To evaluate the performance of a comorbidity-based risk-adjustment model for surgical-site infection (SSI) reporting and benchmarking using a panel of variables extracted from the hospital discharge database (HDD), including comorbidities, compared to other models that use variables from different data sources. METHODS: The French national surveillance program for SSI (SPICMI) has collected data from voluntary hospitals in the first 6 months of 2020 and 2021, for 16 selected surgery procedures, using a semiautomated algorithm for detection. Four risk-adjustment models were selected with logistic regression analysis, combining the different patterns of variables: National Nosocomial Infections Surveillance System (NNIS) risk-index components, individual operative data, and 6 individual comorbidities according to International Classification of Disease, Tenth Revision (ICD-10) diagnosis: obesity, diabetes, malnutrition, hypertension, cancer, or immunosuppression. Areas under the curve (AUCs) were calculated and compared. RESULTS: Overall, 294 SSI were detected among 11,975 procedures included. All 6 comorbidities were related to SSI in the univariate analysis. The AUC of the selected model including comorbidities (0.675; 95% confidence interval [CI], 0.642-0.707), was significantly higher than the AUC of the model without comorbidities (0.641; 95% CI, 0.609-0.672; P = .016) or the AUC using the NNIS-index components (0.598; 95% CI, 0.564-0.630; P < .001). The HDD-based model AUC (0.659; 95% CI, 0.625-0.692) did not differ significantly from the selected model without comorbidities (P = .23). CONCLUSION: Including HDD-based comorbidities as patient case-mix variables instead of NNIS risk index factors could be an effective approach for risk-adjustment of automated SSI surveillance more widely accessible to hospitals.

Validation of the first computerized indicator for orthopaedic surgical site infections in France: ISO-ORTHO.

BACKGROUND: The French national authority for health (HAS) develops in-hospital indicators for improving quality of care, safety and patient outcome. Since 2017, it has developed a measurement of surgical site infections (SSI) after total hip or knee arthroplasty (TH/KA) by using a computerized indicator, called ISO-ORTHO, based on a hospital discharge database (HDD) algorithm. The aim of the study was to assess the performance of this new indicator . METHODS: The ISO-ORTHO performance was estimated via its positive predictive value (PPV) among adult patients having undergone a TH/KA between January 1st and September 30th 2018, based on the orthopaedic procedure codes. Patients at very high risk of SSI and/or with SSI not related to the in-hospital care were excluded. SSI were detected from the date of admission up to 90 days after the TH/KA using the ISO-ORTHO algorithm, based on 15 combinations of ICD-10 and procedure codes. Its PPV was estimated by a chart review in volunteer healthcare organisations (HCO). RESULTS: Over the study period, 777 HCO including 143,227 TH/KA stays were selected, providing 1,279 SSI according to the ISO-ORTHO indicator. The 90-day SSI rate was 0.89 per 100 TH/KA stays (0.98% for THA and 0.80% for TKA). Among the 448 HCO with at least 1 SSI, 250 HCO participated in reviewing 725 SSI charts; 665 were confirmed, giving a PPV of 90.3% [88.2-92.5%], 89.9% [87.1-92.8%] in THA and 90.9% [87.7-94.2%] in TKA. CONCLUSIONS: The PPV of ISO-ORTHO over 90% confirms its validity for any use according to the HAS method. ISO-ORTHO and detailed information were provided in 2020 to HCO and used for quality assessment and in-hospital risk management.

Multilevel approach to individual and organisational predictors of stress and fatigue among healthcare workers of a university hospital: a longitudinal study.

OBJECTIVE: Healthcare workers (HCWs) are at high risk of experiencing stress and fatigue due to the demands of their work within hospitals. Improving their physical and mental health and, in turn, the quality and safety of care requires considering factors at both individual and organisational/ward levels. Using a multicentre prospective cohort, this study aims to identify the individual and organisational predictors of stress and fatigue of HCWs in several wards from university hospitals. METHODS: Our cohort consists of 695 HCWs from 32 hospital wards drawn at random within four volunteer hospital centres in Paris-area. Three-level longitudinal analyses, accounting for repeated measures (level 1) across participants (level 2) nested within wards (level 3) and adjusted for relevant fixed and time-varying confounders, were performed. RESULTS: At baseline, the sample was composed by 384 registered nurses, 300 auxiliary nurses and 11 midwives. According to the three-level longitudinal models, some predictors were found in common for both stress and fatigue (low social support from supervisors, work overcommitment, sickness presenteeism and number of beds per ward). However, specific predictors for high level of stress (negative life events, low social support from colleagues and breaks frequently cancelled due to work overload) and fatigue (longer commuting duration, frequent use of interim staff in the ward) were also found. CONCLUSION: Our results may help identify at-risk HCWs and wards, where interventions to reduce stress and fatigue should be focused. These interventions could include manager training to favour better staff support and overall safety culture of HCWs.

A computerized indicator for surgical site infection (SSI) assessment after total hip or total knee replacement: The French ISO-ORTHO indicator.

OBJECTIVE: The French National Authority for Health (HAS), with a multidisciplinary working group, developed an indicator 'ISO-ORTHO' to assess surgical site infections (SSIs) after total hip arthroplasty or total knee arthroplasty (THA/TKA) based on the hospital discharge database. We present the ISO-ORTHO indicator designed for SSI automated detection and its relevance for quality improvement and hospital benchmarks. METHODS: The algorithm is based on a combination of International Statistical Classification of Diseases, Tenth Revision (ICD-10) and procedure codes of the hospital stay. The target population was selected among adult patients who had a THA or TKA between January 1, 2017, and September 30, 2017. Patients at very high risk of SSI and/or with SSI not related to hospital care were excluded. We searched databases for SSIs up to 3 months after THA/TKA. The standardized infection ratio (SIR) of observed versus expected SSIs was calculated (logistic regression) and displayed as funnel plot with 2 and 3 standard deviations (SD) after adjustment for 13 factors known to increase SSI risk. RESULTS: In total, 790 hospitals and 139,926 THA/TKA stays were assessed; 1,253 SSI were detected in the 473 included hospitals (incidence, 0.9%: 1.0% for THA, 0.80% for TKA). The SSI rate was significantly higher in males (1.2%), in patients with previous osteo-articular infection (4.4%), and those with cancer (2.3%), obesity, or diabetes. Most hospitals (89.9%) were within 2 SD; however, 12 hospitals were classified as outliers at more than +3 SD (1.6% of facilities), and 59 hospitals (7.9%) were outliers between +2 SD and +3 SD. CONCLUSION: ISO-ORTHO is a relevant indicator for automated surveillance; it can provide hospitals a metric for SSI assessment that may contribute to improving patient outcomes.

PRAISE: providing a roadmap for automated infection surveillance in Europe.

INTRODUCTION: Healthcare-associated infections (HAI) are among the most common adverse events of medical care. Surveillance of HAI is a key component of successful infection prevention programmes. Conventional surveillance - manual chart review - is resource intensive and limited by concerns regarding interrater reliability. This has led to the development and use of automated surveillance (AS). Many AS systems are the product of in-house development efforts and heterogeneous in their design and methods. With this roadmap, the PRAISE network aims to provide guidance on how to move AS from the research setting to large-scale implementation, and how to ensure the delivery of surveillance data that are uniform and useful for improvement of quality of care. METHODS: The PRAISE network brings together 30 experts from ten European countries. This roadmap is based on the outcome of two workshops, teleconference meetings and review by an independent panel of international experts. RESULTS: This roadmap focuses on the surveillance of HAI within networks of healthcare facilities for the purpose of comparison, prevention and quality improvement initiatives. The roadmap does the following: discusses the selection of surveillance targets, different organizational and methodologic approaches and their advantages, disadvantages and risks; defines key performance requirements of AS systems and suggestions for their design; provides guidance on successful implementation and maintenance; and discusses areas of future research and training requirements for the infection prevention and related disciplines. The roadmap is supported by accompanying documents regarding the governance and information technology aspects of implementing AS. CONCLUSIONS: Large-scale implementation of AS requires guidance and coordination within and across surveillance networks. Transitions to large-scale AS entail redevelopment of surveillance methods and their interpretation, intensive dialogue with stakeholders and the investment of considerable resources. This roadmap can be used to guide future steps towards implementation, including designing solutions for AS and practical guidance checklists.

Mortality review as a tool to assess the contribution of healthcare-associated infections to death: results of a multicentre validity and reproducibility study, 11 European Union countries, 2017 to 2018.

IntroductionThe contribution of healthcare-associated infections (HAI) to mortality can be estimated using statistical methods, but mortality review (MR) is better suited for routine use in clinical settings. The European Centre for Disease Prevention and Control recently introduced MR into its HAI surveillance.AimWe evaluate validity and reproducibility of three MR measures.MethodsThe on-site investigator, usually an infection prevention and control doctor, and the clinician in charge of the patient independently reviewed records of deceased patients with bloodstream infection (BSI), pneumonia, Clostridioides difficile infection (CDI) or surgical site infection (SSI), and assessed the contribution to death using 3CAT: definitely/possibly/no contribution to death; WHOCAT: sole cause/part of causal sequence but not sufficient on its own/contributory cause but unrelated to condition causing death/no contribution, based on the World Health Organization's death certificate; QUANT: Likert scale: 0 (no contribution) to 10 (definitely cause of death). Inter-rater reliability was assessed with weighted kappa (wk) and intra-cluster correlation coefficient (ICC). Reviewers rated the fit of the measures.ResultsFrom 2017 to 2018, 24 hospitals (11 countries) recorded 291 cases: 87 BSI, 113 pneumonia , 71 CDI and 20 SSI. The inter-rater reliability was: 3CAT wk 0.68 (95% confidence interval (CI): 0.61-0.75); WHOCAT wk 0.65 (95% CI: 0.58-0.73); QUANT ICC 0.76 (95% CI: 0.71-0.81). Inter-rater reliability ranged from 0.72 for pneumonia to 0.52 for CDI. All three measures fitted 'reasonably' or 'well' in > 88%.ConclusionFeasibility, validity and reproducibility of these MR measures was acceptable for use in HAI surveillance.

Gradual decline in outpatient antibiotic prescriptions in paediatrics: A data warehouse-based 11-year cohort study.

AIM: To describe trends in antibiotic (AB) prescriptions in children in primary care over 11 years, using a large data warehouse. METHODS: A retrospective cohort study assessed outpatient AB prescriptions 2007-2017, using the Massachusetts Health Disparities Repository. The evolution of paediatric outpatient AB prescriptions was assessed using time-series analyses through annual per cent change (APC) for the population and for children with or without comorbid condition. RESULTS: About 25 000 children were followed in primary care with 31 248 AB prescriptions reported in the data warehouse. The youngest children had more AB prescriptions. Penicillins were prescribed most frequently (46%), then macrolides (28%). One third of children had comorbid conditions, receiving significantly more antibiotics (30.3 vs 21.0 AB/100 child-years, relative risk: 1.43, 95% CI: 1.40, 1.46). Overall AB prescription decreased over the period (APC = -5.34%, 95% CI: -7.10, -3.54), with similar trends for penicillins (APC = -5.49; 95% CI: -8.27, -2.62) and macrolides (APC = -6.46; 95% CI: -8.37, -4.58); antibiotic prescribing declined more in children with comorbid conditions. CONCLUSION: Outpatient AB prescribing decline was gradual and consistent in paediatrics over the period. Prescription differences persisted between age groups, conditions and indication. The availability of routine care data through data warehouse fosters the surveillance automation, providing inexpensive fast tools to design appropriate antimicrobial stewardship.

Epidemiology of complex bone and joint infections in France using a national registry: The CRIOAc network.

OBJECTIVES: In France, a network of reference centers for bone and joint infections (BJI) was created in 2008, focused on the management of complex BJI (previous failure, difficult-to-treat microorganisms, heavy comorbidities or surgical procedures). A national registry was implemented from 2012, collecting decisions advised in periodic multidisciplinary meetings. We present here an epidemiological overview. METHODS: All consecutive adult patients presented from 2014 to 2019 in 23/30 reference centers were included in this cohort. Characteristics of patients, BJI, and medico-surgical management advice were described. RESULTS: 27,483 individual patients were included, corresponding to 28,365 distinct infectious episodes, which 17,328 were complex. Median age was 65 years, with 62% of men, 1/3 patients presented more than 2 comorbidities. Prosthetic joint infections (PJI) represented 42% of all BJIs (11,812 episodes). Staphylococcus aureus, coagulase-negative staphylococci and polymicrobial PJI represented 26%, 25% and 16% respectively. DAIR (debridement, antibiotics and implant retention) was proposed for 3,157 (27%), whereas one-stage and two-stage revision for 3,683 (31%) and 1,764 (15%). An antibiotic treatment was advised in 10,493 episodes (87%), with combination therapy in 88%. CONCLUSION: This national network allows an optimized management of complex BJIs. Its cohort is a unique opportunity to draw up a detailed epidemiological picture and to follow the trends of these infrequent infections.

Time-series modelling for the quantification of seasonality and forecasting antibiotic-resistant episodes: application to carbapenemase-producing Enterobacteriaceae episodes in France over 2010-20.

BACKGROUND: Carbapenemase-producing Enterobacteriaceae (CPE) cause resistant healthcare-associated infections that jeopardize healthcare systems and patient safety worldwide. The number of CPE episodes has been increasing in France since 2009, but the dynamics are still poorly understood. OBJECTIVES: To use time-series modelling to describe the dynamics of CPE episodes from August 2010 to December 2016 and to forecast the evolution of CPE episodes for the 2017-20 period. METHODS: We used time series to analyse CPE episodes from August 2010 to November 2016 reported to the French national surveillance system. The impact of seasonality was quantified using seasonal-to-irregular ratios. Seven time-series models and three ensemble stacking models (average, convex and linear stacking) were assessed and compared with forecast CPE episodes during 2017-20. RESULTS: During 2010-16, 3559 CPE episodes were observed in France. Compared with the average yearly trend, we observed a 30% increase in the number of CPE episodes in the autumn. We noticed a 1 month lagged seasonality of non-imported episodes compared with imported episodes. Average stacking gave the best forecasts and predicted an increase during 2017-20 with a peak up to 345 CPE episodes (95% prediction interval = 124-1158, 80% prediction interval = 171-742) in September 2020. CONCLUSIONS: The observed seasonality of CPE episodes sheds light on potential factors associated with the increased frequency of episodes, which need further investigation. Our model predicts that the number of CPE episodes will continue to rise in the coming years in France, mainly due to local dissemination, associated with bacterial carriage by patients in the community, which is becoming an immediate challenge with regard to outbreak control.

Computerized registry as a potential tool for surveillance and management of complex bone and joint infections in France: French registry of complex bone and joint infections.

AIMS: The French registry for complex bone and joint infections (C-BJIs) was created in 2012 in order to facilitate a homogeneous management of patients presented for multidisciplinary advice in referral centres for C-BJI, to monitor their activity and to produce epidemiological data. We aimed here to present the genesis and characteristics of this national registry and provide the analysis of its data quality. METHODS: A centralized online secured database gathering the electronic case report forms (eCRFs) was filled for every patient presented in multidisciplinary meetings (MM) among the 24 French referral centres. Metrics of this registry were described between 2012 and 2016. Data quality was assessed by comparing essential items from the registry with a controlled dataset extracted from medical charts of a random sample of patients from each centre. Internal completeness and consistency were calculated. RESULTS: Between 2012 and 2016, 30,607 presentations in MM were recorded corresponding to 17,748 individual patients (mean age 62.1 years (SD 18.4); 10,961 (61.8%) males). BJI was considered as complex for 63% of cases (n = 19,355), and 13,376 (44%) had prosthetic joint infections (PJIs). The controlled dataset, available for 19 centres, included 283 patients. Global consistency and completeness were estimated at 88.2% and 88.9%, respectively, considering missing items in the eCRFs as negative results. CONCLUSION: This national registry is one of the largest prospective databases on BJI and its acceptable data quality parameters allow further use for epidemiological purposes.Cite this article: Bone Joint Res 2020;9(9):635-644.

Assessing the role of inter-facility patient transfer in the spread of carbapenemase-producing Enterobacteriaceae: the case of France between 2012 and 2015.

The spread of carbapenemase-producing Enterobacteriaceae (CPE) in healthcare settings is a major public health threat that has been associated with cross-border and local patient transfers between healthcare facilities. Since the impact of transfers on spread may vary, our study aimed to assess the contribution of a patient transfer network on CPE incidence and spread at a countrywide level, with a case study of France from 2012 to 2015. Our results suggest a transition in 2013 from a CPE epidemic sustained by internationally imported episodes to an epidemic sustained by local transmission events through patient transfers. Incident episodes tend to occur within close spatial distance of their potential infector. We also observe an increasing frequency of multiple spreading events, originating from a limited number of regional hubs. Consequently, coordinated prevention and infection control strategies should focus on transfers of carriers of CPE to reduce regional and inter-regional transmission.

How to measure hospital antibiotic consumption: comparison of two methods from data surveillance in France.

BACKGROUND: Antibiotic use (ABU) surveillance in healthcare facilities (HCFs) is essential to guide stewardship. Two methods are recommended: antibiotic consumption (ABC), expressed as the number of DDD/1000 patient-days; and prevalence of antibiotic prescription (ABP) measured through point prevalence surveys. However, no evidence is provided about whether they lead to similar conclusions. OBJECTIVES: To compare ABC and ABP regarding HCF ranking and their ability to identify outliers. METHODS: The comparison was made using 2012 national databases from the antibiotic surveillance network and prevalence study. HCF rankings according to each method were compared with Spearman's correlation coefficient. Analyses included the ABU from entire HCFs as well as according to type, clinical ward and by antibiotic class and specific molecule. RESULTS: A total of 1076 HCFs were included. HCF rankings were strongly correlated in the whole cohort. The correlation was stronger for HCFs with a higher number of beds or with a low or moderate proportion of acute care beds. ABU correlation between ABC or ABP was globally moderate or weak in specific wards. Furthermore, the two methods did not identify the same outliers, whichever HCF characteristics were analysed. Correlation between HCF ranking varied according to the antibiotic class. CONCLUSIONS: Both methods ranked HCFs similarly overall according to ABC or ABP; however, major differences were observed in ranking of clinical wards, antibiotic classes and detection of outliers. ABC and ABP are two markers of ABU that could be used as two complementary approaches to identify targets for improvement.

Epidemiology of Clostridioides difficile infections, France, 2010 to 2017.

BackgroundClostridioides difficile is a leading cause of healthcare-associated diarrhoea in middle and high-income countries. Up to 2018, there has been no systematic, annual surveillance for C. difficile infections (CDI) in France.AimsTo provide an updated overview of the epidemiology of CDI in France between 2010 and 2017 based on five different data sources.MethodsThis is a descriptive study of retrospective surveillance and alerts data. Incidence of CDI cases was estimated through the CDI incidence survey (2016) and data from the French National Uniform Hospital Discharge Database (PMSI; 2010-16). Testing frequency for CDI was estimated through the CDI incidence survey and point prevalence studies on healthcare-associated infections (HAI; 2012 and 2017). The national early warning response system for HAI (HAI-EWRS, 2012-17) and National Reference Laboratory data (2012-17) were used to follow the number of severe CDI cases and/or outbreaks.ResultsIn 2016, CDI incidence in acute care was 3.6 cases per 10,000 patient days (PD). There was a statistically significant increase in CDI incidence between 2010 and 2016 (+ 14% annually) and testing frequency was 47.4 per 10,000 PD. The number of CDI HAI-EWRS notifications decreased between 2015 and 2017 with only a few large outbreaks reported.ConclusionThe CDI incidence estimate increased from 2010, but remained below the European average of 7 per 10,000 PD in 2014; there were fewer severe cases or clusters reported in France. The consistency between PMSI and laboratory-based estimated CDI incidence could allow for more routine monitoring of CDI incidence.

Scope of Antibiotic Stewardship Programs in Pediatrics.

This review of pediatric antibiotic stewardship programs (ASPs) summarized the antibiotic prescribing interventions and their impact on antibiotic use and antimicrobial resistance. We reviewed studies of pediatric ASP, including the search terms "antimicrobial stewardship," "antibiotic stewardship," "children," and "pediatric." The articles' selection and review were performed independently by 2 investigators, according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Twenty-one studies were included, from the past 15 years, increasing after the 2007 IDSA (Infectious Diseases Society of America) guidelines for ASP with a large variability of the programs, and the virtual exclusive focus on inpatient settings (90%): 16 formalized ASP and 5 non-ASP actions. A reduction in antibiotic prescribing in ASP has been demonstrated in the studies reporting pediatric ASP, but only one ASP showed a significant impact on antimicrobial resistance. However, the impact on antibiotic consumption in pediatrics demonstrated the important contribution of these strategies to improve antibiotic use in children, without complications or negative issues.

Infectious complications of endoarterial interventional radiology: protocol for an observational study of a longitudinal national cohort of patients assessed in the French hospital discharge database (MOEVA study).

Around seven million patients undergo endoarterial interventional radiology procedures (EAIRP) annually worldwide. These procedures have become part of the standard repertoire of vascular surgery. However, the healthcare-associated infections related to these procedures are relatively unknown. Prevalence and adverse outcome of infectious complication (IC) post-EAIRP may be underestimated. We aim to provide national trend estimation of EAIRP incidence and outcome in France. METHODS AND ANALYSIS: From the French Common Classification of Medical Acts, we will define four categories of EAIRP. We will collect procedures via the French nationwide hospital discharge database, called Programme de Médicalisation des Systèmes d'Information (PMSI) and derived from the Diagnosis Related Group system. Various combinations to identify the numerator will be employed according to a pre-established algorithm. Technical data wrangling tools facilitating the use of PMSI will be developed to obtain a clean and well-structured database ready for statistical analysis. This protocol will require competences in medicine, epidemiology, statistics, data processing and techniques through various stages of the study. The cohort will contain the denominator (the first act of the first stay of each patient) and the corresponding numerator (the IC which will occur during the first stay). ETHICS AND DISSEMINATION: No nominative, sensitive or personal data on patients have been collected. The study of the MOrtality and infectious complications of therapeutic EndoVAscular interventional radiology (MOEVA) study does not involve humans, and falls within the scope of the French Reference Methodology MR-004 according to 2016-41 law dated 26 January 2016 on the modernisation of the French health system. Our study involves the reuse of already recorded data, which require neither information or non-opposition of the included individuals. Access to linked ANOnymous (ANO) file in the PMSI databases was approved by the French National Commission for Data Protection and Liberties (CNIL number 1564135). The results will be disseminated through a peer-reviewed publication.

[Regulatory science in public health: What are we talking about?] / Science réglementaire en santé publique : de quoi parle-t-on ?

This article sheds light on a concept little known to public health actors in France: regulatory science, used to describe the range of scientific activities used to produce the knowledge mobilized to support, develop or adapt public policy decisions. The objective is to understand how the expression appeared in the mid-1980s and was formalized into a sociological concept by the American writer Sheila Jasanoff in 1990, and has gradually imposed itself in American, Japanese and European regulatory agencies as a new scientific discipline. The article examines the evolution of the concept and the various approaches proposed to define regulatory science. It highlights its hybrid and heterogeneous nature, underlining the different characteristics that the expression covers according to the institution which formulates it (FDA, EMA, PMDA) and the scope of application that it covers. Based on concrete examples of the application of regulatory science practices in three broad areas of health risk, the paper focuses on the role of research in the decision-making process by showing how the emergence of new methods designed to strengthen the regulatory capacities of regulators and the role of academic communities associated with this approach, contribute to the strengthening of public health policies in France and worldwide.

Surgical site infection after trans urethral resection of the prostate (TURP): 2008-2013 French national SSI surveillance ISO-RAISIN.

OBJECTIVE: To describe surgical site infection (SSI) after transurethral resection of prostate (TURP) from the French national database. METHODS: A national SSI surveillance system was implemented in 1999. Each year, the network included urology departments that included at least two months plus one month follow-up, or at least 100 consecutive targeted surgical procedures. A dataset of patients who underwent urology procedures during the six-year period 2008-2013 was made available. SSI diagnosis was made according to standardised CDC criteria. Descriptive analyses were performed using SAS software version 9.4. RESULTS: A total of 12,897 TURPs were performed by 89 urology departments. The crude incidence SSI rate was 2.43 (95% confidence interval = 2.16-2.79). The mean delay for diagnosis was 11.9 ± 8.9 days. The treatment of the SSI required a new surgical intervention in 1.35%. In the multilevel multivariate analysis, ASA score and duration of follow-up were the only parameters correlated with the SSI rate. CONCLUSIONS: On more than 12,000 TURPs surveyed, the SSI rate was 2.43. ASA score and duration of follow-up were the only parameters correlated with the SSI rate.

A clone of the emergent Streptococcus pyogenes emm89 clade responsible for a large outbreak in a post-surgery oncology unit in France.

An outbreak of nosocomial infections due to Streptococcus pyogenes (Group A Streptococcus; GAS) occurred in a post-surgery oncology unit and concerned more than 60 patients and lasted 20 months despite enhanced infection control and prophylaxis measures. All GAS strains were characterized (emm genotype, toxin gene profile and pulse-field gel electrophoresis subtype). Selected strains were sequenced and phylogenetic relationship established. Capacity to form biofilm and interaction with human pulmonary epithelial cells and macrophages were determined. Twenty-six GAS strains responsible for invasive infections (II) and 57 for non-II or colonization were isolated from patients (n = 66) or healthcare workers (n = 13). Seventy strains shared the same molecular markers and 69 the same PFGE pattern; 56 were sequenced. They all belonged to the emerging emm89 clade 3; all but 1 were clonal. Whole genome sequencing identified 43 genetic profiles with sporadic mutations in regulatory genes and acquired mutations in 2 structural genes. Except for two regulatory gene mutants, all strains tested had the same biofilm formation capacity and displayed similar adherence and invasion of pulmonary epithelial cells and phagocytosis and survival in human macrophages. This large outbreak of GAS infection in a post-surgery oncology unit, a setting that contains highly susceptible patients, arose from a strain of the emergent emm89 clade. No relationship between punctual or acquired mutations, invasive status, and strain phenotypic characteristics was found. Noteworthy, the phenotypic characteristics of this clone account for its emergence and its remarkable capacity to elicit outbreaks.