Carlotta Rossi

Noninvasive versus invasive ventilation for acute respiratory failure in patients with hematologic malignancies: A 5-year multicenter observational survey

Background:Mortality is high among patients with hematologic malignancies admitted to intensive care units for acute respiratory failure. Early noninvasive mechanical ventilation seems to improve outcomes. Objective:To characterize noninvasive mechanical ventilation use in Italian intensive care units for acute respiratory failure patients with hematologic malignancies and its impact on outcomes vs. invasive mechanical ventilation. Design, Setting, Participants:Retrospective analysis of observational data prospectively collected in 2002–2006 on 1,302 patients with hematologic malignancies admitted with acute respiratory failure to 158 Italian intensive care units. Measurements:Mortality (intensive care unit and hospital) was assessed in patients treated initially with noninvasive mechanical ventilation vs. invasive mechanical ventilation and in those treated with invasive mechanical ventilation ab initio vs. after noninvasive mechanical ventilation failure. Findings were adjusted for propensity scores reflecting the probability of initial treatment with noninvasive mechanical ventilation. Results:Few patients (21%) initially received noninvasive mechanical ventilation; 46% of these later required invasive mechanical ventilation. Better outcomes were associated with successful noninvasive mechanical ventilation (vs. invasive mechanical ventilation ab initio and vs. invasive mechanical ventilation after noninvasive mechanical ventilation failure), particularly in patients with acute lung injury/adult respiratory distress syndrome (mortality: 42% vs. 69% and 77%, respectively). Delayed vs. immediate invasive mechanical ventilation was associated with slightly but not significantly higher hospital mortality (65% vs. 58%, p = .12). After propensity-score adjustment, noninvasive mechanical ventilation was associated with significantly lower mortality than invasive mechanical ventilation. Limitations:The population could not be stratified according to specific hematologic diagnoses. Furthermore, the study was observational, and treatment groups may have included unaccounted for differences in covariates although the risk of this bias was minimized with propensity score regression adjustment. Conclusions:In patients with hematologic malignancies, acute respiratory failure should probably be managed initially with noninvasive mechanical ventilation. Further study is needed to determine whether immediate invasive mechanical ventilation might offer some benefits for those with acute lung injury/adult respiratory distress syndrome.

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

ObjectiveWe examined the relationship between major ICU characteristics and labour cost per patient.DesignFour-week prospective data collection, in which the hours spent by each physician and nurse on both in-ICU and extra-ICU activities were collected.SettingEighty Italian adult ICUs.Measurements and resultsThe cost of the time actually spent by ICU staff on ICU patients (labour cost) was computed for each participating unit, by applying to the average annual salaries the proportions of in-ICU activity working time for physicians and nurses. Multiple regression analysis was used to identify ICU characteristics that predict labour costs per patient. Labour cost per patient was positively correlated with ICU mortality and patients average length of stay (slopes =0.67, p =0.048 and 0.09, p <0.0001, respectively). Labour cost per patient decreases almost linearly as the number of beds increases up to about eight, and it remains nearly constant above about twelve beds. The number of patients admitted per physician (not per nurse) increases with the number of beds (Spearman correlation coefficient =0.567, p <0.0001).ConclusionsOur findings suggest that ICUs with less than about 12 beds are not cost-effective.

Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: A multicenter randomised controlled clinical trial

Objectives Coupled plasma filtration adsorption (CPFA, Bellco, Italy), to remove inflammatory mediators from blood, has been proposed as a novel treatment for septic shock. This multicenter, randomised, non-blinded trial compared CPFA with standard care in the treatment of critically ill patients with septic shock. Design Prospective, multicenter, randomised, open-label, two parallel group and superiority clinical trial. Setting 18 Italian adult, general, intensive care units (ICUs). Participants Of the planned 330 adult patients with septic shock, 192 were randomised to either have CPFA added to the standard care, or not. The external monitoring committee excluded eight ineligible patients who were erroneously included. Interventions CPFA was to be performed daily for 5 days, lasting at least 10 h/day. Primary and secondary outcome measures The primary endpoint was mortality at discharge from the hospital at which the patient last stayed. Secondary endpoints were: 90-day mortality, new organ failures and ICU-free days within 30 days. Results There was no statistical difference in hospital mortality (47.3% controls, 45.1% CPFA; p=0.76), nor in secondary endpoints, namely the occurrence of new organ failures (55.9% vs 56.0%; p=0.99) or free-ICU days during the first 30 days (6.8 vs 7.5; p=0.35). The study was terminated on the grounds of futility. Several patients randomised to CPFA were subsequently found to be undertreated. An a priori planned subgroup analysis showed those receiving a CPFA dose >0.18 L/kg/day had a lower mortality compared with controls (OR 0.36, 95% CI 0.13 to 0.99). Conclusions CPFA did not reduce mortality in patients with septic shock, nor did it positively affect other important clinical outcomes. A subgroup analysis suggested that CPFA could reduce mortality, when a high volume of plasma is treated. Owing to the inherent potential biases of such a subgroup analysis, this result can only be viewed as a hypothesis generator and should be confirmed in future studies. ClinicalTrials.gov NCT00332371; ISRCTN24534559.

External validation of the Simplified Acute Physiology Score (SAPS) 3 in a cohort of 28,357 patients from 147 Italian intensive care units

ObjectiveTo evaluate the SAPS 3 score predictive ability of hospital mortality in a large external validation cohort.DesignProspective observational study.Setting and patientsA total of 28,357 patients from 147 Italian ICUs joining the Project Margherita national database of the Gruppo italiano per la Valutazione degli interventi in Terapia Intensiva (GiViTI).InterventionsNone.MeasurementEvaluation of discrimination through ROC analysis and of overall goodness-of-fit through the Cox calibration test.Main resultsAlthough discrimination was good, calibration turned out to be poor. The general and the South-Europe Mediterranean countries equations overestimated hospital mortality overall (SMR values 0.73 with 95% CI 0.72–0.75 for both equations) and homogeneously across risk classes. Overprediction was confirmed among important subgroups, with SMR values ranging between 0.47 and 0.82.ConclusionsThe result strictly supported by our data is that the SAPS 3 score calibrates inadequately in a large sample of Italian ICU patients and thus should not be used for benchmarking, at least in Italian settings.

Direct Costs of Schizophrenia in Italian Community Psychiatric Services

AbstractObjective: To estimate resource utilisation and direct costs of treatment for patients with schizophrenia in Italian Community Mental Health Centers (CMHCs). Design: Multicentre, retrospective observational study. CMHCs recruited all patients who attended a follow-up consultation during the period September to December 1998. At enrolment, psychiatrists completed a questionnaire on consumption of resources in the 2 months before recruitment. Setting: 14 CMHCs. Perspective: Italian National Health Service (INHS). Patients: 702 patients with a diagnosis of schizophrenia or other psychotic disorders, defined according to the Diagnostic and Statistical Manual of Mental Disorders-fourth edition. These patients had been followed by the CMHCs for at least 2 years and attended a follow-up consultation either during the period September to December 1998 or on randomly selected days during this period. Patients were classified into seven groups according to their diagnosis. Results: The mean direct cost of patients with schizophrenia in the 2-month observation period was 2 234 475 Italian lire [L] (1154.01 Euro; EUR); direct costs ranged from L.1 545 818 to L.2 775 658 (EUR798.35 to EUR1433.51) by prognostic group. There was wide variability for prognostic groups in the impact of most cost components on total cost. Admissions accounted for between 11.4 and 56.3% of the total cost, daycare centre days for between 11.3 and 35.5%, home visits for 7.8 to 16.4%, and day-hospital days for 5.4 to 32.8%. Antipsychotics and anxiolytics were the most prescribed drugs and also the most costly. Conclusion: Despite the limitations of the study related to the short period considered, we believe this study offers some interesting information on the burden of schizophrenia, a disease for which its cost has received limited attention so far in Italy.

Costi diretti della schizofrenia nei dipartimenti di salute mentale italiani

SummaryObjectiveTo estimate resource utilisation and direct costs of treatment for patients with schizophrenia in Italian Community Mental Health Centers (CMHCs).DesignMulticentre, retrospective observational study. CMHCs recruited all patients who attended a follow-up consultation during the period September to December 1998. At enrolment, psychiatrists completed a questionnaire on consumption of resources in the 2 months before recruitment.Setting14 CMHCs.PerspectiveItalian National Health Service (INHS).Patients702 patients with a diagnosis of schizophrenia or other psychotic disorders, defined according to the Diagnostic and Statistical Manual of Mental Disorders-fourth edition. These patients had been followed by the CMHCs for at least 2 years and attended a follow-up consultation either during the period September to December 1998 or on randomly selected days during this period. Patients were classified into seven groups according to their diagnosis.ResultsThe mean direct cost of patients with schizophrenia in the 2-month observation period was 2 234 475 Italian lire [L.] (1 154.01 Euro; EUR); direct costs ranged from L. 1 545 818 to L. 2 775 658 (EUR798.35 to EUR1 433.51) by prognostic group. There was wide variability for prognostic groups in the impact of most cost components on total cost. Admissions accounted for between 11.4 and 56.3% of the total cost, daycare centre days for between 11.3 and 35.5%, home visits for 7.8 to 16.4%, and day-hospital days for 5.4 to 32.8%. Antipsychotics and anxiolytics were the most prescribed drugs and also the most costly.ConclusionsDespite the limitations of the study related to the short period considered, we believe this study offers some interesting information on the burden of schizophrenia, a disease for which its cost has received limited attention so far in Italy.

Geographical differences in mortality of severely injured patients in Italy

Background In Italy there are no accepted standards for trauma care nor dedicated programs for quality assessment on a national scale, like trauma registries. At the same time there seems to be a north–south gradient in the quality of health care. We hypothesized that geographical inequalities of health-care quality may affect trauma mortality. Methods Retrospective comparison of hospital mortality by Cox regression in three main areas of Italy adjusted for age, Glasgow Coma Scale and source of admission. A leading national database on patients admitted to intensive care units (ICU) in the years 2002–2005 was used. 9162 adult trauma cases admitted to the ICU from the emergency department were included. Results There is a significant north–south gradient of risk. Compared to the north, the risk of death is about 60% higher in the south and about 30% higher in the central region. These figures are similar in both referral centres and other hospitals and both in the head-injured only and total injured cases. Conclusion Despite the limitations of this study, mainly related to sampling issues, risk-adjustment and incomplete follow-up, the large geographic differences in mortality that we found highlight likely deficiencies in the quality of trauma care that deserve further accurate assessment.

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. The timely and correct assessment of the severity of an epidemic can be obtained by investigating ICU admissions, especially when historical comparisons can be made.

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

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 prediction was applied to different subgroups defined by both the level of unit expertise with cirrhotics and the overall unit performance, and compared to the actual mortality. Results: 5506 cirrhotic patients (32.1% admitted to the ICU for non‐cirrhotic‐related reasons) were compared to 130,477 controls. Hospital mortality was higher in cirrhotics (57.2% vs. 35.0%, p < 0.001). ICU volume of cirrhotic patients did not influence mortality, while the overall performance of the unit did. The standardized mortality ratio for overall lower‐performing units was 1.09 (95%CI: 1.05–1.14), for the average‐performing units it was 1.01 (95%CI: 0.98–1.04), for the higher‐performing units it was 0.92 (95%CI: 0.89–0.96). Conclusions: The outcome of critically ill cirrhotic patients is quite poor, but not to limit their admission to the ICU. When cirrhosis accompanies other acute conditions, the general level of intensive care medicine is more important than the specific liver‐oriented expertise in treating these patients. HIGHLIGHTSThe survival of cirrhotics in ICU is quite poor but not so as to disinvest on them.Overall ICU performance more than specific expertise improves survival in cirrhotics.Prevention of infection is crucial in critically ill cirrhotic patients.

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

PurposeTo 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).MethodsWe 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.ResultsA 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).ConclusionsIn 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.