Validation on Clinical Data

Gather in prospective clinical studies unique personalised multi-dimensional longitudinal datasets reflecting patient's trajectory for validation.

This objective aims to collect high-quality patient data (n=1200) from two prospective studies. The first prospective study will target stage 2, acute stroke. The other prospective study will target stage 3 and 4, stroke rehabilitation and reintegration. For both studies, the definition of study parameters will be performed according to the defined inputs and outputs in objective 2. This will ensure the seamless merging of study data with the project data warehouse and data harmonisation. Additionally, for both studies a patient-reported outcome concept will be developed. Currently, the gathering of the data is researcher-centred as data are collected topdown by the performing clinical staff. This is often inefficient and does not consider patient motivation leading to high rates of “lost-to-follow-up”. To facilitate the gathering of high quality data, end-user-based technologies wil be employed to obtain patient-centered data. To this end an electronic case report form (eCRF) will be developed allowing the fine-meshed recording of patient-reported outcome by research staff and by the patients themselves. The result will be an electronic patient recorded outcome (ePRO).