A proposal for a new PhD level curriculum on quantitative methods for drug development.
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ABSTRACT:
SUBMITTER: Jaki T
PROVIDER: S-EPMC6174936 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Data from clinical trials in adults, extrapolated to predict benefits in paediatric patients, could result in fewer or smaller trials being required to obtain a new drug licence for paediatrics. This article outlines the place of such extrapolation in the development of drugs for use in paediatric epilepsies. Based on consensus expert opinion, a proposal is presented for a new paradigm for the clinical development of drugs for focal epilepsies. Phase I data should continue to be collected in adults, and phase II and III trials should simultaneously recruit adults and paediatric patients aged above 2 years. Drugs would be provisionally licensed for children subject to phase IV collection of neurodevelopmental safety data in this age group. A single programme of trials would suffice to license the drug for use as either adjunctive therapy or monotherapy. Patients, clinicians and sponsors would all benefit from this new structure through cost reduction and earlier access to novel treatments. Further work is needed to elicit the views of patients, their parents and guardians as appropriate, regulatory authorities and bodies such as the National Institute for Health and Care Excellence (UK).
| S-EPMC5078157 | biostudies-other
Project description:PurposeThis work is part of an international, interdisciplinary initiative to synthesize research on response shift in results of patient-reported outcome measures. The objective is to critically examine current response shift methods. We additionally propose advancing new methods that address the limitations of extant methods.MethodsBased on literature reviews, this critical examination comprises design-based, qualitative, individualized, and preference-based methods, latent variable models, and other statistical methods. We critically appraised their definition, operationalization, the type of response shift they can detect, whether they can adjust for and explain response shift, their assumptions, and alternative explanations. Overall limitations requiring new methods were identified.ResultsWe examined 11 methods that aim to operationalize response shift, by assessing change in the meaning of one's self-evaluation. Six of these methods distinguish between change in observed measurements (observed change) and change in the construct that was intended to be measured (target change). The methods use either (sub)group-based or individual-level analysis, or a combination. All methods have underlying assumptions to be met and alternative explanations for the inferred response shift effects. We highlighted the need to address the interpretation of the results as response shift and proposed advancing new methods handling individual variation in change over time and multiple time points.ConclusionNo single response shift method is optimal; each method has strengths and limitations. Additionally, extra steps need to be taken to correctly interpret the results. Advancing new methods and conducting computer simulation studies that compare methods are recommended to move response shift research forward.
| S-EPMC8602164 | biostudies-literature
Project description:Introduction: Radiology plays a crucial role in the emergency care setting by delivering early and precise diagnoses under pressure of time, right at the beginning of patient treatment. Although there is a need for postgraduate education in emergency radiology, most of the national bodies responsible do not offer it in a uniform fashion and a general proof of qualification is missing in Europe. Therefore, the European Society of Radiology (ESR) has founded the (Sub-)Society of Emergency Radiology (ESER), prompting them to develop a European curriculum. This trend, which is currently also encouraged in many other non-radiological specialties which demand the highest professional qualifications, often lacks expertise in medical education. Goals: The goal of this article is the general description of the curricular planning process for a European postgraduate subspecialisation programme, using the example of Emergency Radiology (European Diploma in Emergency Radiology, EDER), including the utilisation of TOOLS and recommendations derived from comparable projects. Project description: The project was divided into partial steps: the timeline displayed in a GANTT chart, and tasks and responsibilities assigned in a RASCI matrix. The curriculum was iteratively developed using the KERN approach and steps were prioritised using the PARETO principle. Furthermore, the following TOOLS were used: limitations and needs assessment, SWOT analysis, formulating learning objectives and categorising them after MILLER and SCLO, and using BLOOM's taxonomy for cognitive learning objectives and operationalising them according to MAGER. Psychomotoric and affective learning objectives were assigned to CANMEDS roles, grouped by topic using CLUSTERING, and then mapped by MATRIX analysis to appropriate learning and evaluation methods. Striving for continuous improvement, the curriculum was finally embedded in curricular quality management. Results: The standardisation of the EDER access, considering the different national conditions, the minimisation of European learners' attendance phases, restricting expenses by best possible use of existing structures, respecting the requirements and retaining the support of the European umbrella society ESR, finishing the project by a specific deadline and the demands of continuous improvement were particular challenges. A curriculum with the eligibility of five years' speciality training in general radiology has evolved on schedule. The subspeciality training lasts at least one year and is divided into webinars, workshops during congresses (e.g. the annual ESR and ESER congresses) and one year practical training at the individual learner's corresponding local hospitals, which adhere to a catalogue of requirements, comparable to national educational policies. The curriculum is completed by passing a written and oral exam (diploma) and re-accreditation every five years. Conclusions: Despite complex requirements, the TOOLS utilised allowed an almost seamless, resource-minimised, professional, location-independent distributed development of a European subspeciality curriculum within one year. The definitive implementation is still due. If any deviations from the draft presented should become necessary in the future, the embedment in the curricular quality management will lead to a redirection in the right way and, furthermore, secure a continuous improvement in the best way possible.
| S-EPMC5704608 | biostudies-other
Project description:BackgroundTo support the development of social medicine curricula that empower medical school graduates to redress health inequities, we conducted a mixed methods student and faculty evaluation of an expanded and innovative preclinical social medicine curriculum.MethodsWe implemented a longitudinal, interactive preclinical social medicine curriculum that was closely integrated with foundational science teaching then conducted a survey-based mixed methods student and faculty curriculum evaluation. Based on these results, we propose a novel conceptual roadmap for social medicine curriculum design.ResultsStudent and faculty evaluations of an expanded and innovative longitudinal preclinical social medicine curriculum were strongly favorable. Both student and faculty respondents indicated a particular desire for deeper coverage of race and poverty among other social medicine domains. Qualitative student evaluations highlighted the importance of faculty champions to social medicine teaching as well as the educational impact of stories that exemplify the practical impact of the social determinants of health on specific patient experiences. Qualitative faculty evaluations pointed to the challenges of curriculum integration and the need for faculty career development in social medicine teaching.ConclusionsBased on mixed methods student and faculty curriculum evaluation data, we propose a novel conceptual roadmap for the design of social medicine curricula at other institutions.
| S-EPMC8376629 | biostudies-literature
Project description:Road infrastructures represent a key point in the development of smart cities. In any case, the environmental impact of road traffic should be carefully assessed. Acoustic noise is one of the most important issues to be monitored by means of sound level measurements. When a large measurement campaign is not possible, road traffic noise predictive models (RTNMs) can be used. Standard RTNMs present in literature usually require in input several information about the traffic, such as flows of vehicles, percentage of heavy vehicles, average speed, etc. Many times, the lack of information about this large set of inputs is a limitation to the application of predictive models on a large scale. In this paper, a new methodology, easy to be implemented in a sensor concept, based on video processing and object detection tools, is proposed: the Equivalent Acoustic Level Estimator (EAgLE). The input parameters of EAgLE are detected analyzing video images of the area under study. Once the number of vehicles, the typology (light or heavy vehicle), and the speeds are recorded, the sound power level of each vehicle is computed, according to the EU recommended standard model (CNOSSOS-EU), and the Sound Exposure Level (SEL) of each transit is estimated at the receiver. Finally, summing up the contributions of all the vehicles, the continuous equivalent level, Leq, on a given time range can be assessed. A preliminary test of the EAgLE technique is proposed in this paper on two sample measurements performed in proximity of an Italian highway. The results will show excellent performances in terms of agreement with the measured Leq and comparing with other RTNMs. These satisfying results, once confirmed by a larger validation test, will open the way to the development of a dedicated sensor, embedding the EAgLE model, with possible interesting applications in smart cities and road infrastructures monitoring. These sites, in fact, are often equipped (or can be equipped) with a network of monitoring video cameras for safety purposes or for fining/tolling, that, once the model is properly calibrated and validated, can be turned in a large scale network of noise estimators.
| S-EPMC7038443 | biostudies-literature
Project description:BackgroundContinuing professional development (CPD) is essential for career progression and maintaining military nursing competency. A well-designed CPD programme can improve the effectiveness of transforming knowledge and skills in healthcare organisations. This study aimed to develop a competency-based CPD curriculum for military nurses in China and evaluate its effectiveness from a developmental pilot study.MethodsIn phase one, a two-round Delphi was conducted to design a competency-based curriculum of CPD based on a clinical ladder model among military nurses. In phase two, the curriculum of one CPD programme was redesigned, and a pilot quasi-experiment was conducted to evaluate the effectiveness of this programme.ResultsA competency-based curriculum was developed for primary, intermediate, and senior titles, respectively. The trainees' overall satisfaction with the redesigned CPD programme was 100%. The four themes in the qualitative data were: 1) learning motivation and learning barriers; 2) professional growth; 3) role model promoted career planning; 4) learning environment mattered.ConclusionThis study developed a competency-based curriculum for continuing professional development among military nurses that can be used in designing CPD programmes. Competency-based curriculum can be utilised in the CPD activities to facilitate the improvement of nursing competency.
| S-EPMC9667581 | biostudies-literature
Project description:Many antimalarial drugs kill malaria parasites, but antimalarial drug resistance (ADR) and toxicity to normal cells limit their usefulness. To solve this problem, we suggest a new therapy for drug-resistant malaria. The approach consists of data integration and inference through homology analysis of yeast-human-Plasmodium. If one gene of a Plasmodium synthetic lethal (SL) gene pair has a mutation that causes ADR, a drug targeting the other gene of the SL pair might be used as an effective treatment for drug-resistant strains of malaria. A simple computational tool to analyze the inferred SL genes of Plasmodium species (malaria parasites Plasmodium falciparum and Plasmodium vivax for human malarial therapy, and rodent parasite Plasmodium berghei for in vivo studies of human malarias) was established to identify SL genes that can be used as drug targets. Information on SL gene pairs with ADR genes and their first neighbors was inferred from yeast SL genes to search for pertinent antimalarial drug targets. We not only suggest drug target gene candidates for further experimental validation, but also provide information on new usage for already-described drugs. The proposed specific antimalarial drug candidates can be inferred by searching drugs that cause a fitness defect in yeast SL genes.
| S-EPMC3862410 | biostudies-literature
Project description:BACKGROUND:The published recommendations for international emergency medicine curricula cover the content, but exclude teaching and learning methods, assessment, and evaluation. We aim to provide an overview on available emergency medicine clerkship curricula and report the development and application experience of our own curriculum. METHODS:Our curriculum is an outcome-based education, enriched by e-learning and various up-to-date pedagogic principles. RESULTS:Teaching and learning methods, assessment, and evaluation are described. The theory behind our practice in the light of recent literature is discussed aiming to help other colleagues from developing countries to have a clear map for developing and tailoring their own curricula depending on their needs. The details of our emergency medicine clerkship will serve as an example for developing and developed countries having immature undergraduate emergency medicine clerkship curricula. However, these recommendations will differ in various settings depending on available resources. CONCLUSIONS:The main concept of curriculum development is to create a curriculum having learning outcomes and content relevant to the local context, and then align the teaching and learning activities, assessments, and evaluations to be in harmony. This may assure favorable educational outcome even in resource limited settings.
| S-EPMC5991107 | biostudies-literature
Project description:BackgroundThe assessment and treatment of pediatric patients in the out-of-hospital environment often presents unique difficulties and stress for EMS practitioners.ObjectiveUse a mixed-methods approach to assess the current experience of EMS practitioners caring for critically ill and injured children, and the potential role of a simulation-based curriculum to improve pediatric prehospital skills.MethodsData were obtained from three sources in a single, urban EMS system: a retrospective review of local pediatric EMS encounters over one year; survey data of EMS practitioners' comfort with pediatric skills using a 7-point Likert scale; and qualitative data from focus groups with EMS practitioners assessing their experiences with pediatric patients and their preferred training modalities.Results2.1% of pediatric prehospital encounters were considered "critical," the highest acuity level. A total of 136 of approximately 858 prehospital providers responded to the quantitative survey; 34.4% of all respondents either somewhat disagree (16.4%), disagree (10.2%), or strongly disagree (7.8%) with the statement: "I feel comfortable taking care of a critically ill pediatric patient." Forty-seven providers participated in focus groups that resulted in twelve major themes under three domains. Specific themes included challenges in medication dosing, communication, and airway management. Participants expressed a desire for more repetition and reinforcement of these skills, and they were receptive to the use of high-fidelity simulation as a training modality.ConclusionsCritically ill pediatric prehospital encounters are rare. Over one third of EMS practitioners expressed a low comfort level in managing critically ill children. High-fidelity simulation may be an effective means to improve the comfort and skills of prehospital providers.
| S-EPMC8465767 | biostudies-literature
Project description:The plant homeodomain (PHD) finger is found in many chromatin-remodeling proteins. This small approximately 65-residue domain functions as an "effector" that binds specific epigenetic marks on histone tails, recruiting transcription factors and nucleosome-associated complexes to chromatin. Mutations in the PHD finger or deletion of this domain are linked to a number of human diseases, including cancer, mental retardation, and immunodeficiency. PHD finger-containing proteins may become valuable diagnostic markers and targets to prevent and treat these disorders. In this review, we highlight the progress recently made in understanding the functional significance of chromatin targeting by mammalian PHD fingers, detail the molecular mechanisms and structural features of "histone code" recognition, and discuss the therapeutic potential of PHD fingers.
| S-EPMC2861807 | biostudies-literature