Several studies report the benefits and accuracy of using autosegmentation for organ at risk (OAR) outlining in radiotherapy treatment planning. Typically, evaluations focus on accuracy metrics, and other parameters such as perceived utility and safety are routinely ignored. Here, we report our finding from the implementation and clinical evaluation of OSAIRIS, an open-source AI model for radiotherapy image segmentation that was carried out as part of its development into a medical device.
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November 2024
Objectives: The aim of this study was to determine the prevalence of restless leg syndrome (RLS) among patients with SLE, describe their clinical characteristics, examine its impact on health-related quality of life (HRQoL), and evaluate its association with depression.
Methods: A total of 124 SLE patients were recruited, with data on demographics, and clinical features collected. RLS diagnosis was based on the international RLS study group criteria, while depression was assessed by the patient health questionnaire.
The Prescribing Information (PI) in the United States (US) and the Summary of Product Characteristics (SmPC) in the European Union (EU) are approved by the US Food & Drug Administration (FDA), and the European Medicines Agency (EMA), respectively. The inclusion of overdosage information in these documents is a regulatory requirement in both regions. This research evaluates the content of the overdosage section of US and EU labeling.
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