Child and Adolescent Behavior Inventory (CABI): Standardization for age 6-17 years and first clinical application

Background: The Child and Adolescent Behavior Inventory (CABI) is a questionnaire designed to collect information from the parents of children and adolescents, both for the preparation of screening and epidemiological studies and for clinical evaluation. It has been published in CPEMH in 2013, with the first data on 8-10 years old school children. Here we report an extended standardization on a school population 6-17 years old and the first results of the application in a clinical sample. Methods: Parents, after giving their informed consent, answered to the questionnaire. Complete and reliable data were obtained from the parents of 659 school children and adolescents 6-17 y.o., with a balanced distribution of gender. Moreover, in a population of 84 patients, the results with the CABI were compared with the clinical evaluation and the CBCL. Results: In the school population, scores were different in relation to gender and age. The values of externalizing disorders were higher in males, with the highest values for ADHD in the 6-10 y.o. children. On the contrary, the scores of internalizing disorders and of eating disorders tended to be slightly higher in females. In the clinical population, scores at the CABI were in agreement with the clinical evaluation in 84% cases for depressive symptoms (compared to CBCL 66%), 53% for anxiety symptoms (CBCL 42%) and 87% for ODD (CBCL 69%), differences, however; without statistical significance (chi square). Conclusion: The study obtained normative data for the CABI and gave information of the behavioral differences in relation to age and gender of the school population as evaluated by parents/caregivers. Clinically, the CABI provided useful information for the clinical evaluation of the patient, sometimes with better agreement with the final diagnosis compared to the CBCL

Long-term "real-life" safety of omalizumab in patients with severe uncontrolled asthma: A nine-year study

Background Randomized Controlled Trials showed that omalizumab exhibited a good safety and tolerability profile in patients with moderate-to-severe asthma. However, safety data of long-term treatment with omalizumab are scarce. Our aim was to assess the safety of omalizumab in patients under long-term treatment in a real-life setting. Methods Difficult-to-control asthmatic patients treated with omalizumab up to 9 years were retrospectively evaluated. Mild to severe adverse events any and reasons for discontinuation were recorded. Results Ninety-one patients (26.4% males, mean age 49.9 ± 14.9 years) were included: mean treatment length, 3.8 ± 2.6 years; mean individual monthly dose, 514.5 ± 345.7 mg (range, 150â\u80\u931200 mg). A total of 10,472 single injections were given cumulatively to the 91 patients (115 single injections per patients, on average, over a treatment period up to 9 years). Fifty-nine patients (64.8%) were treated for a period of time from 3 to 9 years, 14 of whom from 6 to 9 years. A high proportion of patients who discontinued treatment dropped out within the first year (18, 39.1%), mainly for reasons unrelated to treatment. Six patients (6.6%) discontinued omalizumab for treatment-related adverse events: arthralgia/myalgia (3 patients); urticaria, angioedema (1 patients); metrorrhagia (1 patient); relapsing herpes labialis (1 patient). Four other patients complained of mild adverse events (rhinitis/conjunctivitis, injection site reaction, fatigue, thrombosis) but continued the treatment. Anaphylaxis was not reported. Conclusions Long-term treatment with omalizumab appears remarkably safe and well tolerated in real-life setting. Prolonged omalizumab treatment for many consecutive years did not increase the risk of side effects, particularly anaphylaxis

Severe asthma: One disease and multiple definitions

Introduction There is, so far, no universal definition of severe asthma. This definition usually relies on: number of exacerbations, inhaled therapy, need for oral corticosteroids, and respiratory function. The use of such parameters varies in the different definitions used. Thus, according to the parameters chosen, each patient may result in having severe asthma or not. The aim of this study was to evaluate how the choice of a specific definition of severe asthma can change the allocation of patients. Methods Data collected from the Severe Asthma Network Italy (SANI) registry were analyzed. All the patients included were then reclassified according to the definitions of U-BIOPRED, NICE, WHO, ATS/ERS, GINA, ENFUMOSA, and TENOR. Results 540 patients, were extracted from the SANI database. We observed that 462 (86%) met the ATS/ERS criteria as well as the GINA criteria, 259 (48%) the U-Biopred, 222 (41%) the NICE, 125 (23%) the WHO, 313 (58%) the Enfumosa, and 251 (46%) the TENOR criteria. The mean eosinophil value were similar in the ATS/ERS, U-Biopred, and Enfumosa (528, 532 and 516 cells/mcl), higher in WHO and Tenor (567 and 570 cells/mcl) and much higher in the NICE classification (624 cells/mcl). Lung function tests resulted similarly in all groups, with WHO (67%) and ATS/ERS-GINA (73%), respectively, showing the lower and upper mean FEV1 values. Conclusions The present observations clearly evidence the heterogeneity in the distribution of patients when different definitions of severe asthma are used. However, the recent definition of severe asthma, provided by the GINA document, is similar to that indicated in 2014 by ATS/ERS, allowing mirror reclassification of the patients examined. This lack of homogeneity could complicate the access to biological therapies. The definition provided by the GINA document, which reflects what suggested by ATS/ERS, could partially overcome the problem