Analysis of Reporting Adverse Drug Reactions in Paediatric Patients in a University Hospital in the Netherlands

AIMS: The risk to develop adverse drug reactions (ADRs) is high for paediatric patients. This is, amongst other reasons, due to the inevitable use of off-label and unlicensed medicines. Moreover, there is limited knowledge on ADRs in children. Thus, adequate recognition may be challenging. The lack of dedicated studies and the voluntary nature of pharmacovigilance systems used to gain insight into the characteristics of ADRs contribute to this problem. The goal of this study is to identify whether ADRs in paediatric patients are adequately documented by the medical team and whether they are subsequently reported to the national pharmacovigilance system. METHODS: All patients admitted to the paediatric medium care of the Radboudumc Amalia Children's hospital during 1 month, and using one or more drugs, were included. Two researchers analysed retrospectively and independently the number of possible ADRs in the medical records. The ADRs were listed per paediatric subspecialty, to evaluate any differences in documentation and reporting of the ADRs. Subsequently, the causality, severity, and seriousness of the ADRs were assessed. The ADRs were categorised by system organ class and drug class. The national pharmacovigilance centre was consulted to check if there were any reports coming from our hospital and to collect the total number of reports. RESULTS: The medical records of 301 patients were analysed, 81 patients were suffering from one or more ADRs. In total 132 suspected ADRs were found, divided among 19 different paediatric subspecialties. Numbers were too small to investigate the differences in ADR documentation. Of these found ADRs, 55% were not explicitly noted as such in the medical records by the treating physician. None of the ADRs were reported to the national pharmacovigilance centre. Most ADRs scored 'possible' in the causality assessment, were mild or moderate, and a small number were serious. The ADRs occurred in 25 different organ systems. In total 25 different drug classes were involved. CONCLUSIONS: The results of the present study show that a large number of ADRs are not registered in the medical records and are not reported to the national pharmacovigilance system. Furthermore, it is shown that the number of ADRs occurring at our centre is much higher than the number reported to the national pharmacovigilance centre. Only an average of 513 ADRs in paediatric patients are reported per year nationwide, suggesting that there is extensive underreporting

Effectiveness of High Fidelity Video-Assisted Real-Time Simulation: A Comparison of Three Training Methods for Acute Pediatric Emergencies

Background. Video-assisted real-time simulation (VARS) offers the possibility of developing competence in acute medicine in a realistic and safe environment. We investigated the effectiveness of the VARS model and compared it with educational methods like Problem-Based Learning (PBL) and Pediatric Advanced Life Support (PALS). Methods. 45 fourth-year medical students were randomized for three educational methods. Level of knowledge and self-efficacy were measured before and after intervention. Clinical performance was measured by a blinded observer using a video checklist of prescripted scenarios on a high-fidelity simulator. Results. Knowledge test and self-efficacy scores improved significantly (P < 0.001) without differences between educational groups. The VARS group showed significantly (P < 0.05) higher scores on both postintervention scenarios concerning structure and time. Conclusion. VARS training is an effective educational method teaching pediatric acute care skills in the undergraduate curriculum. When compared to PBL and PALS training, VARS training appears to be superior in enhancing short-term clinical performance

Advanced medical life support procedures in vitally compromised children by a helicopter emergency medical service

<p>Abstract</p> <p>Background</p> <p>To determine the advanced life support procedures provided by an Emergency Medical Service (EMS) and a Helicopter Emergency Medical Service (HEMS) for vitally compromised children. Incidence and success rate of several procedures were studied, with a distinction made between procedures restricted to the HEMS-physician and procedures for which the HEMS is more experienced than the EMS.</p> <p>Methods</p> <p>Prospective study of a consecutive group of children examined and treated by the HEMS of the eastern region of the Netherlands. Data regarding type of emergency, physiological parameters, NACA scores, treatment, and 24-hour survival were collected and subsequently analysed.</p> <p>Results</p> <p>Of the 558 children examined and treated by the HEMS on scene, 79% had a NACA score of IV-VII. 65% of the children had one or more advanced life support procedures restricted to the HEMS and 78% of the children had one or more procedures for which the HEMS is more experienced than the EMS. The HEMS intubated 38% of all children, and 23% of the children intubated and ventilated by the EMS needed emergency correction because of potentially lethal complications. The HEMS provided the greater part of intraosseous access, as the EMS paramedics almost exclusively reserved this procedure for children in cardiopulmonary resuscitation. The EMS provided pain management only to children older than four years of age, but a larger group was in need of analgesia upon arrival of the HEMS, and was subsequently treated by the HEMS.</p> <p>Conclusions</p> <p>The Helicopter Emergency Medical Service of the eastern region of the Netherlands brings essential medical expertise in the field not provided by the emergency medical service. The Emergency Medical Service does not provide a significant quantity of procedures obviously needed by the paediatric patient.</p

Resonant two-site tunnelling dynamics of bosons in a tilted optical superlattice

We study the non-equilibrium dynamics of a 1D Bose-Hubbard model in a gradient potential and a superlattice, beginning from a deep Mott insulator regime with an average filling of one particle per site. Studying a quench that is near resonance to tunnelling of the particles over two lattice sites, we show how a spin model emerges consisting of two coupled Ising chains that are coupled by interaction terms in a staggered geometry. We compare and contrast the behavior in this case with that in a previously studied case where the resonant tunnelling was over a single site. Using optimized tensor network techniques to calculate finite temperature behavior of the model, as well as finite size scaling for the ground state, we conclude that the universality class of the phase transition for the coupled chains is that of a tricritical Ising point. We also investigate the out-of-equilibrium dynamics after the quench in the vicinity of the resonance and compare dynamics with recent experiments realized without the superlattice geometry. This model is directly realizable in current experiments, and reflects a new general way to realize spin models with ultracold atoms in optical lattices.Comment: 12 pages, 6 figure

A Pilot Study of Abnormal Growth in Autism Spectrum Disorders and Other Childhood Psychiatric Disorders

The aims of the current study were to examine whether early growth abnormalities are (a) comparable in autism spectrum disorders (ASD) and other childhood psychiatric disorders, and (b) specific to the brain or generalized to the whole body. Head circumference, height, and weight were measured during the first 19 months of life in 129 children with ASD and 59 children with non-ASD psychiatric disorders. Both groups showed comparable abnormal patterns of growth compared to population norms, especially regarding height and head circumference in relation to height. Thus abnormal growth appears to be related to psychiatric disorders in general and is mainly expressed as an accelerated growth of height not matched by an increase in weight or head circumference

Lucas Kier: moordenaar of cotardpatient? Een historisch grensgeval

De positie van kwetsbare groepen ten opzichte van de overheid en de betekenis van individuele mensenrechten in een internationale context zijn belangrijke aandachtspunten. De karakteristiek daarvan is – traditioneel – gelegen in de combinatie van een juridische en sociaalwetenschappelijke benadering van strafrechtelijke problemen. De bescherming en handhaving van fundamentele rechten in een veranderende wereld is het centrale thema van het onderzoeksprogramma van het Willem Pompe Instituut. De positie van kwetsbare groepen ten opzichte van de overheid en de betekenis van individuele mensenrechten in een internationale context zijn daarbij belangrijke aandachtspunten

Physical Activity and Asthma: A Systematic Review and Meta-Analysis

INTRODUCTION: This review aims to give an overview of available published evidence concerning the association between physical activity and asthma in children, adolescents and adults. METHODS: We included all original articles in which both physical activity and asthma were assessed in case-control, cross-sectional or longitudinal (cohort) studies. Excluded were studies concerning physical fitness, studies in athletes, therapeutic or rehabilitation intervention studies such as physical training or exercise in asthma patients. Methodological quality of the included articles was assessed according to the Newcastle-Ottawa Scale (NOS). RESULTS: A literature search was performed until June 2011 and resulted in 6,951 publications derived from PubMed and 1,978 publications from EMBASE. In total, 39 studies met the inclusion criteria: 5 longitudinal studies (total number of subjects n = 85,117) with physical activity at baseline as exposure, and asthma incidence as outcome. Thirty-four cross-sectional studies (n = 661,222) were included. Pooling of the longitudinal studies showed that subjects with higher physical activity levels had lower incidence of asthma (odds ratio 0.88 (95% CI: 0.77-1.01)). When restricting pooling to the 4 prospective studies with moderate to good study quality (defined as NOS≥5) the pooled odds ratio only changed slightly (0.87 (95% CI: 0.77-0.99)). In the cross-sectional studies, due to large clinical variability and heterogeneity, further statistical analysis was not possible. CONCLUSIONS: The available evidence indicates that physical activity is a possible protective factor against asthma development. The heterogeneity suggests that possible relevant effects remain hidden in critical age periods, sex differences, or extremes of levels of physical activity (e.g. sedentary). Future longitudinal studies should address these issues

Methods to quantify soft-tissue based facial growth and treatment outcomes in children: a systematic review.

Contains fulltext : 108661.pdf (publisher's version ) (Open Access)CONTEXT: Technological advancements have led craniofacial researchers and clinicians into the era of three-dimensional digital imaging for quantitative evaluation of craniofacial growth and treatment outcomes. OBJECTIVE: To give an overview of soft-tissue based methods for quantitative longitudinal assessment of facial dimensions in children until six years of age and to assess the reliability of these methods in studies with good methodological quality. DATA SOURCE: PubMed, EMBASE, Cochrane Library, Web of Science, Scopus and CINAHL were searched. A hand search was performed to check for additional relevant studies. STUDY SELECTION: Primary publications on facial growth and treatment outcomes in children younger than six years of age were included. DATA EXTRACTION: Independent data extraction by two observers. A quality assessment instrument was used to determine the methodological quality. Methods, used in studies with good methodological quality, were assessed for reliability expressed as the magnitude of the measurement error and the correlation coefficient between repeated measurements. RESULTS: In total, 47 studies were included describing 4 methods: 2D x-ray cephalometry; 2D photography; anthropometry; 3D imaging techniques (surface laser scanning, stereophotogrammetry and cone beam computed tomography). In general the measurement error was below 1 mm and 1 degrees and correlation coefficients range from 0.65 to 1.0. CONCLUSION: Various methods have shown to be reliable. However, at present stereophotogrammetry seems to be the best 3D method for quantitative longitudinal assessment of facial dimensions in children until six years of age due to its millisecond fast image capture, archival capabilities, high resolution and no exposure to ionizing radiation

Laparoscopic treatment of intestinal malrotation in children

Purpose: Intestinal malrotation is a congenital intestinal rotation anomaly, which can be treated by either laparotomy or laparoscopy. Our hypothesis is that laparoscopic treatment leads to less small bowel obstruction because of the fewer adhesions in comparison to laparotomy, without increasing the risk of recurrent volvulus. We analyzed the outcome of patients who had a correction for intestinal malrotation after the introduction of laparoscopy. Methods: All patients between 0 and 18 years who underwent a surgical procedure for malrotation in the Radboudumc Amalia Children's Hospital, Nijmegen, the Netherlands, between January 2004 and December 2011 were retrospectively reviewed for duration of operation, perioperative complications, length of hospital stay, and rate of redo surgery for intestinal volvulus or obstruction. Results: A total of 83 patients were included of which 33 had a laparoscopic procedure and 50 had a laparotomy for suspected malrotation. Operating time was 63 minutes for the laparoscopic procedure versus 76 minutes for laparotomy (p = 0.588). Significantly more complications were found in the laparotomy group (11 vs. 35%, p = 0.047). However, one patient (aged 4 months) in the laparoscopy group developed an early (< 24 hours) recurrent volvulus. Length of hospital stay was significantly longer after a laparotomy (9 vs. 16 days, p = 0.002). Three (17%) patients in the laparoscopy group needed redo surgery compared with six (9%) in the laparotomy group (p = 0.400). No late volvulus occurred in both groups. After laparotomy, redo surgery because of the small bowel obstruction was more frequent (5 vs. 0%), although this was not statistically significant. Conclusion: In both the laparoscopy and laparotomy group, no cases of long-term recurrent volvulus were seen. After laparotomy, more patients developed a late small bowel obstruction because of the adhesions for which redo surgery was needed. In the laparotomy group, the number of complications was significantly higher and the length of hospital stay was significantly longer. Comparing laparoscopy and laparotomy for the treatment of malrotation, no difference exists for the long-termrisk of recurrent volvulus. In children aged 6 months or older with suspicion of intestinal malrotation but not presenting with an acute abdomen or hemodynamically instability, laparoscopy should be considered as a first approach to diagnose and subsequently treat intestinal malrotation

Various experiences and preferences of Dutch parents in prenatal counseling in extreme prematurity

Contains fulltext : 198249.pdf (publisher's version ) (Closed access