18,579 research outputs found

    Rationale Management Challenges in Requirements Engineering

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    Rationale and rationale management have been playing an increasingly prominent role in software system development mainly due to the knowledge demand during system evaluation, maintenance, and evolution, especially for large and complex systems. The rationale management for requirements engineering, as a commencing and critical phase in software development life cycle, is still under-exploited. In this paper, we first survey briefly the state-of-the-art on rationale employment and applications in requirements engineering. Secondly, we identify the challenges in integrating rationale management in requirements engineering activities in order to promote further investigations and define a research agenda on rationale management in requirements engineering.

    A cognitive approach to improve software engineering processes

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    Cognitive Informatics is a new research area that combines concepts from cognitive sciences and informatics. Particularly, classification according to cognitive styles or learning styles is a common practise in educational and business areas in order to obtain better performance from people involved in learning and collaborative tasks. Humanintensive processes in software engineering make it similar to those areas. In this paper, we propose using a kind of people classification to improve those processes of software engineering where human behaviour is a critical influence on their success.Eje: Ingeniería en SoftwareRed de Universidades con Carreras en Informática (RedUNCI

    Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program.

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    BackgroundPatient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process.MethodsConcept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items.ResultsDuring concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders.ConclusionDevelopment of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program
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