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Aims: To assess the extent of off-label drug use and the occurrence of suspected adverse drug reactions (ADRs) among paediatric patients in Italian hospitals., Methods: We conducted a 2-year prospective cohort study across 22 Italian hospital wards from September 2020 to September 2022. As part of the surveillance project, we performed a 6-month retrieval of all reported ADRs and evaluated all drug prescriptions for their possible off-label use. Following an educational project on pharmacovigilance addressed to healthcare professionals in participating wards, the same data collection was performed., Results: Among the 892 patients included in the study, 64% were admitted to paediatric wards and 36% to neonatal wards. Fifty per cent of all drugs prescribed were used off-label and mainly concerned the administration of a different dose from the one authorized. In neonatal wards, off-label prescriptions occurred slightly more often, with antibacterials being the most frequently used off-label drugs. A total of 35 reports of suspected ADRs were collected, five before the educational project and 30 afterwards. Based on product licence, 10 of the total 35 reports concerned at least one off-label drug use., Conclusions: The off-label use of drugs in treating paediatric patients was extensive in Italian hospitals. Regulatory interventions are needed to promote the use of drugs based on the latest available literature and improve ADR reporting on children. Paediatric indications and dosages of the drugs most commonly used in children should be supported by appropriate ad hoc studies., (© 2024 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)

This cross-sectional investigation examined the prevalence and severity of dysphonia, globus pharyngeus, and dysphagia in patients affected by immunomediated (IM) diseases. Seventy subjects were administered the Voice Handicap Index (VHI) (scale 0-4), Glasgow-Edinburgh Throat Scale (GETS) (scale from 0 to 7) for globus pharyngeus assessment, and modified Swallowing Outcomes After Revised Laryngectomy (SOAL) (scale 0, 1, 2) to test swallowing symptoms. VHI: the mean percentage of answers with a score greater than 1 (corresponding to a frequency of situation's occurrence "sometimes," "almost always," or "always") was 25.7, 26.7, and 44.1% for functional, emotional, and physical groups of sub-items respectively. GETS: the mean percentage of answers with a score ≥ 3 was 60.85%, significantly higher if compared with that of answers with a score < 3 (40.14%). The mean percentages of answers with a score 0-2, 3-4, and 5-7 were 40.1, 16.7, and 43.7% respectively. SOAL: a mean of 57.9% of answers gained a symptomatic score (1 ["a little"] or 2 ["a lot"]) and 41.9%, the score 0. The difference was statistically significant (p < 0.05). The first two most recurrent items with a score 2 ("a lot") were "Do you have a problem swallowing dry food?" (46%) and "Do you have a problem swallowing solid food?" (36%). The study represents the first to describe the globus pharyngeus symptoms in IM population. Moreover, it allows to confirm the recurrence of dysphonia and dysphagia in this type of patients. Particularly, it has been demonstrated that the alteration of swallowing function is related to solid and dry food. The self-assessment questionnaires proved as a useful tool to early detection of dysfunctions in order to avoid further deterioration of quality of life and to prevent serious life-threatening complications.

Objectives: We performed systematic optical coherence tomography (OCT) analyses after bioresorbable vascular scaffolds (BVS) implantation in a "real world" setting aiming at evaluating scaffold expansion and longitudinal integrity., Background: a comprehensive elucidation of BVS acute performance in the "real-world" setting is lacking., Methods: acute BVS expansion compared with compliance chart information and longitudinal integrity were assessed in 29 patients (32 lesions) by OCT. In addition, bench experiments with four scaffolds were performed with different combinations of deployment pressures and tube stiffness., Results: scaffold underexpansion, using compliance chart information as reference, was observed in 97% of OCT cross-sections in vivo; however, only 8.3% of the cross-section analyzed revealed BVS area <5 mm(2) . Calcified plaques were more common in the lowest (9.7%) compared with the mid (8.8%) and highest (6.3%) tertiles of scaffold expansion (P = 0.003 and P = 0.001 for lowest vs. mid, and lowest vs. highest, respectively). Seventeen (54.8%) scaffolds were elongated during implantation, but no signs of scaffold fracture were revealed. Elongation and impaired expansion were reproduced in the bench testing when the scaffold was deployed with high pressure in a hard tube., Conclusions: compliance chart information should not be used to predict final BVS dimensions in the clinical setting. While BVS expansion could be potentially impaired by calcified plaques, they may elongate during deployment. Bench experiments confirmed the elongation phenomenon when BVS were deployed with high pressure in hard tubes., (© 2014 Wiley Periodicals, Inc.)