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- A process model for quality in use evaluation on clinical decision support systemsPublication . Pereira, Leonice Maria Reis de Souza; Pombo, Nuno Gonçalo Coelho CostaDeveloping or purchasing software is an expensive investment and needs to be justified. Furthermore, the software must be useful in its purpose, reliable, efficient and, among other characteristics, meet the expectations of users [1, 2]. It would be no different in the case of a clinical Decision Support System - CDSS. CDSS are systems developed to support clinicians and other health professionals in a medical decision making [3]. They are developed within a clinical context, following medical guidelines, with varied purposes such as diagnoses [4, 5, 6] patient monitoring [7, 8, 9], prevention [10] and disease treatment [11, 12]. Conversely, even with all the benefits offered by a CDSS, its acceptance in the medical field is still a matter of debate [13, 14]. The CDSS acceptance is linked to the perception of the end user, such as 1) the system’s ease of use and utility, 2) the quality of its results and its reliability [14], 3) the contextual accessibility of the system, sometimes not included in the health professional’s routine and workflow, and 4) the fact that numerous CDSSs are not integrated with existing systems [15]. One manner to extend the use and disseminate positive contributions of CDSSs to the medical world is to develop them in a reliable and useful way. For this, one must follow the best practices of software engineering (SE, acronym in English) [16] and be concerned with its quality, both in the design and development process and in its effective use. Evaluating the quality of the software is to measure its characteristics and sub-characteristics of quality. In order to better structure the assessment, a series of international standards, with models and frameworks, were developed for assisting software developers in assessing the quality of software products. The latest series is the ISO/IEC 25000 - System and Software Quality Requirements and Evaluation (SQuaRE) [17]. Two of the SQuaRE divisions are addressed in this thesis: 1) Division of quality models standard (ISO/IEC 25010) [18], and 2) Quality measurement division standard (ISO/IEC 25022) [19]. The ISO/IEC 25010 are divided in product quality model and the quality model in use. Quality in use (QiU), a model of ISO/IEC 25010, is the focus of this study, through its evaluation in the context of a CDSS. The quality in use model refers to the quality of the software when executed, mentioning the result of the interaction between users and the software system/product in a specific context. This model consists of five quality characteristics: • Effectiveness - means the level of precision and completeness with which users achieve their specific goals when using the system; • Efficiency - refers to the resources spent to achieve the goals and its measure is related to the level of effectiveness achieved with the consumed resources; • Satisfaction - refers to whether user requirements are satisfied in a particular context of system use; • Freedom from risk - refers to the degree to which the quality of a system reduces or avoids potential risks to human life, the economic situation, and health of the environment; • Context coverage - deals with the use of the system in all specific contexts and/or in contexts that extend beyond the initially identified contexts. Context completeness and flexibility are the sub-characteristics that represent context coverage. Thus, when measuring the quality of a CDSS, we must consider both the context of use and the choice of the characteristic and sub-characteristic that best suits the purpose of the measurement [20]. The QiU model provides a powerful contribution to the practice of evaluating a system and determining its quality. According to Harrison et al. [21], Effectiveness, Efficiency and Satisfaction are considered the key criteria to reflect the quality of use. Therefore, these QiU characteristics meet the needs and expectations of the users of the systems, in our case of CDSSs, as they consider the user experience. As a contribution, we proposed a process model to evaluate two QiU characteristics in a CDSS: satisfaction and efficiency. We believe these characteristics are important in the evaluation of a CDSS because, due to its links with the user experience and the usability of the system, when measured, can corroborate the quality of the CDSS and mitigate the non-use and non-acceptance of this type of software. Other contributions from our work are 1) in the academic context, a significant study in the area of software quality, focusing on its characteristics, especially on the quality in use. A guideline for collecting and measuring these characteristics was built into our process model; 2) in the area of software development, professionals can make use of a simple and adaptable process, applicable to other types of systems, to measure the quality-in-use characteristics of their products.