The Development of a Clinical Decision-Support Web-Based Tool for Predicting the Risk of Gastrointestinal Cancer in Iron Deficiency Anaemia—The IDIOM App

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To facilitate the clinical use of an algorithm for predicting the risk of gastrointestinal malignancy in iron deficiency anaemia—the IDIOM score, a software application has been developed, with a view to providing free and simple access to healthcare professionals in the UK. A detailed requirements analysis for intended users of the application revealed the need for an automated decision-support tool in which anonymised, individual patient data is entered and gastrointestinal cancer risk is calculated and displayed immediately, which lends itself to use in busy clinical settings. Human-centred design was employed to develop the solution, focusing on the users and their needs, whilst ensuring that they are provided with sufficient details to appropriately interpret the risk score. The IDIOM App has been developed using R Shiny as a web-based application enabling access from different platforms with updates that can be carried out centrally through the host server. The application has been evaluated through literature search, internal/external validation, code testing, risk analysis, and usability assessments. Legal notices, contact system with research and maintenance teams, and all the supportive information for the application such as description of the population and intended users have been embedded within the application interface. With the purpose of providing a guide of developing standalone software medical devices in academic setting, this paper aims to present the theoretical and practical aspects of developing, writing technical documentation, and certifying standalone software medical devices using the case of the IDIOM App as an example.

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