Structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof

A method of performing a structured collection procedure, comprising:

• providing a collection device comprising a hand-held device having an improved user interface for diagnostic or therapy support of a patient and for improving compliancy with a structured collection procedure with a chronic disease, comprising
• a display;
• a user interface;
• and
• a processor coupled to the display and the user interface;
• and
• program instructions that when executed by the processor causes the processor to:
• prompt a plurality of medical use cases or questions related to the chronic disease for selection on the display,
• receive a selected medical use case or question via the user interface,
• select automatically the structured collection procedure for the diagnostic or therapy support of the patient with the chronic disease based on the selected medical use case or question from a plurality of structured collection procedures stored in a memory, and
• implement the selected structured collection procedure,
• said selected structured collection procedure having parameters defining a schedule of events and adherence criterion, each of said events comprising a request for collection of at least one type of biomarker data, wherein the at least one type of biomarker data comprises a biomarker measurement and wherein when the biomarker measurement is within a range associated with or at a prescheduled time when compared to a data event request as determined by the processor through a comparison of a time of the biomarker measurement to a time of the data event request, the processor will give the biomarker measurement a unique identifier in a data file, and when the time of the biomarker measurement compared to the time of the data event request is outside the range associated with the prescheduled time, the processor will not give the unique identifier;
• and when the unique identifier is provided by the processor, a user is prompted by the processor to provide context for the biomarker measurement, the adherence criterion used to qualitatively assess that an event performed according to the schedule of events provided data which is acceptable to addressing the medical use case such as acceptable data comprising the biomarker measurement given the unique identifier in the data file;
• and
• authorizing the structured collection procedure on the collection device.

A non-transitory computer readable storage medium storing instruction that, when executed by a processor of a computer, causes the processor to perform a structured testing method to obtain contextualized biomarker data from a patient, said method comprising:

• retrieving automatically from an electronic component a structured collection procedure, said structured collection procedure being based on a medical use case and having parameters defining:
• entry criterion which establishes conditions needed to be met prior to obtaining biomarker data,
• a schedule of events, each of said events comprising a performance time, guidance to perform the event, a request for patient action, a request for information, a request for collection of at least one type of biomarker data, and combinations thereof, wherein the at least one type of biomarker data comprises a biomarker measurement and wherein when the biomarker measurement is within a range associated with or at a prescheduled time when compared to a data event request as determined by the processor through a comparison of a time of the biomarker measurement to a time of the data event request, the processor will give the biomarker measurement a unique identifier in a data file, and when the time of the biomarker measurement compared to the time of the data event request is outside the range associated with the prescheduled time, the processor will not give the unique identifier;
• and when the unique identifier is provided by the processor, a user is prompted by the processor to provide context for the biomarker measurement,
• adherence criterion which is used to qualitatively assess that an event performed according to the schedule of events provided data which is acceptable to addressing the medical use case such as acceptable data comprising the biomarker measurement given the unique identifier in the data file, and
• exit criterion which establishes the conditions needed to be met prior to exiting the structured collection procedure;
• permitting adjustment of the parameters of the selected structured collection procedure;
• and
• prescribing the selected structured collection procedure to the patient, wherein the processor of the computer provides as output the selected structured collection procedure to the patient to perform when prescribed.