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Background: The assessment of the quality of care pathways delivered to people with severe mental disorders in a community-based system remains uncommon, especially using healthcare utilization databases. The aim of the study was to evaluate the quality of care provided to people with bipolar disorders taken-in-care by mental health services of four Italian areas (Lombardy, Emilia-Romagna, Lazio, province of Palermo). Methods: Thirty-six quality indicators were implemented to assess quality of mental health care for patients with bipolar disorders, according to three dimensions (accessibility and appropriateness, continuity, and safety). Data were retrieved from healthcare utilization (HCU) databases, which contain data on mental health treatments, hospital admissions, outpatient interventions, laboratory tests and drug prescriptions. Results: 29,242 prevalent and 752 incident cases taken-in-care by regional mental health services with a diagnosis of bipolar disorder in 2015 were identified. Age-standardized treated prevalence rate was 16.2 (per 10,000 adult residents) and treated incidence rate 1.3. In the year of evaluation, 97% of prevalent cases had ≥ 1 outpatient/day-care contacts and 88% had ≥ 1 psychiatric visits. The median of outpatient/day-care contacts was 9.3 interventions per-year. Psychoeducation was provided to 3.5% of patients and psychotherapy to 11.5%, with low intensity. 63% prevalent cases were treated with antipsychotics, 71.5% with mood stabilizers, 46.6% with antidepressants. Appropriate laboratory tests were conducted in less than one-third of prevalent patients with a prescription of antipsychotics; three quarters of those with a prescription of lithium. Lower proportions were observed for incident patients. In prevalent patients, the Standardized Mortality Ratio was 1.35 (95% CI: 1.26–1.44): 1.18 (1.07–1.29) in females, 1.60 (1.45–1.77) in males. Heterogeneity across areas was considerable in both cohorts. Conclusions: We found a meaningful treatment gap in bipolar disorders in Italian mental health services, suggesting that the fact they are entirely community-based does not assure sufficient coverage by itself. Continuity of contacts was sufficient, but intensity of care was low, suggesting the risk of suboptimal treatment and low effectiveness. Care pathways were monitored and evaluated using administrative healthcare databases, adding evidence that such data may contribute to assess the quality of clinical pathways in mental health.

International audience; Background : Dupilumab is approved for use in moderate-to-severe atopic dermatitis (AD) and as an add-on maintenancetreatment in patients suffering from severe asthma with type 2 inflammation. Ocular adverse events (OAEs) havebeen reported with dupilumab almost exclusively in patients treated for AD. Objectives : The objectives of this study were to describe the incidence and nature of dupilumab-induced OAEs and toassess the potential predisposing factors. Patients and methods We conducted a prospective, single-centre, real-life study in adult AD patients treated with dupilumab, who were systematically examined by an ophthalmologist before and during treatment. Results : Forty-six patients were included prospectively with a median age of 41.1 years and a median initial SCOring Atopic Dermatitis of 46.0 (IQR: 34.5–55.5). OAEs concerned 34.8% of patients and were mostly of mild to moderate severity. Two patients had to discontinue treatment due to OAE. The majority of patients developed or aggravated dry eye disease, with superficial punctate keratitis (SPK). Six patients developed conjunctivitis. Dupilumab-induced OAEs,were associated with the following pre-existing parameters: dry eye disease with SPK (Odds ratio (OR); 6.3 [95% confidence interval (CI): 1.3–31.6]), eyelid eczema (OR: 8.7 [95%CI:1.8–40.6]), history of food allergy (OR 3.8 (95% CI: 1.002– 14,070) and IgE serum level> 1000 kU/L (OR:10.6 [CI 95%: 1.2–91.3]).Conclusion : Atopic dermatitis patients with eyelid eczema or dry eye disease symptoms may be referred to an ophthalmologist before starting dupilumab to consider initiating preventive eye hydration measures. Further multicentric and translational studies are warranted to better explain OAEs pathophysiology.

International audience; BACKGROUND: Mastocytosis is associated with mast cell (MC) mediator-related symptoms for which limited therapies are available. OBJECTIVE: Our aim was to assess the efficacy and safety of omalizumab in the treatment of MC mediator-related symptoms in adult patients with mastocytosis.RESULTS: We identified one multi-centre retrospective cohort study (39 patients), one retrospective cohort study (13 patients), 4 case series and 10 case reports. No published controlled randomized study was identified. We included 69 patients (13 patients with cutaneous mastocytosis and 56 with systemic mastocytosis). The mean age was 48 years. Omalizumab maintenance dose was 300 mg for the majority of patients. The mean duration of treatment was 17 months. Treatment led to a tolerability of venom immunotherapy and to a complete resolution of severe reactions in all patients with post-honeybee sting anaphylaxis. Complete resolution of idiopathic anaphylaxis episodes was noted in 84% of the patients. Complete resolution of palpitations, gastrointestinal, cutaneous, neuropsychiatric, respiratory and musculoskeletal symptoms was observed at a rate of 43%, 29%, 27%, 11%, 9% and 0%, respectively. Efficacy was maintained for the entire duration of the treatment in all but four responders. Adverse events were reported for 13 patients. CONCLUSIONS AND CLINICAL RELEVANCE: Omalizumab appears to prevent some life-threatening reactions associated with mastocytosis and may be a good option to treat the associated symptoms. However, the evidence relied upon is observational, uncontrolled and from a small number of patients. A randomized controlled trial is needed to better understand the place of omalizumab in mastocytosis treatment.

Introduction: Clinical trials indicate that oral BP reduce the incidence of osteoporotic fractures up to 60%. Although the safety of BP appears similar to placebo, adverse reaction reports have suggested an association between BP use and ONJ. On this concern, no epidemiological study including ‘validated’ cases of ONJ has been still conducted. Methods: A case-control study was nested into a cohort of 65,220 fractured osteoporotic patients. An Adjudication Committee selected codes plausibly related to ‘true’ cases of ONJ according to two levels of contiguity: level I ‘possibly contiguous with ONJ’ (e.g. 730.08 ‘multiple bone infections, site unspecified’), level II ‘probably contiguous with ONJ’ (e.g. 526.4 ‘jaw inflammation’). Up to 20 controls were matched to each case according to gender, age (±3 years), month and year of the cohort entry. Odds Ratio [OR; 95% Confidence Intervals (CIs)] of being exposed to BPs among cases vs. controls were estimated through conditional logistic regression model. Multivariable analysis includes use of steroids, proton pump inhibitors and diabetes as confounders. Results: Among (43 level I, 61 level II) 104 cases of ONJ the odds of being exposed to BPs was not different from controls (OR = 1.1; 95% CI: 0.6–1.1). When the analysis was restricted to level II cases, OR was 2.8 (95% CI, 1.3–5.9) higher among current users (last prescription within 1 year before the case’s date) of BP than never users. Conclusions: These findings seem to suggest an association between use of oral BP and ONJ. Further analyses on definitively validated cases are needed.

A multi-centre, observational, cross-sectional study was carried out to determine whether the healthrelated quality of life (HRQOL) of adolescents with type 1 diabetes is affected by different insulin treatment systems, and which features of HRQOL are impacted by the respective insulin treatment. The study regarded 577 adolescents, aged 10–17 years, with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) (n = 306) or multiple daily injections (MDI) (n = 271). The Insulin Delivery System Rating Questionnaire was validated in Italian and was self-completed by the subjects during a routine visit to the centres. Subjects were compared following the domains of the questionnaire. Good HRQOL was seen in subjects treated with either MDI or CSII. Significant differences were not found in the domains for general diabetes, including diabetes worries, social burden and psychological well-being. Multiple quantile regression analysis showed that CSII confers significant advantages in terms of HRQOL with improvements in treatment satisfaction, perceived clinical efficacy and reduction in treatment interference with daily activities.This favourable impact was more evident in subjects reporting lower HRQOL scores, suggesting that CSII may be especially useful for individuals perceiving a poor HRQOL. Analysis of the domains indicated that CSII was associated with a higher HRQOL than MDI. Life-course HRQOL evaluation using a standardised questionnaire can ensure better chronic disease management. This is particularly important when providing individualized care for adolescents, as they become increasingly responsible for managing their diabetes.

AIM. The Biphosphonates Efficacy-Safety Tradeoff (BEST) study was designed to evaluate efficacy and safety of oral BP in primary care. METHODS. Hospital discharges and pharmacy claims, collected over a population of 19 million enrolees in the Italian National Health System, were used to select records of subjects aged 55+ years, discharged from hospital with a primary diagnosis of fracture at osteoporotic sites. Exclusion criteria included cancer, Paget disease, and previous BP use. Post-discharge prescription of oral BP was recorded. Outcomes of the BEST study are: 1) occurrence of osteonecrosis of the jaw (ONJ), 2) gastro-intestinal bleeding, and 3) recurrent fracture. Data on BP utilization and ICD9CM-based diagnoses of ONJ are currently available. RESULTS. Out of 72,675 eligible subjects (mean age: 67 years; 71% females), 11% (females: 16%, males: 6%; p

OBJECTIVE - To investigate age-period-cohort effects on the temporal trend of type 1 diabetes in children age 0-14 years in Italian registries. RESEARCH DESIGN AND METHODS - This report is based on 5,180 incident cases in the period 1990-2003 from the Registry for Type 1 Diabetes Mellitus in Italy (RIDI). Multilevel (random intercept) Poisson regression models were used to model the effects of sex, age, calendar time, and birth cohorts on temporal trends, taking into account the registry-level variance component. RESULTS - The incidence rate was 12.26 per 100,000 personyears and significantly higher in boys (13.13 [95% CI 12.66-13.62]) than in girls (11.35 [10.90-11.82]). Large geographical variations in incidence within Italy were evident; incidence was highest in Sardinia, intermediate in Central-Southern Italy, and high in Northern Italy, particularly in the Trento Province, where the incidence rate was 18.67 per 100,000 person-years. An increasing temporal trend was evident (2.94% per year [95% CI 2.22-3.67]). With respect to the calendar period 1990-1992, the incidence rates increased linearly by 15, 27, 35, and 40% in the following time periods (P for trend < 0.001). With respect to the 1987-1993 birth cohort, the incidence rate ratio increased approximately linearly from 0.63 (95% CI 0.54-0.73) in the 1975-1981 cohort to 1.38 (1.06-1.80) in the 1999-2003 cohort. The best model, however, included sex, age, and a linear time trend (drift). CONCLUSIONS - Large geographical variations and an increasing temporal trend in diabetes incidence are evident among type 1 diabetic children in Italy. Age-period-cohort analysis shows that the variation over time has a linear component that cannot be ascribed to either the calendar period or the birth cohort. © 2010 by the American Diabetes Association.

Objective. The Registry for Type 1 Diabetes Mellitus in Italy (RIDI) Study Group was established to coordinate the registries of type 1 diabetes in Italy. This report is based on 3,606 children younger than 15 years diagnosed with type 1 diabetes and prospectively registered during 1990-1999 by nine centers, covering > 35% of the Italian population. Research design and methods. Registries were pooled in four geographic macro-areas: north, central, south and insular. The completeness of registration was assessed by the capture-recapture method. Poisson regression analysis was used to evaluate temporal trend in incidence. Results. Large variation in incidence were confirmed not only between Sardegna and the mainland but also among peninsular areas. In Sardegna, there was an excess of boys (the boy-to-girl incidence ratio was 1.4). The overall incidence showed average increases of 3.6% (p

Background and Aims: During the last decade several studies reported an increase in the incidence of type I diabetes mellitus (TlDM). Such increase varies among the European countries in both age groups and gender. Furthermore, in some countries a rising incidence of TI DM has been reported in children

International audience; INTRODUCTION: Topical steroids are used for more than 50 years to treat mild-to-moderate plaque psoriasis. The purpose of this systematic review was to evaluate the efficacy but also the optimal modalities of administration of topical corticosteroids in psoriasis i.e. influence of steroid potency on clinical response, putative impact of topical formulation, occlusion procedure, rate of application to control the initial response and the potential interest of a maintenance treatment to prolong psoriasis clearance. Material and METHODS: A systematic search was performed between 1980 and January 2011 in Medline, Embase and Cochrane databases (English and French language, adults), using the keywords 'psoriasis'/exp/mj AND 'corticosteroid'/exp/mj. To analyse response across studies, three levels of response were categorized depending on the data available in studies: percentage of patients who achieved more than 50%, 75% or 90% improvement of initial psoriasis severity. RESULTS: From an initial selection of 1269 references, 1166 references were excluded on reading the title or the abstract and 32 on reading the article and 71 were finally retained and analysed. Fifty randomized controlled trials (RCT) assessing topical steroids in the initial treatment of mild-to-severe psoriasis body plaque psoriasis were retained: 40 were parallel-group studies and 10 were within-patient studies. Treatment duration was mostly 4 weeks. Sample size varied from 30 to 1 603 patients. Outcome measures to assess efficacy were highly variable. A total of 30-90% patients across parallel group studies experienced more than 50% of initial mild-to-severe psoriasis improvement while from 7% to 85% experienced more than 75% improvement and from 5% to 85% experienced at least 90% of improvement. The success rate in the within-patient studies varied from 10% to 70%. Eighteen RCT were performed in scalp psoriasis: 16 were parallel-group and two were within-patient studies, with a treatment follow-up time from 2 weeks to 6 months, enrolling 42-1417 patients. A total from 40% to 75% patients across studies experienced more than 75% of initial scalp psoriasis improvement and from 43% to 90% experienced more than 90% initial psoriasis improvement. Only three RCT studies evaluated topical steroids as a maintenance treatment for body psoriasis and one for scalp lesions. Despite heterogeneity in treatment schedule, topical steroid intermittent maintenance treatment was shown to prolong remission. The literature analysis did not provide with high evidence-based quality data on the role of formulation, topical steroid potency, number of applications per day to obtain the highest rate of success excepting occlusion dressing which provided with additional benefit. CONCLUSION: The clinical development of topical steroids in psoriasis did not follow state of the art modern methodology. Treatment success appears to be highly variable across studies. Maintenance intermittent treatment appears to be useful to prolong remission. Recommendations concerning topical steroids treatment modalities in plaque psoriasis should be mostly based on expert opinion.