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BACKGROUND: For Attention Deficit/Hyperactivity Disorder (ADHD) youth transitioning from child to adult services, protocols that guide the transition process are essential. While some guidelines are available, they do not always consider the effective workload and scarce resources. In Italy, very few guidelines are currently available, and they do not adhere to common standards, possibly leading to non-uniform use. METHODS: The present study analyzes 6 protocols collected from the 21 Italian services for ADHD patients that took part in the TransiDEA (Transitioning in Diabetes, Epilepsy, and ADHD patients) Project. The protocols' content is described, and a comparison with the National Institute for Clinical Health and Excellence (NICE) guidelines is carried out to determine whether the eight NICE fundamental dimensions were present. RESULTS: In line with the NICE guidelines, the dimensions addresses in the 6 analyzed documents are: early transition planning (although with variability in age criteria) (6/6), individualized planning (5/6), and the evaluation of transfer needs (5/6). All protocols also foresee joint meetings between child and adult services. The need to include the families is considered by 4 out of 6 protocols, while monitoring (2/6), and training programs (1/6) are less encompassed. In general, a highly heterogeneous picture emerges in terms of quality and quantity of regulations provided. CONCLUSIONS: While some solid points and core elements are in common with international guidelines, the content's variability highlights the need to standardize practices. Finally, future protocols should adhere more to the patients' needs and the resources available to clinicians.
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Trastorno por Déficit de Atención con Hiperactividad , Servicios de Salud Mental , Transición a la Atención de Adultos , Humanos , Trastorno por Déficit de Atención con Hiperactividad/terapia , Adolescente , Transición a la Atención de Adultos/normas , Servicios de Salud Mental/normas , Italia , Adulto , Guías de Práctica Clínica como Asunto , Masculino , Protocolos Clínicos/normas , Femenino , Adulto JovenRESUMEN
BACKGROUND: Supporting young ADHD patients in transition to adult services is essential. Yet, the low percentages of successful referrals and the issues reported by patients and clinicians stress the need for further attention to transitioning practices. The present study assessed the transitioning process of Attention-Deficit/Hyperactivity Disorder (ADHD) patients in Child and Adolescent Mental Health Services (CAMHS) and Adult Mental Health Services (AMHS) in the Italian territory. We asked child and adult psychiatrists to report the current state of services and their observations on limitations and possible future matters that must be addressed. METHOD: Seventy-seven centers (42 CAMHS, 35 AMHS) filled in a web-based survey in which they reported the number of ADHD patients, how many transitioning patients they had within the past year, and how they structured transition. RESULTS: A fragmented picture emerged from the survey. Lack of resources, training, and communication between services hinder the transition process, and many adult patients remain under CAMHS' care. While some services have a protocol, there is no structured guidance that can help improve integration and continuity of treatment. CONCLUSION: The observed situation reflects a need for improvement and standard guidelines to enable a successful transition process, considering clinicians' and patients' necessities.
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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.
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Recolección de Datos , Registros Electrónicos de Salud , Proyectos de Investigación , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana EdadRESUMEN
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.
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Unidades de Cuidados Intensivos/estadística & datos numéricos , Cirrosis Hepática/mortalidad , Admisión del Paciente/estadística & datos numéricos , Anciano , Cuidados Críticos , Femenino , Mortalidad Hospitalaria , Humanos , Italia/epidemiología , Modelos Logísticos , Masculino , Persona de Mediana EdadRESUMEN
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. Antibiotic use was guideline-driven and aggressive in the Pisa-based unit (165 eligible patients), and very conservative and coupled with non-pharmacological prevention measures in Cesena (262 patients). Data were also compared with those of 208 Italian ICUs participating in the same infection surveillance program. RESULTS: Patient case mix and general care were similar in the two units. Overall antibiotic pressure was higher in Pisa (58.9% vs. 26.1% of beds occupied by patients receiving antibiotics, P<0.0001), as was antibiotic prophylaxis in eligible patients (87.3% vs. 7.6%, P<0.0001; Italian ICUs, 69.2%) and empirical therapy in those who developed VAP (60.8% vs. 25.2%, P<0.0001; Italian ICUs, 51.6%). The incidence rate of VAP did not significantly differ (39.8 per 1000 days of mechanical ventilation in Pisa, 49.3 in Cesena, P=0.16), although it occurred earlier in Cesena (23.0% early VAP in Pisa vs. 61.2% in Cesena, P<0.0001). Mortality was higher in Pisa but Cesena transferred more patients to other hospitals, precluding comparison of the two rates. The prevalence of MDR was higher in Pisa (38.2% vs. 9.9%, P<0.0001; Italian ICUs, 30.2%). CONCLUSIONS: Although not conclusive, these results call into question the prevalent aggressive use of antibiotics in TBI patients and urge the scientific community to produce better evidence for clinical recommendations.
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Antibacterianos/uso terapéutico , Neumonía Asociada al Ventilador/tratamiento farmacológico , Neumonía Asociada al Ventilador/prevención & control , Adulto , Anciano , Lesiones Traumáticas del Encéfalo/complicaciones , Prescripciones de Medicamentos/estadística & datos numéricos , Farmacorresistencia Bacteriana Múltiple , Femenino , Humanos , Incidencia , Puntaje de Gravedad del Traumatismo , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Neumonía Asociada al Ventilador/epidemiología , Neumonía Asociada al Ventilador/etiologíaRESUMEN
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. CLINICALTRIALSGOV: NCT00332371; ISRCTN24534559.
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Hemofiltración , Choque Séptico/terapia , Adolescente , Adsorción , Adulto , Anciano , Femenino , Hemofiltración/métodos , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: The Register was aimed at monitoring the use, possible side effects, and clinical effectiveness of Xigris® - drotrecogin alfa (activated) - for the treatment of severe sepsis in Italian intensive care units (ICUs). METHODS: Data collection was performed using an online web form or a specific electronic module of the software Margherita, available only for the ICUs adhering to the GiViTI. Drug purchase information available for each center was used to identify and stimulate collaboration of non-compliant centers. Several countermeasures were taken to have the largest participation. RESULTS: We analyzed data from 1001 patients treated in 161 ICUs between July 2003 and September 2007, corresponding to 70% of all the patients who received the drug in that period. The off-label use of the drug was frequent: 15.6% of cases before and 27.3% after the label change with the introduction of timing restrictions. Treatment was temporarily interrupted in 10%, and definitely stopped in 25% of cases, after the occurrence of adverse events, the most frequent being bleeding. Severe bleeding occurred in 3.8% of patients. Multivariable analysis, which allowed an adjusted comparison with a control group, showed that treatment increased mortality among elective-surgery patients (OR 2.79, 95%CI 1.31-5.97). DISCUSSION: The results of this study and other evidences led the European Medicines Agency (EMA) to require a confirmatory trial in 2007. In October 2011 Ely-Lilly, the producer of the drug, announced the worldwide withdrawal from the market of Xigris®, on the basis of the negative results of the confirmatory trial. CONCLUSIONS: The availability of purchase information is essential to carry out post-marketing drug surveillance studies, since it allows to identify and contact non-compliant centers. Actually, a representative sample of treated patients provides reliable information on the use, efficacy, and safety of the drug in daily clinical practice that could positively influence healthcare policies.
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Antiinfecciosos/uso terapéutico , Proteína C/uso terapéutico , Sistema de Registros , Cuidados Críticos , Femenino , Humanos , Unidades de Cuidados Intensivos , Italia , Masculino , Vigilancia de Productos Comercializados , Proteínas Recombinantes/uso terapéuticoRESUMEN
OBJECTIVE: To evaluate the SAPS 3 score predictive ability of hospital mortality in a large external validation cohort. DESIGN: Prospective observational study. SETTING AND PATIENTS: A 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). INTERVENTIONS: None. MEASUREMENT: Evaluation of discrimination through ROC analysis and of overall goodness-of-fit through the Cox calibration test. MAIN RESULTS: Although 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. CONCLUSIONS: The 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.