Methods and Systems for Assessing Clinical Outcomes

• US 20120053425A1
• Filed: 09/26/2011
• Published: 03/01/2012
• Est. Priority Date: 03/26/2008
• Status: Active Grant

• Current Assignee: Theranos IP Company, LLC
• Original Assignee: Theranos Incorporated
• Inventors: Kemp, Timothy Michael, Gibbons, Ian, Holmes, Elizabeth A., MICHELSON, Seth
• Granted Patent: US 8,265,955 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16B 40/00 ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
• CPC Class Codes: G16B 40/30 Unsupervised data analysis
• CPC Class Codes: G16C 20/70 Machine learning, data mining or chemometrics
• CPC Class Codes: G16C 20/90 Programming languages; Computing architectures; Database systems; Data warehousing
• 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 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Described herein are methods and systems useful for characterizing clinical outcomes of a subject. Provided herein includes computer-assessed methods, medical information systems, and computer-readable instructions that can aid an end-user in diagnosis, prognosis, and treatment of a clinical outcome.

Claims

1. A method for characterizing the probability of a clinical outcome of a subject, comprising:

a. constructing a probability space defined by a set of discrete clinical outcomes, each of which is characterized by a statistical distribution of at least one biological marker;

b. obtaining subject data corresponding to the at least one biological marker;

c. calculating the position of said subject data in said probability space, thereby characterizing the probability of the clinical outcome of said subject; and

d. repeating steps b) and c) at various time points to yield a trajectory within said probability space, wherein said trajectory is indicative of the likelihood of progression to the clinical outcome.

2. The method of claim 1, further comprising calculating a velocity based on said trajectory, wherein said velocity is indicative of the progression of a medical condition of said subject.

3. The method of claim 1, further comprising calculating an acceleration based on said trajectory, wherein said acceleration is indicative of the progression of a medical condition of said subject.

4. The method of claim 1 further comprising notifying a medical personnel or the subject of a need for taking a medical action upon assessing or characterizing the position of said subject data in said probability space.

5. The method of claim 4 wherein the medical action involves at least one action selected from the group consisting of altering a dosage of an existing therapeutic agent administered to said subject, administering a different a therapeutic agent, and administering a different combination of therapeutic agents.

6. The method of claim 4, wherein the notification is wirelessly transmitted.

7. The method of claim 4 further comprising, upon selection of the at least one action, performing an outcome analysis for assessing a result of said selected action, and automatically updating the probability of a discrete clinical outcome of said subject.

8. The method of claim 1 wherein the clinical outcome is selected from the group consisting of complete response (CR), partial response (PR), stable disease (SR), non-response(NR), adverse drug effect (ADR), and drug toxicity.

9. A method of characterizing a clinical outcome of a subject comprising:

a. constructing, with the aid of a processor within a server, a probability space defined by a set of discrete clinical outcomes, each of which is characterized by the statistical distribution of at the least one biological marker;

b. providing data of a subject to the server, said data corresponding to the at least one biological marker;

c. calculating the position of said subject data in said probability space thereby characterizing the clinical outcome of the subject; and

d. repeating steps b) and c) at various time points to yield a trajectory within said probability space, wherein said trajectory is indicative of the likelihood of progression to the clinical outcome.

10. The method of claim 9 further comprising notifying a medical personnel or the subject of a need for taking a medical action upon assessing or characterizing the position of said subject data in said probability space.

11. The method of claim 9 wherein the clinical outcome is selected from the group consisting of complete response (CR), partial response (PR), stable disease (SR), non-response(NR), adverse drug effect (ADR), and drug toxicity.

12. A medical information system for subject data analysis comprising:

a. an input device for receiving subject data and in communication with a processor;

b. a storage unit in communication with the processor having a database for;

(i) storing data corresponding to a probability space defined by a set of discrete clinical outcomes, each of which is characterized by statistical distribution of at least one biological marker; and

(ii) storing subject data corresponding to the at least one biological marker, said subject data representing measurements of said at least one biological marker;

c. a processor that i) calculates the position of said subject data in said probability space as a way of assessing the probability of a discrete clinical outcome of said subject, and ii) calculates a trajectory within the probability space from said measurements, wherein the trajectory is indicative of the likelihood of progression of the discrete clinical outcome; and

d. an output device that transmits information relating to the discrete clinical outcome of c) to an end user.

13. The medical information system of claim 12, wherein said output device transmits selected portions of the subject data and the probability space in response to instructions from the end user.

14. The medical information system of claim 12, wherein the storage unit stores historical reference data of a plurality of subjects in relationship to the at least one biological marker.

15. The medical information system of claim 12, wherein the data stored in the storage unit are selected from the categories consisting of pathology, anatomy, treatment option, treatment outcome, pharmacological parameter, pharmacokinetics parameter, psychological parameter, and genomic information.

16. The medical information system of claim 12 wherein the information transmitted by the output device is encrypted.

17. The medical information system of claim 12, wherein the input device and/or the output device comprises a user interface that can remotely access the network.

18. The medical information system of claim 12, wherein the processor calculates the position of said subject data in said probability space as a way of assessing the probability of a discrete clinical outcome of said subject.

19. The medical information system of claim 12, wherein the input device comprises a touch screen.

20. The medical information system of claim 12, wherein the input device comprises a data entry portal or a keyboard.

21. The medical information system of claim 12, wherein the subject data are textual or numeric, and said data are solicited from the end user.

22. The medical information system of claim 12, wherein the subject data represent measurements of the at least one biological marker present in a bodily fluid.

23. The medical information system of claim 12, wherein the measurements of the at least one biological marker are obtained by a point-of-care device that is operated by the subject.

24. The medical information system of claim 21, wherein the measurements are taken at various time points, wherein said trajectory represents a time series of an assessed clinical outcome.

25. The medical information system of claim 24, wherein the information transmitted by the output device represents an assessment of the clinical outcome of said subject at a single time point.

26. The medical information system of claim 24, wherein the information transmitted by the output device represents a time series of the assessed clinical outcome.

27. The medical information system of claim 12, wherein the end user is a health care provider.

28. A medical information system for subject data analysis, comprising:

a. a processor for executing computer readable instructions, which when executed by said processor implement a method, the method comprising;

i. constructing a probability space defined by a set of discrete clinical outcomes, each of which is characterized by a statistical distribution of at least one biological marker;

ii. obtaining subject data corresponding to the at least one biological marker;

iii. calculating the position of said subject data in said probability space, thereby characterizing the probability of the clinical outcome of a subject; and

iv. repeating steps ii) and iii) at various time points to yield a trajectory within said probability space, wherein said trajectory is indicative of the likelihood of progression to the clinical outcome; and

b. a storage unit in communication with the processor, the storage unit having a database for;

(i) storing data corresponding to said probability space; and

(ii) storing subject data corresponding to the at least one biological marker.

29. The medical information system of claim 28, further comprising an input device for receiving subject data, the input device in communication with said processor.

30. The medical information system of claim 28, further comprising an output device that transmits information relating to the discrete clinical outcome or the trajectory of a) to an end user.