Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device

• US 9,659,037 B2
• Filed: 12/21/2009
• Issued: 05/23/2017
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Walling, P. Douglas, Greenburg, Alan M., Rasch-Menges, Juergen, Weinert, Stefan, Soni, Abhishek S., Bousamra, Steven A.
• Primary Examiner(s): Chow, Doon
• Assistant Examiner(s): PACK, CONRAD R
• Application Number:
  US12/643,415
• Publication Number:
  US 20100218132A1
• Time in Patent Office: 2,710 Days
• Field of Search: 715771
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G06F 16/21 Design, administration or maintenance of databases
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Embodiments related to a system and method managing the implementation, execution, data collection, and data analysis of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor causes the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and mark/indicate the structured collection procedure as completed if no exception occurred during performance of an event in the schedule of events.

Claims

1. A collection device for performing a structured collection procedure on a patient which addresses a medical use case or question, said device comprising:

a portable electronic device comprising a blood glucose meter configured for determining and storing a biomarker value;

a memory;

a user interface;

a processor connected to the memory and the user interface; and

program instructions which when executed by the processor cause the processor to;

receive via the user interface a defined medical use case or question,

select automatically a structured collection procedure from a plurality of structured collection procedures, each comprising at least a primary schedule of events and a secondary schedule of events, based on and matching the defined medical use case or question received via the user interface,

initiate automatically the primary schedule of events of the selected structured collection procedure upon the processor determining that one or more entry criterions have been met, in which the one or more entry criterions comprises at least one specific question to which the processor requires a specific answer to be received from the patient via input from the user interface before the primary schedule of events is started,

provide guidance to collect biomarker data according to an event scheduled in the primary schedule of events of the selected structured collection procedure,

store in the memory a use case parameter which identifies the defined medical use case or question which the selected structured collection procedure is addressing, and patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events, said patient data being associated with the event and the use case parameter, wherein the event provides context to the associated patient data, thereby defining contextual data,

end automatically the selected structured collection procedure upon the processor determining that one or more context specific exit criterions have been met, in which the one or more context specific exit criterions establishes at least one requirement for exiting or completing the selected structured collection procedure such that the selected structured collection procedure has adequate contextual data to address the defined medical use case or question being addressed, wherein the processor continues automatically to a next event scheduled in the primary schedule of events by which to collect further patient data until the one or more context specific exit criterions are met,

mark the selected structured collection procedure as completed based upon no exception occurring during performance of the event in the primary schedule of events, wherein the selected structured collection procedure can be used only once, and wherein each successive download of the selected structured collection procedure requires access from an authorized user with a valid ID,

indicate non-completion of the selected structured collection procedure upon one or more exceptions occurring,

dynamically change the selected structured collection procedure by switching to the secondary schedule of events upon the one or more exceptions occurring and fill missing data caused by the one or more exceptions with at least one of historical data and an estimate from historical data, and

upon the one or more exceptions occurring;

mark the patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events as invalid;

cancel all remaining events in the primary schedule of events for a current day; and

reschedule the primary schedule of events for a next day after the current day;

wherein the collection device is communicatively coupled to a computer, wherein the computer provides a graphical user interface to implement the selected structured collection procedure on the collection device.

2. A collection device according to claim 1 wherein the processor uses a state condition to indicate completion of the selected structured collection procedure.

3. A collection device according to claim 1 wherein the processor provides a completion flag in the memory to indicate completion of the selected structured collection procedure.

4. A collection device according to claim 1 wherein at time of initiation of the selected structured collection procedure, the program instructions cause the processor to create a data structure in the memory for the patient data.

5. A collection device according to claim 3 wherein the program instructions further cause the processor to mark the completion flag as completed based upon the one or more exceptions being resolved.

6. A collection device according to claim 1 wherein the program instructions further cause the processor to perform an analysis on the patient data.

7. A collection device according to claim 1 wherein the program instructions further cause the processor to provide a snooze feature to enable an allowable delay to the collection of the biomarker data when prompted.

8. A collection device according to claim 1 wherein the program instructions further cause the processor to apply one or more acceptance criterions to determine whether the patient data was collected within a specific time-window around each event provided in the schedule of events for the selected structured collection procedure.

9. A collection device according to claim 1 wherein the program instructions further cause the processor to apply one or more adherence criterions to determine whether data was successfully collected for each event provided in the schedule of events applied for the selected structured collection procedure.

10. A collection device according to claim 9 wherein the program instructions further cause the processor to associate in the patient data the data collected successfully with a date-time stamp, the event, any available contextual information, and a unique identifier.

11. A collection device according to claim 9 wherein the program instructions further cause the processor to indicate in the patient data the one or more exceptions for the event not meeting the one or more adherence criterions.

12. A collection device according to claim 1 wherein the program instructions further cause the processor to end the selected structured collection procedure when an adverse event occurs.

13. A collection device according to claim 1, wherein:

the plurality of structured collection procedures comprises at least a first structured collection procedure and a second structured collection procedure;

the selected collection procedure is the first structured collection procedure;

the one or more context specific exit criterion for the first structured collection procedure establish one or more conditions to meet for one or more entry criterions of the second collection procedure; and

further comprising program instructions which when executed by the processor cause the processor to;

implement automatically a schedule of events of the second structured collection procedure upon meeting the one or more context specific exit criterion of the first structured collection procedure.

14. A collection device according to claim 1, wherein:

the plurality of structured collection procedures comprises at least a first structured collection procedure and a second structured collection procedure;

the selected collection procedure is the first structured collection procedure;

the one or more context specific exit criterion for the first structured collection procedure are based on one or more contraindications;

one or more entry criterions of the second collection procedure are based on the one or more contraindications of the first structured collection procedure; and

further comprising program instructions which when executed by the processor cause the processor to;

upon occurrence of a contraindication of the one or more contraindications, exit the first structured collection procedure and automatically start the schedule of events of the second structured collection procedure.

27. A collection device according to claim 8 wherein the program instructions further cause the processor to indicate in the patient data the one or more exceptions for the event not meeting one or more acceptance criterions.

28. The collection device according to claim 1, further comprising a display for visualizing results of an analysis of the collected patient data.

15. A system for managing implementation, execution, data collection, and a data analysis of a structured collection procedure, said system comprising:

a collection device wherein the collection device is a blood glucose meter comprising;

a portable electronic device configured for determining and storing a biomarker value;

a memory;

a user interface;

a processor connected to the memory and the user interface; and

program instructions which when executed by the processor cause the processor to;

receive via the user interface a defined medical use case or question,

select automatically a structured collection procedure from a plurality of structured collection procedures, each comprising at least a primary schedule of events and a secondary schedule of events, based on and matching the defined medical use case or question received via the user interface,

initiate automatically the primary schedule of events of the selected structured collection procedure upon the processor determining that one or more entry criterions have been met, in which the one or more entry criterions comprises at least one specific question to which the processor requires a specific answer to be received from a patient via input from the user interface before the primary schedule of events is started,

provide guidance to collect biomarker data according to an event scheduled in the primary schedule of events of the selected structured collection procedure,

store in the memory a use case parameter which identifies the defined medical use case or question which the selected structured collection procedure is addressing, and patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events, said patient data being associated with the event and the use case parameter, wherein the event provides context to the associated patient data, thereby defining contextual data,

end automatically the selected structured collection procedure upon the processor determining that one or more context specific exit criterions have been met, in which the one or more context specific exit criterions establishes at least one requirement for exiting or completing the structured collection procedure such that the selected structured collection procedure has adequate contextual data to address the defined medical use case or question being addressed, wherein the processor continues automatically to a next event scheduled in the primary schedule of events by which to collect further patient data until the one or more context specific exit criterions are met,

mark the selected structured collection procedure as completed based upon no exception occurring during performance of the event in the primary schedule of events, wherein the selected structured collection procedure can be used only once, and wherein each successive download of the selected structured collection procedure requires access from an authorized user with a valid ID,

indicate non-completion of the selected structured collection procedure upon an exception one or more exceptions occurring,

dynamically change the selected structured collection procedure by switching to the secondary schedule of events upon the one or more exceptions occurring and fill missing data caused by the one or more exceptions with at least one of historical data and an estimate from historical data, and

upon the one or more exceptions occurring;

mark the patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events as invalid;

cancel all remaining events in the primary schedule of events for a current day; and

reschedule the primary schedule of events for a next day after the current day;

wherein the collection device is communicatively coupled to a computer, wherein the computer provides a graphical user interface to implement the selected structured collection procedure on the collection device.

16. A system according to claim 15, further comprising a server connected to the computer which serves as a central repository for one or more structured collection procedures.

17. A system according to claim 15, wherein the graphical user interface provides information about collection procedures already completed by a patient and associated results, and the collection procedure that the patient is currently performing on the collection device.

18. A system according to claim 15, wherein the graphical user interface provides steps in a workflow for therapy administration for a patient, and the steps are represented as displayed icons and the graphical user interface shades the icons to the steps of the workflow already completed.

19. A system according to claim 15, wherein the graphical user interface provides for all available initializing options for initializing a therapy which includes selecting from one or more structured collection procedure available for addressing the therapy.

20. A system according to claim 15, wherein the graphical user interface provides a snapshot of conditions set in the structured collection procedure.

21. A system according to claim 15, wherein the graphical user interface provides a modify protocol icon which when selected permits modification of parameters in the structured collection procedure.

22. A system according to claim 15, wherein the graphical user interface provides an accept icon which when selected causes the computer to send the structured collection procedure to the collection device.

23. A system according to claim 16 wherein communication between the computer and server does not support a full two-way data transfer to protect patient data.

24. A system according to claim 15, wherein the data analysis of the data collected by the collection device can be completed on one or more of the collection device, the computer, and a device reader.

30. The system according to claim 15, further comprising a server, wherein each collection procedure downloaded from the server can be used only once and wherein each successive download of the collection procedure requires access from an authorized user with a valid ID.

31. The system according to claim 15, further comprising a server, wherein the server provides updates to the processor.

32. The system according to claim 31, wherein the server can only access information related to the program instructions.

33. The system according to claim 15, wherein the computer interfaces with a database, said database arranges relevant patient data by an individual patient ID.

34. The system according to claim 33, wherein a user can access the relevant patient data from the database using the individual patient ID.

35. The system of claim 15, wherein the data analysis of the data collected ensures integrity is maintained.

36. The system of claim 15, wherein emails are sent to patients which contain reminders and/or reports.

37. The system of claim 15, wherein once a collection procedure is downloaded to the collection device, the collection procedure is associated by a patient ID and cannot be altered by the patient.

38. The system of claim 15, wherein a report generated at completion of the collection procedure is clinician-selected.

39. The system of claim 15, wherein the system can connect with an electronic medical records system.

40. The system of claim 16, wherein the structured collection procedure can be introduced into the collection device by downloading the structured collection procedure from the server via a connecting cable, by inserting a chip into the collection device, by using a RFID tagged chip, or by any combination thereof.

41. The system of claim 15, wherein the graphical user interface can display instructions to the patient.

42. The system of claim 15, wherein the collection procedure introduces patient and/or clinician identifiers into the collection device.

25. A collection device for performing a structured collection procedure, said device comprising a blood glucose meter comprising:

a memory for storing patient data comprising collected biomarker data, a date-time stamp, a completion flag, and other data associated with each instance of the collected biomarker data obtained according to a selected structured collection procedure, said other data comprising contextualized data which characterizes associated collected biomarker;

an input means;

a processor connected to the memory and the input means; and

program instructions that when executed by the processor cause the processor to;

receive via the input means a defined medial use case or question,

select automatically the selected structured collection procedure from a plurality of structured collection procedures, each comprising at least a primary schedule of events and a secondary schedule of events, stored in the memory, based on and matching the defined medical use case or question,

retrieve automatically from memory the selected structured collection procedure having parameters defining;

entry criterions which establish conditions needed to be met prior to obtaining biomarker data, the primary schedule of events, each event of said primary schedule of events comprising at least one or more of a performance time, guidance to perform the event, a request for one or more of information, patient actions, and a collection of at least one type of biomarker data, and context specific exit criterions which establish the conditions needed to be met prior to exiting the selected structured collection procedure, and

initiate automatically the primary schedule of events of the selected structured collection procedure upon the entry criterions being met, in which the one or more entry criterions comprises at least one specific question to which the processor requires a specific answer to be received from the patient via input from the input means before the primary schedule of events is started,

provide guidance to collect biomarker data according to an event scheduled in the primary schedule of events of the selected structured collection procedure,

store in the memory a use case parameter which identifies the defined medical use case or question which the selected structured collection procedure is addressing, and the patient data comprising the biomarker data collected in accordance to the primary schedule of events, wherein the biomarker data is collected after the primary schedule of events is initiated, said patient data being associated with the event and the use case parameter, wherein the event provides context to the associated patient data, thereby defining contextual data,

end automatically the selected structured collection procedure upon the context specific exit criterions being met, in which the one or more context specific exit criterions establishes at least one requirement for exiting or completing the selected structured collection procedure such that the selected structured collection procedure has adequate contextual data to address the defined medical use case or question being addressed, wherein the processor continues automatically to a next event scheduled in the primary schedule of events by which to collect further patient data until the one or more context specific exit criterions are met,

indicate the selected structured collection procedure as completed based upon no exception occurring during performance of a critical event in the primary schedule of events to collect the biomarker data, wherein the selected structured collection procedure can be used only once, and wherein each successive download of the selected structured collection procedure requires access from an authorized user with a valid ID, otherwise indicate non-completion of the selected structured collection procedure upon an exception one or more exceptions occurring during performance of the critical event in the primary schedule of events,

dynamically change the primary structured collection procedure by switching to the secondary schedule of events upon the one or more exceptions occurring and fill missing data caused by the one or more exceptions with at least one of historical data and an estimate from historical data, and

upon the one or more exceptions occurring;

mark the patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events as invalid;

cancel all remaining events in the primary schedule of events for a current day; and

reschedule the primary schedule of events for a next day after the current day;

wherein the collection device is communicatively coupled to a computer, wherein the computer provides a graphical user interface to implement the selected structured collection procedure on the collection device.

26. A method of managing a structured collection procedure comprising:

providing a collection device comprising a blood glucose meter with program instructions;

receiving via a user interface a defined medical use case or question;

downloading to the collection device a selected structured collection procedure comprising at least a primary schedule of events and a secondary schedule of events to the collection device based on and matching the defined medical use case or question to be addressed; and

executing the program instructions on the collection device which cause a processor of the collection device to;

initiate automatically the primary schedule of events of the selected structured collection procedure upon one or more entry criterions being met, in which the one or more entry criterions comprises at least one specific question to which the processor requires a specific answer to be received from the patient via input from the user interface before the primary schedule of events is started,

provide guidance to collect biomarker data according to an event scheduled in the primary schedule of events of the selected structured collection procedure,

store in memory a use case parameter which identifies the defined medical use case or question which the selected structured collection procedure is addressing, and patient data comprising biomarker data collected in accordance to the primary schedule of events, wherein the biomarker data is collected after the primary schedule of events is initiated, said patient data being associated with the event and the use case parameter, wherein the event provides context to the associated patient data, thereby defining contextual data,

end automatically the selected structured collection procedure upon one or more context specific exit criterions being met, in which the one or more context specific exit criterions establishes at least one requirement for exiting or completing the selected structured collection procedure such that the selected structured collection procedure has adequate contextual data to address the defined medical use case or question being addressed, wherein the primary schedule of events of the selected structured collection procedure continues automatically onto a next event in the primary schedule of events by which to collect further patient data until the one or more context specific exit criterions are met,

indicate completion of the selected structured collection procedure based upon no exception occurring during performance of an event in the schedule of events, wherein the selected structured collection procedure can be used only once, and wherein each successive download of the selected structured collection procedure requires access from an authorized user with a valid ID,

indicate non-completion of the selected structured collection procedure upon an exception one or more exceptions occurring,

dynamically change the selected structured collection procedure by switching to the secondary schedule of events upon the one or more exceptions occurring and fill missing data caused by the one or more exceptions with at least one of historical data and an estimate from historical data, and

upon the one or more exceptions occurring;

mark the patient data comprising the biomarker data collected in accordance with the event in the primary schedule of events as invalid;

cancel all remaining events in the primary schedule of events for a current day; and

reschedule the primary schedule of events for a next day after the current day;

wherein the collection device is communicatively coupled to a computer, wherein the computer provides a graphical user interface to implement the selected structured collection procedure on the collection device.

29. A method according to claim 26, further comprising visualizing results of an analysis of the collected patient data on a display.