SYSTEM AND METHOD FOR COLLECTING AND MANAGING PATIENT DATA

• US 20100063848A1
• Filed: 07/31/2009
• Published: 03/11/2010
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: CorEvitas LLC (Thermo Fisher Scientific Incorporated)
• Original Assignee: Consortium of Rheumatology Researchers of North America, Inc.
• Inventors: GIBOFSKY, Allan, Reed, George, Kremer, Joel, Greenberg, Jeffrey, Harrington, Timothy
• Granted Patent: US 8,036,915 B2
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

A system and method that employs standardized data collection forms for use by health care providers and patients to enable efficient collection, storage and management of patient data for treatment of diseases, such as rheumatoid arthritis.

Claims

1. A method for collecting and managing patient data, the method comprising controlling at least one computer to perform steps including:

generating editable forms for recording respective historical and clinical information regarding a respective medical condition of each of a plurality of authorized patients at a plurality of different participating sites;

providing access to said editable forms to each of the authorized patients, such that each authorized patient is required to enter the same type of information on the respective forms;

providing access to said editable forms to each of the participating physicians, such that each participating physician is required to enter the same type of information on the respective forms, wherein said information entered by the participating physician includes dosage and start and end dates for each biologic agent used by the authorized patient;

generating a database comprising the information entered by authorized patients and participating physicians on said editable forms for the plurality of patients having the same or similar medical condition; and

manipulating the information in the database to provide desired outputs for access by authorized users.

2. The method of claim 1, wherein access to information in the database is provided for at least one of the following purposes:

diagnosing the patient, researching the medical condition, researching treatments for the medical condition, obtaining clinical trial evidence for drugs or treatments of the medical condition, and selecting treatments for the patient.

3. The method of claim 1 further comprising providing incentives to participating physicians to participate, the incentives include at least one of payments for completed editable forms and access to the database.

4. The method of claim 1 further comprising providing indirect access to the database to pharmaceutical companies or contract research organizations.

5. The method of claim 4, wherein, when the access is indirect, the authorized user submits queries to an administrator of the database to compare characteristics of one agent to a class of drugs.

6. The method of claim 1 further including the step of matching detailed patient information in the database to enrollment criteria for clinical studies to identify sites most capable of reaching enrollment targets.

7. The method of claim 1, wherein the medical condition is a rheumatic disease.

8. The method of claim 7, wherein the rheumatic disease is at least one of the following:

rheumatoid arthritis (RA), psoriatic arthritis (PsA), osteoarthritis (OA), osteoporosis (OP), juvenile rheumatoid arthritis (JRA), and osteoporosis risk (OP Risk).

9. The method of claim 1 further comprising the step of forming a quantitative disease activity score from the information provided in the editable forms.

10. The method of claim 9, wherein the activity score includes a Global Arthritis Score (GAS).

11. The method of claim 1, wherein the type of information on the respective forms entered by the patient and physician in the providing access to said editable forms steps includes the patient'"'"'s visual analogue score (VAS) for pain, a mini health assessment questionnaire (HAQ), and a tender joint count.

12. The method of claim 11, wherein the tender joint count includes indications of tenderness and swollenness for twenty-eight joints.

13. The method of claim 1 further comprising adding information entered on said editable forms to the database by at least one of the following:

on-line data entry, facsimile, mail, and courier.

14. The method of claim 1 further comprising providing access to said editable forms to each of the authorized patients and participating physicians at follow-up visits so as to add further information to the authorized patient'"'"'s record.

15. The method of claim 1, wherein said information entered by the participating physician includes reasons for the authorized patient to end the use of any biologic agent.

16. The method of claim 1, wherein said information entered by the participating physician includes dosage and start and end dates for all drugs other than biologic agents used by the authorized patient.

17. The method of claim 1 comprising the steps of transferring the information from the editable forms to a computer at the participating physician location and then transferring the information via the internet to the database at a central location.

18. The method of claim 1, wherein the step of manipulating the information in the database to provide desired outputs for access by authorized users includes providing access to information in the database regard an authorized patient to that authorized patient and their physician, while other participating physicians, pharmaceutical companies, research organizations, and other authorized users have access to general information from the combination of a plurality of individual authorized patients.

19. The method of claim 1, wherein the editable forms for all authorized patients and participating physicians contain the same queries.

20. The method of claim 1, wherein the desired outputs include activity reports and data analysis tools.