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.

Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.

Background: Ethical approval (EA) must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study.

Methods: Sixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA.

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.

Mid regional pro-adrenomedullin for the prediction of organ failure in infection. Results from a single centre study.

Biomarkers are widely used to confirm the presence of infection. However, it would be of the greatest importance to predict in advance the occurrence or worsening of organ dysfunction in infected patients allowing timely antibiotic escalation. This study investigates the ability of procalcitonin (PCT) and MR-proADM to predict the transition to sepsis in infected patients.

Cirrhotic patients admitted to the ICU for medical reasons: Analysis of 5506 patients admitted to 286 ICUs in 8years.

Purpose: To describe characteristics and prognostic factors of cirrhotic patients admitted to a representative sample of Italian intensive care units (ICUs).

Materials And Methods: All patients admitted to 286 ICUs for medical reasons between 2002 and 2010 (excluding 2007) were considered. A logistic regression model was developed on cirrhotics to predict hospital mortality.

The prognostic importance of chronic end-stage diseases in geriatric patients admitted to 163 Italian ICUs.

Background: The number of elderly patients undergoing major surgical interventions and then needing admission to intensive care unit (ICU) grows steadily. We investigated this issue in a cohort of 232,278 patients admitted in five years (2011-2015) to 163 Italian general ICUs.

Methods: Surgical patients older than 75 registered in the GiViTI MargheritaPROSAFE project were analyzed.

Current adoption of lung ultrasound in Intensive Care Units: an Italian multi-center survey.

Background: Lung ultrasound (LUS) is a useful tool for assessing lung status in critically ill patients, but is not widely applied in intensive care units (ICUs). The aim of this study was to investigate the use of LUS in Italian ICUs.

Methods: A questionnaire was distributed to 116 ICU representatives belonging to the Italian GiViTI network, participating in a national project on continuous quality of care assessment.

Aggressive versus conservative antibiotic use to prevent and treat ventilator-associated pneumonia in patients with severe traumatic brain injury: comparison of two case series.

Background: In patients with traumatic brain injury (TBI), ventilator-associated pneumonia (VAP) is considered a dangerous complication, prompting early aggressive antibiotic treatment and prophylaxis. While this approach increases the selection of multidrug-resistant bacteria (MDR), its clinical benefit has not been demonstrated.

Methods: One-year incidence of VAP in severe TBI patients (ICU stay >48 hours, with either Glasgow Coma Scale ≤8 or receiving intracranial pressure monitoring, or having undergone emergency surgery) and the prevalence of MDR among those who eventually developed it, were compared in two Italian intensive care units (ICUs) adopting different antibiotic approaches.

A new test and graphical tool to assess the goodness of fit of logistic regression models.

A prognostic model is well calibrated when it accurately predicts event rates. This is first determined by testing for goodness of fit with the development dataset. All existing tests and graphic tools designed for the purpose suffer several drawbacks, related mainly to the subgrouping of observations or to heavy dependence on arbitrary parameters.

The role of the intensive care unit in real-time surveillance of emerging pandemics: the Italian GiViTI experience.

The prompt availability of reliable epidemiological information on emerging pandemics is crucial for public health policy-makers. Early in 2013, a possible new H1N1 epidemic notified by an intensive care unit (ICU) to GiViTI, the Italian ICU network, prompted the re-activation of the real-time monitoring system developed during the 2009-2010 pandemic. Based on data from 216 ICUs, we were able to detect and monitor an outbreak of severe H1N1 infection, and to compare the situation with previous years.

A new calibration test and a reappraisal of the calibration belt for the assessment of prediction models based on dichotomous outcomes.

Calibration is one of the main properties that must be accomplished by any predictive model. Overcoming the limitations of many approaches developed so far, a study has recently proposed the calibration belt as a graphical tool to identify ranges of probability where a model based on dichotomous outcomes miscalibrates. In this new approach, the relation between the logits of the probability predicted by a model and of the event rates observed in a sample is represented by a polynomial function, whose coefficients are fitted and its degree is fixed by a series of likelihood-ratio tests.

Use of Drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey.

Objective: To monitor the use of drotrecogin alfa activated (DrotAA) in Italy and its effects on patients' health.

Design: Prospective pharmaco-surveillance program with a parallel non-randomized control group.

Setting: The Ministry of Health required all intensive care units (ICUs) using DrotAA to participate in the pharmaco-surveillance program.

The relationship between labour cost per patient and the size of intensive care units: a multicentre prospective study.

Objective: We examined the relationship between major ICU characteristics and labour cost per patient.

Design: Four-week prospective data collection, in which the hours spent by each physician and nurse on both in-ICU and extra-ICU activities were collected.

Setting: Eighty Italian adult ICUs.

Early enteral immunonutrition in patients with severe sepsis: results of an interim analysis of a randomized multicentre clinical trial.

Objective: To compare the mortality of critically ill patients given either enteral feeding with an immune-enhancing formula or parenteral nutrition (PN). We report the results of a planned interim analysis on patients with severe sepsis which was undertaken earlier than planned once a meta-analysis suggested excess mortality in patients with severe sepsis given enteral immunonutrition.

Design: Randomised multicentre unblinded controlled clinical trial.

The use of analgesic drugs in postoperative patients: the neglected problem of pain control in intensive care units. An observational, prospective, multicenter study in 128 Italian intensive care units.

Objective: The use of analgesic drugs in patients admitted to Italian intensive care units (ICUs) was assessed.

Methods: An observational, prospective, cohort study was conducted, involving all adult patients admitted during a 1-month period in 128 Italian general ICUs. The use of analgesic drugs was evaluated for the first 2 postoperative days in surgical patients who stayed in ICU for at least 2 days.

The performance of SAPS II in a cohort of patients admitted to 99 Italian ICUs: results from GiViTI. Gruppo Italiano per la Valutazione degli interventi in Terapia Intensiva.

Objective: To assess the validity of SAPS II (new Simplified Acute Physiology Score) in a cohort of patients admitted to a large sample of Italian intensive care units (ICU).

Design And Setting: The ability of the SAPS II scoring system to predict the probability of hospital mortality was assessed with calibration and discrimination measures obtained using published coefficients. A new logistic regression equation was then developed and further formal calibration and discrimination measures were estimated for the customized model.