Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers (QIBs) to measure changes in these features. Critical to the performance of a QIB in preclinical or clinical settings are three primary metrology areas of interest: measurement linearity and bias, repeatability, and the ability to consistently reproduce equivalent results when conditions change, as would be expected in any clinical trial. Unfortunately, performance studies to date differ greatly in designs, analysis method and metrics used to assess a QIB for clinical use. It is therefore, difficult or not possible to integrate results from different studies or to use reported results to design studies. The Radiological Society of North America (RSNA) and the Quantitative Imaging Biomarker Alliance (QIBA) with technical, radiological and statistical experts developed a set of technical performance analysis methods, metrics and study designs that provide terminology, metrics and methods consistent with widely accepted metrological standards. This document provides a consistent framework for the conduct and evaluation of QIB performance studies so that results from multiple studies can be compared, contrasted or combined.

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This paper describes why and how DICOM, the standard that has been the basis for medical imaging interoperability around the world for several decades, has been extended into a full web technology-based standard, DICOMweb. At the turn of the century, healthcare embraced information technology, which created new problems and new opportunities for the medical imaging industry; at the same time, web technologies matured and began serving other domains well. This paper describes DICOMweb, how it extended the DICOM standard, and how DICOMweb can be applied to problems facing healthcare applications to address workflow and the changing healthcare climate.

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Demographic and supply-side changes are occurring in the tertiary educational sector in Japan. These changes have begun to diminish the importance of the highly competitive and influential university entrance examination system, as many students, particularly at the non-elite level, are able to gain university entrance without having to sit for an entrance examination. Given this evolving context, this study uncovers how incoming freshmen at a small non-elite university studied English in secondary school and examines the attitudes and motivations that they hold about language learning. The findings reveal that participants’ English language educational experiences at the secondary level remain little changed from the past; parents and teachers continue to emphasize the importance of studying English in order to prepare for entrance examinations. Most participants have a generally negative assessment of their secondary English language experiences. Student beliefs about both the general nature of language learning and learning and communication strategies continue to parallel many of the traditional practices of their secondary language experiences once they reach the tertiary level. The author concludes that university instructors of English must come to know their students’ language experiences and consequent attitudes and motivations in order to bridge possible cultural and pedagogical gaps. In this way, instructors may find ways to help their students find a purpose for increasing their language proficiency while they are studying at university.

This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered to be any control that is put in place to assure product quality and regulatory compliance. This improved approach is also based on how the detectability of risks is assessed. This is important because when producing medicines, it is not always good practice to place a high reliance upon detection-type controls in the absence of an adequate level of assurance in the manufacturing process that leads to the finished medicine.