STRUCTURED TESTING METHOD FOR DIAGNOSTIC OR THERAPY SUPPORT OF A PATIENT WITH A CHRONIC DISEASE AND DEVICES THEREOF

摘要

A structured testing method (200, 300, 388) for diagnostic or therapy support of a patient (12) with a chronic disease and devices (18) thereof are disclosed, devices (18) implement the structured collection procedure (70) based on a medical use case and/or question which provides at least one or more parameters (220, 222, 224, 226, 228, 230, 232, 237, 238, 240) defining at least one entry criterion (226), a schedule of events (222), at least one adherence criterion (224), and at least one exit criterion (228). The entry criterion (226) establish conditions needed to be met prior to obtaining biomarker data (256) from the patient (12). Each event (237) in the schedule of events (222) can include at least one or more of a performance time (238), guidance (230) to perform the event (237), a request (240) for information from the patient (12), a request (240) for patient action, and a request (240) for collection of at least one type of biomarker data (256) from the patient (12). The adherence criterion (224) is used to assess qualitatively whether an event (237) performed according to the schedule of events (222) provided data (256, 170, 145) which is acceptable to addressing the medical use case and/or question, and the exit criterion (228) establishes conditions needed to be met prior to exiting the structured collection procedure (70).