CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

Efficient computation of discrete polynomial transforms

This letter presents a new recursive method for computing discrete polynomial transforms. The method is shown for forward and inverse transforms of the Hermite, binomial, and Laguerre transforms. The recursive flow diagrams require only 2 additions, 2( +1) memory units, and +1multipliers for the +1-point Hermite and binomial transforms. The recursive flow diagram for the +1-point Laguerre transform requires 2 additions, 2( +1) memory units, and 2( +1) multipliers. The transform computation time for all of these transforms is ( )

CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalizability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies.The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers.This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated web site (http://www.strobe-statement.org) should be helpful resources to improve reporting of observational research.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.

[Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration]

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and elaboration

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.

Diagramas de flujo para el diseño de un sistema de control de calidad : proceso de elaboración de vino blanco

Para la implementación de un sistema de control de calidad es necesario tener una clara visión de los procesos involucrados, las responsabilidades, organización, registros de la calidad, acciones preventivas y correctivas. En la actualidad se exige un enfoque integrador, donde se estructuran actividades y recursos físicos. Es por ello que los diagramas de flujo tienen una importancia fundamental en las decisiones de dirección. Entre los distintos diagramas de flujo posibles, en este trabajo se propone utilizar los de procesos que permiten ordenar secuencialmente una serie de actividades y recursos físicos. Se presenta un diagrama de flujo en la elaboración de vino blanco en una bodega experimental. A través de él se puede conocer la lógica del proceso de elaboración, realizar un diagnóstico del proceso, detectar los puntos críticos de control que puedan provocar deterioro en la calidad del producto o del ambiente. También es un punto de partida para armar y poner en funcionamiento un plan de inspección y ensayos, para la documentación necesaria en las auditorías y una técnica para detectar puntos de contaminación ambiental.

Modelización del cálculo de Indicadores Ambientales, a partir de sensores ópticos de alta resolución temporal a bordo de satélite

La presente tesis doctoral tiene por objeto el estudio y análisis de técnicas y modelos de obtención de parámetros biofísicos e indicadores ambientales, de manera automatizada a partir de imágenes procedentes de satélite de alta resolución temporal. En primer lugar se revisan los diferentes programas espaciales de observación del territorio, con especial atención a los que proporcionan dicha resolución. También se han revisado las metodologías y procesos que permiten la obtención de diferentes parámetros cuantitativos y documentos cualitativos, relacionados con diversos aspectos de las cubiertas terrestres, atendiendo a su adaptabilidad a las particularidades de los datos. En segundo lugar se propone un modelo de obtención de parámetros ambientales, que integra información proveniente de sensores espaciales y de otras fuentes auxiliares utilizando, en cierta medida, las metodologías presentadas en apartados anteriores y optimizando algunas de las referidas o proponiendo otras nuevas, de manera que se permita dicha obtención de manera eficiente, a partir de los datos disponibles y de forma sistemática. Tras esta revisión de metodologías y propuesta del modelo, se ha procedido a la realización de experimentos, con la finalidad de comprobar su comportamiento en diferentes casos prácticos, depurar los flujos de datos y procesos, así como establecer las situaciones que pueden afectar a los resultados. De todo ello se deducirá la evaluación del referido modelo. Los sensores considerados en este trabajo han sido MODIS, de alta resolución temporal y Thematic Mapper (TM), de media resolución espacial, por tratarse de instrumentos de referencia en la realización de estudios ambientales. También por la duración de sus correspondientes misiones de registro de datos, lo que permite realizar estudios de evolución temporal de ciertos parámetros biofísicos, durante amplios periodos de tiempo. Así mismo. es de destacar que la continuidad de los correspondientes programas parece estar asegurada. Entre los experimentos realizados, se ha ensayado una metodología para la integración de datos procedentes de ambos sensores. También se ha analizado un método de interpolación temporal que permite obtener imágenes sintéticas con la resolución espacial de TM (30 m) y la temporal de MODIS (1 día), ampliando el rango de aplicación de este último sensor. Asimismo, se han analizado algunos de los factores que afectan a los datos registrados, tal como la geometría de la toma de los mismos y los episodios de precipitación, los cuales alteran los resultados obtenidos. Por otro lado, se ha comprobado la validez del modelo propuesto en el estudio de fenómenos ambientales dinámicos, en concreto la contaminación orgánica de aguas embalsadas. Finalmente, se ha demostrado un buen comportamiento del modelo en todos los casos ensayados, así como su flexibilidad, lo que le permite adaptarse a nuevos orígenes de datos, o nuevas metodologías de cálculo. Abstract This thesis aims to the study and analysis of techniques and models, in order to obtain biophysical parameters and environmental indicators in an automated way, using high temporal resolution satellite data. Firstly we have reviewed the main Earth Observation Programs, paying attention to those that provide high temporal resolution. Also have reviewed the methodologies and process flow diagrams in order to obtain quantitative parameters and qualitative documents, relating to various aspects of land cover, according to their adaptability to the peculiarities of the data. In the next stage, a model which allows obtaining environmental parameters, has been proposed. This structure integrates information from space sensors and ancillary data sources, using the methodologies presented in previous sections that permits the parameters calculation in an efficient and automated way. After this review of methodologies and the proposal of the model, we proceeded to carry out experiments, in order to check the behavior of the structure in real situations. From this, we derive the accuracy of the model. The sensors used in this work have been MODIS, which is a high temporal resolution sensor, and Thematic Mapper (TM), which is a medium spatial resolution instrument. This choice was motivated because they are reference sensors in environmental studies, as well as for the duration of their corresponding missions of data logging, and whose continuity seems assured. Among the experiments, we tested a methodology that allows the integration of data from cited sensors, we discussed a proposal for a temporal interpolation method for obtaining synthetic images with spatial resolution of TM (30 m) and temporal of MODIS (1 day), extending the application range of this one. Furthermore, we have analyzed some of the factors that affect the recorded data, such as the relative position of the satellite with the ground point, and the rainfall events, which alter the obtained results. On the other hand, we have proven the validity of the proposed model in the study of the organic contamination in inland water bodies. Finally, we have demonstrated a good performance of the proposed model in all cases tested, as well as its flexibility and adaptability.

Desarrollo de un sistema de almacenamiento térmico para la central termosolar Astexol 2

En este proyecto se elabora la ingeniería básica de un sistema de almacenamiento térmico para la central termosolar Astexol 2 (Badajoz, España). Para ello, primeramente se decidió que el sistema térmico de almacenamiento a diseñar fuera indirecto de dos tanques con sales fundidas. Una vez seleccionado el tipo de almacenamiento adecuado, se seleccionó la capacidad de almacenamiento óptima, en base a unos objetivos establecidos para la instalación del TES en Astexol 2. Finalmente, se procedió con el diseño de los equipos principales y con la realización de los planos de implantación y de los PFD’s (diagramas de flujo) y P&ID’s (diagramas de instrumentación y control) del sistema de almacenamiento. ABSTRACT This project includes the basic engineering of a thermal storage system for the concentrating solar power plant Astexol 2 (Badajoz, Spain). First of all, it was decided that the type of thermal storage system to design had to be an indirect two-tank molten salt thermal storage system. Once the proper type of storage system was chosen, the optimum storage capacity was selected, according to the main aims designated for the thermal storage system installation in Astexol 2.Finally, the design of the main equipment of the thermal storage system was done, together with the elaboration of the associated plot plans, PFD’s (Process Flow Diagrams) and P&ID’s (Process and Instrumentation Diagrams).

Computer control of machines utilising independent drive mechanisms

The thesis describes an investigation into methods for the specification, design and implementation of computer control systems for flexible manufacturing machines comprising multiple, independent, electromechanically-driven mechanisms. An analysis is made of the elements of conventional mechanically-coupled machines in order that the operational functions of these elements may be identified. This analysis is used to define the scope of requirements necessary to specify the format, function and operation of a flexible, independently driven mechanism machine. A discussion of how this type of machine can accommodate modern manufacturing needs of high-speed and flexibility is presented. A sequential method of capturing requirements for such machines is detailed based on a hierarchical partitioning of machine requirements from product to independent drive mechanism. A classification of mechanisms using notations, including Data flow diagrams and Petri-nets, is described which supports capture and allows validation of requirements. A generic design for a modular, IDM machine controller is derived based upon hierarchy of control identified in these machines. A two mechanism experimental machine is detailed which is used to demonstrate the application of the specification, design and implementation techniques. A computer controller prototype and a fully flexible implementation for the IDM machine, based on Petri-net models described using the concurrent programming language Occam, is detailed. The ability of this modular computer controller to support flexible, safe and fault-tolerant operation of the two intermittent motion, discrete-synchronisation independent drive mechanisms is presented. The application of the machine development methodology to industrial projects is established.

“Digital Diagnostics and Communication (DDC) system” Redesigning the Emergency Ambulance

During the development of a new treatment space for the UK emergency ambulance participatory observations with front-line clinicians revealed the need for an integrated patient monitoring, communication and navigation system. The research identified the different information touch-points and requirements through modes of use analysis, day-in-the-life study and simulation workshops with clinicians. Emergency scenario and role-play with paramedics identified 5 distinct ambulance modes of use. Information flow diagrams were created and checked by paramedics and digital User Interface (UI) wireframes were developed and evaluated by clinicians during clinical evaluations. Feedback from clinicians defined UI design specification further leading to a final design proposal. This research was a further development from the 2007 EPSRC funded “Smart Pods” project. The resulting interactive prototype was co-designed in collaboration with ambulance crews and provides a vision of what could be achieved by integrating well-proven IT technologies and protocols into a package relevant in the emergency medicine field. The system has been reviewed by over 40 ambulance crews and is part of a newly co-designed ambulance treatment space.

Towars a chemical reagents and residues management at the teaching laboratories of the Chemistry School of the Universidad Nacional

The academic activities carried out at the School of Chemistry make indispensable to develop actions oriented toward the consolidation of a reagent and residue management system, especially in the teaching laboratories. The project “Management of reagents and residues in the teaching laboratories of the School of Chemistry” works under the Green Chemistry values which designs products and chemical processes that reduce or eliminate the use and production of dangerous substances, to benefit the environment. With a preventive vision, a change from the  laboratory practices is looked to select those with less environmental impact. Additionally, residue quantification is made and its management protocols are developed for each practice. The project has several stages: diagnose, action implementation, student, teacher and administration personnel training and evaluation during the process and at the end of it. The article describes methodological aspects of the project operation emphasizing on reagent and residue quantification through flow diagrams.

A Mapping-Scheduling Algorithm for Hardware Acceleration on Reconfigurable Platforms

Reconfigurable platforms are a promising technology that offers an interesting trade-off between flexibility and performance, which many recent embedded system applications demand, especially in fields such as multimedia processing. These applications typically involve multiple ad-hoc tasks for hardware acceleration, which are usually represented using formalisms such as Data Flow Diagrams (DFDs), Data Flow Graphs (DFGs), Control and Data Flow Graphs (CDFGs) or Petri Nets. However, none of these models is able to capture at the same time the pipeline behavior between tasks (that therefore can coexist in order to minimize the application execution time), their communication patterns, and their data dependencies. This paper proves that the knowledge of all this information can be effectively exploited to reduce the resource requirements and the timing performance of modern reconfigurable systems, where a set of hardware accelerators is used to support the computation. For this purpose, this paper proposes a novel task representation model, named Temporal Constrained Data Flow Diagram (TCDFD), which includes all this information. This paper also presents a mapping-scheduling algorithm that is able to take advantage of the new TCDFD model. It aims at minimizing the dynamic reconfiguration overhead while meeting the communication requirements among the tasks. Experimental results show that the presented approach achieves up to 75% of resources saving and up to 89% of reconfiguration overhead reduction with respect to other state-of-the-art techniques for reconfigurable platforms.

SYSTEM DYNAMICS MODELING AS A QUANTITATIVE-QUALITATIVE FRAMEWORK FOR SUSTAINABLE WATER RESOURCES MANAGEMENT: INSIGHTS FOR WATER QUALITY POLICY IN THE GREAT LAKES REGION

Early water resources modeling efforts were aimed mostly at representing hydrologic processes, but the need for interdisciplinary studies has led to increasing complexity and integration of environmental, social, and economic functions. The gradual shift from merely employing engineering-based simulation models to applying more holistic frameworks is an indicator of promising changes in the traditional paradigm for the application of water resources models, supporting more sustainable management decisions. This dissertation contributes to application of a quantitative-qualitative framework for sustainable water resources management using system dynamics simulation, as well as environmental systems analysis techniques to provide insights for water quality management in the Great Lakes basin. The traditional linear thinking paradigm lacks the mental and organizational framework for sustainable development trajectories, and may lead to quick-fix solutions that fail to address key drivers of water resources problems. To facilitate holistic analysis of water resources systems, systems thinking seeks to understand interactions among the subsystems. System dynamics provides a suitable framework for operationalizing systems thinking and its application to water resources problems by offering useful qualitative tools such as causal loop diagrams (CLD), stock-and-flow diagrams (SFD), and system archetypes. The approach provides a high-level quantitative-qualitative modeling framework for "big-picture" understanding of water resources systems, stakeholder participation, policy analysis, and strategic decision making. While quantitative modeling using extensive computer simulations and optimization is still very important and needed for policy screening, qualitative system dynamics models can improve understanding of general trends and the root causes of problems, and thus promote sustainable water resources decision making. Within the system dynamics framework, a growth and underinvestment (G&U) system archetype governing Lake Allegan's eutrophication problem was hypothesized to explain the system's problematic behavior and identify policy leverage points for mitigation. A system dynamics simulation model was developed to characterize the lake's recovery from its hypereutrophic state and assess a number of proposed total maximum daily load (TMDL) reduction policies, including phosphorus load reductions from point sources (PS) and non-point sources (NPS). It was shown that, for a TMDL plan to be effective, it should be considered a component of a continuous sustainability process, which considers the functionality of dynamic feedback relationships between socio-economic growth, land use change, and environmental conditions. Furthermore, a high-level simulation-optimization framework was developed to guide watershed scale BMP implementation in the Kalamazoo watershed. Agricultural BMPs should be given priority in the watershed in order to facilitate cost-efficient attainment of the Lake Allegan's TP concentration target. However, without adequate support policies, agricultural BMP implementation may adversely affect the agricultural producers. Results from a case study of the Maumee River basin show that coordinated BMP implementation across upstream and downstream watersheds can significantly improve cost efficiency of TP load abatement.