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

• US 10,733,154 B2
• Filed: 01/02/2019
• Issued: 08/04/2020
• 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: Bousamra, Steven A., Soni, Abhishek
• Primary Examiner(s): Bashore, William L
• Assistant Examiner(s): Distefano, Gregory A
• Application Number:
  US16/238,226
• Publication Number:
  US 20190138505A1
• Time in Patent Office: 580 Days
• 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 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 to perform a structured collection procedure, the method comprising:

with a collection device communicatively coupled to one or more processors and a memory, 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 in response to the data collection being actually performed and at least one condition of the pre-selected adherence criteria for the data event instance being 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 of the 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

in response to availability of substitute data being determined, selecting the substitute data for inclusion in the data file record of the corresponding data event instance such that the data file is configured to be complete for analysis of the collection procedure through inclusion of the substitute data.

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 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 initiating comprises one of meeting an entry criteria for the collection procedure and determining an occurrence of a first of the one or more data event instances.

5. The method of claim 1, further comprising instructions to determine 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 determining availability of existing data stored in the first memory, the 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 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 closing the collection procedure upon the occurrence of an exit criteria.

9. The method of claim 8, wherein upon the occurrence of said exit criteria, 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 in response to no substitute data being available for one or more unsuccessful data collections, further comprising 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 in response to no substitute data being available for an unsuccessful data collection, further comprising storing in the data file record of the corresponding data event instance an exception value.

12. The method of claim 1, wherein in response to no substitute data being available for an unsuccessful data collection, further comprising storing in the data file record of the corresponding data event instance an exception value, and further comprising 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 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 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 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:

in response to no substitute data being available for an unsuccessful data collection, 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. The method of claim 1, further comprising:

by the one or more processors, running a first script comprising collection protocol instructions prepared for executing by the one or more processors machine readable instructions stored in the memory.

18. The method of claim 17, wherein the first script further comprises collection protocol instructions prepared to, in response to no substitute data being 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, by the one or more processors, running a second script comprising data parsing instructions to determine 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, by the one or more processors, running a third script comprising analysis instructions to analyze one or both of the records and the data of the completed data file.