WO1999005960A1 - Portable and programmable interactive visual analogue scale data-logger device - Google Patents

Portable and programmable interactive visual analogue scale data-logger device Download PDF

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Publication number
WO1999005960A1
WO1999005960A1 PCT/CA1997/000544 CA9700544W WO9905960A1 WO 1999005960 A1 WO1999005960 A1 WO 1999005960A1 CA 9700544 W CA9700544 W CA 9700544W WO 9905960 A1 WO9905960 A1 WO 9905960A1
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WO
WIPO (PCT)
Prior art keywords
means
patient
data
portable
logger device
Prior art date
Application number
PCT/CA1997/000544
Other languages
French (fr)
Inventor
Serge Daigle
Serge Marchand
Catherine Bushnell
Gilles Lavigne
Sylvain Saint-Jacques
Original Assignee
Universite De Montreal
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universite De Montreal filed Critical Universite De Montreal
Priority to PCT/CA1997/000544 priority Critical patent/WO1999005960A1/en
Publication of WO1999005960A1 publication Critical patent/WO1999005960A1/en

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires

Abstract

A portable, interactive clinical data-logger device signals to a patient under investigation a succession of recording time periods spaced apart by predetermined time intervals. After a recording time period has been signalled, questions such as 'What intensity of pain are you feeling ?', 'What degree of discomfort are you feeling ?' or 'How severe is a given symptom ?' are displayed. The patient answers each question by means of a pushbutton-controlled bar graph associated to a pain intensity, discomfort degree and/or symptom severeness representative V.A.S. scale. The V.A.S. data are then stored and available for further processing into an outside computer.

Description

PORTABLE AND PROGRAMMABLE INTERACTIVE

VISUAL ANALOGUE SCALE DATA-LOGGER DEVICE

BACKGROUND OF THE INVENTION

1. Field of the invention:

The present invention relates to a portable clinical data-logger device of the visual analogue scale (V.A.S.) type to be carried by the patient. This data- logger device is both interactive and programmable, and finds wide applicability in research and clinical practice.

2. Brief description of the prior art:

The company Autenta AB, Box 9028, S-750 09

Uppsala, Sweden is fabricating and commercializing a data-logger of the above type, under the name SYMTRACK®. The SYMTRACK® data-logger is portable and carried by the patient to record the intensity/severity of a given symptom in time. The SYMTRACK® data-logger emits a signal to remind the patient of each recording procedure. User selectable sample periods of 1, 5 or 10 minutes are available .

At each recording, the patient indicates by means of a visual analogue scale (V.A.S.) the intensity/severity of the symptom. Corresponding symptom data are then recorded and available for analysis purposes.

By concealing previous recordings from the patient, the SYMTRACK® data-logger prevents the patient to enter symptom data retrospectively. As retrospective symptom data are notoriously inaccurate, the SYMTRACK® data-logger substantially improves the accuracy of the collected data.

The SYMTRACK® data-logger presents the following drawbacks :

- programming is limited (for example, a very limited number of user selectable sample periods are available) ;

- data relative to only one symptom can be recorded at a time. OBJECTS OF THE INVENTION

An object of the present invention is therefore to provide a portable visual analogue scale data-logger device which is fully programmable.

Another object of the present invention is to provide a portable visual analogue scale data- logger device which is interactive to enable recording at the same time of different types of clinical data.

SUMMARY OF THE INVENTION

More specifically, in accordance with the present invention, there is provided a portable, interactive data-logger device for recording clinical data relative to a patient under investigation, comprising: timer means for signalling to the patient a succession of recording time periods spaced apart by predetermined time intervals; means for communicating a message to the patient after a recording time period has been signalled; data-entering means for allowing the patient to enter clinical data relative to the patient and related to the message; and memory means for receiving and storing the entered clinical data.

In accordance with preferred embodiments of the portable, interactive data-logger device of the invention:

the message communicating means comprises a display unit for displaying a question to be answered by the patient;

- the portable, interactive data-logger device further comprises means for turning the datalogger device on, the message communicating means then comprising means for communicating a message to the patient following turning on of the data-logger device;

- the portable, interactive data-logger device further comprises means for preventing the patient to enter or alter any data entered during one recording time period after this recording time period has elapsed;

- the message asks to the patient what intensity of pain he is feeling, what degree of discomfort he is feeling, and/or how severe is a given symptom, the data-entering means comprises means for allowing the patient to enter the intensity of pain he is feeling, the degree of discomfort he is feeling and/or the severeness of the given symptom;

- the data-entering means comprises a bar graph, scale means along the bar graph, and pushbutton means for controlling the bar graph;

- the time intervals between the successive recording time periods and the message to be communicated to the patient after a recording time period has been signalled are fully programmable; and

- the message communicating means comprises means for communicating to the patient a plurality of messages, and the data-entering means comprises means for allowing the patient to enter clinical data related to each message. The objects, advantages and other features of the present invention will become more apparent upon reading of the following non restrictive description of a preferred embodiment thereof, given by way of example only with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the appended drawings :

Figure 1 is a schematic block diagram of the preferred embodiment of the portable and programmable interactive visual analogue scale (V.A.S.) data-logger device according to the invention, comprising a central processing unit, an electroacoustic transducer, an alphanumeric display, a V.A.S. including a bar graph controllable through an up/down pushbutton switch, a control keyboard, a data memory, a program memory and an RS 232 port interface; and

Figure 2 is a flow chart showing operation of the portable and programmable interactive visual analogue scale (V.A.S.) data-logger device of Figure 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to Figure 1 of the appended drawings, the portable and programmable interactive visual analogue scale (V.A.S.) data-logger device 1, hereinafter referred to as "data-logger device 1" comprises :

- a central processing unit 2;

- an electroacoustic transducer 3 connected to the central processing unit 2;

- an alphanumeric display 4 connected to the central processing unit 2;

- a V.A.S. unit 5 connected to the central processing unit 2 and including a bar graph 6 controllable through an up/down pushbutton switch 7; - a control keyboard 8 comprising a plurality of keys 13 and connected to the central processing unit 2 ;

- a data memory 9 connected to the central processing unit 2;

- a program memory 10 in bidirectional communication with the central processing unit 2; and

- an RS 232 port interface 11 connectable to an outside personal computer 12 to establish bidirectional communication between the personal computer 12 and the central processing unit 2, unidirectional communication from the personal computer 12 to the program memory 10 and unidirectional communication from the data memory 9 to the personal computer 12.

Reference will now be made to both Figures 1 and 2 to describe operation of the data-logger device 1.

The data-logger device 1 is programmed

(step 20 of Figure 2) for recording clinical data relative to a patient under investigation.

Programming is carried out by means of the personal computer 12 through the RS 232 port interface 11. More specifically, the personal computer 12 communicates with the central processing unit 2 to store the new program in the memory 10.

In particular, successive recording time periods spaced apart by predetermined time intervals are programmed along with questions to be answered by the patient at each recording time period. Different questions may be asked to the patient at successive recording time periods, and the time intervals between the successive recording time periods is programmable at will.

Examples of questions that can be asked to the patient are the following:

What intensity of pain are you feeling?;

- What degree of discomfort are you feeling?;

- How severe is (a given symptom) ?;

- etc. A timer is incorporated in the central processing unit 2 to allow this central processing unit 2 to signal to the patient each recording time period (step 21 of Figure 2) . This is carried out by the central processing unit 2 by emitting a sound signal through the electroacoustic transducer 3.

In response to the sound signal emitted through the electroacoustic transducer 3, the patient should turn the data-logger device 1 on (step 22 of Figure 2) by depressing one of the keys 13 of the control keyboard 8.

Each recording time period has a given length. After a recording time period has been signalled, the central processing unit 2 counts time. After the recording time period has elapsed (step 23 of Figure 2) the program returns to step 21 and the patient is no longer enabled to enter and/or alter any data related to this particular recording time period. A corresponding message is then displayed (step 24 of Figure 2) on the alphanumeric display 4. This prevents the patient to enter data retrospectively, retrospective data being as mentioned in the foregoing description notoriously inaccurate. As long as the recording time period has not elapsed (step 23 of Figure 2) , the patient is enabled to enter data. It should be pointed out here that the length of the recording time periods is well sufficient to allow the patient to enter the clinical data related to the questions.

If the recording time period is not elapsed, the central processing unit 2 is responsive to turning on of the data-logger device 1 to display on the alphanumeric display 4 a message, in particular but not exclusively a question to be answered by the patient (step 25 of Figure 2) .

For example, if the question is "What intensity of pain are you feeling?", the patient operates the up/down pushbutton switch 7 (step 26 of Figure 2) to control the bar graph 6 so as to indicate the intensity of pain he is feeling on the 0-100% scale 14 (Figure 1) appearing along that bar graph 6. To facilitate answering by the patient, indications such as NONE, LOW, MEDIUM, HIGH and EXTREME (see 15 in Figure 1) are distributed along the scale 14.

The patient then depress an "ENTER" key (step 27 of Figure 2) amongst the keys 13 of the keyboard 8 to command the central processing unit 2 to store or record in the memory 9 the V.A.S. data indicative of the intensity of the pain the patient is feeling (step 28 of Figure 2) .

If the patient has to answer another question (step 29 of Figure 2) in the same recording time period, the program of the central processing unit 2 returns to step 25 and steps 25-28 are repeated for the additional question. Therefore, many questions may be asked to the patient during each recording time period.

As another example, if the question is "What degree of discomfort are you feeling?", the patient operates the up/down pushbutton switch 7 to control the bar graph 6 so as to indicate the degree of discomfort he is feeling on the 0-100% scale 14 (Figure 1) taking into consideration the indications 15.

The questions "What intensity of pain are you feeling?" and "What degree of discomfort are you feeling?" can be combined and the V.A.S. unit provided with two bar graphs 6 and 6' respectively controlled through up/down pushbutton switches 7 and 7 ' . To answer, the patient operates the up/down pushbutton switches 7 and 7 ' to indicate the intensity of pain through the bar graph 6 and the degree of discomfort he is feeling through the bar graph 6 ' , that is on the 0-100% scale 14 (Figure 1) taking into consideration the indications 15. Depression of the "ENTER" key of the keyboard 8 (step 27) will then cause recording of both V.A.S. data (step 28) related to the intensity of pain and degree of discomfort .

Another possible question is "How severe is (a given symptom) ? " . Again, to answer that question the patient operates the up/down pushbutton switch 7 to indicate, by means of the bar graph 6, how severe is the symptom of concern on the 0-100% scale 14 (Figure 1) taking into consideration the indications 15.

Those skilled in the art will appreciate that a plurality of other messages such as questions can be contemplated to collect clinical data concerning a given patient and related to these messages. The present invention is in no way limited by the type of messages .

When no additional question is to be answered (step 29 of Figure 2) , an "END" message is displayed on the alphanumeric display 4 (step 30 of Figure 2) . The patient then turns the data-logger device 1 off (step 31 of Figure 2) .

The V.A.S. data collected in the memory 9 can be retrieved by the outside personal computer 12 through the RS 232 port interface 11 and through appropriate commands transmitted to the central processing unit 2. The collected data can then be processed as desired in the computer 12.

The dimensions of the portable data-logger device 1 are as reduced as possible to be easily carried by the examiner. Acceptable dimensions are those of an electronic calculator.

Although the present invention has been described hereinabove by way of a preferred embodiment thereof, this embodiment can be modified at will, within the scope of the appended claims, without departing from the spirit and nature of the subject invention.

Claims

WHAT IS CLAIMED IS:
1. A portable, interactive data-logger device for recording clinical data relative to a patient under investigation, comprising: timer means for signalling to the patient a succession of recording time periods spaced apart by predetermined time intervals; means for communicating a message to the patient after a recording time period has been signalled; data-entering means for allowing the patient to enter clinical data relative to the patient and related to the message; and memory means for receiving and storing the entered clinical data.
2. A portable, interactive data-logger device as recited in claim 1, in which said message communicating means comprises a display unit for displaying a question to be answered by the patient.
3. A portable, interactive data-logger device as recited in claim 1, further comprising means for turning the data-logger device on, wherein said message communicating means comprises means for communicating a message to the patient following turning on of the data-logger device.
4. A portable, interactive data-logger device as recited in claim 1, further comprising means for preventing the patient to enter or alter any data entered during one of said recording time periods after said recording time period has elapsed.
5. A portable, interactive data-logger device as recited in claim 1, wherein: said message communicating means comprises means for asking to the patient what intensity of pain he is feeling; and said data-entering means comprises means for allowing the patient to enter the intensity of pain he is feeling.
6. A portable, interactive data-logger device as recited in claim 5, wherein said means for allowing the patient to enter the intensity of pain he is feeling comprises:
- a bar graph;
- pain intensity scale means along said bar graph; and
- pushbutton means for controlling said bar graph.
7. A portable, interactive data-logger device as recited in claim 1, wherein: said message communicating means comprises means for asking to the patient what degree of discomfort he is feeling; and said data-entering means comprises means for allowing the patient to enter the degree of discomfort he is feeling.
8. A portable, interactive data-logger device as recited in claim 7, wherein said means for allowing the patient to enter the degree of discomfort he is feeling comprises:
- a bar graph; - discomfort degree scale means along said bar graph; and
- pushbutton means for controlling said bar graph.
9. A portable, interactive data-logger device as recited in claim 1, wherein: said message communicating means comprises means for asking to the patient how severe is a given symptom; and said data-entering means comprises means for allowing the patient to enter the severeness of said given symptom.
10. A portable, interactive data-logger device as recited in claim 9, wherein said means for allowing the patient to enter the severeness of said given symptom comprises:
- a bar graph;
- symptom severeness scale means along said bar graph; and
- pushbutton means for controlling said bar graph.
11. A portable, interactive data-logger device as recited in claim 1, wherein: said message communicating means comprises means for asking to the patient both what intensity of pain and what degree of discomfort he is feeling; and said data-entering means comprises means for allowing the patient to enter both the intensity of pain and the degree of discomfort he is feeling.
12. A portable, interactive data-logger device as recited in claim 11, wherein said means for allowing the patient to enter the intensity of pain and the degree of discomfort he is feeling comprises:
- a first bar graph; - pain intensity scale means along said first bar graph;
- first pushbutton means for controlling said first bar graph; - a second bar graph;
- discomfort degree scale means along said second bar graph; and
- second pushbutton means for controlling said second bar graph.
13. A portable, interactive data-logger device as recited in claim 1, comprising means for programming the time intervals between the successive recording time periods.
14. A portable, interactive data-logger device as recited in claim 1, comprising means for programming the message to be communicated to the patient after a recording time period has been signalled.
15. A portable, interactive data-logger device as recited in claim 1, wherein said message communicating means comprises means for communicating to the patient a plurality of messages, and wherein said data-entering means comprises means for allowing the patient to enter clinical data related to each of said messages.
PCT/CA1997/000544 1997-07-30 1997-07-30 Portable and programmable interactive visual analogue scale data-logger device WO1999005960A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CA1997/000544 WO1999005960A1 (en) 1997-07-30 1997-07-30 Portable and programmable interactive visual analogue scale data-logger device

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US20090149719A1 (en) * 2007-12-05 2009-06-11 Cardiac Pacemakers, Inc. System And Method For Performing Remote Patient Risk Assessment Through A Visual Analog Scale
CN103230276A (en) * 2013-02-01 2013-08-07 上海中医药大学附属岳阳中西医结合医院 Device and method for quantitatively evaluating and recording human body subjective feeling
US8846090B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
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CN105852812A (en) * 2016-04-08 2016-08-17 温州医科大学 Multifunctional pain scale and operation method thereof
US10071089B2 (en) 2013-07-23 2018-09-11 Euro-Celtique S.A. Combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation

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Cited By (33)

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US8936808B1 (en) 1997-12-22 2015-01-20 Purdue Pharma L.P. Opioid agonist/opioid antagonist/acetaminophen combinations
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US9474750B2 (en) 1997-12-22 2016-10-25 Purdue Pharma L.P. Opioid agonist/opioid antagonist/acetaminophen combinations
US9283216B2 (en) 2001-05-11 2016-03-15 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9283221B2 (en) 2001-05-11 2016-03-15 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9345701B1 (en) 2001-05-11 2016-05-24 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
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US9161937B2 (en) 2001-05-11 2015-10-20 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9358230B1 (en) 2001-05-11 2016-06-07 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9511066B2 (en) 2001-05-11 2016-12-06 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US8969369B2 (en) 2001-05-11 2015-03-03 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
US9084729B2 (en) 2001-05-11 2015-07-21 Purdue Pharma L.P. Abuse-resistant controlled-release opioid dosage form
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US8846091B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US8846090B2 (en) 2002-04-05 2014-09-30 Euro-Celtique S.A. Matrix for sustained, invariant and independent release of active compounds
US9655855B2 (en) 2002-04-05 2017-05-23 Purdue Pharma L.P. Matrix for sustained, invariant and independent release of active compounds
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US9555000B2 (en) 2002-04-05 2017-01-31 Purdue Pharma L.P. Pharmaceutical preparation containing oxycodone and naloxone
KR20130133269A (en) * 2005-02-28 2013-12-06 유로-셀띠끄 소시에떼 아노님 Method and device for the assessment of bowel function
KR101579765B1 (en) * 2005-02-28 2015-12-23 유로-셀띠끄 소시에떼 아노님 Method and device for the assessment of bowel function
US20080167533A1 (en) * 2005-02-28 2008-07-10 Petra Leyendecker Method and Device for the Assessment of Bowel Function
CN101128147A (en) * 2005-02-28 2008-02-20 欧洲凯尔特公司 Method and device for the assessment of bowel function
EP1702558A1 (en) * 2005-02-28 2006-09-20 Euro-Celtique S.A. Method and device for the assessment of bowel function
WO2006089970A1 (en) * 2005-02-28 2006-08-31 Euro-Celtique S.A. Method and device for the assessment of bowel function
US10258235B2 (en) 2005-02-28 2019-04-16 Purdue Pharma L.P. Method and device for the assessment of bowel function
US20090149719A1 (en) * 2007-12-05 2009-06-11 Cardiac Pacemakers, Inc. System And Method For Performing Remote Patient Risk Assessment Through A Visual Analog Scale
US9271940B2 (en) 2009-03-10 2016-03-01 Purdue Pharma L.P. Immediate release pharmaceutical compositions comprising oxycodone and naloxone
US9820983B2 (en) 2009-03-10 2017-11-21 Purdue Pharma L.P. Immediate release pharmaceutical compositions comprising oxycodone and naloxone
CN103230276A (en) * 2013-02-01 2013-08-07 上海中医药大学附属岳阳中西医结合医院 Device and method for quantitatively evaluating and recording human body subjective feeling
US10071089B2 (en) 2013-07-23 2018-09-11 Euro-Celtique S.A. Combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation
CN105852812A (en) * 2016-04-08 2016-08-17 温州医科大学 Multifunctional pain scale and operation method thereof

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