Clinical end points in coronary stent trials: a case for standardized definitions

BACKGROUND: Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. METHODS AND RESULTS: The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. CONCLUSION: Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.

Feo, inútil, inestable: pensamiento crítico contemporáneo y procesos proyectivos en arquitectura = Ugly, useless, unstable: contemporary critical thought and projective processes in architecture

La presente tesis doctoral persigue dos objetivos simultáneos: Determinar el alcance de los criterios clásicos para la evaluación de arquitectura y poner en crisis la prevalencia de esos mismos criterios dentro del marco crítico y productivo actual. En concreto, esta tesis se interroga sobre la posible contribución de determinadas corrientes del pensamiento post-estructuralista y neo-materialista a las tareas de expansión y transformación de los criterios clásicos antes mencionados. Asimismo, se plantea la oportunidad de formalizar estas incorporaciones conceptuales como metodologías para el proyectar arquitectónico. La tesis emplea un análisis pormenorizado de las cualidades implícitas en la triada Firmitas, Utilitas, Venustas elaborada por Vitruvio como vehículo para calibrar la influencia de los paradigmas de pensamiento clásico en nuestras posiciones críticas contemporáneas. Como reacción al carácter dominante de dichos paradigmas, y con la ayuda de una compilación selectiva de ejemplos procedentes de los campos artístico y arquitectónico, la presente tesis procede a examinar y clasificar diversas estrategias arquitectónicas basadas en la no conformidad con los criterios clásicos de evaluación de la disciplina. A la hora de realizar esta tarea, y con el objetivo de superar el dualismo trascendental que caracteriza la gran mayoría de dichos criterios clásicos, se propone un modelo analítico y multidimensional que formula las instancias arquitectónicas como posibles posiciones dentro de un extenso continuo combinatorio de cualidades formales, estructurales y organizativas. Este modelo conceptual permite replantear el aparente antagonismo entre los principios de Vitruvio y sus opuestos, estableciendo en su lugar un dominio operativo continuo de producción arquitectónica. Esta operación abre una ventana de oportunidad para expandir los límites del marco crítico actual más allá de las fronteras establecidas por nuestra herencia clásica. En consecuencia con esta voluntad, la presente tesis pretende habilitar un ámbito para el análisis crítico de las estrategias que caracterizan ciertas corrientes del proyectar contemporáneo, pero también contribuir a informar nuevas aproximaciones metodológicas al proceso de proyecto, desplazando progresivamente su foco desde lo descriptivo hacia lo proyectivo. ABSTRACT This doctoral thesis attempts to simultaneously determine the scope of the classical criteria for the evaluation of architecture and challenge their prevalence within the current framework of architectural production and criticism. It examines how specific strands of post-structuralism and neo-materialism may contribute to both the expansion and the transformation of these criteria and, in doing so, sets itself the goal of mobilising these conceptual incorporations as explicit design methodologies. A detailed analysis of the formal, structural and organisational qualities implicit in Vitruvius’ triad Firmitas, Utilitas, Venustas is used as a starting point to determine the influence of classical paradigms in our current critical positions. As a reaction to this critical pervasiveness, and supported by a curated collection of artistic and architectural works, diverse approaches to non-compliance with the classical criteria of assessment are examined and classified. In order to facilitate this endeavour -and to overcome the transcendental dualism of most classical critical approaches in architecture- this thesis puts forward an analytical, multidimensional model that formulates architectural instances as possible positions within a larger combinatory continuum of formal, structural and organisational qualities. Using this conceptual model, the apparent antagonism between Vitruvius’ principles and its non-compliant opposites is reframed as a continuous operative domain of architectural production, which in turn opens up a window of opportunity to expand the limits of our critical framework beyond the boundaries of classical paradigms. In doing so, this thesis attempts not only to foster a better understanding of some of the strategic approaches that characterise contemporary systems of architectural production, but also to inform future methodological approaches to architectural design, hence situating itself beyond the domain of the descriptive and moving towards the projective.

Long-term effects of air pollutants: in canine species /

Mode of access: Internet.

Methodology for assessing health risks associated with indirect exposure to combustor emissions : interim final.

Mode of access: Internet.

Indoor air : reference bibliography.

"EPA/600/8-89/067F."

Symposium on Chemical and Biological Characterization of Municipal Sludges, Sediments, Dredge Spoils, and Drilling Muds : abstracts, May 20-22, 1986.

Mode of access: Internet.

Quality of life instruments in studies of menorrhagia: a systematic review

BACKGROUND: The use of quality of life (QoL) instruments in menorrhagia research is increasing but there is concern that not enough emphasis is placed on patient-focus in these measurements, i.e. on issues which are of importance to patients and reflect their experiences and concerns (clinical face validity). The objective was to assess the quality of QoL instruments in studies of menorrhagia. STUDY DESIGN: A systematic review of published research. Papers were identified through MEDLINE (1966-April 2000), EMBASE (1980-April 2000), Science Citation Index (1981-April 2000), Social Science Citation Index (1981-April 2000), CINAHL (1982-1999) and PsychLIT (1966-1999), and by manual searching of bibliographies of known primary and review articles. Studies were selected if they assessed women with menorrhagia for life quality, either developing QoL instruments or applying them as an outcome measure. Selected studies were assessed for quality of their QoL instruments, using a 17 items checklist including 10 items for clinical face validity (issues of relevance to patients' expectations and concerns) and 7 items for measurement properties (such as reliability, responsiveness, etc.). RESULTS: A total of 19 articles, 8 on instrument development and 11 on application, were included in the review. The generic Short Form 36 Health Survey Questionnaire (SF36) was used in 12/19 (63%) studies. Only two studies developed new specific QoL instruments for menorrhagia but they complied with 7/17 (41%) and 10/17 (59%) of the quality criteria. Quality assessment showed that only 7/19 (37%) studies complied with more than half the criteria for face validity whereas 17/19 (90%) studies complied with more than half of the criteria for measurement properties (P = 0.0001). CONCLUSION: Among existing QoL instruments, there is good compliance with the quality criteria for measurement properties but not with those for clinical face validity. There is a need to develop methodologically sound disease specific QoL instruments in menorrhagia focussing both on face validity and measurement properties.

Development of a risk-oriented strategic sourcing (ROSS) framework for the construction and electronics manufacturing industries

Strategic sourcing has increased in importance in recent years, and now plays an important role in companies’ planning. The current volatility in supply markets means companies face multiple challenges involving lock-in situations, supplier bankruptcies or supply security issues. In addition, their exposure can increase due to natural disasters, as witnessed recently in the form of bird flu, volcanic ash and tsunamis. Therefore, the primary focus of this study is risk management in the context of strategic sourcing. The study presents a literature review on sourcing based on the 15 years from 1998–2012, and considers 131 academic articles. The literature describes strategic sourcing as a strategic, holistic process in managing supplier relationships, with a long-term focus on adding value to the company and realising competitive advantage. Few studies discovered the real risk impact and status of risk management in strategic sourcing, and evaluation across countries and industries was limited, with the construction sector particularly under-researched. This methodology is founded on a qualitative study of twenty cases across Ger-many and the United Kingdom from the construction sector and electronics manufacturing industries. While considering risk management in the context of strategic sourcing, the thesis takes into account six dimensions that cover trends in strategic sourcing, theoretical and practical sourcing models, risk management, supply and demand management, critical success factors and the strategic supplier evaluation. The study contributes in several ways. First, recent trends are traced and future needs identified across the research dimensions of countries, industries and companies. Second, it evaluates critical success factors in contemporary strategic sourcing. Third, it explores the application of theoretical and practical sourcing models in terms of effectiveness and sustainability. Fourth, based on the case study findings, a risk-oriented strategic sourcing framework and a model for strategic sourcing are developed. These are based on the validation of contemporary requirements and a critical evaluation of the existing situation. It contemplates the empirical findings and leads to a structured process to manage risk in strategic sourcing. The risk-oriented framework considers areas such as trends, corporate and sourcing strategy, critical success factors, strategic supplier selection criteria, risk assessment, reporting, strategy alignment and reporting. The proposed model highlights the essential dimensions in strategic sourcing and guides us to a new definition of strategic sourcing supported by this empirical study.

Quality of life instruments in studies of menorrhagia: a systematic review

BACKGROUND: The use of quality of life (QoL) instruments in menorrhagia research is increasing but there is concern that not enough emphasis is placed on patient-focus in these measurements, i.e. on issues which are of importance to patients and reflect their experiences and concerns (clinical face validity). The objective was to assess the quality of QoL instruments in studies of menorrhagia. STUDY DESIGN: A systematic review of published research. Papers were identified through MEDLINE (1966-April 2000), EMBASE (1980-April 2000), Science Citation Index (1981-April 2000), Social Science Citation Index (1981-April 2000), CINAHL (1982-1999) and PsychLIT (1966-1999), and by manual searching of bibliographies of known primary and review articles. Studies were selected if they assessed women with menorrhagia for life quality, either developing QoL instruments or applying them as an outcome measure. Selected studies were assessed for quality of their QoL instruments, using a 17 items checklist including 10 items for clinical face validity (issues of relevance to patients' expectations and concerns) and 7 items for measurement properties (such as reliability, responsiveness, etc.). RESULTS: A total of 19 articles, 8 on instrument development and 11 on application, were included in the review. The generic Short Form 36 Health Survey Questionnaire (SF36) was used in 12/19 (63%) studies. Only two studies developed new specific QoL instruments for menorrhagia but they complied with 7/17 (41%) and 10/17 (59%) of the quality criteria. Quality assessment showed that only 7/19 (37%) studies complied with more than half the criteria for face validity whereas 17/19 (90%) studies complied with more than half of the criteria for measurement properties (P = 0.0001). CONCLUSION: Among existing QoL instruments, there is good compliance with the quality criteria for measurement properties but not with those for clinical face validity. There is a need to develop methodologically sound disease specific QoL instruments in menorrhagia focussing both on face validity and measurement properties.

Multi-criteria assessment of innovative technology in the beef industry

In Australia rural research and development corporations and companies expended over $AUS500 million on agricultural research and development. A substantial proportion of this is invested in R&D in the beef industry. The Australian beef industry exports almost $AUS5billionof product annually and invest heavily in new product development to improve the beef quality and improve production efficiency. Review points are critical for effective new product development, yet many research and development bodies, particularly publicly funded ones, appear to ignore the importance of assessing products prior to their release. Significant sums of money are invested in developing technological innovations that have low levels and rates of adoption. The adoption rates could be improved if the developers were more focused on technology uptake and less focused on proving their technologies can be applied in practice. Several approaches have been put forward in an effort to improve rates of adoption into operational settings. This paper presents a study of key technological innovations in the Australian beef industry to assess the use of multiple criteria in evaluating the potential uptake of new technologies. Findings indicate that using multiple criteria to evaluate innovations before commercializing a technology enables researchers to better understand the issues that may inhibit adoption.

Improving criteria and feedback in student assessment in law

Spurred on by both the 1987 Pearce Report1 and the general changes to higher education spawned by the “Dawkins revolution” from 1988, there has been much critical self-evaluation leading to profound improvements to the quality of teaching in Australian law schools.2 Despite the changes there are still areas of general law teaching practice which have lagged behind recent developments in our understanding of what constitutes high quality teaching. One such area is assessment criteria and feedback. The project Improving Feedback in Student Assessment in Law is an attempt to remedy this. It aims to produce a manual containing key principles for the design of assessment and the provision of feedback, with practical yet flexible ideas and illustrations which law teachers may adopt or modify. Most of the examples have been developed by teachers at the University of Melbourne Law School. The project was supported in 1996 by a Committee for the Advancement of University Teaching grant and the manual will be published late in 1997.3 This note summarises the core principles which are elaborated further in the manual.

Criteria for working-correlation-structure selection in GEE: Assessment via simulation

Efficiency of analysis using generalized estimation equations is enhanced when intracluster correlation structure is accurately modeled. We compare two existing criteria (a quasi-likelihood information criterion, and the Rotnitzky-Jewell criterion) to identify the true correlation structure via simulations with Gaussian or binomial response, covariates varying at cluster or observation level, and exchangeable or AR(l) intracluster correlation structure. Rotnitzky and Jewell's approach performs better when the true intracluster correlation structure is exchangeable, while the quasi-likelihood criteria performs better for an AR(l) structure.

Information preferences for the evaluation of coastal development impacts on ecosystem services: A multi-criteria assessment in the Australian context

Ecosystem based management requires the integration of various types of assessment indicators. Understanding stakeholders' information preferences is important, in selecting those indicators that best support management and policy. Both the preferences of decision-makers and the general public may matter, in democratic participatory management institutions. This paper presents a multi-criteria analysis aimed at quantifying the relative importance to these groups of economic, ecological and socio-economic indicators usually considered when managing ecosystem services in a coastal development context. The Analytic Hierarchy Process (AHP) is applied within two nationwide surveys in Australia, and preferences of both the general public and decision-makers for these indicators are elicited and compared. Results show that, on average across both groups, the priority in assessing a generic coastal development project is for the ecological assessment of its impacts on marine biodiversity. Ecological assessment indicators are globally preferred to both economic and socio-economic indicators regardless of the nature of the impacts studied. These results are observed for a significantly larger proportion of decision-maker than general public respondents, questioning the extent to which the general public's preferences are well reflected in decision-making processes.