IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage

OBJECTIVE: To extend the IDEAL Framework for device innovation, IDEAL-D, to include the preclinical stage of development (Stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL Framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects and minimisation of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness prior to progression to clinical studies (Stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice

Symbolic meanings and e-learning in the workplace: The case of an intranet-based training tool

This article contributes to the debate on work-based e-learning, by unpacking the notion of ‘the learning context’ in a case where the mediating tool for training also supports everyday work. Users’ engagement with the information and communication technology tool is shown to reflect dynamic interactions among the individual, peer group, organizational and institutional levels. Also influential are professionals’ values and identity work, alongside their interpretations of espoused and emerging symbolic meanings. Discussion draws on pedagogically informed studies of e-learning and the wider organizational learning literature. More centrally, this article highlights the instrumentality of symbolic interactionism for e-learning research and explores some of the framework’s conceptual resources as applied to organizational analysis and e-learning design. </jats:p

A Thermodynamically-Based Mesh Objective Work Potential Theory for Predicting Intralaminar Progressive Damage and Failure in Fiber-Reinforced Laminates

A thermodynamically-based work potential theory for modeling progressive damage and failure in fiber-reinforced laminates is presented. The current, multiple-internal state variable (ISV) formulation, enhanced Schapery theory (EST), utilizes separate ISVs for modeling the effects of damage and failure. Damage is considered to be the effect of any structural changes in a material that manifest as pre-peak non-linearity in the stress versus strain response. Conversely, failure is taken to be the effect of the evolution of any mechanisms that results in post-peak strain softening. It is assumed that matrix microdamage is the dominant damage mechanism in continuous fiber-reinforced polymer matrix laminates, and its evolution is controlled with a single ISV. Three additional ISVs are introduced to account for failure due to mode I transverse cracking, mode II transverse cracking, and mode I axial failure. Typically, failure evolution (i.e., post-peak strain softening) results in pathologically mesh dependent solutions within a finite element method (FEM) setting. Therefore, consistent character element lengths are introduced into the formulation of the evolution of the three failure ISVs. Using the stationarity of the total work potential with respect to each ISV, a set of thermodynamically consistent evolution equations for the ISVs is derived. The theory is implemented into commercial FEM software. Objectivity of total energy dissipated during the failure process, with regards to refinements in the FEM mesh, is demonstrated. The model is also verified against experimental results from two laminated, T800/3900-2 panels containing a central notch and different fiber-orientation stacking sequences. Global load versus displacement, global load versus local strain gage data, and macroscopic failure paths obtained from the models are compared to the experiments

Autism as a disorder of neural information processing: directions for research and targets for therapy

The broad variation in phenotypes and severities within autism spectrum disorders suggests the involvement of multiple predisposing factors, interacting in complex ways with normal developmental courses and gradients. Identification of these factors, and the common developmental path into which theyfeed, is hampered bythe large degrees of convergence from causal factors to altered brain development, and divergence from abnormal brain development into altered cognition and behaviour. Genetic, neurochemical, neuroimaging and behavioural findings on autism, as well as studies of normal development and of genetic syndromes that share symptoms with autism, offer hypotheses as to the nature of causal factors and their possible effects on the structure and dynamics of neural systems. Such alterations in neural properties may in turn perturb activity-dependent development, giving rise to a complex behavioural syndrome many steps removed from the root causes. Animal models based on genetic, neurochemical, neurophysiological, and behavioural manipulations offer the possibility of exploring these developmental processes in detail, as do human studies addressing endophenotypes beyond the diagnosis itself

Towards mentoring as feminist praxis in early childhood education and care in England

Following our contribution to a study of mentoring in seven European countries, we explored epistemological and ontological inconsistencies within mainstream mentoring systems and their regulated practice in England. We considered how feminist mentoring praxis can unsettle conceptualisations of mentoring relationships and challenge inequity in the early education systems and the practice of teaching young children. Predominantly female, early childhood educators suffer from low status in England, and their working lives may be controlled and policed through inequitable systems. On entering the workforce, trainees encounter a reductionist policy milieu where mentoring structures and normative assessment arrangements contribute to inequity. Mentors play pivotal roles in inducting trainees into their worlds of work with young children. Mentoring relationships can determine whether trainees accept the status quo. Principles derived from feminist praxis enable mentors to practise an ‘engaged pedagogy’, co-constructing knowledge, subverting hierarchies and contesting taken-for-granted aspects of policy and practice

Long-term annual and monthly changes in mysids and caridean decapods in a macrotidal estuarine environment in relation to climate change and pollution

© 2018 Elsevier B.V. A 26-year time series of monthly samples from the water intake of a power station has been used to analyse the trends exhibited by number of species, total abundance, and composition of the mysids and caridean decapods in the inner Bristol Channel. During this period, annual water temperatures, salinities and the North Atlantic Oscillation Index (NAOI) in winter did not change significantly, whereas annual NAOI declined. Annual mean monthly values for the number of species and total abundance both increased over the 26 years, but these changes were not correlated with any of the measured physico-chemical/climatic factors. As previous studies demonstrated that, during a similar period, metal concentrations in the Severn Estuary and Bristol Channel (into which that estuary discharges) declined and water quality increased, it is proposed that the above changes are due to an improved environment. The fauna was dominated by the mysids Mesopodopsis slabberi and Schistomysis spiritus, which collectively contributed 94% to total abundance. Both species, which were represented by juveniles, males, non-brooding females and brooding females, underwent statistically-indistinguishable patterns of change in abundance over the 26 years. When analysis was based on the abundances of the various species, the overall species composition differed significantly among years and changed serially with year. When abundances were converted to percentage compositions, this pattern of seriation broke down, demonstrating that changes in abundance and not percentage composition were responsible for the seriation. As with the number and abundance of species, changes in composition over the 26 years were not related to any of the physico-chemical/climatic factors tested. Species composition changed monthly in a pronounced cyclical manner throughout the year, due to statistically different time-staggered changes in the abundance of each species. This cyclicity was related most strongly to salinity