BackgroundIn Germany 37.1% of dispensed medicinal products were intended to use in self-medication in 2017.1 An investigation showed that 25.2% of children and adolescents used self-medication in Germany.2 Hence, pharmacists’ education needs to include training for competence in consultation.3A modern method to train this competence is the use of OSCEs (Objective Structured Clinical Examinations). The aim of this study was to assess whether the use of OSCEs in pharmacy students to train the consultation performance on self-medication is more effective than a conservative teaching method.MethodsThis randomised controlled investigation was conducted in a pre-post-design with pre-OSCEs before training and post-OSCEs after training in each group. Clinical skills at baseline and after the training were measured. Forty students in their last year of pharmacy studies were randomised into a control and an intervention group. The control group attended a lecture on self-medication and the intervention group had additionally to the lecture one hour of OSCEs for training purpose. An analytical checklist was used for measuring consultation skills and a global rating scale for assessing communication skills.ResultsComplete data was received from 30 students (n=16 intervention group, n=14 control group). Consultation skills improved significantly (analytical checklist: 19.88% ± 10.95% intervention group vs. 9.29% ± 10.89% control group, p< 0.05). However, the communication skills (global rating scale: 20.83% ± 24.33% in the intervention group vs. 11.90% ± 17.12% in the control group, p= 0.380) did not improve significantly during the one-hour training period.ConclusionOSCEs for training purpose are an effective method to convey pharmacy students consultation skills in self-medication. However, communication skills need more training. Based on these results OSCEs on self-medication for the paediatric population should be investigated. This is relevant due to the frequency of self-medication in the paediatric population.ReferencesAbda.de. [Internet]. Berlin: Federal union of German associations of pharmacists. Numbers, data, facts 2016. [Cited January 30, 2019]. Available from: https://www.abda.de/fileadmin/assets/ZDF/ZDF_2018/ABDA_ZDF_2018_Brosch.pdf Du Y, Knopf H. Self-medication among children and adolescents in Germany: results of the National Health Survey for children and adolescents (KiGGS). Br J Clin Pharmacol 2009;68:599–608.Joint Statement by the International Pharmaceutical Federation (FIP) and the World Self Medication Industry (WSMI). [Internet]. Responsible Self-medication. 1998. [Cited January 30, 2019]. Available from: https://www.fip.org/www/uploads/database_file.php?id=241&table_id=.Disclosure(s)Imaneh Farahani, Anna Laven, Samieh Farahani, Maira A. Deters, Martin Feickert, Fabian K. Suessenbach, Holger Schwender and Stephanie Laeer declare that they have no conflict of interest.
BackgroundPhysiological and pathophysiological circumstances of the paediatric renin-angiotensin-aldosterone-system (RAAS) are still inadequately understood. Due to the limited paediatric data available, the LENA (Labeling of Enalapril from Neonates up to Adolescents) project aimed to comprehensively investigate the drug enalapril and its effect on humoral parameters of the RAAS. Examination of four humoral parameters, including plasma renin activity (PRA), was conducted regarding cardiac diseased paediatric population receiving enalapril, of which 60% were below 1 year of age. To fully address the agreed Paediatric Investigation Plan (EMEA-001706-PIP) of the LENA project, reliable small-volume assays for pharmacodynamics determination were mandatory to ensure the reliable data sets.Materials and methodsA commercial PRA enzyme linked immunosorbent assay (ELISA) was tailored for paediatric application and validated according to European Medicine Agency (EMA) and U.S. Food and Drug Administration (FDA) bioanalytical guidelines.1 2 In this context, accuracy, precision, total error, linearity, parallelism, matrix effects and stability were investigated.ResultsThe adopted bioanalytical PRA-assay was successfully validated. Between-run precision (CV) and accuracy (relative error) ranged from 1.6% to 19.6% and -13.0% to +11.2% respectively. Samples of five different human sources showed no substantial matrix effect and facilitated the assay’s application to heterogeneous populations. The obtained precision of parallelism of five dilution steps ranged from 7.7% to 8.3% allowing to dilute high samples within the calibration range. Stability measurements proved four freeze and thaw cycles plus short-term and long-term (37 weeks) stability. Overall, all results were complied with guideline requirements.ConclusionThe FDA/EMA-compliant PRA assay is able to accurately and precisely quantify PRA values in 50 µL plasma and is applicable for GCLP-compliant clinical studies enabling sophisticated investigations in children within the LENA project.ReferencesCommittee for Medicinal Products for Human Use (CHMP): EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2** Guideline on bioanalytical method validation, June, 2015U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM): Bioanalytical Method Validation Guidance for Industry, May 2018Disclosure(s)Fabian K. Suessenbach, Martin Feickert, Jutta Tins and Bjoern B. Burckhardt declare that there is no conflict of interest. The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA).
BackgroundThe physiological and pathophysiological characteristics regarding plasma renin activity (PRA) in the context of the renin-angiotensin-aldosterone-system (RAAS) are well investigated in adults, whereas less is known in paediatric population suffering from heart failure. Challenges in the conduct of paediatric investigations limit the enrolled children often to specific age groups allowing only a partial revaluation of the maturating RAAS. To constitute the comprehensive picture of the paediatric RAAS from 0–18 years, a compilation of available PRA data was conducted via literature search.MethodsA systematic literature search was accomplished in the context of the ‘Labeling of Enalapril from Neonates up to Adolescence’ (LENA) project in the MEDLINE database via PubMed in January 2019. Key words: plasma renin activity and congenital heart disease/dilative cardiomyopathy/heart failure/congenital heart defect and child/neonate/infant/toddler/paediatric. Eligible records included PRA values in children of 0–18 years of age. Exclusion criteria comprised foetuses, preterm, cord blood, urine, adults, < 2500 g birthweight, ex vivo studies and deviant diseases.ResultsLiterature search resulted in 167 findings of which 58 full-text articles were assessed for eligibility. Finally, 33 publications were classified as relevant. Of these, 21 and 12 records were assigned for healthy and cardiac diseased population respectively, leading to PRA data sets of 2000 healthy and 254 diseased children. Visual check of data revealed an age dependent decrease of PRA, in particular in the early childhood, and a substantial elevation of PRA in heart failure patients.ConclusionThe conducted literature search allowed a systematic description of PRA values in healthy and cardiac diseased paediatrics, which facilitates a classification of reference ranges of the maturing RAAS for LENA and future paediatric trials.Disclosure(s)Fabian K. Suessenbach, Tanja Gangnus, Ilja Burdman, Nina Makowski, Stephanie Laeer and Bjoern B Burckhardt declare that there is no conflict of interest. The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grant agreement n°602295 (LENA).
BackgroundN-terminal pro-brain natriuretic peptide (NT-proBNP) is a valuable biomarker for diagnosis and prognosis of heart failure in adults, included into the European Society Guidelines for heart failure (2016).1 It is also considered as a diagnostic and follow-up marker in paediatric heart failure. The aetiology of paediatric heart failure is heterogeneous and maturation of the cardiac and neurohumoral system influences NT-proBNP levels. Since substantial information is mandatory to enable a long-term follow-up of children with heart failure, the aim was to collect published paediatric NT-proBNP data.MethodsIn January 2019, a literature search using PubMed was performed comprising the following keywords: NT-proBNP, heart failure/dilated cardiomyopathy/congenital heart defect/congenital heart disease/healthy and child/neonate/toddler/infant/paediatric. Eligible publications had to determine levels of NT-proBNP in plasma or serum in paediatric heart failure or healthy children (0–18 years) with the Roche NT-proBNP-immunoassay.ResultsThe search resulted in 343 records, of which 95 measured NT-proBNP in paediatric controls or heart failure. Of them, 48 studies were excluded due to the use of other immunoassays. Following, 47 studies were included into the analysis of which 27 reported NT-proBNP levels in 3435 healthy children and 38 NT-proBNP concentrations in 1885 children with heart failure. The age range of reported levels comprised the day of birth up to 18 years in both groups. The data set revealed that younger children have higher NT-proBNP values than older children and that heart failure patients had increased NT-proBNP levels compared to healthy controls which are also dependent on the severity of disease.ConclusionThe literature search and analysis confirmed that NT-proBNP is an important marker for the detection of heart failure and classification of disease severity in children. Thus, the compiled data set forms a solid data basis for long-term follow-up of a paediatric patient population with heart failure.ReferencesPonikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The task force for the diagnosis and treatment of acute and chronic heart failure of the european society of cardiology (ESC)developed with the special contribution of the heart failure association (HFA) of the esc. Eur Heart J 2016;37(27):2129–200.Disclosure(s)Tanja Gangnus, Fabian K. Suessenbach, Nina Makowski, Ilja Burdman, Stephanie Laeer, Björn B. Burckhardt declare that there is no conflict of interest. The research leading to these results has received funding from the European Union Seventh Framework programme (FP/2007–2013) under grant agreement n°602295 (LENA).
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