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

• US 20140365534A1
• Filed: 08/26/2014
• Published: 12/11/2014
• 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
• Granted Patent: US 10,216,767 B2
• Time in Patent Office: Days
• US Class Current: 707/804
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G06F 16/20 of structured data, e.g. relational data
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

Methods for performing a structured collection procedure by utilizing a collection device are disclosed herein, in which a collection procedure is initiated for performing one or more data collections for one or more data event instances occurring according to a schedule of events. Each data event instances comprises a data collection pertaining to a biomarker to be performed according to one or more conditions of an adherence criterion. Each data event instance is determined to be successful or unsuccessful on the basis of actual performance of the data collection and meeting certain conditions of the predetermined adherence criteria for the data event instance. Contextual information for successful data collections is generated and a data file generated for storing records relating to successful data collections. For unsuccessful data event instances, substitute data relating to data collections performed separately from the collection procedure are included in the data file records for the collection procedure if the substitute data is determined to meet conditions of the predetermined adherence criterion for the corresponding data event instance.

Claims

1. A method for performing a structured collection procedure, comprising the steps of:

with a collection device, initiating a collection procedure comprising one or more data event instances occurring according to a schedule of events, wherein each said data event instance comprises a data collection for a biomarker, said data collection to be performed according to one or more conditions of an adherence criteria pre-selected for each data event instance;

performing a data collection for at least one of said one or more data event instances;

after each data event instance, determining that a successful data collection has been performed if the data collection has been actually performed and if at least one condition of the pre-selected adherence criteria for the data event instance is met, and otherwise determining that the data collection for the data event instance is an unsuccessful data collection;

generating contextual information for each successful data collection, said contextual information comprising at least a date and time of performing the data collection;

generating a data file for the collection procedure and storing said data file in a first memory, said data file comprising a record for each data event instance comprising data of the successful data collection corresponding to the data event instance including the contextual information of the successful data collection;

for each data event instance having an unsuccessful data collection, determining availability of substitute data from a data collection performed separately from the collection procedure and stored with corresponding contextual information in the first memory or a second memory, wherein availability of the substitute data is determined according to whether the substitute data meets at least one condition of the pre-selected adherence criteria for the corresponding data event instance; and

if availability of substitute data is determined, then selecting the substitute data for inclusion in the data file record of the corresponding data event instance.

2. The method of claim 1, wherein the at least one condition comprises the data collection being performed within a specified time-window.

3. The method of claim 1, further comprising the step of selecting the collection procedure from a plurality of predefined structured collection procedures stored in one of the first memory, the second memory and a third memory.

4. The method of claim 1, wherein the initiating step comprises one of meeting an entry criteria for the collection procedure and occurrence of a first of the one or more data event instances.

5. The method of claim 1, further comprising the step of determining whether the contextual information for each successful data collection and substitute data stored in the data file is complete or incomplete.

6. The method of claim 5, wherein for each determination of incomplete contextual information the method further comprises the step of determining availability of existing data stored in the first memory, second memory or in a third memory, said existing data comprising data collected from a data collection performed separately from the collection procedure.

7. The method of claim 1, further comprising the step of designating the data file as complete when the data of a successful data collection or substitute data is stored in each record of the data file for the collection procedure.

8. The method of claim 1, further comprising the step of closing the collection procedure upon the occurrence of an exit criteria.

9. The method of claim 8 wherein said exit criteria comprises storing in each record of the data file the data of a successful data collection or substitute data.

10. The method of claim 1, wherein if no substitute data is available for one or more unsuccessful data collections, the method further comprises the step of generating additional data event instances in the collection procedure for each data event instance for which an unsuccessful data collection has been determined, each additional data event instance comprising a biomarker data collection to be performed according to other adherence criteria conditions at least substantially similar to the conditions pre-selected for the corresponding unsuccessful data collection.

11. The method of claim 1 wherein if no substitute data is available for an unsuccessful data collection, the method further comprises the step of storing in the data file record of the corresponding data event instance an exception value.

12. The method of claim 1, wherein if no substitute data is available for an unsuccessful data collection, the method further comprises the step of storing in the data file record of the corresponding data event instance an exception value, and further comprising the step of determining whether the contextual information for each successful data collection and substitute data stored in the data file is complete or incomplete, wherein a stored exception value is determined as incomplete contextual information.

13. The method of claim 12, further comprising the step of addressing each exception value and each incomplete contextual information with existing stored data from data collection events separate from the collection procedure if available.

14. The method of claim 13, further comprising the step of designating the collection procedure as complete only when all exception values and incomplete contextual information are addressed in a manner that fulfills the requirements of the collection procedure.

15. The method of claim 7, further comprising the step of performing an analysis of one or both of the records and the data of the completed data file.

16. The method of claim 1, further comprising the steps of:

if no substitute data is available for an unsuccessful data collection, then storing in the data file record of the corresponding data event instance an exception value;

designating the data file as complete when one of data of a successful data collection, substitute data and an exception value is stored in each record of the data file for the collection procedure; and

determining whether the contextual information for each successful data collection and substitute data stored in the data file is complete or incomplete.

17. A method for performing a structured collection procedure with a collection device comprising a processor, comprising the step of:

by the processor, running a first script comprising collection protocol instructions prepared for performing the steps of the method of claim 1.

18. The method of claim 17, wherein the first script further comprises collection protocol instructions prepared for performing the further steps of, if no substitute data is available for an unsuccessful data collection, storing in the data file record of the corresponding data event instance an exception value, and designating the data file as complete when one of the data of a successful data collection or substitute data or an exception value is stored in each record of the data file for the collection procedure.

19. The method of claim 18, further comprising the step of:

by the processor, running a second script comprising data parsing instructions prepared for performing steps for determining whether the contextual information for each successful data collection and substitute data stored in the data file is complete or incomplete.

20. The method of claim 19, further comprising the step of:

by the processor, running a third script comprising analysis instructions prepared for performing steps for analyzing one or both of the records and the data of the completed data file.

21. A collection device configured to perform the method of claim 1.

22. The collection device of claim 21, further configured to perform the method of claim 15.

23. The collection device of claim 21, further configured to perform the method of claim 16.

24. The collection device of claim 21, the collection device comprising a processor configured to run a first script comprising collection protocol instructions prepared to perform the method of claim 1.

25. The collection device of claim 24, wherein the first script further comprises collection protocol instructions prepared for performing the further steps of, if no substitute data is available for an unsuccessful data collection, storing in the data file record of the corresponding data event instance an exception value, and designating the data file as complete when one of the data of a successful data collection or substitute data or an exception value is stored in each record of the data file for the collection procedure.

26. The collection device of claim 25, the processor being further configured to run a second script comprising data parsing instructions prepared for performing steps for determining whether the contextual information for each successful data collection and substitute data stored in the data file is complete or incomplete.

27. The collection device of claim 26, the processor being further configured to run a third script comprising analysis instructions prepared for performing steps for analyzing one or both of the records and the data of the completed data file.

28. A system comprising a collection device and a separate device communicatively connected to the collection device, the collection device being configured to perform the method of claim 16 and to transmit the completed data file to the separate device, the separate device being configured to analyze one or both of the records and the data of the completed data file.

29. The system of claim 28, wherein the collection device comprises a measurement device and the separate device comprises a smartphone.

30. The system of claim 29, the measurement device and the smartphone being wirelessly connected, wherein the completed data file is wirelessly transmitted to the smartphone by the measurement device.