The IDEA-FAST project assesses the value of modern wearable measurement devices and the data and information they generate in the context of sleep disturbance and fatigue assessments. The assessment is based on two studies: Feasibility Study (FS) and Clinical Validation Study (CVS). The subjects in the studies will be patients of chronic diseases such as neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID) as well as healthy participants. Work package 4 (WP4) in the project is responsible for device specific data analytics. This document describes the assessment protocol for the FS which is the first deliverable of WP4.
The assessment protocol described in this document will be based on data that will be collected in the FS: clinical data, baseline and online questionnaire data and device data. As the absolute reference of the sleep- and fatigue related data will not be available, the assessment will be based on three factors: 1) Data quality and reliability of the digital measure, 2) Performance as compared to patient reported outcomes, 3) Performance across patient cohorts.
The protocol suggests that the outcome of device assessment will be provided as a recommendation based on the above 3 factors. The device performance will be represented in visual formats like Bland-Altman plots and radar charts. This allows reader to compare the devices across the above factors in an intuitive objective manner.