Behavioural side effects of inhaled corticosteroids among children and adolescents with asthma

BACKGROUND: Inhalation corticosteroids (ICS) are prescribed for treatment of asthma in approximately 3% of all children in Denmark. Despite limited evidence, case reports suggest that ICS-related behavioural adverse drug events (ADEs) may be frequent. In general, underreporting of ADEs to official databases is common, and little is known about doctor’s clinical experiences with behavioural ADEs when prescribing ICS for children with asthma. The objective was to investigate the extent of behavioural ADEs in children with asthma treated with ICS by comparing database findings to experiences of specialist doctors. METHODS: First, databases of the European Medicines Agency (EMA) and the Danish Medicines Agency (DKMA) were searched for reports made by healthcare professionals about behavioural ADEs in children from 2009 to 2018. Second, questionnaire data on behavioural ADEs were collected from eight of the 11 specialist doctors responsible for treating children with asthma at the six paediatric departments in Central Denmark Region and North Denmark Region. RESULTS: EMA and DKMA had registered 104 and 3 reports, respectively, on behavioural ADEs during the 10-year study period. In contrast, five of the eight specialist doctors (45.5%) had experienced patients who had developed behavioural changes during ICS treatment. However, none of the five specialist doctors had filed reports on these events to DKMA. CONCLUSION: Behaviour-related ADEs to ICS in children with asthma are likely to be highly underreported in official databases and doctors treating children with ICS should be aware of potential ADEs and consider submitting ADE reports whenever appropriate. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12931-022-02112-8

What is the impact of a national postgraduate medical specialist education reform on the daily clinical training 3.5 years after implementation? A questionnaire survey

<p>Abstract</p> <p>Background</p> <p>Many countries have recently reformed their postgraduate medical education (PGME). New pedagogic initiatives and blueprints have been introduced to improve quality and effectiveness of the education. Yet it is unknown whether these changes improved the daily clinical training. The purpose was to examine the impact of a national PGME reform on the daily clinical training practice.</p> <p>Methods</p> <p>The Danish reform included change of content and format of specialist education in line with outcome-based education using the CanMEDS framework. We performed a questionnaire survey among all hospital doctors in the North Denmark Region. The questionnaire included items on educational appraisal meetings, individual learning plans, incorporating training issues into work routines, supervision and feedback, and interpersonal acquaintance. Data were collected before start and 31/2 years later. Mean score values were compared, and response variables were analysed by multiple regression to explore the relation between the ratings and seniority, type of hospital, type of specialty, and effect of attendance to courses in learning and teaching among respondents.</p> <p>Results</p> <p>Response rates were 2105/2817 (75%) and 1888/3284 (58%), respectively. We found limited impact on clinical training practice and learning environment. Variances in ratings were hardly affected by type of hospital, whereas belonging to the laboratory specialities compared to other specialties was related to higher ratings concerning all aspects.</p> <p>Conclusions</p> <p>The impact on daily clinical training practice of a national PGME reform was limited after 31/2 years. Future initiatives must focus on changing the pedagogical competences of the doctors participating in daily clinical training and on implementation strategies for changing educational culture.</p

Behavioural side effects of inhaled corticosteroids among children and adolescents with asthma

Abstract Background Inhalation corticosteroids (ICS) are prescribed for treatment of asthma in approximately 3% of all children in Denmark. Despite limited evidence, case reports suggest that ICS-related behavioural adverse drug events (ADEs) may be frequent. In general, underreporting of ADEs to official databases is common, and little is known about doctor’s clinical experiences with behavioural ADEs when prescribing ICS for children with asthma. The objective was to investigate the extent of behavioural ADEs in children with asthma treated with ICS by comparing database findings to experiences of specialist doctors. Methods First, databases of the European Medicines Agency (EMA) and the Danish Medicines Agency (DKMA) were searched for reports made by healthcare professionals about behavioural ADEs in children from 2009 to 2018. Second, questionnaire data on behavioural ADEs were collected from eight of the 11 specialist doctors responsible for treating children with asthma at the six paediatric departments in Central Denmark Region and North Denmark Region. Results EMA and DKMA had registered 104 and 3 reports, respectively, on behavioural ADEs during the 10-year study period. In contrast, five of the eight specialist doctors (45.5%) had experienced patients who had developed behavioural changes during ICS treatment. However, none of the five specialist doctors had filed reports on these events to DKMA. Conclusion Behaviour-related ADEs to ICS in children with asthma are likely to be highly underreported in official databases and doctors treating children with ICS should be aware of potential ADEs and consider submitting ADE reports whenever appropriate

Lymphocytic interstitial pneumonia and follicular bronchiolitis in children: A registry-based case series

Objectives: Pediatric lymphocytic interstitial pneumonia (LIP) and follicular bronchiolitis (FB) are poorly characterized lymphoproliferative disorders. We present and quantify demographics, radiological and histopathologic patterns, treatments and their responses, and outcomes in non-HIV-infected children with LIP and FB. Methods: This structured registry-based study included a retrospective chart review, blinded analysis of imaging studies and lung biopsies, genetic testing, and evaluation of treatments and outcomes. Results: Of the 13 patients (eight females) studied, eight had FB, four had combined LIP/FB, and one had isolated LIP; diagnoses were highly concordant between the pathologists. Most patients became symptomatic during the first 2 years of life, with a mean lag time to diagnosis of 4 years. The most common symptoms were coughing and respiratory infections (11 out of 13 each), dyspnea (10 out of 13), and wheezing (eight out of 13). Autoantibodies were found in eight out of 13 patients. In three patients, disease-causing mutations in the COPA gene were identified. CT revealed hilar lymphadenopathy (five out of 12), ground-glass opacity (eight out of 12), consolidation (five out of 12), and cysts (four out of 13). Systemic steroids as intravenous pulses (11 out of 13) or oral intake (10 out of 13) were the main treatments and showed high response rates of 100% and 90%, respectively. Within the mean observation period of 68 months, all children had chronic courses, eight out of 13 had severe diseases, two died, and one worsened. Conclusions: Children with LIP/FB have chronic diseases that occurred in early childhood and were commonly associated with immune dysregulation as well as high morbidity and mortality. Early diagnosis and treatment may be crucial to improve the outcome