Computerized system for conducting medical studies

• US 6,839,678 B1
• Filed: 02/11/1999
• Issued: 01/04/2005
• Est. Priority Date: 02/11/1998
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare GMBH (Siemens AG)
• Original Assignee: Siemens AG
• Inventors: Striebel, Werner, Schmidt, Volker
• Primary Examiner(s): KEMPER, MELANIE A
• Application Number:
  US09/247,919
• Time in Patent Office: 2,154 Days
• Field of Search: 705/2, 705/3, 600/300, 707/104.1, 707/10
• US Class Current: 705/3
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

In a system for conducting medical studies a number of medical locations, such as clinics or medical practices, are connected to a central server via a computer network. The system is constructed in modular fashion, and it is automatically determined, with computer support within the system, whether a specific patient is eligible to participate in a medical study of the system, and if so, the sequence of the corresponding medical study is controlled centrally by corresponding modules, automatically and in a study-specific and patient-specific fashion.

Claims

1. A system for conducting medical studies comprising:

a computer network;

a plurality of local computers respectively disposed at medical locations available for participation in a medical study, each medical location having at least one patient associated therewith available for participation in a medical study, said at least one patient having patient data associated therewith accumulated prior to and independently of said medical study;

a central server connecting said plurality of local computers to said computer network;

a study administration module in said central server for managing all study information relating to current and future medical studies, said study administration module comprising a memory for storing study-specific study information, including a time sequence for each of said current and future medical studies, conditions for participation of a patient in each of said current and future medical studies, and a current number of participants in a current medical study;

a patient identification module at each of said local computers for receiving said patient data and having access to said study information, for comparing said patient data to said study information for determining, isolated from said central server, whether the patient associated with the patient data is eligible for participation in a specific medical study among said current and future studies, said patient identification module automatically determining whether a specific patient is eligible for participation in said specific medical study using said patient data associated with said specific patient and said conditions for participation of a patient in said specific medical study stored in said memory in said study administration module and, if said specific patient is eligible, for automatically conducting a procedure to obtain consent of said specific patient for said participation and, only if said consent is obtained, communicating said patient data associated with said specific patient to said study administration module; and

a study sequence control module in said central server which is informed of said eligibility and said patient data of said specific patient by said study administration module, for controlling a sequence of a study for which the specific patient is eligible by communicating with the medical location with which the specific patient is associated via the local computer at the medical location, and for gathering study data from the specific patient.

2. A system as claimed in claim 1 wherein said computer network comprises a telephone network.

3. A system as claimed in claim 1 further comprising a location management module in said central server for managing information about all of said medical locations connected to the central server via the respective local computers.

4. A system as claimed in claim 1 further comprising a participant data management module in said central server for managing study-specific participant data of all patients participating in a medical study.

5. A system as claimed in claim 4 wherein said participant data management module includes a memory wherein data are stored, in patient-specific fashion, for all patients participating in a medical study, said data including said study data collected by said study sequence control module and supplied to said memory.

6. A system as claimed in claim 5 further comprising a patient assignment module in said central server for assigning a specific patient to a study group for a specific medical study, after said specific patient is determined to be eligible for said specific study by said patient identification module.

7. A system as claimed in claim 6 wherein said patient assignment module comprises means for, depending on participant data for patients already participating in said specific study, said participant being stored in said participant data management module, assigning a participating patient to said study group of said specific medical study for generating a plurality of study groups which are substantially comparable to each other.

8. A system as claimed in claim 1 further comprising a patient assignment module in said central server for assigning a specific patient to a study group for a specific medical study, after said specific patient is determined to be eligible for said specific study by said patient identification module.

9. A system as claimed in claim 1 wherein said patient identification module employs the determination of whether said specific patient is eligible for participation in a specific medical study as a first criteria, and additionally determines whether said specific patient is already participating in said specific medical study as a second criterion and, if said first and second criteria are met, informs said study administration module of said eligibility.

10. A system as claimed in claim 1 wherein said patient identification module comprises means for emitting an error message if said patient data are insufficient for evaluating whether said patient is eligible to participate in one of said medical studies.

11. A system as claimed in claim 1 further comprising, at each of said local computers, a patient data input module for entering and managing said patient data for said at least one patient associated with the medical location at which said local computer is disposed.

12. A system as claimed in claim 1 further comprising, at each of said local computers, a patient master file identifying all patients associated with said medical location, and wherein said patient data module is connected to said patient master file and comprises means for automatically reading patient data from said patient master file for making the data from said patient master file available to said patient identification module.

13. A system as claimed in claim 11 wherein said patient data input module comprises means for entering patient data into a memory in said patient data input module as said patient data become available.

14. A system as claimed in claim 13 wherein said patient data input module comprises means for entering patient data acquired via a telephone query with said patient.

15. A system as claimed in claim 14 wherein said patient data input module comprises means for entering data produced by a telephone keyboard.

16. A system as claimed in claim 1 wherein said study sequence control module comprises means for controlling a time sequence of a specific one of said studies for a specific patient using the patient data associated with said specific patient and the study information about said specific study.

17. A system as claimed in claim 1 wherein said study sequence control module comprises means for controlling a time sequence of each of said medical studies by generating messages to respective medical locations having patients associated therewith who are participants in one of said medical studies.

18. A system as claimed in claim 17 wherein said study sequence control module comprises means for automatically generating and transmitting said messages depending on a current status of one of said medical studies.

19. A system as claimed in claim 18 wherein said study sequence control module comprises means for transmitting said messages electronically via said computer network to said respective medical locations.

20. A system as claimed in claim 17 wherein said study sequence control module comprises means for monitoring feedback from said respective medical locations produced in response to said messages and, given an absence of feedback from a respective medical location, for generating an error message to the respective medical location from which feedback is absent.

21. A system as claimed in claim 1 wherein said study sequence control module controls only a specific one of said studies for said specific patient.