WO2009100482A1

WO2009100482A1 - A method and system for preparing a report of results of medical testing carried out by a medical diagnostic device

Info

Publication number: WO2009100482A1
Application number: PCT/AU2009/000154
Authority: WO
Inventors: Neva Bull; Janet Burns
Original assignee: Bull Scientific Pty Ltd
Priority date: 2008-02-14
Filing date: 2009-02-12
Publication date: 2009-08-20

Abstract

A method and system for preparing a report of results of medical testing carried out by a medical diagnostic device, the method including the steps of: conducting a test on a patient by way of the diagnostic device; receiving test information from the device in an electronic format; processing the test information in accordance with a predefined schema; and populating a report template with the processed test information.

Description

A METHOD AND SYSTEM FOR PREPARING A REPORT OF RESULTS OF MEDICAL TESTING CARRIED OUT BY A MEDICAL DIAGNOSTIC DEVICE

Technical Field The present invention relates to methods and systems for preparing reports of results of medical testing carried out by medical diagnostic devices.

Background to the Invention

It has been tried to provide automated report generating systems for use in clinical environments. However, systems using device integration standards such as HL7 require a server environment with complex Ethernet based messaging. This is beyond the scope of a typical physicians' installed information technology base. Further, use of HL7 typically requires that the diagnostic devices must be capable of two way communication to acknowledge receipt of data and other control signals. Many diagnostic devices do not have this capability and so cannot operate effectively in an HL7 environment.

Summary of the Invention

In a first aspect the present invention provides a method of preparing a report of results of medical testing carried out by a medical diagnostic device, the method including the steps of: conducting a test on a patient by way of the diagnostic device; receiving test information from the device in an electronic format; processing the test information in accordance with a predefined schema; and populating a report template with the processed test information. The test information may be received in an ASCII or binary format.

The predefined schema may be an XML schema.

The method may further include the step of deleting the test information received from the testing device, which is performed before the step of populating the report. The method may further including the step of storing the processed test information in a database.

The method may further include the step of deleting the information from the database following the step of populating the report.

The method may further include the step of detecting when information is produced by the diagnostic device.

In a second aspect the present invention provides a system for preparing a report of results of medical testing carried out by a medical diagnostic device, the system including: receiving means for receiving test information from the diagnostic device in an electronic format; processing means for processing the test information in accordance with a predefined schema; and populating means for populating a report template with the processed test information. The system may be arranged to detect when information is produced by the diagnostic device.

Brief Description of the Drawings

An embodiment of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is a schematic illustration of a system for preparing a report according to an embodiment of the invention;

Figure 2 is a flow diagram illustrating steps in a method of preparing a report according to an embodiment of the invention; Figure 3 shows an example of a results output file produced by a medical diagnostic device;

Figure 4 shows an example of a report template; and

Figure 5 shows a report which has been produced by populating the template of figure 4.

Detailed Description of the Preferred Embodiment

Referring to figure 1, a system 10 is shown for preparing a report of results of testing carried out by a medical diagnostic device 12. The system includes a computing device in the form of a personal computer 14. The computer 14 is of a well known type of computer known as IBM compatible and features the usual combination of processor, memory, mouse keyboard and monitor (all not shown). The computer 14 is in communication with a database 16 and a printer 18.

Computer 14 is configured to run a software application. The application transforms raw data from any medical diagnostic device capable of exporting data and creates a fully customizable editable report document.

Referring to figure 2, the process involves the following steps:

1. Medical diagnostic device exports data 20.

2. A determination is made as to whether the device which produced the data is known to produce valid XML 22.

3. Transforming the device data into a standard XML schema 24.

4. Storing the data from the device in a generic database 26. 5. Generating and displaying the report document 28 to 34.

Communication with the diagnostic device 12 may be as either binary or ASCII. Binary data transmission generally occurs via a port. A port can be a TCP/IP port via Ethernet or a hardware port such as a serial, parallel or USB port. ASCII data transmission is usually achieved by writing the ASCII stream to a file on a disk accessible to the device. Examples of ASCII transmission are plain text files, Extensible Markup Language (XML) and Health Level Seven (HL7).

Binary data received from the device via port communications is transformed into XML. This is achieved by a custom piece of computer code instantiated in a dynamic linked library (DLL) written specifically to accommodate the idiosyncratic export format for any given particular device.

ASCII data written to file by the device is captured by a piece of computer code called the directory watcher which watches for changes to the contents of the disk location that the device is set to export to thereby detect when the diagnostic device produces information. When a new file appears, or an existing one is modified, the watcher alerts the application to process the new or modified file. The application then reads the new or modified file and a DLL written specifically for each device is called to parse the ASCII into a standard predetermined XML schema. A database may be created with a table specific for each device supported by the application. The XML created from the device export data is loaded into the appropriate database table using a Structured Query Language (SQL) insert query. An editable and printable report document is generated using the data from the appropriate table in the database.

Preferred Embodiment 1

The application consists of a directory watcher, a DLL for transforming the data into XML, and a routine for inserting the XML into the database and a report generation module.

An XML configuration file containing modifiable parameters is read by the application at start-up. These parameters include but are not limited to:

• The specific device to receive data from. This determines which DLL to call to import the raw data. • The database connection string.

• The report document filename and path.

• The directory that raw data is exported to . This is the directory that the directory watcher watches.

In the preferred embodiment the report document is a Microsoft Word 2007 Document (MS Word). Data is inserted into the document via the Mail Merge functionality of MS Word. This enables the end-user to easily modify the report template and edit the data imported by the mail merge. The steps to achieve this are as follows:

1. Any existing data in the database is deleted.

2. The raw data file, identified by the Directory Watcher is read into the database using the DLL specific to the device. The database can be of any type that MS

Word supports (Microsoft Access, SQL Server, Fox-Pro etc). The result is a device specific table containing one record.

3. The raw data file is then deleted.

4. The application then launches MS Word in a minimized state and opens the document template defined in the XML configuration file. The document template is a Macro-Enabled Template.

5. The document template is created by using the mail merge functionality of MS Word and placing fields on the document in the desired locations.

A Visual Basic module is included in the Macro-Enabled template that runs when the document loads. This module performs the following steps:

1. Opens the document in a minimized state.

2. Turns all warnings and dialog boxes off. 3. Creates a Mail Merge object.

4. Opens the database containing the data for use by the mail merge object.

5. Declares a Structured Query Language statement that returns all data in the device specific table.

6. Executes the Mail Merge to a new document. 7. Opens the new document in a normal window state.

8. Cancels addition of the template document to the recent files list.

9. Closes the template document.

This results in a new document being created that contains the data read from the device. This document can then be edited, printed and saved.

The reasons for deleting all data from the database and for deleting the raw data file before populating the report are as follows. Firstly MS Word Mail Merge by default creates merged documents for each record in the database. Providing it with a database containing only one record ensures that the report generated is not only the only report produced, but also ensures that it is the correct report. This eliminates the need for querying the database for the desired record and eliminated the need for the associated error checking.

Furthermore it removes the possibility of regenerating the report from the database or the raw data file. This is important because there should be only one source of "truth" for reports. This is the saved MS Word document. The reporting physician can review the machine generated data embodied in the report and modify it to represent his/her clinical judgment. When the document is saved it will contain these corrections. If reports can be regenerated from the raw data then these expert corrections can be lost, potentially resulting in a multitude of non-identical report documents for the same event.

Example XML specification

One possible embodiment of the standard XML contains (but is not limited to) the following blocks of XML tags: 1. Block of tags describing the patient a. Unique identifier b. Surname c. First name d. Date of Birth e. Address f. Telephone number

2. Block of tags describing the location/company/Physician of the test a. Practice Name b. Practice Address c. Physician Name d. Technician Name

3. Block of tags describing the type of test. a. Test Category b. Test Subcategory c. Test Formal Name d. Test Abbreviated Name e. Test Friendly Name 4. Block of tags describing the device used to capture data. a. Device function b. Device Manufacturer c. Device Name d. Device Version Identifier.

5. Date Time Stamps. a. Date Time Stamp of device data acquisition (if available) b. Date Time Stamp of data export.

6. Block of tags containing test specific data captured from the device. a. Idiosyncratic tags specific to the test and device.

Worked Example

A worked example illustrating the first embodiment will now be described. In this example, the diagnostic device used is a Norav PEC exercise stress machine. This machine can be set to produce a plain text file at the completion of the study containing study measurement parameters. An example of one of these files is shown in figure 3.

The following steps are carried out: 1. A directory watcher embodied in computer code waits until a new file matching predetermined criteria (e.g. *.txt) is written to the target directory (the directory set as the export directory on the stress machine).

2. The main program then calls computer code being embodied in a DLL written specific to the PEC exercise machine which reads the idiosyncratic file format produced by the PEC exercise machine and returns to the calling code a list of variables describing the data embodied in the export file. The list of variables contains one entry for every data point outputted by the diagnostic device.

3. The code further causes the list of variables to be inserted into a predetermined database object. A custom database object is in essence custom XML and can intrinsically generate XML from its structure. The XML produced is shown in

Appendix A.

4. An MS Word template (see figure 4) includes a Microsoft Word Macro which runs when the document loads. The macro code opens the PEC XML data source and returns all data from the PECDATA table. It then closes the template document and launches the merged document to thereby produce a finished report (see figure 5). Preferred Embodiment 2

In this embodiment the need for a database is redundant. The initial steps of reading data from the diagnostic device are unchanged. A piece of computer code transforms the device's data into XML if it is not already in XML, writes this output to a file and then calls a report generation module and points it to the XML document. This module then generates the report. An example of this is Adobe Flex which can be used to generate predetermined reports directly from XML documents.

In the embodiments described above, the diagnostic device was a Norav PEC exercise stress machine. In other embodiments, other diagnostic devices may be used including Holter Monitors, Point of Care Diagnostic Devices (such as devices which measure glucose, INR, Troponin etc) and Pacemaker Programmers.

This invention is primarily aimed at environments with stand-alone PC's or small local area networks. This invention makes use of commonly available and used software applications such as Microsoft Office in combination with executable computer code written to run natively on standard operating systems such as Windows XP/Vista based PC's or Apple Mac's.

Any reference to prior art contained herein is not to be taken as an admission that the information is common general knowledge, unless otherwise indicated.

Finally, it is to be appreciated that various alterations or additions may be made to the parts previously described without departing from the spirit or ambit of the present invention.

Appendix A

XML produced:

<?xml version="1.0" encoding="UTF-8" ?>

<PatientLastName> Smith</PatientLastName> <PatientFirstName> appleby</PatientFirstName>

<PatietnWeight> 75.00</PatietnWeignt> <TestFileName> C:\Program

Files\PCECG\Data\Smith. str</TestFileName>

<ReasonForTest>Leg pain</ReasonForTest> <REasonForTestEnd>ECG abnormalities</REasonForTestEnd>

<Conclusions>Normal blood pressure</Conclusions>

<Protocol> Bruce</Protocol>

<RestHeader> 100/50;HR: 86;Product: 8600;ST Level (mm),

Slope (mV/sec) (-1.0mm/-0.2mV/sec ,-1.1/0.0 ,-0.1/0.2 ,1.0/0.0 ,-0.4/-0.2 ,-0.6/0.0 ,1.2/-0.2 ,0.3/0.0 ,-0.7/0.0

,-1.2/0.2 ,-1.0/0.0 ,-0.9/0.0 ) </RestHeader>

<Rest> 100/50;HR: 86;Product: 8600;ST Level (mm), Slope

(mV/sec) (-1.0mm/-0.2mV/sec ,-1.1/0.0 ,-0.1/0.2 ,1.0/0.0 ,-

0.4/-0.2 ,-0.6/0.0 ,1.2/-0.2 ,0.3/0.0 ,-0.7/0.0 ,-1.2/0.2 ,-1.0/0.0 ,-0.9/0.0 ) </Rest>

<MaxHR>Time: 00:05;HR: 86;ST Level (mm), Slope (mV/sec) (-

1.0/-0.2 ,-1.1/0.0 ,-0.1/0.2 ,1.0/0.0 ,-0.4/-0.2 ,-0.6/0.0

,1.2/-0.2 ,0.3/0.0 ,-0.7/0.0 ,-1.2/0.2 ,-1.0/0.0 ,-0.9/0.0

) </MaxHR> <WorstST>Time: 00:05;Lead Vl :1.2mm; HR: 86;ST Level (mm),

Slope (mV/sec) (-1.0/-0.2 ,-1.1/0.0 ,-0.1/0.2 ,1.0/0.0 ,-

0.4/-0.2 ,-0.6/0.0 ,1.2/-0.2 ,0.3/0.0 ,-0.7/0.0 ,-1.2/0.2 ,-1.0/0.0 ,-0.9/0.0 ) </WorstST>

<Recovery>Time: 01:05;BP: 150/75;HR: 86;Product: 12900;ST

Level (mm), Slope (mV/sec) (-1.0/-0.2 ,-1.1/0.0 ,-0.1/0.2

,1.0/0.0 ,-0.4/-0.2 ,-0.6/0.0 ,1.2/-0.2 ,0.3/0.0 ,-0.7/0.0 ,-1.2/0.2 ,-1.0/0.0 ,-0.9/0.0 ) </Recovery>

</PECDATA>

Claims

CLAIMS:

1. A method of preparing a report of results of medical testing carried out by a medical diagnostic device, the method including the steps of: conducting a test on a patient by way of the diagnostic device; receiving test information from the device in an electronic format; processing the test information in accordance with a predefined schema; and populating a report template with the processed test information.

2. A method according to claim 1 wherein the test information is received in an ASCII or binary format.

3. A method according to claim 1 wherein the predefined schema is an XML schema.

4. A method according to claim 1 further including the step of deleting the test information received from the testing device before carrying out the step of populating the report.

5. A method according to claim 1 further including the step of storing the processed test information in a database.

6. A method according to claim 5 further including the step of deleting the information from the database following the step of populating the report.

7. A method according to any preceding claim further including the step of detecting when information is produced by the diagnostic device.

8. A system for preparing a report of results of medical testing carried out by a medical diagnostic device, the system including: receiving means for receiving test information from the diagnostic device in an electronic format; processing means for processing the test information in accordance with a predefined schema; and populating means for populating a report template with the processed test information.

9. A system according to claim 8 which is configured to detect when information is produced by the diagnostic device.