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

• US 9,117,015 B2
• Filed: 06/21/2011
• Issued: 08/25/2015
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Bousamra, Steven A., Soni, Abhishek S.
• Primary Examiner(s): Bashore, William
• Assistant Examiner(s): Distefano, Gregory A
• Application Number:
  US13/165,220
• Publication Number:
  US 20120089893A1
• Time in Patent Office: 1,526 Days
• Field of Search: 711/154, 714/807
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 10/65 stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A collection device for performing a structured collection procedure may include a processor that executes program instructions communicably coupled to at least one memory. The processor can initiate a schedule of events of the structured collection procedure upon one or more entry criterions being met and segregate the at least one memory into a primary data store and a secondary data store. The processor can write structured patient data collected in accordance to the schedule of events to the secondary data store. The processor can transform a relevant portion of the structured patient data into an evaluated data object. The processor can generate a data abstraction based in part upon the evaluated data object. The processor can link the primary data store and the secondary data store with the data abstraction.

Claims

1. A collection device for performing a structured collection procedure, the collection device comprising:

a processor communicably coupled to at least one memory; and

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

initiate a schedule of events of the structured collection procedure upon one or more entry criterions being met;

segregate the at least one memory into a primary data store and a secondary data store;

write structured patient data collected in accordance to the schedule of events to the secondary data store of the at least one memory;

transform a relevant portion of the structured patient data into an evaluated data object;

generate a data abstraction based at least in part upon the evaluated data object; and

link the primary data store and the secondary data store with the data abstraction;

wherein the at least one memory comprises dynamic and static allocation such that the quantity of the at least one memory can remain fixed, can be increased, and can be decreased; and

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

mark the collection procedure as complete if there are no exceptions;

signify that appropriate data has not been collected if there are the exceptions;

resolve any of the exceptions that have arisen at the time of execution of the collection procedure; and

change the structured collection procedure by switching to a secondary schedule of events that is easier for a patient to perform.

2. The collection device of claim 1, wherein the relevant portion of the structured patient data comprises a primary sample, wherein the primary sample is promoted from a secondary sample.

3. The collection device of claim 1, wherein the program instructions cause the processor to write casual patient data collected by the collection device to the primary data store of the at least one memory.

4. The collection device of claim 3, wherein the structured patient data is a subset of the casual patient data, and the program instructions cause the processor to:

write the data abstraction to the primary data store and/or the secondary data store;

associate the data abstraction with an associated portion of the structured patient data, wherein a non-relevant portion of the structured patient data is not the associated portion of the structured patient data; and

omit the non-relevant portion of the structured patient data from the secondary data store of the at least one memory.

5. The collection device of claim 4, wherein the program instructions cause the processor to compress the associated portion of the structured patient data with a data compression algorithm.

6. The collection device of claim 3, wherein the program instructions cause the processor to write automatically the evaluated data object to the secondary data store.

7. The collection device of claim 3, wherein the program instructions cause the processor to:

associate the data abstraction with an associated portion of the structured patient data; and

write the data abstraction to the secondary data store.

8. The collection device of claim 7, wherein the data abstraction is a unique identifier indicative of a corresponding portion of the casual patient data written in the primary data store, wherein the corresponding portion of the casual patient data corresponds to the relevant portion of the structured patient data.

9. The collection device of claim 7, wherein the data abstraction is a relevant portion pointer indicative of a corresponding address of the primary data store, wherein the corresponding address of the primary data store corresponds to the relevant portion of the structured patient data.

10. The collection device of claim 7, wherein the data abstraction comprises reconstruction information indicative of an address of the primary data store corresponding to the casual patient data and the program instructions cause the processor to reconstruct a reconstructed structured patient data corresponding to the structured patient data written to the secondary data store.

11. The collection device of claim 7, wherein a non-relevant portion of the structured patient data is not the associated portion of the structured patient data, and the program instructions cause the processor to compress the non-relevant portion of the structured patient data with a data compression algorithm.

12. The collection device of claim 6, wherein the program instructions cause the processor to:

associate the data abstraction with at least one instance of the casual patient data; and

write the data abstraction to the primary data store.

13. The collection device of claim 12, wherein the data abstraction is an evaluated data object pointer indicative of an address of the secondary data store corresponding to the evaluated data object stored in the secondary data store.

14. The collection device of claim 1 wherein:

the primary data store comprises a first quantity of logically accessible segments;

the secondary data store comprises a second quantity of logically accessible segments; and

the first quantity of logically accessible segments and/or the second quantity of logically accessible segments are allocated prior to initiating the schedule of events.

15. The collection device of claim 1 wherein:

the primary data store comprises a first quantity of logically accessible segments;

the secondary data store comprises a second quantity of logically accessible segments;

the program instructions cause the processor to increase the first quantity of logically accessible segments and/or the second quantity of logically accessible segments after an event of the schedule of events ends.

16. The collection device of claim 1, wherein the evaluated data object is a therapy result, a disease assessment, a therapy assessment, a therapy optimization and/or an adverse event.

17. The collection device of claim 3, wherein the casual patient data comprises biomarker data, a date-time stamp, a completion flag, or contextualized data.

18. The collection device of claim 1, wherein the at least one memory comprises a main memory disposed within the collection device.

19. The collection device of claim 1, wherein the at least one memory comprises a computer readable medium and/or a network database.

20. The collection device of claim 1, wherein the program instructions cause the processor to:

apply an error checking algorithm to the primary data store after writing to the primary data store; and

apply a different error checking algorithm to the secondary data store after writing to the secondary data store.

21. The collection device of claim 20, wherein each of the error checking algorithm and the different error checking algorithm is a cyclic redundancy check.

22. A collection device for performing a structured collection procedure, the collection device comprising:

a processor communicably coupled to at least one memory wherein the at least one memory comprises dynamic and static allocation such that the quantity of the at least one memory can remain fixed, can be increased, and can be decreased; and

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

initiate a schedule of events of the structured collection procedure upon one or more entry criterions being met;

segregate the at least one memory into a primary data store and a secondary data store;

write casual patient data collected by the collection device to the primary data store of the at least one memory;

write structured patient data collected in accordance to the schedule of events to the secondary data store of the at least one memory;

transform a relevant portion of the structured patient data into an evaluated data object, the evaluated data object is a therapy result, a disease assessment, a therapy assessment, a therapy optimization and/or an adverse event;

write automatically the evaluated data object to the secondary data store;

apply an error checking algorithm to the primary data store after writing to the primary data store;

apply a different error checking algorithm to the secondary data store after writing to the secondary data store;

link the primary data store and the secondary data store with the evaluated data object; and

mark the collection procedure as complete if there are no exceptions;

signify that appropriate data has not been collected if there are the exceptions;

resolve any of the exceptions that have arisen at the time of execution of the collection procedure; and

change the structured collection procedure by switching to a secondary schedule of events that is easier for a patient to perform.

23. A method for managing data collected from a structured collection procedure comprising:

providing at least one memory comprising dynamic and static allocation such that the quantity of the at least one memory can remain fixed, can be increased, and can be decreased;

initiating a schedule of events of the structured collection procedure upon one or more entry criterions being met;

segregating the at least one memory into a primary data store and a secondary data store;

writing casual patient data collected by a collection device to the primary data store of the at least one memory;

writing structured patient data collected in accordance to the schedule of events to the secondary data store of the at least one memory;

transforming a relevant portion of the structured patient data into an evaluated data object;

generating a data abstraction based at least in part upon the evaluated data object;

linking the primary data store and the secondary data store with the data abstraction; and

if there are no exceptions, marking the collection procedure as complete;

if there are the exceptions, signifying that appropriate data has not been collected;

resolving any of the exceptions that have arisen at the time of execution of the collection procedure; and

changing the structured collection procedure by switching to a secondary schedule of events that is easier for a patient to perform.

24. The method of claim 23, further comprising writing automatically the evaluated data object to the secondary data store.

25. The method of claim 24, further comprising:

associating the data abstraction with an associated portion of the structured patient data; and

writing the data abstraction to the secondary data store.

26. The method of claim 25, further comprising resetting automatically the secondary data store wherein the associated portion of the structured patient data is unassociated.

27. The method of claim 24, further comprising:

associating the data abstraction with at least one instance of the casual patient data; and

writing the data abstraction to the primary data store.