STRUCTURED TESTING METHOD FOR DIAGNOSTIC OR THERAPY SUPPORT OF A PATIENT WITH A CHRONIC DISEASE AND DEVICES THEREOF
First Claim
1. A device for diagnostic or therapy support of a patient 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 a 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, andimplement the selected structured collection procedure,said structured collection procedure having parameters defining a schedule of events, each of said events comprising at least one or more of a performance time, guidance to perform the event, a request for patient action, a request for information, and a request for collection of at least one type of biomarker data.
4 Assignments
0 Petitions
Accused Products
Abstract
A structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof are disclosed which implement a structured collection procedure based on a medical use case and/or question which provides at least one or more parameters defining entry criterion, a schedule of events, adherence criterion, and exit criterion. The entry criterion establish conditions needed to be met prior to obtaining biomarker data from the patient. Each event can include one or more of a performance time, patient guidance to perform the event, a request for information from the patient a request for patient action, and a request for collection of biomarker data from the patient. The adherence criterion can be used to assess whether an event performed is acceptable to addressing the medical use case and/or question, and the exit criterion establishes conditions needed to be met prior to exiting the collection procedure.
234 Citations
67 Claims
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1. A device for diagnostic or therapy support of a patient with a chronic disease, comprising:
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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 a 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 structured collection procedure having parameters defining a schedule of events, each of said events comprising at least one or more of a performance time, guidance to perform the event, a request for patient action, a request for information, and a request for collection of at least one type of biomarker data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 66)
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17. A device for diagnostic or therapy support of a patient with a chronic disease, comprising:
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a processor; and program instructions that when executed by the processor causes the processor to; retrieve automatically from memory a structured collection procedure, said structured collection procedure being based on a medical use case or question of and having parameters defining; entry criterion which establishes conditions needed to be met prior to obtaining biomarker data, and a schedule of events, each of said events comprising at least one or more of a performance time, guidance to perform the event, a request for patient action, a request for information, and a request for collection of at least one type of biomarker data, and implement automatically the schedule of events of the structured collection procedure upon the entry criterion being met at some unknown time. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A device for diagnostic or therapy support of a patient with a chronic disease, comprising:
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a processor; and program instructions that when executed by the processor causes the processor to; retrieve automatically from memory a structured collection procedure, said structured collection procedure being based on a medical use case or question of and having parameters defining; a schedule of events, each of said events comprising at least one or more of a performance time, guidance to perform the event, a request for patient action, a request for information, and a request for collection of at least one type of biomarker data, and adherence criterion which is used to assess whether an event is performed according to the schedule of events, or whether data provided according to the event is acceptable to addressing the medical use case, and implement automatically the schedule of events of the structured collection procedure, and take one or more additional actions if the adherence criterion is not met. - View Dependent Claims (31, 32, 33, 34)
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35. A device for diagnostic or therapy support of a patient with a chronic disease, comprising:
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a processor; and program instructions that when executed by the processor causes the processor to; retrieve automatically from memory a structured collection procedure, said structured collection procedure being based on a medical use case or question of and having parameters defining a schedule of events, each of said events comprising at least one or more of a performance time, guidance to perform the event, a request (240) for patient action, a request for information, and a request for collection of at least one type of biomarker data, receive biomarker data according to the structured collection procedure, store the biomarker data together with data of the schedule of events as contextualized biomarker data, and calculate measured noise from the contextualized biomarker data by applying a noise function, wherein the noise function comprises one or more of measured noise, procedure noise, and system noise. - View Dependent Claims (36, 37, 38, 39, 40)
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41. A structured testing method for diagnostic or therapy support of a patient with a chronic disease, comprising:
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selecting a structured collection procedure on a computer for the diagnostic or therapy support; having a processor of the computer retrieve automatically from memory the 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 at least one or more of a performance time, guidance to perform the event, a request (240) for patient action, a request for information, and a request for collection of at least one type of biomarker data, adherence criterion which is used to qualitatively assess whether an event performed according to the schedule of events provided data which is acceptable to addressing the medical use case, and exit criterion which establishes the conditions needed to be met prior to exiting the 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. - View Dependent Claims (42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64)
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65. A collection device for performing a prescribed structured collection procedure, said device comprising:
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memory storing a structured collection procedure and for storing patient data, said patient data comprising collected biomarker data and other data associated with each instance of the collected biomarker data, said other data comprising contextualized data which characterizes the associated collected biomarker, and said structured collection procedure comprising entry criterion to begin the structured collection procedure, exit criterion to end the structured collection procedure, a schedule of events in which each of said events comprising at least one or more of guidance to perform the collection event, a request for information, a request for patient action, a request for at least one type of biomarker data, and adherence criterion to qualitatively assess whether an event performed according to the schedule of events provided data which is acceptable to addressing the medical use case; a user interface for selecting the structured collection procedure; at least one biomarker reader to provide the at least one type of biomarker data specified in the structured collection procedure; a processor coupled to the memory, the display, the user interface, and the biomarker reader; and a program having instructions that when executed by the processor causes the processor to; receive input from the user interface indicating selection of the structured collection procedure, implement automatically the schedule of events if after the selection the entry criterion is met, store in memory the patient data resulting from each of the events when performed, associate automatically a unique identifier in memory with the data if a performed event met the adherence criterion, and end automatically the selected structured collection procedure when the exit criterion is met.
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67. A 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:
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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, adherence criterion which is used to qualitatively assess whether an event performed according to the schedule of events provided data which is acceptable to addressing the medical use case, 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.
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Specification