IMI – industry guidelines and ethical considerations for myopia control report

PURPOSE. To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC). METHODS. Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments. RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed. CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments.</p

Generando música a través de la Actividad Cerebral / Generating music through Brain Activity

El presente artículo muestra la forma en que las interfaces cerebro computador (BCI) pueden ser utilizadas para generar música. Para lograr lo anterior, se realiza una revisión de fuentes académicas que contienen definiciones esenciales relacionadas con ambas áreas del conocimiento; de esta forma se podrá establecerse un puente que permita la descripción de una herramienta computacional que permita cumplir con el objetivo planteado

Painlev\'e-Gullstrand synchronizations in spherical symmetry

A Painlev\'e-Gullstrand synchronization is a slicing of the space-time by a family of flat spacelike 3-surfaces. For spherically symmetric space-times, we show that a Painlev\'e-Gullstrand synchronization only exists in the region where $(dr)^2 \leq 1$, $r$ being the curvature radius of the isometry group orbits ($2$-spheres). This condition says that the Misner-Sharp gravitational energy of these 2-spheres is not negative and has an intrinsic meaning in terms of the norm of the mean extrinsic curvature vector. It also provides an algebraic inequality involving the Weyl curvature scalar and the Ricci eigenvalues. We prove that the energy and momentum densities associated with the Weinberg complex of a Painlev\'e-Gullstrand slice vanish in these curvature coordinates, and we give a new interpretation of these slices by using semi-metric Newtonian connections. It is also outlined that, by solving the vacuum Einstein's equations in a coordinate system adapted to a Painlev\'e-Gullstrand synchronization, the Schwarzschild solution is directly obtained in a whole coordinate domain that includes the horizon and both its interior and exterior regions.Comment: 16 page

Genome-wide Association Analysis Tracks Bacterial Leaf Blight Resistance Loci In Rice Diverse Germplasm

Genome-wide association analysis of bacterial blight resistance to nine Xoo strains in 198 indica genotypes based on Efficient Mixed-Model Association eXpedited Model (EMMAX). Manhattan plots for nine Xoo strains (a) PXO61, (b) PXO86, (c) PXO79, (d) PXO71, (e) PXO112, (f) PXO99, (g) PXO339, (h) PXO349, and (i) PXO341. X-axis shows the SNPs along each chromosome; y axis is the − log10 (P-value) for the association. Significant SNPs are those beyond the red line having P-value < 1 × 10 −5. Quantile-quantile plots for nine Xoo strains (j) PXO61, (k) PXO86, (l) PXO79, (m) PXO71, (n) PXO112, (o) PXO99, (p) PXO339, (q) PXO349, and (r) PXO341. (PPTX 521 kb

FAK acts as a suppressor of RTK-MAP kinase signalling in Drosophila melanogaster epithelia and human cancer cells

Receptor Tyrosine Kinases (RTKs) and Focal Adhesion Kinase (FAK) regulate multiple signalling pathways, including mitogen-activated protein (MAP) kinase pathway. FAK interacts with several RTKs but little is known about how FAK regulates their downstream signalling. Here we investigated how FAK regulates signalling resulting from the overexpression of the RTKs RET and EGFR. FAK suppressed RTKs signalling in Drosophila melanogaster epithelia by impairing MAPK pathway. This regulation was also observed in MDA-MB-231 human breast cancer cells, suggesting it is a conserved phenomenon in humans. Mechanistically, FAK reduced receptor recycling into the plasma membrane, which resulted in lower MAPK activation. Conversely, increasing the membrane pool of the receptor increased MAPK pathway signalling. FAK is widely considered as a therapeutic target in cancer biology; however, it also has tumour suppressor properties in some contexts. Therefore, the FAK-mediated negative regulation of RTK/MAPK signalling described here may have potential implications in the designing of therapy strategies for RTK-driven tumours

Digital endpoints in clinical trials of Alzheimer's disease and other neurodegenerative diseases: challenges and opportunities.

Alzheimer's disease (AD) and other neurodegenerative diseases such as Parkinson's disease (PD) and Huntington's disease (HD) are associated with progressive cognitive, motor, affective and consequently functional decline considerably affecting Activities of Daily Living (ADL) and quality of life. Standard assessments, such as questionnaires and interviews, cognitive testing, and mobility assessments, lack sensitivity, especially in early stages of neurodegenerative diseases and in the disease progression, and have therefore a limited utility as outcome measurements in clinical trials. Major advances in the last decade in digital technologies have opened a window of opportunity to introduce digital endpoints into clinical trials that can reform the assessment and tracking of neurodegenerative symptoms. The Innovative Health Initiative (IMI)-funded projects RADAR-AD (Remote assessment of disease and relapse-Alzheimer's disease), IDEA-FAST (Identifying digital endpoints to assess fatigue, sleep and ADL in neurodegenerative disorders and immune-mediated inflammatory diseases) and Mobilise-D (Connecting digital mobility assessment to clinical outcomes for regulatory and clinical endorsement) aim to identify digital endpoints relevant for neurodegenerative diseases that provide reliable, objective, and sensitive evaluation of disability and health-related quality of life. In this article, we will draw from the findings and experiences of the different IMI projects in discussing (1) the value of remote technologies to assess neurodegenerative diseases; (2) feasibility, acceptability and usability of digital assessments; (3) challenges related to the use of digital tools; (4) public involvement and the implementation of patient advisory boards; (5) regulatory learnings; and (6) the significance of inter-project exchange and data- and algorithm-sharing

Who settles for less? Subjective dispositions, objective circumstances, and housing satisfaction

In recent years there has been growing interest in individuals’ self-perceptions of their wellbeing on the grounds that these complement well-established objective indicators of welfare. However, individuals’ assessments depend on both objective circumstances and subjective, idiosyncratic dispositions, such as aspirations and expectations. We add to the literature by formulating a modelling strategy that uncovers how these subjective dispositions differ across socio-demographic groups. This is then tested using housing satisfaction data from a large-scale household panel survey from Australia. We find that there are significant differences in the way in which individuals with different characteristics rate the same objective reality. For instance, male, older, migrant, and Indigenous individuals rate equal housing conditions more favourably than female, younger, Australian-born, and non-Indigenous individuals. These findings have important implications for how self-reported housing satisfaction, and wellbeing data in general, are to be used to inform evidence-based policy

Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis

Background: Infections due to antibiotic-resistant bacteria are threatening modern health care. However, estimating their incidence, complications, and attributable mortality is challenging. We aimed to estimate the burden of infections caused by antibiotic-resistant bacteria of public health concern in countries of the EU and European Economic Area (EEA) in 2015, measured in number of cases, attributable deaths, and disability-adjusted life-years (DALYs). Methods: We estimated the incidence of infections with 16 antibiotic resistance–bacterium combinations from European Antimicrobial Resistance Surveillance Network (EARS-Net) 2015 data that was country-corrected for population coverage. We multiplied the number of bloodstream infections (BSIs) by a conversion factor derived from the European Centre for Disease Prevention and Control point prevalence survey of health-care-associated infections in European acute care hospitals in 2011–12 to estimate the number of non-BSIs. We developed disease outcome models for five types of infection on the basis of systematic reviews of the literature. Findings: From EARS-Net data collected between Jan 1, 2015, and Dec 31, 2015, we estimated 671 689 (95% uncertainty interval [UI] 583 148–763 966) infections with antibiotic-resistant bacteria, of which 63·5% (426 277 of 671 689) were associated with health care. These infections accounted for an estimated 33 110 (28 480–38 430) attributable deaths and 874 541 (768 837–989 068) DALYs. The burden for the EU and EEA was highest in infants (aged <1 year) and people aged 65 years or older, had increased since 2007, and was highest in Italy and Greece. Interpretation: Our results present the health burden of five types of infection with antibiotic-resistant bacteria expressed, for the first time, in DALYs. The estimated burden of infections with antibiotic-resistant bacteria in the EU and EEA is substantial compared with that of other infectious diseases, and has increased since 2007. Our burden estimates provide useful information for public health decision-makers prioritising interventions for infectious diseases