Method and system for processing electrocardiograms

• US 8,805,483 B2
• Filed: 01/20/2010
• Issued: 08/12/2014
• Est. Priority Date: 11/20/2001
• Status: Expired due to Term

• Current Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Original Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Inventors: Morganroth, Joel
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US12/690,519
• Publication Number:
  US 20100168598A1
• Time in Patent Office: 1,665 Days
• Field of Search: 600508-509, 600/513, 600/519, 600522-523, 600/525, 128920-925
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof

Abstract

In a method and system for processing an electrocardiogram (ECG), digital ECG data are received. The digital ECG data evinces a plurality of a patient'"'"'s heartbeats detected during an ECG. Digital annotation data are generated representing marking to be shown on an ECG tracing of the plurality of heartbeats. An annotated ECG tracing image is produced using the digital ECG data and the digital annotation data.

Claims

1. A system for automated processing of electrocardiograms (ECGs) in one or more sponsor trials comprising:

one or more data storage units;

a processor unit programmed with;

a trial setup module configured to receive protocol parameters for a sponsor trial and to store the protocol parameters in the one or more data storage units, said protocol parameters identifying data to be collected for ECGs processed in the sponsor trial and rules governing the sponsor trial;

a data entry module configured to receive the data to be collected as dictated by the protocol parameters for the sponsor trial received by the trial setup module and to store the data in the one or more data storage units;

a query resolution module configured to automatically identify problems with the data received with and stored by the data entry module and automatically generate a query for prompting resolution of the problems;

an interval duration measurement module configured to receive and store in the one or more data storage units interval duration measurements for the ECGs processed in the sponsor trial, the interval duration measurements obtained through on-screen measurement of ECG intervals by a technician;

a cardiologist evaluation module configured to present the ECG interval duration measurement data to a cardiologist for the ECGs processed in the sponsor trial, to receive and store in the one or more data storage units cardiological evaluation of the ECGs for which the ECG interval duration measurement data is presented, to queue uncertified ECGs for which the ECG interval duration measurement data is presented to the interval duration measurement module for interval remeasurement using the interval duration measurement module in response to cardiologist input designating the ECGs for remeasurement, and to receive certification of an evaluated ECG from the cardiologist; and

a reporting module for automatically generating a report representing the cardiological evaluation for an evaluated ECG that has been certified through the cardiologist evaluation module; and

a user terminal comprising a processor, a monitor and an input device, wherein the user terminal is configured to display an image of an ECG on the monitor for on-screen measurement of ECG intervals by the technician, generate an annotation file linked to an ECG file corresponding to the displayed ECG, the annotation file representing annotations corresponding to the on-screen measurement of the ECG intervals, and provide the interval duration measurements for the interval duration measurement module,

wherein the query resolution module is configured to classify each of the problems based on whether outside contact interaction is needed to resolve the problem, generate an internal alert if outside contact interaction is not required and generated an external query if outside contact interaction is required.

2. The system of claim 1, further comprising a quality control module configured to automatically designate an ECG for which an interval duration measurement has been received with the interval duration measurement module for quality control review based on predefined quality control review rules before the ECG is released to the cardiological evaluation module for cardiological evaluation.

3. The system of claim 1, further comprising a quality control module configured to automatically designate an evaluated ECG that has been certified through the cardiologist evaluation module for quality control review and to re-queue the designated ECG for remeasurement with the interval duration measurement module.

4. The system of claim 1, wherein the problems identified by the query resolution module include errors, absences or inconsistencies with the data received with the data entry module.

5. The system of claim 1, wherein the cardiologist evaluation module is configured to check evaluation data provided by the cardiologist for consistency.

6. The system of claim 1, wherein the trial setup module is configured to check received protocol parameters and flag problems with the received protocol parameters.

7. The system of claim 1, wherein the query resolution module is configured to batch multiple external queries together for transmission to an outside contact.

8. The system of claim 1, wherein the interval duration measurement module is further configured to check received interval duration measurements and prompt the technician to re-measure the ECG if a problem is detected with the received interval duration measurements.

9. The system of claim 1, wherein the annotation data represents interval endpoints and measurement markings.

10. A system for automated processing of electrocardiograms (ECGs) in one or more sponsor trials comprising:

one or more data storage units;

a processor unit programmed with;

a trial setup module configured to receive protocol parameters for a sponsor trial and to store the protocol parameters in the one or more data storage units, said protocol parameters identifying data to be collected for ECGs processed in the sponsor trial and rules governing the sponsor trial;

a data entry module configured to receive the data to be collected as dictated by the protocol parameters for the sponsor trial received by the trial setup module and to store the data in the one or more data storage units;

a query resolution module configured to automatically identify problems with the data received with and stored by the data entry module and automatically generate a query for prompting resolution of the problems;

an interval duration measurement module configured to receive and store in the one or more data storage units interval duration measurements for the ECGs processed in the sponsor trial, the interval duration measurements obtained through on-screen measurement of ECG intervals by a technician;

a cardiologist evaluation module configured to present the ECG interval duration measurement data to a cardiologist for the ECGs processed in the sponsor trial, to receive and store in the one or more data storage units cardiological evaluation of the ECGs for which the ECG interval duration measurement data is presented, to queue uncertified ECGs for which the ECG interval duration measurement data is presented to the interval duration measurement module for interval remeasurement using the interval duration measurement module in response to cardiologist input designating the ECGs for remeasurement, and to receive certification of an evaluated ECG from the cardiologist; and

a reporting module for automatically generating a report representing the cardiological evaluation for an evaluated ECG that has been certified through the cardiologist evaluation module; and

a user terminal comprising a processor, a monitor and an input device, wherein the user terminal is configured to display an image of an ECG on the monitor for on-screen measurement of ECG intervals by the technician, generate an annotation file linked to an ECG file corresponding to the displayed ECG, the annotation file representing annotations corresponding to the on-screen measurement of the ECG intervals, and provide the interval duration measurements for the interval duration measurement module,

wherein the interval duration measurement module is further configured to check received interval duration measurements and prompt the technician to re-measure the ECG if a problem is detected with the received interval duration measurements, and

wherein the interval duration measurement module is configured to check if the received interval duration measurements are compliant with a rule regarding leads from which the measurements may be taken and prompt the technician to re-measure if the rule is violated.

11. The system of claim 10, further comprising a quality control module configured to automatically designate an ECG for which an interval duration measurement has been received with the interval duration measurement module for quality control review based on predefined quality control review rules before the ECG is released to the cardiological evaluation module for cardiological evaluation.

12. The system of claim 10, further comprising a quality control module configured to automatically designate an evaluated ECG that has been certified through the cardiologist evaluation module for quality control review and to re-queue the designated ECG for remeasurement with the interval duration measurement module.

13. The system of claim 10, wherein the problems identified by the query resolution module include errors, absences or inconsistencies with the data received with the data entry module.

14. The system of claim 10, wherein the cardiologist evaluation module is configured to check evaluation data provided by the cardiologist for consistency.

15. The system of claim 10, wherein the trial setup module is configured to check received protocol parameters and flag problems with the received protocol parameters.

16. The system of claim 10, wherein the interval duration measurement module is further configured to check received interval duration measurements and prompt the technician to re-measure the ECG if a problem is detected with the received interval duration measurements.

17. The system of claim 10, wherein the annotation data represents interval endpoints and measurement markings.