GP trainees’ perceptions on learning EBM using conversations in the workplace : a video-stimulated interview study

Background To be able to practice evidence-based medicine (EBM) when making decisions for individual patients, it is important to learn how to combine the best available evidence with the patient's preferences and the physician's clinical expertise. In general practice training, these skills can be learned at the workplace using learning conversations: meetings between the supervising general practitioner (GP) and GP trainee to discuss medical practice, selected topics or professional performance. This study aimed to give insight into the perceptions of GP trainees on their EBM learning processes during learning conversations. Methods We held semi-structured video-stimulated elicitation interviews (n = 22) with GP trainees affiliated to GP training institutes in the Netherlands and Belgium. GP trainees were shown fragments of their learning conversations, enabling reflection during the interview. Taking an inductive approach, interview recordings were transcribed verbatim and analysed with NVivo software. Results GP trainees perceived learning conversations as useful for learning and discussing EBM. Multiple EBM learning activities were identified, such as discussing evidence together, relating evidence to cases in daily practice and discussing the supervisor's experience and the specific local context in the light of what the evidence recommends. However, for learning to occur, trainees need and expect specific behaviour, both from their supervisors and themselves. Supervisors should supply well-substantiated answers that are applicable in practice and give the trainee confirmation. In turn, the trainee needs to prepare well in order to ask focused, in-depth questions. A safe space allowing equal and open discussion between trainee and supervisor is perceived as an essential context for optimal EBM learning. Conclusions Our findings show that trainees find learning conversations useful for EBM learning in general practice. To bring EBM learning to its full potential, attention should be paid to optimising the behavioural and contextual factors found relevant to enhancing EBM learning

Economic viability of extracting high value metals from end of life vehicles

Electronics containing growing quantities of high value and critical metals are increasingly used in automobiles. The conventional treatment practice for end-of-life vehicles (ELV) is shredding after de-pollution and partial separation of spare parts. Despite opportunities for resource recovery, the selective separation of components containing relevant amounts of critical metals for the purpose of material recycling is not commonly implemented. This article is aimed to contribute to recycling strategies for future critical metal quantities and the role of extended material recovery from ELVs. The study examines the economic feasibility of dismantling electronic components from ELVs for high value metal recycling. The results illustrate the effects of factors as dismantling time, labour costs and logistics on the economic potential of resource recovery from ELVs. Manual dismantling is profitable for only a few components at the higher labour costs in western/northern parts of Europe and applicable material prices, including the inverter for hybrid vehicles, oxygen sensor, side assistant sensor, distance and near distance sensors. Depending on the vehicle model, labour costs and current material prices, manual dismantling can also be cost-efficient for also some other such as the heating blower, generator, starter, engine and transmission control, start/stop motor, drive control, infotainment and chassis control

Learning conversations with trainees : an undervalued but useful EBM learning opportunity for clinical supervisors

Phenomenon: Supervisors and trainees can learn skills related to evidence-based medicine from each other in the workplace by collaborating and interacting, in this way benefiting from each other's strengths. This study explores supervisors' perceptions of how they currently learn evidence-based medicine by engaging in learning conversations with their trainee. Approach: Semi-structured, video-stimulated elicitation interviews were held with twenty-two Dutch and Belgian supervisors in general practice. Supervisors were shown fragments of their video-recorded learning conversations, allowing them to reflect. Recorded interviews were analyzed using a grounded theory-based approach.Findings: Supervisors did not immediately perceive workplace learning conversations as an opportunity to learn evidence-based medicine from their trainee. They mostly saw these conversations as a learning opportunity for trainees and a chance to maintain the quality of care within their practice. Nevertheless, during the interviews, supervisors did acknowledge that learning conversations help them to gain up-to-date knowledge and search skills or more awareness of their own knowledge or gaps in their knowledge. Not identified as a learning outcome was how to apply evidence-based medicine within a clinical practice by combining evidence with clinical expertise and the patient's preferences. Insights: Supervisors acknowledge that they learn elements of the three aspects of evidence-based medicine by having learning conversations with their trainee, but they currently see this as secondary to the trainee's learning process. Emphasizing opportunities for bidirectional learning could improve learning of evidence-based medicine during workplace learning conversations

Overview of the European Medicines Agency's development of product-specific bioequivalence guidelines

The authors thank the observers of the PKWP who have supported the development of the PSBGL and also Efthymios Manolis, Quirine Fillekes, and Milton Bonelli for constructive comments. Pharmacokinetics Working Party: Ridha Belaiba (ANSM, France); Eva-Gil Berglund (MPA, Sweden); Susan Cole (MHRA, UK); Alfredo García-Arieta (AEMPS, Spain); Sotiris Michaleas (Ministry of Health Pharmaceutical Services, Cyprus); Janet Mifsud (Medicines Authority, Malta); Jan Neuhauser (AGES, Austria); Henrike Potthast (BfArM, Germany); Carolien Versantvoort (MEB, The Netherlands).The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided.peer-reviewe

Requirements for generic anti-epileptic medicines: a regulatory perspective

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The Next Generation of Platinum Drugs: Targeted Pt(II) Agents, Nanoparticle Delivery, and Pt(IV) Prodrugs

The platinum drugs, cisplatin, carboplatin, and oxaliplatin, prevail in the treatment of cancer, but new platinum agents have been very slow to enter the clinic. Recently, however, there has been a surge of activity, based on a great deal of mechanistic information, aimed at developing nonclassical platinum complexes that operate via mechanisms of action distinct from those of the approved drugs. The use of nanodelivery devices has also grown, and many different strategies have been explored to incorporate platinum warheads into nanomedicine constructs. In this Review, we discuss these efforts to create the next generation of platinum anticancer drugs. The introduction provides the reader with a brief overview of the use, development, and mechanism of action of the approved platinum drugs to provide the context in which more recent research has flourished. We then describe approaches that explore nonclassical platinum(II) complexes with trans geometry or with a monofunctional coordination mode, polynuclear platinum(II) compounds, platinum(IV) prodrugs, dual-threat agents, and photoactivatable platinum(IV) complexes. Nanoparticles designed to deliver platinum(IV) complexes will also be discussed, including carbon nanotubes, carbon nanoparticles, gold nanoparticles, quantum dots, upconversion nanoparticles, and polymeric micelles. Additional nanoformulations, including supramolecular self-assembled structures, proteins, peptides, metal–organic frameworks, and coordination polymers, will then be described. Finally, the significant clinical progress made by nanoparticle formulations of platinum(II) agents will be reviewed. We anticipate that such a synthesis of disparate research efforts will not only help to generate new drug development ideas and strategies, but also will reflect our optimism that the next generation of approved platinum cancer drugs is about to arrive.National Cancer Institute (U.S.) (CA034992

Kompleksi platine sa edda (etilendiamin-N, N'-diacetat) ligandima kao potencijalni antitumorski agensi

e design of platinum based drugs is not a new field of interest. Platinum complexes are widely used as anticancer agents and currently, approximately 30 platinum(II) and platinum(IV) entered into some of the phases of clinical trials. A special place in today’s research belongs to platinum complexes with diammine ligands. A large number of edda (ethylenediamine- N, N’-diacetate)-type ligands and their corresponding metal complexes has been successfully synthesized. is article summarizes recent progress in research on edda-type-platinum complexes. Some of these agents achieves better effect compared to the gold standard (cisplatin). It has been shown that there is a possible relationship between the length of the ligand ester group carbon chain and its cytotoxic effect. In most cases the longer the ester chain is the greater is the antitumor activity. Of particular interest are the noticeable effects of some new platinum compound with edda-type ligand on cell lines that are known to have a high level of cisplatin-resistance. Exanimate complexes appear to have a diff erent mode of mechanism of action compared with cisplatin which includes apoptotic and necrotic cell death. ere are indications that further investigations of these compounds may be very useful in overcoming the problems associated global cancer statistic. © 2016, University of Kragujevac, Faculty of Science. All rights reserved.Kompleski platine koriste se kao osnova za dizajn novih lekova. Oni su u širokoj upotrebi kao antitumorski agensi i do danas je oko 30 komplesa platine(II) i platine(IV) u nekoj od faza kliničkog ispitivanja. Posebno mesto u današnjim istaživanjima zauzimaju kompleksi metala sa edda ligandima. Uspešno je sintetisan veliki broj novih edda liganda i odgovarajućih kompleksa. Neki od ovih agensa pokazuju bolju aktivnost od zlatnog standarda, cisplatine. Pokazano je da postoji moguća veza između dužine ugljovodiničnog lanca estraske grupe liganda i citotoksičnog efekta. U većini slučajeva dužina lanca direktno korelira sa antitumorskom aktivnošću. Zabeležena je efikasnija citotoksicna aktivnost određenih kompleska platine sa edda ligandima na ćelijskim linijama tumora koji pokazuju odgovarajući stepen rezistencije na cisplatinu. Ispitivani komleksi imaju različit mehanizam dejstva od cisplatine, koji uključuje elemente nekrotične i programirane ćelijske smrti. Postoje nagoveštaji da dalja istraživanja ovih agensa mogu biti značajna za prevazilaženje globalnog problema sa kojim se svet danas suočava, a koji se odnosi na stalni porast osoba obolelih od karcinoma