Somatic symptoms and depression in general practice in Italy.

Among primary care attenders, depression is a common and debilitating disturbance. These patients imply higher medical costs compared with those without depression, even after controlling for comorbid physical illness. A study performed in 15 countries worldwide has shown that ICD-10 mental disorders were present in 24% of primary care attenders. Detection and management of depression in primary care have received increasing attention. Most individuals with depression have been shown to consult their GPs for somatic symptoms rather than psychological ones. In the study mentioned above, 69% of the depressed patients reported only somatic symptoms. Another study found that GPs were able to diagnose a mental disorder in 90% of subjects presenting psychopathological symptoms and in 50% of those with somatic symptoms. In the light of the above, the Italian College of General Practitioners (Società Italiana di Medicina Generale-SIMG) in the area of Varese (north of Italy) organised a course on depression. Then a study was carried out in our setting. The aim was to evaluate the frequency of depression in patients who seek care for somatic symptoms, where tests showed that these symptoms were without an organic cause

Critical issues and opportunities of emergency psychiatry in Italian emergency departments

In Italy emergency physicians are the front line of care for patients with medical conditions such as trauma, heart attacks, strokes or psychiatric disorders. Triage represents the first clinical contact with the person to determine urgency of care, and includes initial risk assessment and determination of observation level. It is necessary to undertake mental health triage for all service users on entry to the Emergency Department (ED), alongside physical health triage. The recourse to emergency services for psychiatric complaints is increasing and ED providers are often the first contact a patient will have with psychiatric care. The organization of Italian EDs is constantly evolving under the pressure of various external forces (population aging, increasing use of new substances, immigration, choices of economic policy, and technological development). The psychiatric emergency service contact represents a key to addressing the presenting problem and it is a critical link for continuity of care. The management of psychiatric disorders is an evolving issue in Italy as in other countries. Research increasingly suggests the importance of specific training for EDs teams in order to provide appropriate handling in acute settings. Psychiatrists and ED physicians can – and should – play a fundamental role in promoting a targeted and shared training for emergency services to deal with crisis according to evidence-based medicine. Service organization, legal issues, safety, training and education are not well defined and established and still imply improvisation, while they deserve attention as fundamental prerequisite to implement specific treatment guidelines

Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs

Introduction: From the perspective of healthcare organizations and public health care systems, the value of a clinical trial can be assessed from a clinical and economical perspective. However, to date, there is no standardized model for systematically capturing the economic value of clinical trials at organizational and system levels. The aim of this study was to develop and test a methodology for estimating the avoided costs deriving from the management of patients as part of a clinical trial. Methods: Our methodology is based on the assumption that the economic value of a clinical trial derives from 1) the funding received by the experimental site from a trial's sponsor, and from 2) the cost avoided by the experimental site with the treatment of patients within a study and not according to standard care by the experimental site. Results: By applying the methodology to onco-hematological clinical trials conducted in two academic hospitals from 2011 to 2016, we demonstrate that savings between 2 million and 4 million euros were achieved over a five-year period. Thus, for every 1,000 euros invested by the pharmaceutical company into the clinical studies conducted at these hospitals, the hospitals saved on average 2,200 euros due to costs not incurred as a result of the trials. Conclusions: The study has proposed and tested a methodology for estimating the economic value of clinical trials by taking into account avoided costs deriving from the treatment of patients enrolled in sponsored trials. The study has proposed a management tool for healthcare institutions to govern clinical trials

Management of acute behavioral disturbance in the Emergency Department: An Italian position paper from AcEMC, CNI-SPDC, SIP-Lo, SITOX

The phenomenon of acute behavioral disturbance is an underrecognized and potentially life-threatening syndrome, and sometimes an emergency in psychiatric settings. Patients presenting to the Italian emergency department (ED) with acute behavioral disturbances account for approximately 3.2% of all ED visits. The spectrum of behaviors and signs overlap with many clinical disease processes. In addition to patients with behavioral problems related to mental disorders or substance abuse, there is also a large group whose behavioral emergencies directly result from medical illness. The complexity of these patients, as well as the interdisciplinary nature of their care, requires a clear and consensual framework for care. A network of Italian scientific societies developed ten reccomendations for good clinical practice. The main purpose is to draw up a document that presents a standardized method for the organization of the care of patients with acute behavioral disorders in E

The interplay among psychopathology, personal resources, context-related factors and real-life functioning in schizophrenia: stability in relationships after 4 years and differences in network structure between recovered and non-recovered patients

Improving real-life functioning is the main goal of the most advanced integrated treatment programs in people with schizophrenia. The Italian Network for Research on Psychoses previously explored, by using network analysis, the interplay among illness-related variables, personal resources, context-related factors and real-life functioning in a large sample of patients with schizophrenia. The same research network has now completed a 4-year follow-up of the original sample. In the present study, we used network analysis to test whether the pattern of relationships among all variables investigated at baseline was similar at follow-up. In addition, we compared the network structure of patients who were classified as recovered at follow-up versus those who did not recover. Six hundred eighteen subjects recruited at baseline could be assessed in the follow-up study. The network structure did not change significantly from baseline to follow-up, and the overall strength of the connections among variables increased slightly, but not significantly. Functional capacity and everyday life skills had a high betweenness and closeness in the network at follow-up, as they had at baseline, while psychopathological variables remained more peripheral. The network structure and connectivity of non-recovered patients were similar to those observed in the whole sample, but very different from those in recovered subjects, in which we found few connections only. These data strongly suggest that tightly coupled symptoms/dysfunctions tend to maintain each other's activation, contributing to poor outcome in schizophrenia. Early and integrated treatment plans, targeting variables with high centrality, might prevent the emergence of self-reinforcing networks of symptoms and dysfunctions in people with schizophrenia

The interplay among psychopathology, personal resources, context-related factors and real-life functioning in schizophrenia: stability in relationships after 4 years and differences in network structure between recovered and non-recovered patients

Improving real-life functioning is the main goal of the most advanced integrated treatment programs in people with schizophrenia. The Italian Network for Research on Psychoses previously explored, by using network analysis, the interplay among illness-related variables, personal resources, context-related factors and real-life functioning in a large sample of patients with schizophrenia. The same research network has now completed a 4-year follow-up of the original sample. In the present study, we used network analysis to test whether the pattern of relationships among all variables investigated at baseline was similar at follow-up. In addition, we compared the network structure of patients who were classified as recovered at follow-up versus those who did not recover. Six hundred eighteen subjects recruited at baseline could be assessed in the follow-up study. The network structure did not change significantly from baseline to follow-up, and the overall strength of the connections among variables increased slightly, but not significantly. Functional capacity and everyday life skills had a high betweenness and closeness in the network at follow-up, as they had at baseline, while psychopathological variables remained more peripheral. The network structure and connectivity of non-recovered patients were similar to those observed in the whole sample, but very different from those in recovered subjects, in which we found few connections only. These data strongly suggest that tightly coupled symptoms/dysfunctions tend to maintain each other's activation, contributing to poor outcome in schizophrenia. Early and integrated treatment plans, targeting variables with high centrality, might prevent the emergence of self-reinforcing networks of symptoms and dysfunctions in people with schizophrenia

Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study.

OBJECTIVE: Mepolizumab proved to be an efficacious treatment for eosinophilic granulomatosis with polyangiitis (EGPA) at a dose of 300 mg every 4 weeks in the randomized, controlled MIRRA trial. In a few recently reported studies, successful real-life experiences with the approved dose for treating severe eosinophilic asthma (100 mg every 4 weeks) were observed. We undertook this study to assess the effectiveness and safety of mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks in a large European EGPA cohort. METHODS: We included all patients with EGPA treated with mepolizumab at the recruiting centers in 2015-2020. Treatment response was evaluated from 3 months to 24 months after initiation of mepolizumab. Complete response to treatment was defined as no disease activity (Birmingham Vasculitis Activity Score [BVAS] = 0) and a prednisolone or prednisone dose (or equivalent) of ≤4 mg/day. Respiratory outcomes included asthma and ear, nose, and throat (ENT) exacerbations. RESULTS: Two hundred three patients, of whom 191 received a stable dose of mepolizumab (158 received 100 mg every 4 weeks and 33 received 300 mg every 4 weeks) were included. Twenty-five patients (12.3%) had a complete response to treatment at 3 months. Complete response rates increased to 30.4% and 35.7% at 12 months and 24 months, respectively, and rates were comparable between mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks. Mepolizumab led to a significant reduction in BVAS score, prednisone dose, and eosinophil counts from 3 months to 24 months, with no significant differences observed between 100 mg every 4 weeks and 300 mg every 4 weeks. Eighty-two patients (40.4%) experienced asthma exacerbations (57 of 158 [36%] who received 100 mg every 4 weeks; 17 of 33 [52%] who received 300 mg every 4 weeks), and 31 patients (15.3%) experienced ENT exacerbations. Forty-four patients (21.7%) experienced adverse events (AEs), most of which were nonserious AEs (38 of 44). CONCLUSION: Mepolizumab at both 100 mg every 4 weeks and 300 mg every 4 weeks is effective for the treatment of EGPA. The 2 doses should be compared in the setting of a controlled trial