PROSAFE: a European endeavor to improve quality of critical care medicine in seven countries.

BACKGROUND: Long-lasting shared research databases are an important source of epidemiological information and can promote comparison between different healthcare services. Here we present PROSAFE, an advanced international research network in intensive care medicine, with the focus on assessing and improving the quality of care. The project involved 343 ICUs in seven countries. All patients admitted to the ICU were eligible for data collection. METHODS: The PROSAFE network collected data using the same electronic case report form translated into the corresponding languages. A complex, multidimensional validation system was implemented to ensure maximum data quality. Individual and aggregate reports by country, region, and ICU type were prepared annually. A web-based data-sharing system allowed participants to autonomously perform different analyses on both own data and the entire database. RESULTS: The final analysis was restricted to 262 general ICUs and 432,223 adult patients, mostly admitted to Italian units, where a research network had been active since 1991. Organization of critical care medicine in the seven countries was relatively similar, in terms of staffing, case mix and procedures, suggesting a common understanding of the role of critical care medicine. Conversely, ICU equipment differed, and patient outcomes showed wide variations among countries. CONCLUSIONS: PROSAFE is a permanent, stable, open access, multilingual database for clinical benchmarking, ICU self-evaluation and research within and across countries, which offers a unique opportunity to improve the quality of critical care. Its entry into routine clinical practice on a voluntary basis is testimony to the success and viability of the endeavor.

Case-mix affects calibration of cardiosurgical severity scores.

BACKGROUND: Prognostic models are often used to assess the quality of healthcare. Several scores were developed to predict mortality after cardiac surgery, but none has reached optimal performance in subsequent validations. We validate the most used scores (EUROSCORE I and II, STS, and ACEF) on a cohort of cardiac-surgery patients, assessing their robustness against case-mix changes. METHODS: The scores were validated on 14,559 patients admitted to 16 Italian cardiosurgical ICUs participating to Margherita-Prosafe project in 2014 and 2015. Calibration was assessed through Hosmer-Lemeshow Test, standardized mortality ratio, and GiViTI calibration test and belt. Discrimination was measured by the area under the ROC curve. RESULTS: The study included 10,317 patients who were eligible to the calculation of the STS Score (4156 isolated valve, 4681 isolated CABG and 1480 single valve and CABG) which calibrated well in these subgroups. The ACEF Score and EUROSCORE I and II were available for 14,139, and 14,071 patients, respectively. EUROSCORE I significantly overestimated mortality; EUROSCORE II calibrated well overall, but underestimated mortality of patients undergoing complex surgery and non-elective ones. The ACEF Score calibrated poorly in elective and non-elective patients. Discrimination was acceptable for all models (AUC>0.70), but not for the ACEF Score. CONCLUSIONS: Cardiac surgery scores calibrate poorly when the case-mix of validation and development samples differs. To grant reliability for benchmarking, they should be validated in the clinical settings on which they are applied and updated periodically. Advanced statistical tools are essential for the correct interpretation and application of severity scores.

Mortality attributable to different Klebsiella susceptibility patterns and to the coverage of empirical antibiotic therapy: a cohort study on patients admitted to the ICU with infection.

PURPOSE: To evaluate the prognostic importance of different Klebsiella spp. sensitivity patterns: multi-susceptible Klebsiella (MS-K), extended-spectrum cephalosporin-resistant, but carbapenem-susceptible Klebsiella (ESCR-CS-K), and carbapenem-resistant Klebsiella (CR-K). METHODS: We developed a prognostic model to predict hospital mortality in patients with infection on admission to the intensive care units (ICUs), and assessed its calibration in the subgroups of interest: patients with infections due to MS-K, ESCR-CS-K, CR-K. We assessed the calibration of the model also in ESCR-CS-K treated empirically with carbapenems and with piperacillin-tazobactam. RESULTS: A total of 13,292 adults with an ongoing infection were admitted to 137 Italian ICUs in 2012-2013. Of 801 Klebsiella spp. infected patients, 451 had MS-K, 116 ESCR-CS-K, and 234 CR-K. The prognostic model calibrated well for the MS-K and ESCR-CS-K subgroups. In the CR-K subgroup there were more deaths than predicted (standardized mortality ratio 1.20; 95% CI 1.08-1.31), indicating a negative prognostic role of the infection, mainly in the medium and high risk-of-death patients. When infection was caused by ESCR-CS-K, treatment with piperacillin-tazobactam increased adjusted mortality among the most severe patients (similarly to CR-K), while treatment with carbapenems did not (similarly to MS-K). CONCLUSIONS: In low risk-of-death patients admitted to the ICU with a Klebsiella spp. infection, the appropriateness of empirical antibiotic therapy seemed uninfluential to eventual mortality, while it appeared to be crucial in high-risk ones. The use of piperacillin-tazobactam may be inappropriate in severe patients with ESCR-CS-K infection. CR-K is associated to a significant 20% increase of adjusted mortality, only for patients at higher risk of death.

Data collection and research with MargheritaTre.

OBJECTIVE: MargheritaTre is an electronic health record developed by the Italian Group for the Evaluation of Interventions in Intensive Care Medicine designed to support clinical practice in intensive care units (ICUs) and ensure high-quality data for research purposes. APPROACH: MargheritaTre was developed in collaboration with clinical experts, researchers, and IT specialists. It is currently installed in 40 ICUs and its database contains complete records of more than 65,000 patients. To facilitate data analysis, information is mostly stored in structured or partially structured form. MAIN RESULTS: Data collected with MargheritaTre allow one to conduct research studies on complex clinical problems from manifold perspectives and with different levels of detail, such as epidemiological studies, analyses of the process of care and physiopathological investigations, at both single-organ and organism level. In this paper we describe some of the first projects based on this electronic health record to illustrate its potential for research. SIGNIFICANCE: The MargheritaTre database is a huge and rapidly growing mine of data that will be exploited by our laboratory and shared with other groups to address complex and innovative research and clinical questions. The ultimate aim of these projects is the improvement of the quality of care and patient outcomes, through the development of expert systems integrated in the electronic health record to support clinical practice.

The impact of a model-based clinical regional registry for attention-deficit hyperactivity disorder.

This article describes the development and clinical impact of the Italian Regional ADHD Registry, aimed at collecting and monitoring diagnostic and therapeutic pathways of care for attention-deficit hyperactivity disorder children and adolescents, launched by the Italian Lombardy Region in June 2011. In particular, the model-based software used to run the registry and manage clinical care data acquisition and monitoring, is described. This software was developed using the PROSAFE programme, which is already used for data collection in many Italian intensive care units, as a stand-alone interface case report form. The use of the attention-deficit hyperactivity disorder regional registry led to an increase in the appropriateness of the clinical management of all patients included in the registry, proving to be an important instrument in ensuring an appropriate healthcare strategy for children and adolescents with attention-deficit/hyperactivity disorder.

Parenteral Nutrition Is One of the Most Significant Risk Factors for Nosocomial Infections in a Pediatric Cardiac Intensive Care Unit.

BACKGROUND: Nosocomial infections (NIs) are associated with significant morbidity and mortality and increased healthcare costs. We aimed to assess the NI epidemiology and associated risk factors in a pediatric cardiac intensive care unit (PCICU). MATERIALS AND METHODS: Prospective observational study on 1106 patients admitted to a PCICU from January 1, 2012, to October 31, 2013. NIs were defined and recorded weekly by a multidisciplinary team. Independent risk factors for NIs were assessed by logistic regression analysis in the overall cohort, in cardiac surgical patients, and in those who had cardiopulmonary bypass (CPB). RESULTS: Ninety-two patients (8.3%) had NIs. Overall mortality was 2% but 8.3% in children with NIs ( P < .001). The most frequent NIs were pneumonia (19.6%), bacteremia of unknown origin (16.3%), and catheter-associated bloodstream infection (14.1%) caused mainly by Staphylococcus aureus and Pseudomonas aeruginosa. In the overall cohort, independent risk factors for NIs were number of days of parenteral nutrition (PN), days of invasive and noninvasive ventilation, ward before PCICU admission, and days of PCICU stay; in the cardiac surgical patients, the risk factors were days of PN and days of invasive and noninvasive ventilation; in children who had undergone CPB, the risk factors for NIs were days of PN, delayed sternal closure, reintervention, length of CPB, younger age, and days of invasive ventilation. CONCLUSION: Mortality was significantly higher in patients with NIs. The use of PN was one of the most significant predictors for NIs in the overall cohort of PCICU patients, cardiac surgical patients, and those who required CPB.