Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX) : an open-label randomised phase III trial

Background: Use of cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), has the potential to increase survival in patients with advanced non-small-cell lung cancer. We therefore compared chemotherapy plus cetuximab with chemotherapy alone in patients with advanced EGFR-positive non-small-cell lung cancer. Methods: In a multinational, multicentre, open-label, phase III trial, chemotherapy-naive patients (≥18 years) with advanced EGFR-expressing histologically or cytologically proven stage wet IIIB or stage IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio to chemotherapy plus cetuximab or just chemotherapy. Chemotherapy was cisplatin 80 mg/m 2 intravenous infusion on day 1, and vinorelbine 25 mg/m 2 intravenous infusion on days 1 and 8 of every 3-week cycle) for up to six cycles. Cetuximab-at a starting dose of 400 mg/m 2 intravenous infusion over 2 h on day 1, and from day 8 onwards at 250 mg/m 2 over 1 h per week-was continued after the end of chemotherapy until disease progression or unacceptable toxicity had occurred. The primary endpoint was overall survival. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00148798. Findings: Between October, 2004, and January, 2006, 1125 patients were randomly assigned to chemotherapy plus cetuximab (n=557) or chemotherapy alone (n=568). Patients given chemotherapy plus cetuximab survived longer than those in the chemotherapy-alone group (median 11·3 months vs 10·1 months; hazard ratio for death 0·871 [95% CI 0·762-0·996]; p=0·044). The main cetuximab-related adverse event was acne-like rash (57 [10%] of 548, grade 3). Interpretation: Addition of cetuximab to platinum-based chemotherapy represents a new treatment option for patients with advanced non-small-cell lung cancer. Funding: Merck KGaA. © 2009 Elsevier Ltd. All rights reserved.

Could MOOCs answer the problems of teaching AQF required skills in Australian tertiary programmes?

From 2015, Australian universities will be required to demonstrate that their programmes explicitly teach, and assess achievement of, knowledge and skills and the application of both as specified by the Australian Qualifications Framework (AQF). Over the last twenty years, the sector has applied significant effort and resource to embedding the development of skills through tertiary programmes. Despite these national and institutional efforts, employer and industry concerns remain about the quality of graduate skills. The authors propose a ‘massive open online course’ (MOOC) approach to teaching and assessing AQF required skills. As an example the paper identifies the skills modules that would need to be developed by experts in each skill area for AQF level 9 master’s by coursework programmes. The proposed MOOC would include assessment tasks and rubrics allowing students to develop and demonstrate achievement of the AQF required skills. The assessment tasks could be used by institutions to provide evidence of attainment of coursework master’s standards.

How to Facilitate Open Disclosure Simulations

Open Disclosure comprises two main components: Clinician Disclosure (CD), an informal process usually conducted by the treating clinician; and Formal Open Disclosure (FOD), a more structured process led by a senior clinician trained as an Open Disclosure Consultant. Training programs for both CD and FOD incorporate interactive role-play based scenarios called ‘simulations’. This section of the Open Disclosure Training Program Handbook provides guidelines and resources for facilitating the simulation components of both Clinician Disclosure and Open Disclosure Consultant training.

Monitoring foods and beverages provided and sold in public sector settings

This paper outlines a step-wise framework for monitoring foods and beverages provided or sold in publicly funded institutions. The focus is on foods in schools, but the framework can also be applied to foods provided or sold in other publicly funded institutions. Data collection and evaluation within this monitoring framework will consist of two components. In component I, information on existing food or nutrition policies and/or programmes within settings would be compiled. Currently, nutrition standards and voluntary guidelines associated with such policies/programmes vary widely globally. This paper, which provides a comprehensive review of such standards and guidelines, will facilitate institutional learnings for those jurisdictions that have not yet established them or are undergoing review of existing ones. In component II, the quality of foods provided or sold in public sector settings is evaluated relative to existing national or sub-national nutrition standards or voluntary guidelines. Where there are no (or only poor) standards or guidelines available, the nutritional quality of foods can be evaluated relative to standards of a similar jurisdiction or other appropriate standards. Measurement indicators are proposed (within ‘minimal’, ‘expanded’ and ‘optimal’ approaches) that can be used to monitor progress over time in meeting policy objectives, and facilitate comparisons between countries.

Transparency tools in gene patenting for informing policy and practice

In the recent decision Association for Molecular Pathology v. Myriad Genetics1, the US Supreme Court held that naturally occurring sequences from human genomic DNA are not patentable subject matter. Only certain complementary DNAs (cDNA), modified sequences and methods to use sequences are potentially patentable. It is likely that this distinction will hold for all DNA sequences, whether animal, plant or microbial2. However, it is not clear whether this means that other naturally occurring informational molecules, such as polypeptides (proteins) or polysaccharides, will also be excluded from patents. The decision underscores a pressing need for precise analysis of patents that disclose and reference genetic sequences, especially in the claims. Similarly, data sets, standards compliance and analytical tools must be improved—in particular, data sets and analytical tools must be made openly accessible—in order to provide a basis for effective decision making and policy setting to support biological innovation. Here, we present a web-based platform that allows such data aggregation, analysis and visualization in an open, shareable facility. To demonstrate the potential for the extension of this platform to global patent jurisdictions, we discuss the results of a global survey of patent offices that shows that much progress is still needed in making these data freely available for aggregation in the first place.

Assessment for Education : Standards, Judgement and Moderation

Do you need a practical guide to assessment, curriculum and policy? Are you also looking for a book that is firmly grounded in the theory of this subject? Assessment for Education combines both theory and practice, making it the perfect guide for students, researchers, academics and teachers. This book makes assessment processes transparent for practitioners, and shows how assessment should relate to education. It looks at evidence-informed decision-making and the interrelationships between standards, judgment and moderation practice for improved assessment, teacher quality, schools and systems. The book will provide you with: ' Knowledge about quality assessment and judgement practice ' Understanding of relationships across curriculum, assessment, teaching and learning ' Knowledge of the concept of front-ending assessment based on the learner's needs ' An analysis of practitioner judgement approaches ' Understanding of the conditions under which teacher assessment can be valid ' Principles derived from research of social moderation practices Whether you are studying and researching assessment or working in curriculum and assessment policy, this book will show you how practitioner use of achievement standards can improve learning, equity, social justice and accountability.

Implementing open licensing in government open data initiatives : a review of Australian government practice

As support grows for greater access to information and data held by governments, so does awareness of the need for appropriate policy, technical and legal frameworks to achieve the desired economic and societal outcomes. Since the late 2000s numerous international organizations, inter-governmental bodies and governments have issued open government data policies, which set out key principles underpinning access to, and the release and reuse of data. These policies reiterate the value of government data and establish the default position that it should be openly accessible to the public under transparent and non-discriminatory conditions, which are conducive to innovative reuse of the data. A key principle stated in open government data policies is that legal rights in government information must be exercised in a manner that is consistent with and supports the open accessibility and reusability of the data. In particular, where government information and data is protected by copyright, access should be provided under licensing terms which clearly permit its reuse and dissemination. This principle has been further developed in the policies issued by Australian Governments into a specific requirement that Government agencies are to apply the Creative Commons Attribution licence (CC BY) as the default licensing position when releasing government information and data. A wide-ranging survey of the practices of Australian Government agencies in managing their information and data, commissioned by the Office of the Australian Information Commissioner in 2012, provides valuable insights into progress towards the achievement of open government policy objectives and the adoption of open licensing practices. The survey results indicate that Australian Government agencies are embracing open access and a proactive disclosure culture and that open licensing under Creative Commons licences is increasingly prevalent. However, the finding that ‘[t]he default position of open access licensing is not clearly or robustly stated, nor properly reflected in the practice of Government agencies’ points to the need to further develop the policy framework and the principles governing information access and reuse, and to provide practical guidance tools on open licensing if the broadest range of government information and data is to be made available for innovative reuse.

Sex and the virtual suburbs : the pornosphere and community standards

This chapter looks at the management and zoning of online sexual culture–the web sites which make up the pornosphere (McNair 2013). It explores the concept of ‘community standards’, which has been a central part of the management of sexually explicit materials in the offline world, and asks what it might mean to talk about ‘community standards’ on the Internet. And finally, it uses the concept of virtual-community standards to revisit the question of managing access to sexually explicit materials on the Internet.

μAV - Design and implementation of an open source micro quadrotor

This paper presents the design of μAV, a palm size open source micro quadrotor constructed on a single Printed Circuit Board. The aim of the micro quadrotor is to provide a lightweight (approximately 86g) and cheap robotic research platform that can be used for a range of robotic applications. One possible application could be a cheap test bed for robotic swarm research. The goal of this paper is to give an overview of the design and capabilities of the micro quadrotor. The micro quadrotor is complete with a 9 Degree of Freedom Inertial Measurement Unit, a Gumstix Overo® Computer-On-Module which can run the widely used Robot Operating System (ROS) for use with other research algorithms.

Magnetic convection heat transfer in an open-ended enclosure filled with paramagnetic fluids

Numerical simulations of thermomagnetic convection of paramagnetic fluids placed in a micro-gravity condition (g ≈ 0) and under a uniform vertical gradient magnetic field in an open ended square enclosure with ramp heating temperature condition applied on a vertical wall is investigated in this study. In presence of the strong magnetic gradient field thermal convection of the paramagnetic fluid might take place even in a zero-gravity environment as a direct consequence of temperature differences occurring within the fluid. The thermal boundary layer develops adjacent to the hot wall as soon as the ramp temperature condition is applied on it. There are two scenarios can be observed based on the ramp heating time. The steady state of the thermal boundary layer can be reached before the ramp time is finished or vice versa. If the ramp time is larger than the quasi-steady time then the thermal boundary layer is in a quasi-steady mode with convection balancing conduction after the quasi-steady time. Further increase of the heat input simply accelerates the flow to maintain the proper thermal balance. Finally, the boundary layer becomes completely steady state when the ramp time is finished. Effects of magnetic Rayleigh number, Prandtl number and paramagnetic fluid parameter on the flow pattern and heat transfer are presented.

Discomfort glare in open plan green buildings

This study presents the largest-known, investigation on discomfort glare with 493 surveys collected from five green buildings in Brisbane, Australia. The study was conducted on full-time employees, working under their everyday lighting conditions, all of whom had no affiliation with the research institution. The survey consisted of a specially tailored questionnaire to assess potential factors relating to discomfort glare. Luminance maps extracted from high dynamic range (HDR) images were used to capture the luminous environment of the occupants. Occupants who experienced glare on their monitor and/or electric glare were excluded from analysis leaving 419 available surveys. Occupants were more sensitive to glare than any of the tested indices accounted for. A new index, the UGP was developed to take into account the scope of results in the investigation. The index is based on a linear transformation of the UGR to calculate a probability of disturbed persons. However all glare indices had some correlation to discomfort, and statistically there was no difference between the DGI, UGR and CGI. The UGP broadly reflects the demographics of the working population in Australia and the new index is applicable to open plan green buildings.

A short-term production scheduling methodology for open-pit mines

A multi-resource multi-stage scheduling methodology is developed to solve short-term open-pit mine production scheduling problems as a generic multi-resource multi-stage scheduling problem. It is modelled using essential characteristics of short-term mining production operations such as drilling, sampling, blasting and excavating under the capacity constraints of mining equipment at each processing stage. Based on an extended disjunctive graph model, a shifting-bottleneck-procedure algorithm is enhanced and applied to obtain feasible short-term open-pit mine production schedules and near-optimal solutions. The proposed methodology and its solution quality are verified and validated using a real mining case study.

Birth control : to what extent do women report being informed and involved in decisions about pregnancy and birth procedures?

Background: Health policy, guidelines, and standards advocate giving patients comprehensive information and facilitating their involvement in health-related decision-making. Routine assessment of patient reports of these processes is needed. Our objective was to examine decision-making processes, specifically information provision and consumer involvement in decision-making, for nine pregnancy, labour, and birth procedures, as reported by maternity care consumers in Queensland, Australia. Methods: Participants were women who had a live birth in Queensland in a specified time period and were not found to have had a baby that died since birth, who completed the extended Having a Baby in Queensland Survey, 2010 about their maternity care experiences, and who reported at least one of the nine procedures of interest. For each procedure, women answered two questions that measured perceived (i) receipt of information about the benefits and risks of the procedure and (ii) role in decision-making about the procedure. Results: In all, 3,542 eligible women (34.2%) completed the survey. Between 4% (for pre-labour caesarean section) and 60% (for vaginal examination) of women reported not being informed of the benefits and risks of the procedure they experienced. Between 2% (epidural) and 34% (episiotomy) of women reported being unconsulted in decision-making. Over one quarter (26%) of the women who experienced episiotomy reported being neither informed nor consulted. Conclusions: There is an urgent need for interventions that facilitate information provision and consumer involvement in decision-making about several perinatal procedures, especially those performed within the time-limited intrapartum care episode.

Knowledge unlatched : encouraging innovation in academic publishing through collective action and Open Access licensing

This case study examines the way in which Knowledge Unlatched is combining collective action and open access licenses to encourage innovation in markets for specialist academic books. Knowledge Unlatched is a not for profit organisation that has been established to help a global community of libraries coordinate their book purchasing activities more effectively and, in so doing, to ensure that books librarians select for their own collections become available for free for anyone in the world to read. The Knowledge Unlatched model is an attempt to re-coordinate a market in order to facilitate a transition to digitally appropriate publishing models that include open access. It offers librarians an opportunity to facilitate the open access publication of books that their own readers would value access to. It provides publishers with a stable income stream on titles selected by libraries, as well as an ability to continue selling books to a wider market on their own terms. Knowledge Unlatched provides a rich case study for researchers and practitioners interested in understanding how innovations in procurement practices can be used to stimulate more effective, equitable markets for socially valuable products.