Planning and reporting of quality-of-life outcomes in cancer trials.

BACKGROUND Information about the impact of cancer treatments on patients' quality of life (QoL) is of paramount importance to patients and treating oncologists. Cancer trials that do not specify QoL as an outcome or fail to report collected QoL data, omit crucial information for decision making. To estimate the magnitude of these problems, we investigated how frequently QoL outcomes were specified in protocols of cancer trials and subsequently reported. DESIGN Retrospective cohort study of RCT protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We compared protocols to corresponding publications, which were identified through literature searches and investigator surveys. RESULTS Of the 173 cancer trials, 90 (52%) specified QoL outcomes in their protocol, 2 (1%) as primary and 88 (51%) as secondary outcome. Of the 173 trials, 35 (20%) reported QoL outcomes in a corresponding publication (4 modified from the protocol), 18 (10%) were published but failed to report QoL outcomes in the primary or a secondary publication, and 37 (21%) were not published at all. Of the 83 (48%) trials that did not specify QoL outcomes in their protocol, none subsequently reported QoL outcomes. Failure to report pre-specified QoL outcomes was not associated with industry sponsorship (versus non-industry), sample size, and multicentre (versus single centre) status but possibly with trial discontinuation. CONCLUSIONS About half of cancer trials specified QoL outcomes in their protocols. However, only 20% reported any QoL data in associated publications. Highly relevant information for decision making is often unavailable to patients, oncologists, and health policymakers.

Packages of interventions for family planning, safe abortion care, maternal, newborn and child health

The evidence shows that high maternal, perinatal, neonatal and child mortality rates are associated with inadequate and poor quality health services. Evidence also suggests that explicit, evidence-based, cost effective packages of interventions can improve the processes and outcomes of health care when appropriately implemented. This document describes the key effective interventions organized in packages across the continuum of care through pre-pregnancy, pregnancy, childbirth, postpartum, newborn care and care of the child. The packages are defined for community and/or facility levels in developing countries and provide guidance on the essential components needed to assure adequacy and quality of care

Using ecological niche models to support tree species selection for forest restoration planning in largely deforested regions

Species selection for forest restoration is often supported by expert knowledge on local distribution patterns of native tree species. This approach is not applicable to largely deforested regions unless enough data on pre-human tree species distribution is available. In such regions, ecological niche models may provide essential information to support species selection in the framework of forest restoration planning. In this study we used ecological niche models to predict habitat suitability for native tree species in "Tierra de Campos" region, an almost totally deforested area of the Duero Basin (Spain). Previously available models provide habitat suitability predictions for dominant native tree species, but including non-dominant tree species in the forest restoration planning may be desirable to promote biodiversity, specially in largely deforested areas were near seed sources are not expected. We used the Forest Map of Spain as species occurrence data source to maximize the number of modeled tree species. Penalized logistic regression was used to train models using climate and lithological predictors. Using model predictions a set of tools were developed to support species selection in forest restoration planning. Model predictions were used to build ordered lists of suitable species for each cell of the study area. The suitable species lists were summarized drawing maps that showed the two most suitable species for each cell. Additionally, potential distribution maps of the suitable species for the study area were drawn. For a scenario with two dominant species, the models predicted a mixed forest (Quercus ilex and a coniferous tree species) for almost one half of the study area. According to the models, 22 non-dominant native tree species are suitable for the study area, with up to six suitable species per cell. The model predictions pointed to Crataegus monogyna, Juniperus communis, J.oxycedrus and J.phoenicea as the most suitable non-dominant native tree species in the study area. Our results encourage further use of ecological niche models for forest restoration planning in largely deforested regions.

Multimodal non-rigid image registration methods for therapy and surgery planning

La planificación pre-operatoria se ha convertido en una tarea esencial en cirugías y terapias de marcada complejidad, especialmente aquellas relacionadas con órgano blando. Un ejemplo donde la planificación preoperatoria tiene gran interés es la cirugía hepática. Dicha planificación comprende la detección e identificación precisa de las lesiones individuales y vasos así como la correcta segmentación y estimación volumétrica del hígado funcional. Este proceso es muy importante porque determina tanto si el paciente es un candidato adecuado para terapia quirúrgica como la definición del abordaje a seguir en el procedimiento. La radioterapia de órgano blando es un segundo ejemplo donde la planificación se requiere tanto para la radioterapia externa convencional como para la radioterapia intraoperatoria. La planificación comprende la segmentación de tumor y órganos vulnerables y la estimación de la dosimetría. La segmentación de hígado funcional y la estimación volumétrica para planificación de la cirugía se estiman habitualmente a partir de imágenes de tomografía computarizada (TC). De igual modo, en la planificación de radioterapia, los objetivos de la radiación se delinean normalmente sobre TC. Sin embargo, los avances en las tecnologías de imagen de resonancia magnética (RM) están ofreciendo progresivamente ventajas adicionales. Por ejemplo, se ha visto que el ratio de detección de metástasis hepáticas es significativamente superior en RM con contraste Gd–EOB–DTPA que en TC. Por tanto, recientes estudios han destacado la importancia de combinar la información de TC y RM para conseguir el mayor nivel posible de precisión en radioterapia y para facilitar una descripción precisa de las lesiones del hígado. Con el objetivo de mejorar la planificación preoperatoria en ambos escenarios se precisa claramente de un algoritmo de registro no rígido de imagen. Sin embargo, la gran mayoría de sistemas comerciales solo proporcionan métodos de registro rígido. Las medidas de intensidad de voxel han demostrado ser criterios de similitud de imágenes robustos, y, entre ellas, la Información Mutua (IM) es siempre la primera elegida en registros multimodales. Sin embargo, uno de los principales problemas de la IM es la ausencia de información espacial y la asunción de que las relaciones estadísticas entre las imágenes son homogéneas a lo largo de su domino completo. La hipótesis de esta tesis es que la incorporación de información espacial de órganos al proceso de registro puede mejorar la robustez y calidad del mismo, beneficiándose de la disponibilidad de las segmentaciones clínicas. En este trabajo, se propone y valida un esquema de registro multimodal no rígido 3D usando una nueva métrica llamada Información Mutua Centrada en el Órgano (Organ-Focused Mutual Information metric (OF-MI)) y se compara con la formulación clásica de la Información Mutua. Esto permite mejorar los resultados del registro en áreas problemáticas incorporando información regional al criterio de similitud, beneficiándose de la disponibilidad real de segmentaciones en protocolos estándares clínicos, y permitiendo que la dependencia estadística entre las dos modalidades de imagen difiera entre órganos o regiones. El método propuesto se ha aplicado al registro de TC y RM con contraste Gd–EOB–DTPA así como al registro de imágenes de TC y MR para planificación de radioterapia intraoperatoria rectal. Adicionalmente, se ha desarrollado un algoritmo de apoyo de segmentación 3D basado en Level-Sets para la incorporación de la información de órgano en el registro. El algoritmo de segmentación se ha diseñado específicamente para la estimación volumétrica de hígado sano funcional y ha demostrado un buen funcionamiento en un conjunto de imágenes de TC abdominales. Los resultados muestran una mejora estadísticamente significativa de OF-MI comparada con la Información Mutua clásica en las medidas de calidad de los registros; tanto con datos simulados (p<0.001) como con datos reales en registro hepático de TC y RM con contraste Gd– EOB–DTPA y en registro para planificación de radioterapia rectal usando OF-MI multi-órgano (p<0.05). Adicionalmente, OF-MI presenta resultados más estables con menor dispersión que la Información Mutua y un comportamiento más robusto con respecto a cambios en la relación señal-ruido y a la variación de parámetros. La métrica OF-MI propuesta en esta tesis presenta siempre igual o mayor precisión que la clásica Información Mutua y consecuentemente puede ser una muy buena alternativa en aplicaciones donde la robustez del método y la facilidad en la elección de parámetros sean particularmente importantes. Abstract Pre-operative planning has become an essential task in complex surgeries and therapies, especially for those affecting soft tissue. One example where soft tissue preoperative planning is of high interest is liver surgery. It involves the accurate detection and identification of individual liver lesions and vessels as well as the proper functional liver segmentation and volume estimation. This process is very important because it determines whether the patient is a suitable candidate for surgical therapy and the type of procedure. Soft tissue radiation therapy is a second example where planning is required for both conventional external and intraoperative radiotherapy. It involves the segmentation of the tumor target and vulnerable organs and the estimation of the planned dose. Functional liver segmentations and volume estimations for surgery planning are commonly estimated from computed tomography (CT) images. Similarly, in radiation therapy planning, targets to be irradiated and healthy and vulnerable tissues to be protected from irradiation are commonly delineated on CT scans. However, developments in magnetic resonance imaging (MRI) technology are progressively offering advantages. For instance, the hepatic metastasis detection rate has been found to be significantly higher in Gd–EOB–DTPAenhanced MRI than in CT. Therefore, recent studies highlight the importance of combining the information from CT and MRI to achieve the highest level of accuracy in radiotherapy and to facilitate accurate liver lesion description. In order to improve those two soft tissue pre operative planning scenarios, an accurate nonrigid image registration algorithm is clearly required. However, the vast majority of commercial systems only provide rigid registration. Voxel intensity measures have been shown to be robust measures of image similarity, and among them, Mutual Information (MI) is always the first candidate in multimodal registrations. However, one of the main drawbacks of Mutual Information is the absence of spatial information and the assumption that statistical relationships between images are the same over the whole domain of the image. The hypothesis of the present thesis is that incorporating spatial organ information into the registration process may improve the registration robustness and quality, taking advantage of the clinical segmentations availability. In this work, a multimodal nonrigid 3D registration framework using a new Organ- Focused Mutual Information metric (OF-MI) is proposed, validated and compared to the classical formulation of the Mutual Information (MI). It allows improving registration results in problematic areas by adding regional information into the similitude criterion taking advantage of actual segmentations availability in standard clinical protocols and allowing the statistical dependence between the two modalities differ among organs or regions. The proposed method is applied to CT and T1 weighted delayed Gd–EOB–DTPA-enhanced MRI registration as well as to register CT and MRI images in rectal intraoperative radiotherapy planning. Additionally, a 3D support segmentation algorithm based on Level-Sets has been developed for the incorporation of the organ information into the registration. The segmentation algorithm has been specifically designed for the healthy and functional liver volume estimation demonstrating good performance in a set of abdominal CT studies. Results show a statistical significant improvement of registration quality measures with OF-MI compared to MI with both simulated data (p<0.001) and real data in liver applications registering CT and Gd–EOB–DTPA-enhanced MRI and in registration for rectal radiotherapy planning using multi-organ OF-MI (p<0.05). Additionally, OF-MI presents more stable results with smaller dispersion than MI and a more robust behavior with respect to SNR changes and parameters variation. The proposed OF-MI always presents equal or better accuracy than the classical MI and consequently can be a very convenient alternative within applications where the robustness of the method and the facility to choose the parameters are particularly important.

Feasibility assessment of the interactive use of a Monte Carlo algorithm in treatment planning for intraoperative electron radiation therapy

This work analysed the feasibility of using a fast, customized Monte Carlo (MC) method to perform accurate computation of dose distributions during pre- and intraplanning of intraoperative electron radiation therapy (IOERT) procedures. The MC method that was implemented, which has been integrated into a specific innovative simulation and planning tool, is able to simulate the fate of thousands of particles per second, and it was the aim of this work to determine the level of interactivity that could be achieved. The planning workflow enabled calibration of the imaging and treatment equipment, as well as manipulation of the surgical frame and insertion of the protection shields around the organs at risk and other beam modifiers. In this way, the multidisciplinary team involved in IOERT has all the tools necessary to perform complex MC dosage simulations adapted to their equipment in an efficient and transparent way. To assess the accuracy and reliability of this MC technique, dose distributions for a monoenergetic source were compared with those obtained using a general-purpose software package used widely in medical physics applications. Once accuracy of the underlying simulator was confirmed, a clinical accelerator was modelled and experimental measurements in water were conducted. A comparison was made with the output from the simulator to identify the conditions under which accurate dose estimations could be obtained in less than 3 min, which is the threshold imposed to allow for interactive use of the tool in treatment planning. Finally, a clinically relevant scenario, namely early-stage breast cancer treatment, was simulated with pre- and intraoperative volumes to verify that it was feasible to use the MC tool intraoperatively and to adjust dose delivery based on the simulation output, without compromising accuracy. The workflow provided a satisfactory model of the treatment head and the imaging system, enabling proper configuration of the treatment planning system and providing good accuracy in the dosage simulation.

Pre-investigation of water electrolysis for flexible energy storage at large scales: the case of the Spanish power system

This report analyzes the basis of hydrogen and power integration strategies, by using water electrolysis processes as a means of flexible energy storage at large scales. It is a prospective study, where the scope is to describe the characteristics of current power systems (like the generation technologies, load curves and grid constraints), and define future scenarios of hydrogen for balancing the electrical grids, considering the efficiency, economy and easiness of operations. We focus in the "Spanish case", which is a good example for planning the transition from a power system holding large reserve capacities, high penetration of renewable energies and limited interconnections, to a more sustainable energy system being capable to optimize the volumes, the regulation modes, the utilization ratios and the impacts of the installations. Thus, we explore a novel aspect of the "hydrogen economy" which is based in the potentials of existing power systems and the properties of hydrogen as energy carrier, by considering the electricity generation and demand globally and determining the optimal size and operation of the hydrogen production processes along the country; e.g. the cost production of hydrogen becomes viable for a base-load scenario with 58 TWh/year of power surplus at 0.025 V/kWh, and large number electrolyzer plants (50 MW) running in variable mode (1-12 kA/m2)

RADIANCE-A planning software for intra-operative radiation therapy

In the last decades accumulated clinical evidence has proven that intra-operative radiation therapy (IORT) is a very valuable technique. In spite of that, planning technology has not evolved since its conception, being outdated in comparison to current state of the art in other radiotherapy techniques and therefore slowing down the adoption of IORT. RADIANCE is an IORT planning system, CE and FDA certified, developed by a consortium of companies, hospitals and universities to overcome such technological backwardness. RADIANCE provides all basic radiotherapy planning tools which are specifically adapted to IORT. These include, but are not limited to image visualization, contouring, dose calculation algorithms-Pencil Beam (PB) and Monte Carlo (MC), DVH calculation and reporting. Other new tools, such as surgical simulation tools have been developed to deal with specific conditions of the technique. Planning with preoperative images (preplanning) has been evaluated and the validity of the system being proven in terms of documentation, treatment preparation, learning as well as improvement of surgeons/radiation oncologists (ROs) communication process. Preliminary studies on Navigation systems envisage benefits on how the specialist to accurately/safely apply the pre-plan into the treatment, updating the plan as needed. Improvements on the usability of this kind of systems and workflow are needed to make them more practical. Preliminary studies on Intraoperative imaging could provide an improved anatomy for the dose computation, comparing it with the previous pre-plan, although not all devices in the market provide good characteristics to do so. DICOM.RT standard, for radiotherapy information exchange, has been updated to cover IORT particularities and enabling the possibility of dose summation with external radiotherapy. The effect of this planning technology on the global risk of the IORT technique has been assessed and documented as part of a failure mode and effect analysis (FMEA). Having these technological innovations and their clinical evaluation (including risk analysis) we consider that RADIANCE is a very valuable tool to the specialist covering the demands from professional societies (AAPM, ICRU, EURATOM) for current radiotherapy procedures.

Shopping malls and neoliberal trends in Southern European cities: Post-metropolitan challenges for urban planning policy

Whilst shopping malls have been explored at length by critical urban studies, there has been little exploration of their role in restructuring the practice of urban and spatial planning. This article uses the shopping mall as an object of study in the light of the neoliberal trends and post-metropolisation in Southern Europe, with the aim of exploring challenges for urban governance and planning practice and with a focus on the role of the ongoing economic crisis. A threefold exploratory framework – the ‘lost-in-time scenario’, the ‘messianic mall model’ and the ‘(im)mature planning explanation’ – is used to make sense of the local versions of shopping mall development in Lisbon (Portugal) and Palermo (Southern Italy). According to findings, we highlight the clash between the multi-scalar nature of shopping malls and the dominance of the municipal scale in regulatory planning frameworks, and the risk that shopping mall development (at least in Southern Europe) may replicate uneven development patterns, reproducing the pre-conditions of the crisis without helping to overcome it.

Préliminaires d'art civique, mis en relation avec le "Cas clinique" de la Belgique.

"Pour la reconstruction des villes de localités détruites ou endommagées en Belgique": p. [167]-298 (with special t.-p.)

Planning and cost sharing policy options for water and related land programs.

Some parts are composed chiefly of statistical tables.

Modelling pre-clearing vegetation distribution using GIS-integrated statistical, ecological and data models: A case study from the wet tropics of Northeastern Australia

Traditional vegetation mapping methods use high cost, labour-intensive aerial photography interpretation. This approach can be subjective and is limited by factors such as the extent of remnant vegetation, and the differing scale and quality of aerial photography over time. An alternative approach is proposed which integrates a data model, a statistical model and an ecological model using sophisticated Geographic Information Systems (GIS) techniques and rule-based systems to support fine-scale vegetation community modelling. This approach is based on a more realistic representation of vegetation patterns with transitional gradients from one vegetation community to another. Arbitrary, though often unrealistic, sharp boundaries can be imposed on the model by the application of statistical methods. This GIS-integrated multivariate approach is applied to the problem of vegetation mapping in the complex vegetation communities of the Innisfail Lowlands in the Wet Tropics bioregion of Northeastern Australia. The paper presents the full cycle of this vegetation modelling approach including sampling sites, variable selection, model selection, model implementation, internal model assessment, model prediction assessments, models integration of discrete vegetation community models to generate a composite pre-clearing vegetation map, independent data set model validation and model prediction's scale assessments. An accurate pre-clearing vegetation map of the Innisfail Lowlands was generated (0.83r(2)) through GIS integration of 28 separate statistical models. This modelling approach has good potential for wider application, including provision of. vital information for conservation planning and management; a scientific basis for rehabilitation of disturbed and cleared areas; a viable method for the production of adequate vegetation maps for conservation and forestry planning of poorly-studied areas. (c) 2006 Elsevier B.V. All rights reserved.

Computer-assisted production scheduling, planning and control in foundries

The present study describes a pragmatic approach to the implementation of production planning and scheduling techniques in foundries of all types and looks at the use of `state-of-the-art' management control and information systems. Following a review of systems for the classification of manufacturing companies, a definitive statement is made which highlights the important differences between foundries (i.e. `component makers') and other manufacturing companies (i.e. `component buyers'). An investigation of the manual procedures which are used to plan and control the manufacture of components reveals the inherent problems facing foundry production management staff, which suggests the unsuitability of many manufacturing techniques which have been applied to general engineering companies. From the literature it was discovered that computer-assisted systems are required which are primarily `information-based' rather than `decision based', whilst the availability of low-cost computers and `packaged-software' has enabled foundries to `get their feet wet' without the financial penalties which characterized many of the early attempts at computer-assistance (i.e. pre-1980). Moreover, no evidence of a single methodology for foundry scheduling emerged from the review. A philosophy for the development of a CAPM system is presented, which details the essential information requirements and puts forward proposals for the subsequent interactions between types of information and the sub-system of CAPM which they support. The work developed was oriented specifically at the functions of production planning and scheduling and introduces the concept of `manual interaction' for effective scheduling. The techniques developed were designed to use the information which is readily available in foundries and were found to be practically successful following the implementation of the techniques into a wide variety of foundries. The limitations of the techniques developed are subsequently discussed within the wider issues which form a CAPM system, prior to a presentation of the conclusions which can be drawn from the study.

Strategic planning in a decentralised industrial group : a process-action study

The research was carried out within a major public company. It sought to implement an approach to strategic planning which accounted for organisational values as well as employing a holistic value-free analysis of the firm and its environment. To this end, an 'ecological' model of the firm was formulated. A series of value-free strategic policies for its development were generated. These policies were validated by the company's top-management.They compared favourably with their own planning outcomes. The approach appeared to be diagnostically strong but lacked sufficient depth in the context of finding realistic corrective measures. However, feedback from the company showed it to be a useful complementary process to conventional procedures, in providing an explicitly different perspective. The research empirically evaluated the company's value-systems and their influence on strategy. It introduced the idea of an organisational 'self-concept' pre-determining the acceptability of various strategies.The values and the "self-concept' of the company were identified and validated, They appeared to have considerable influence on strategy. In addition, tho company's planning process within the decentralised structure was shown to be sub-optimal. This resulted from the variety of value systems maintained by different parts of the organisation. Proposals attempting to redress this situation were ofJered and several accepted. The study was postured as process-action research and the chosen perspective could be succinctly described as a 'worm's-eye view', akin to that of many real planners operating at some distance from the decision-making body. In this way, the normal strategic functionings of the firm and any changes resulting from the researcher's intervention were observed and recorded. Recurrent difficulties of the planning process resulting from the decentralised structure were identified. The overall procedure suggested as a result of the research aimed to increase the viabiIity of planning and the efficiency of the process. It is considered to be flexible enough to be applicable in a broader context.

Pre-conception care : current practice and methods of provision

This thesis examines the present provisions for pre-conception care and the views of the providers of services. Pre-conception care is seen by some clinicians and health educators as a means of making any necessary changes in life style, corrections to imbalances in the nutritional status of the prospective mother (and father) and the assessment of any medical problems, thus maximizing the likelihood of the normal development of the baby. Pre-conception care may be described as a service to bridge the gap between the family planning clinic and the first ante-natal booking appointment. There were three separate foci for the empirical research - the Foresight organisation (a charity which has pioneered pre-conception care in Britain); the pre-conception care clinic at the West London Hospital, Hammersmith; and the West Midlands Regional Health Authority. The six main sources of data were: twenty five clinicians operating Foresight pre-conception clinics, couples attending pre-conception clinics, committee members of the Foresight organisation, staff of the West London Hospital pre-conception clinic, Hammersmith, District Health Education Officers working in the West Midlands Regional Health Authority and the members of the Ante-Natal Care Action Group, a sub-group of the Regional Health Advisory Group on Health Promotion and Preventive Medicine. A range of research methods were adopted. These were as follows: questionnaires and report forms used in co-operation with the Foresight clinicians, interviews, participant observation discussions and informal meetings and, finally, literature and official documentation. The research findings illustrated that pre-conception care services provided at the predominantly private Foresight clinics were of a rather `ad hoc' nature. The type of provision varied considerably and clearly reflected the views held by its providers. The protocol which had been developed to assist in the standardization of results was not followed by the clinicians. The pre-conception service provided at the West London Hospital shared some similarities in its approach with the Foresight provision; a major difference was that it did not advocate the use of routine hair trace metal analysis. Interviews with District Health Education Officers and with members of the Ante Natal Care Action Group revealed a tentative and cautious approach to pre-conception care generally and to the Foresight approach in particular. The thesis concludes with a consideration of the future of pre-conception care and the prospects for the establishment of a comprehensive pre-conception care service.