Using a NPWE model observer to assess suitable image quality for a digital mammography quality assurance programme.

A method of objectively determining imaging performance for a mammography quality assurance programme for digital systems was developed. The method is based on the assessment of the visibility of a spherical microcalcification of 0.2 mm using a quasi-ideal observer model. It requires the assessment of the spatial resolution (modulation transfer function) and the noise power spectra of the systems. The contrast is measured using a 0.2-mm thick Al sheet and Polymethylmethacrylate (PMMA) blocks. The minimal image quality was defined as that giving a target contrast-to-noise ratio (CNR) of 5.4. Several evaluations of this objective method for evaluating image quality in mammography quality assurance programmes have been considered on computed radiography (CR) and digital radiography (DR) mammography systems. The measurement gives a threshold CNR necessary to reach the minimum standard image quality required with regards to the visibility of a 0.2-mm microcalcification. This method may replace the CDMAM image evaluation and simplify the threshold contrast visibility test used in mammography quality.

In vitro-in vivo Pharmacokinetic correlation model for quality assurance of antiretroviral drugs

Introduction: The In vitro-in vivo pharmacokinetic correlation models (IVIVC) are a fundamental part of the drug discovery and development process. The ability to accurately predict the in vivo pharmacokinetic profile of a drug based on in vitro observations can have several applications during a successful development process. Objective: To develop a comprehensive model to predict the in vivo absorption of antiretroviral drugs based on permeability studies, in vitro and in vivo solubility and demonstrate its correlation with the pharmacokinetic profile in humans. Methods: Analytical tools to test the biopharmaceutical properties of stavudine, lamivudine y zidovudine were developed. The kinetics of dissolution, permeability in caco-2 cells and pharmacokinetics of absorption in rabbits and healthy volunteers were evaluated. Results: The cumulative areas under the curve (AUC) obtained in the permeability study with Caco-2 cells, the dissolution study and the pharmacokinetics in rabbits correlated with the cumulative AUC values in humans. These results demonstrated a direct relation between in vitro data and absorption, both in humans and in the in vivo model. Conclusions: The analytical methods and procedures applied to the development of an IVIVC model showed a strong correlation among themselves. These IVIVC models are proposed as alternative and cost/effective methods to evaluate the biopharmaceutical properties that determine the bioavailability of a drug and their application includes the development process, quality assurance, bioequivalence studies and pharmacosurveillance.

Enabling Change in Universities: Enhancing Education for Sustainable Development with Tools for Quality Assurance

Enabling Change in Universities: Enhancing Education for Sustainable Development with Tools for Quality Assurance This thesis deals with enabling change in universities, more explicitly enhancing education for sustainable development with tools for quality assurance. Change management is a discipline within management that was developed in the 1980s because business changed from being predictable to unpredictable. The PEST mnemonic is a method to categorize factors enabling change; such as political, economic, socio-cultural and technological factors, which all affect higher education. A classification of a change, in either hard or soft, can help understanding the type of change that an organization is facing. Hard changes are more applied to problems that have clear objectives and indicators, with a known cause of the problem. Soft changes are applied to larger problems that affect the entire organization or beyond it. The basic definition for sustainable development is: the future generations should have similar opportunities as the previous. The UN has set as a global goal an integration of education for sustainable development (ESD) at all levels of education during 2005- 2014. The goal is set also in universities, the graduates of which are future leaders for all labor markets. The objective for ESD in higher education is that graduates obtain the competence to take economic, social and environmental costs and benefits into account when making decisions. Knowledge outcomes should aim for systematic and holistic thinking, which requires cross disciplinary education. So far, the development of ESD has not achieved its goals. The UN has identified a need for more transdisclipnary research in ESD. A joint global requirement for universities is quality assurance, the aim of which is to secure and improve teaching and learning. Quality, environmental and integrated management systems are used by some universities for filling the quality assurance requirements. The goal of this thesis is to open up new ways for enhancing ESD in universities, beyond the forerunners; by exploring how management systems could be used as tools for promoting ESD. The thesis is based on five studies. In the first study, I focus on if and how tools for quality assurance could be benefitted for promoting ESD. It is written from a new perspective, the memetic, for reaching a diversity of faculty. A meme is an idea that diffuses from brain to brain. It can be applied for cultural evolution. It is a theory that is based on the evolutionary theory by Darwin, applied for social sciences. In the second Paper, I present the results from the development of the pilot process model for enhancing ESD with management systems. The development of the model is based on a study that includes earlier studies, a survey in academia and an analysis of the practice in 11 universities in the Nordic countries. In the third study, I explore if the change depends on national culture or if it is global. It is a comparative study on both policy and implementation level, between the Nordic countries and China. The fourth study is a single case study based on change management. In this study, I identify what to consider in order to enable the change: enhancing ESD with tools for quality assurance in universities. In the fifth Paper, I present the results of the process model for enhancing ESD with management systems. The model was compared with identified drivers and barriers for enhancing ESD and for implementing management systems. Finally, the process model was piloted and applied for identifying sustainability aspects in curricula. Action research was chosen as methodology because there are not already implemented approaches using quality management for promoting ESD, why the only way to study this is to make it happen. Another reason for choosing action research is since it is essential to involve students and faculty for enhancing ESD. Action based research consists of the following phases: a) diagnosing, b) planning action, c) taking action and d) evaluating action. This research was made possible by a project called Education for Sustainable Development in Academia in the Nordic countries, ESDAN, in which activities were divided into these four phases. Each phase ended with an open seminar, where the results of the study were presented. The objective for the research project was to develop a process for including knowledge in sustainable development in curricula, which could be used in the quality assurance work. Eleven universities from the Nordic countries cooperated in the project. The aim was, by applying the process, to identify and publish examples of relevant sustainability aspects in different degree programs in universities in the Nordic countries. The project was partly financed by the Nordic Council of Ministers and partly by the participating pilot universities. Based on the results of my studies, I consider that quality, environmental and integrated management systems can be used for promoting ESD in universities. Relevant sustainability aspects have been identified in different fields of studies by applying the final process model. The final process model was compared with drivers and barriers for enhancing ESD and for implementing management systems in universities and with succeeding with management systems in industry. It corresponds with these, meaning that drivers are taken into account and barriers tackled. Both ESD and management systems in universities could be considered successful memes, which can reflect an effective way of communication among individuals. I have identified that management systems could be used as tools for hard changes and to support the soft change of enhancing ESD in universities with management system. Based on the change management study I have summarized recommendations on what to consider in order to enable the studied change. The main practical implications of the results are that the process model could be applied for assessment, benchmarking and communication of ESD, connected to quality assurance, when applied. This is possible because the information can be assembled in one picture, which facilitates comparison. The memetic approach can be applied for structuring. It is viable to make comparative studies between cultures, for getting insight in special characteristics of the own culture. Action based research is suitable for involving faculty. Change management can be applied for planning a change, which both enhancing ESD and developing management systems are identified to be.

Enabling the evolution of J2EE applications through reverse engineering and quality assurance

Enterprise Applications are complex software systems that manipulate much persistent data and interact with the user through a vast and complex user interface. In particular applications written for the Java 2 Platform, Enterprise Edition (J2EE) are composed using various technologies such as Enterprise Java Beans (EJB) or Java Server Pages (JSP) that in turn rely on languages other than Java, such as XML or SQL. In this heterogeneous context applying existing reverse engineering and quality assurance techniques developed for object-oriented systems is not enough. Because those techniques have been created to measure quality or provide information about one aspect of J2EE applications, they cannot properly measure the quality of the entire system. We intend to devise techniques and metrics to measure quality in J2EE applications considering all their aspects and to aid their evolution. Using software visualization we also intend to inspect to structure of J2EE applications and all other aspects that can be investigate through this technique. In order to do that we also need to create a unified meta-model including all elements composing a J2EE application.

BENCHMARKING AND IMPLEMENTATION OF A NEW INDEPENDENT MONTE CARLO DOSE CALCULATION QUALITY ASSURANCE AUDIT TOOL FOR CLINICAL TRIALS

Introduction Commercial treatment planning systems employ a variety of dose calculation algorithms to plan and predict the dose distributions a patient receives during external beam radiation therapy. Traditionally, the Radiological Physics Center has relied on measurements to assure that institutions participating in the National Cancer Institute sponsored clinical trials administer radiation in doses that are clinically comparable to those of other participating institutions. To complement the effort of the RPC, an independent dose calculation tool needs to be developed that will enable a generic method to determine patient dose distributions in three dimensions and to perform retrospective analysis of radiation delivered to patients who enrolled in past clinical trials. Methods A multi-source model representing output for Varian 6 MV and 10 MV photon beams was developed and evaluated. The Monte Carlo algorithm, know as the Dose Planning Method (DPM), was used to perform the dose calculations. The dose calculations were compared to measurements made in a water phantom and in anthropomorphic phantoms. Intensity modulated radiation therapy and stereotactic body radiation therapy techniques were used with the anthropomorphic phantoms. Finally, past patient treatment plans were selected and recalculated using DPM and contrasted against a commercial dose calculation algorithm. Results The multi-source model was validated for the Varian 6 MV and 10 MV photon beams. The benchmark evaluations demonstrated the ability of the model to accurately calculate dose for the Varian 6 MV and the Varian 10 MV source models. The patient calculations proved that the model was reproducible in determining dose under similar conditions described by the benchmark tests. Conclusions The dose calculation tool that relied on a multi-source model approach and used the DPM code to calculate dose was developed, validated, and benchmarked for the Varian 6 MV and 10 MV photon beams. Several patient dose distributions were contrasted against a commercial algorithm to provide a proof of principal to use as an application in monitoring clinical trial activity.

Quality Assurance in Extreme Programming

Our previous research about possible quality improvements in Extreme Programming (XP) led us to a conclusion that XP supports many good engineering practices but there is still place for refinements. Our proposal was to add dedicated Quality Assurance (QA) measures, which should be sufficiently effective and at the same time simpler enough in the context of XP. This paper intends to analyze the possibilities for an effective way for applying approved quality assurance practices to XP. The last should not affect negatively to the process and in the meantime must lead to better quality assurance. We aim to make changes to XP that even if would slow down a bit the development process, will make it more suitable for widest range of projects including large and very large projects as well as life critical and highly reliable systems.

Implementing the European quality assurance in vocational education and training (EQAVET) at national level: Some insights from the PEN Leonardo project

EQAVET, the quality assurance tool in vocational and educational training, was developed in response to the need for a supply of a trained workforce for labour market needs. Implementation of EQAVET at national level, however, remains a challenge. The research reported here focused on the implementation of QA processes by VET providers in 4 countries: Malta, Italy, Turkey, and Sweden. Data was collected through a questionnaire with 62 VET providers. Responses showed that there is an overall commitment to quality. There is, however, little knowledge of EQAVET across the countries, with the exception of Malta. None the less, all VET providers have implemented some aspects of EQAVET, even if not always intentionally. The situation is, however, far from EQAVET being fully implemented. Reflections are made on whether the EQAVET model specifically or qualification assurance principles assurances should be promoted across Europe. (DIPF/Orig.)

Quality Assurance Through a Continuous Curriculum Review (CCR) Strategy: Reflections on a Pilot Project

Institutional research can be defined as "the activity in which the research effort of an academic institution is directed at the solution of its own problems and to the enhancement of its own performance" (Woodward, 1993, p. 113). This paper describes and reflects on an attempt at the University of Queensland to address the need for course quality appraisal for improvement. The strategy, Continuous Curriculum Review (CCR) is simply an attempt to trial and promote regular comprehensive data collection for developing 'snapshot' views of whole curricula so that decisions about what to change and what to change first can be made in an empirically defensible and timely manner. The strategy and reporting protocols that were developed are described, and the costs and benefits of engaging in this kind of data gathering exercise for quality assurance and quality enhancement purposes are discussed.

Quality assurance and quality control in mammography: a review of available guidance worldwide

Objectives - Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Methods - Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Results - Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. Conclusions - The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources.

Voltammetric quantification of fluoxetine: application to quality control and quality assurance processes

The oxidative behaviour of fluoxetine was studied at a glassy carbon electrode in various buffer systems and at different pH using cyclic, differential pulse and square wave voltammetry. A new square wave voltammetric method suitable for the quality control of fluoxetine in commercial formulations has been developed using a borate pH 9 buffer solution as supporting electrolyte. Under optimized conditions, a linear response was obtained in the range 10 to 16 μM with a detection limit of 1.0 μM. Validation parameters such as sensitivity, precision and accuracy were evaluated. The proposed method was successfully applied to the determination of fluoxetine in pharmaceutical formulations. The results were statistically compared with those obtained by the reference high-performance liquid chromatographic method. No significant differences were found between the methods.

Recommendations on quality control and quality assurance in cervical cytology

Objective: We aimed to critically evaluate the importance of quality control (QC) and quality assurance (QA) strategies in the routine work of uterine cervix cytology. Study Design: We revised all the main principles of QC and QA that are already being implemented worldwide and then discussed the positive aspects and limitations of these as well as proposing alternatives when pertinent. Results: A literature review was introduced after highlighting the main historical revisions, and then a critical evaluation of the principal innovations in screening programmes was conducted, with recommendations being postulated. Conclusions: Based on the analysed data, QC and QA are two essential arms that support the quality of a screening programme.

Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review.

INTRODUCTION: EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients with intermediate risk localized prostate cancer. In order to assess the compliance to the 3D conformal radiotherapy protocol guidelines, all participating centres were requested to participate in a dummy run procedure. An individual case review was performed for the largest recruiting centres as well. MATERIALS AND METHODS: CT-data of an eligible prostate cancer patient were sent to 30 centres including a description of the clinical case. The investigator was requested to delineate the volumes of interest and to perform treatment planning according to the protocol. Thereafter, the investigators of the 12 most actively recruiting centres were requested to provide data on five randomly selected patients for an individual case review. RESULTS: Volume delineation varied significantly between investigators. Dose constraints for organs at risk (rectum, bladder, hips) were difficult to meet. In the individual case review, no major protocol deviations were observed, but a number of dose reporting problems were documented for centres using IMRT. CONCLUSIONS: Overall, results of this quality assurance program were satisfactory. The efficacy of the combination of a dummy run procedure with an individual case review is confirmed in this study, as none of the evaluated patient files harboured a major protocol deviation. Quality assurance remains a very important tool in radiotherapy to increase the reliability of the trial results. Special attention should be given when designing quality assurance programs for more complex irradiation techniques.

New perspectives in the use of ink evidence in forensic science: Part I. Development of a quality assurance process for forensic ink analysis by HPTLC

The level of information provided by ink evidence to the criminal and civil justice system is limited. The limitations arise from the weakness of the interpretative framework currently used, as proposed in the ASTM 1422-05 and 1789-04 on ink analysis. It is proposed to use the likelihood ratio from the Bayes theorem to interpret ink evidence. Unfortunately, when considering the analytical practices, as defined in the ASTM standards on ink analysis, it appears that current ink analytical practices do not allow for the level of reproducibility and accuracy required by a probabilistic framework. Such framework relies on the evaluation of the statistics of the ink characteristics using an ink reference database and the objective measurement of similarities between ink samples. A complete research programme was designed to (a) develop a standard methodology for analysing ink samples in a more reproducible way, (b) comparing automatically and objectively ink samples and (c) evaluate the proposed methodology in a forensic context. This report focuses on the first of the three stages. A calibration process, based on a standard dye ladder, is proposed to improve the reproducibility of ink analysis by HPTLC, when these inks are analysed at different times and/or by different examiners. The impact of this process on the variability between the repetitive analyses of ink samples in various conditions is studied. The results show significant improvements in the reproducibility of ink analysis compared to traditional calibration methods.

Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review.

INTRODUCTION: The phase III EORTC 22033-26033/NCIC CE5 intergroup trial compares 50.4 Gy radiotherapy with up-front temozolomide in previously untreated low-grade glioma. We describe the digital EORTC individual case review (ICR) performed to evaluate protocol radiotherapy (RT) compliance. METHODS: Fifty-eight institutions were asked to submit 1-2 randomly selected cases. Digital ICR datasets were uploaded to the EORTC server and accessed by three central reviewers. Twenty-seven parameters were analysed including volume delineation, treatment planning, organ at risk (OAR) dosimetry and verification. Consensus reviews were collated and summary statistics calculated. RESULTS: Fifty-seven of seventy-two requested datasets from forty-eight institutions were technically usable. 31/57 received a major deviation for at least one section. Relocation accuracy was according to protocol in 45. Just over 30% had acceptable target volumes. OAR contours were missing in an average of 25% of cases. Up to one-third of those present were incorrectly drawn while dosimetry was largely protocol compliant. Beam energy was acceptable in 97% and 48 patients had per protocol beam arrangements. CONCLUSIONS: Digital RT plan submission and review within the EORTC 22033-26033 ICR provide a solid foundation for future quality assurance procedures. Strict evaluation resulted in overall grades of minor and major deviation for 37% and 32%, respectively.