JP2002269231A - Clinical data analysis processing method, system, computer program and medium - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a clinical data analysis processing method and a system capable of collecting and analyzing a clinical data and providing a doctor and a patient with its information. SOLUTION: A breathing function examination device 10 and a respiratory organ information processor 2 are connected to each other through the Internet 3 to provide the clinical data of the asthmatic patient 1. The breathing function examination device 10 is furnished with a communicating function to be connected to a telephone line and can be automatically connected to a telephone number registered of the respiratory organ information processor 2. An exhalation-inspiration measured data is output with a time stamp data at measuring time as the clinical data from the breathing function examination device 10 by operation of the patient 1. This measured data is delivered to the respiratory organ information processor 2 with a discrimination signal of the patient 1 through the Internet 3, and this device is connected to the breathing function examination device 10 of each of the patients through the Internet 3 as a central device of a plural number of the patients.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and system for analyzing clinical data, a computer program for causing a computer and / or a computer system to execute the analyzing method, and a computer-readable recording medium on which the program is recorded. . In particular,
The present invention relates to a system for transmitting measurement data (clinical data) of a patient's condition to a management center (respiratory information processing device), analyzing the clinical data, and feeding it back to a doctor or a patient.

[0002]

2. Description of the Related Art In order to contribute to the long-term management of patients with chronic diseases such as asthma and diabetes, clinical data measured by the patient is sent from a patient to a management center at a remote place through a communication means, and collected and analyzed by the management center. There is a system that performs processing.

[0003] An example of such a system is disclosed in Tokuhyohei 10-5.
No. 00598.

The contents of this publication are as follows.

[0005] That is, a data record having a measurement value and measurement time data (time stamp) measured by a patient is sent to a remote reporting unit.

[0006] The reporting unit updates the relational database based on the data records and creates a time series graph of measured values for a particular patient. The report is then delivered to one or more physicians by telephone facsimile, e-mail, broadcast data communication, or regular postal service.

[0007] The affected patient can also obtain a copy of the delivery report to the physician by similar means.

[0008]

Here, what is important in the management of patients with chronic diseases such as asthma is that the patients can detect the onset / change of the disease state in advance according to the instructions given by the attending physician in advance, and if necessary, Adjusting the dosage, selecting an appropriate drug, receiving treatment by a physician, and the like at a necessary time.

[0009] By properly implementing these, it is possible to control these chronic diseases, and it can be expected that the symptoms disappear and the respiratory function is improved. However, in the above-described conventional technology, only a one-sided report notification is given to the patient, and the tendency of the patient to voluntarily determine whether to perform an appropriate treatment is increased.

[0010] Further, there is a problem that a standard for dealing with measurement data is not clearly defined. Therefore,
The contents of the notification to the patient also largely depend on the nurse and the doctor who handle the measurement data. In the past, if the number of patients increased, the number of nurses had to be increased proportionately.

In addition, the report does not directly reflect the results of the doctor's consultation and treatment, and the doctor using this system has to read and compare the report with the medical record. .

[0012] Further, with the advance of medical technology, the same patient undergoes a more specialized clinic / physician consultation and treatment, and the case where primary care as symbolized by the concept of "home doctor" is received. In a situation where the person in charge of the attending physician changes among multiple doctors, such as in the case of switching between patients according to the change in the patient's medical condition, a conventional referral letter alone may require multiple doctors and clinics There was often a discrepancy in communication between patients and patients, and the amount of information exchanged was not sufficient.

Accordingly, an object of the present invention is to collect and analyze measurement data, that is, clinical data, to provide more efficient and positive feedback to not only doctors but also patients, and to provide more comprehensive and dynamic information. An object of the present invention is to provide a clinical data analysis processing method and system that can be provided.

[0014]

According to the present invention, there is provided a method and system for analyzing clinical data according to the present invention, in which clinical data of a patient is integrated in a respiratory information processing apparatus, where the data is stored, analyzed, evaluated, and processed. Performs information processing such as clinical risk scoring and clinical urgency sorting,
The information processing result can be transmitted to one or more, particularly preferably two or more medical terminals, and information from the medical terminal can be output by the medical terminal together with the information processing result.

That is, in the present invention, a step of measuring clinical data of a patient by a respiratory function testing apparatus based on expiration / inspiration is provided, and a communication unit transmits the measured clinical data together with a signal for identifying a patient to a respirator. Transmitting to the information processing device, the respiratory information processing device performing information processing including at least one of the following (a) to (d), and obtaining the information processing result: (a) for each patient A process of accumulating the clinical data. (B) analyzing and evaluating the accumulated clinical data; (C) a process of scoring the clinical risk according to the evaluation result of the clinical data. (D) A process of sorting the clinical data in the order of clinical urgency in consideration of the clinical risk.

The respiratory information processing apparatus transmits the information processing result to one or more medical terminals, and the medical terminal receives the information processing result and an input from one of the medical terminals; Data analysis processing method including a step of outputting the information and a clinical data analysis processing system including means for executing the analysis processing method, and a computer for causing a computer and / or a computer system to execute the analysis processing method program,
This is typified by a computer-readable recording medium recording this program.

According to a preferred embodiment of the present invention for achieving the above object, the apparatus for testing respiratory function by expiration / inspiration is a spirometer or a peak flow meter, wherein the clinical data of the patient is obtained by the spirometer or the peak flow meter. It is characterized by the patient's expiration and / or inspiration volume being measured. It is preferable that the respiratory function testing device has a communication function.

The clinical data is data indicating a health condition of a patient, and can be arbitrarily determined. Although this clinical data is measured by a respiratory function test device, it is also possible to add information measured by other devices, and also, for example, by a human hand or an instrument separately, such as a pulse and a body temperature. It is also possible to add the measured information as part of the clinical data.

The signal for identifying the patient by the communication means is:
Any data can be used as long as it can show that a specific patient and specific clinical data are in a correspondence relationship. For example, a code for identifying a patient may be used, and a specific respiratory function test device may be a code indicating the respiratory function test device if it is clear that a specific patient uses the device.

The signal for identifying the patient is transmitted together with the clinical data by the communication means to identify the subject of the clinical data, but is also used to ensure the security of the clinical data. can do.
As a technique for transmitting the signal for identification together with clinical data, any existing technique can be applied.

The present invention includes a combination with a security technique such as an encryption process. Here, "send together" does not only mean "together" in terms of time, but also a signal for identifying a specific patient and specific clinical data, and the clinical data is that of the patient. Needless to say, any state may be used as long as it is sufficient to prove the fact.

The accumulation, analysis and evaluation of clinical data in the respiratory information processing apparatus, scoring of clinical risk, sorting by clinical urgency, and the like can be automatically performed by a computer or the like in accordance with certain criteria. it can.

The above criteria for accumulating, analyzing, and evaluating clinical data, scoring for clinical risk, sorting by clinical urgency, and the like can be arbitrarily determined in advance. It is also useful that a person having a specific authority can revise these standards or can set standards to be added to these standards.

It is preferable that the accumulation of the clinical data is made to be able to be output in time series. For example, when judging the health condition of one patient, if necessary, a medical worker such as a doctor or a nurse who uses the clinical data analysis method and the system according to the present invention, may use the past data. This is because appropriate judgment can be facilitated while looking at the data.

In a preferred embodiment of the analysis according to the present invention, the accumulated clinical data is subjected to batch processing for a predetermined period to analyze the maximum expiratory flow.

In another preferred embodiment according to the present invention, when the clinical data is not received by the respiratory information processing apparatus for a predetermined period, the clinical data is explicitly output as an information processing result,
Alternatively, scoring may be performed according to the clinical risk.

In another preferred embodiment according to the present invention, when the clinical data is not received by the respiratory information processing device a predetermined number of times a day, the clinical data is explicitly output as an information processing result, or the clinical data is output. The score may be calculated according to the target risk.

Further, as another preferred embodiment according to the present invention, when the clinical data is not received by the respiratory information processing apparatus for a predetermined period or more, it is explicitly output as an information processing result or the received data is not received. Clinical risk may be scored over time.

Further, another preferred aspect according to the present invention is that when the clinical data is not intermittently received by the respiratory information processing apparatus, the clinical data is explicitly output as an information processing result,
Alternatively, the clinical risk may be scored according to the period during which it is not received intermittently.

In another preferred embodiment according to the present invention, a maximum expiratory flow rate (PE
F) and the self-best value (OEF), ie, the “maximum expiratory flow (PEF) / self-best value (OEF)” value (PEF /
If the number of times the OEF (also referred to as OEF) deviates from the predetermined range continues more than the prescribed number of times, or occurs more than the prescribed number of times within the prescribed period, it is scored according to the clinical risk, It may be explicitly output as the processing result.

The self-best value can be determined separately from the measurement of the expiratory flow rate at a specialized hospital or the like, but it can also be corrected and created as appropriate using clinical data within a certain period.

Further, as another preferred embodiment according to the present invention, when the clinical data deviates from a predetermined value, the clinical data is excluded, and a score is set according to the clinical risk of the excluded clinical data. Or the fact of its exclusion may be explicitly output to the information processing result.

Further, as another preferred embodiment according to the present invention, the daily fluctuation of the clinical data is calculated, the calculated value deviates from a predetermined range, and the number of deviations is within a certain period. When the number of occurrences exceeds a predetermined number, a score may be calculated according to the clinical risk of the calculated value, or may be explicitly output as an information processing result.

In another preferred embodiment according to the present invention, when PEF / OEF indicates a value larger than a predetermined normal setting value, it is determined that the normal condition is satisfied, and even if the normal condition is satisfied, the PEF / OEF exceeds a predetermined number of times. If the number falls continuously, the score may be calculated according to the clinical risk corresponding to the decrease, or may be explicitly output as the information processing result.

Further, as another preferred embodiment according to the present invention, when the PEF / OEF is between a predetermined normal set value and a caution set value, it is determined that caution is required, and even if caution is required, it is determined. If the number of drops falls continuously for more than the given number of times, a score may be calculated according to the clinical risk corresponding to the drop, or the score may be explicitly output as an information processing result.

Further, as another preferred embodiment according to the present invention, when the ratio of the number of times requiring caution to the total number of times of measurement within a certain period continuously increases for a predetermined period or more, the increase is indicated. May be scored according to the clinical risk corresponding to the information, or may be explicitly output as the information processing result.

In another preferred embodiment according to the present invention, if PEF / OEF is smaller than a predetermined caution set value, it is determined to be dangerous, and according to the clinical risk,
It may be scored or output explicitly as the result of information processing.

Further, as another preferred embodiment according to the present invention, when PEF / OEF detects a value of 100% or more for a predetermined number of times or more, the change of the self-best value is explicitly output to the information processing result. And may prompt a change to an appropriate self-best value.

A preferred embodiment of the communication means according to the present invention is a telephone line or the Internet.

In the present invention, the number of medical terminals to which information processing results are transmitted is one or more, but it is particularly preferable that the number is two or more. For example, if a patient who had been treated by a specialist clinic or physician started receiving medical treatment by his or her physician due to an improvement in his medical condition, the physician at the specialty hospital and the physician at the same time By accessing the processing result, communication between doctors and between the doctor and the patient can be achieved, and more accurate treatment can be performed.

In the above invention, the step of the medical terminal outputting the information processing result and the information input from any of the medical terminals is included in the output of only the information processing result by the medical worker. It is intended to positively add the result of diagnosis and treatment by a certain doctor or the like and its judgment.

The output of only the information processing result does not sufficiently reflect the diagnosis and treatment result of the medical worker and the judgment thereof, and the information processing result plays an auxiliary role for the diagnosis and treatment activity of the medical worker. For example, a physician must perform a diagnostic treatment activity while comparing a medical record with an information processing result. In contrast, in the present invention, a physician or the like who is a medical worker actively adds a diagnostic treatment result and its determination. As a result, the value of the information processing result is greatly increased.

When security is sufficiently ensured, part or all of the contents of the medical record are output together with the information processing result, or the electronic medical record is linked to the information processing result to separately process information. The ability to output the result and the chart at the same time also belongs to the aspect of the present invention.

In the present invention, the medical terminal that outputs information input from any one of the medical terminals includes not only the medical terminal that has input the information but also other medical terminals that are appropriately specified. You can go out.

In the present invention, together with the information processing result, an output indicating the patient's health status classified according to the patient's health status, and a content indicating a coping method including a use method of the medicine corresponding thereto are provided. It is also preferable that the treatment control plan is output as a part of the information processing result. Other details may be included in the content of the treatment control plan. Further, the case where the input of information from any of the medical terminals is to select, correct, or add to a method of coping with the treatment control plan output to the medical terminal is also included in the scope of the present invention. Belongs to.
In this case, the information input from the medical terminal described above may be directly included in the treatment control plan. Further, the treatment control plan may be modified or added according to the information input from the medical terminal described above. In such a case, it is needless to say that it is useful to include information in the output, to limit the authority to modify and add to the treatment control plan to specific persons, and to incorporate it into the system. No.

Outputting the updated information and the past information to the medical terminal is useful for performing consistent medical treatment and treatment activities including the past information. Especially useful for sharing correctly.

The time when the information is included, the time when the treatment control plan is modified or added, and the record of who has modified or added the treatment control plan including the information are output to the medical terminal. This is one useful method for achieving the purpose, and it is needless to say that it is preferable for the purpose of clarifying the responsibility.

The information input from the medical terminal may be directly transmitted from the medical terminal to another medical terminal, but may be transmitted to the respiratory function testing apparatus, from which the information may be transmitted to the medical terminal and / or another medical terminal. It can also be sent.
In particular, when this information is reflected in the information processing result and the treatment control plan, the information can be concentrated on the respiratory information processing apparatus, which is advantageous in management, economy, and security. In the specification of the present application, "reflecting information in the information processing result and the treatment control plan" means that the information processing standard and the treatment control plan are corrected in accordance with the input information and added to the contents. Contains.

In the above description, typical examples of “output” in the medical terminal include a personal computer display by a dedicated computer program and a display on the Internet. In addition, for example, electronic mail, facsimile, Any output means such as voice output by telephone can be handled as "output" in the medical terminal as long as it does not contradict the gist of the present invention. That is, the medical terminal in the present invention includes:
A computer, display, telephone, facsimile, etc. for processing the information can be included. Needless to say, these need not be integrated.

As a form of receiving information from the respiratory information processing apparatus, it is preferable that such a medical terminal can always receive information. However, emergency information is received by facsimile, and other information is received. A known access mode such as a mode in which a medical terminal accesses a respiratory information processing apparatus can be used in combination.

The medical terminal can access the respiratory information processing apparatus by, for example, transmitting a signal requesting transmission of an information transmission result or the like to the respiratory information processing apparatus. At this time, only the authorized medical worker transmits the information that the transmission request signal includes a password for enabling the respiratory information processing apparatus to transmit the information processing result and the like to the medical terminal. This is desirable as a reliable method of ensuring that the results can be accessed.

The above object is achieved in that the password is different for each patient and the content of the information processing result which can be transmitted to the medical terminal by the respiratory information processing apparatus is determined by the password. More desirable for. More specifically, the password makes it possible to specify a patient to which a specific medical worker can access.

From the viewpoint of security, it is often desirable that the above-described decryption process be employed not only in transmitting clinical data but also in all aspects of transmission used in the present invention. In order to achieve the object, the respiratory function testing apparatus has signal encryption processing means, and the respiratory information processing apparatus and the medical terminal perform signal encryption processing means and signal decryption processing of the encrypted signal. It is desirable to have means.

[0054]

BRIEF DESCRIPTION OF THE DRAWINGS The features of the present invention will become more apparent from the embodiments of the invention described with reference to the following drawings.

Hereinafter, embodiments of the present invention will be described with reference to tables and drawings. The embodiments shown in the tables and figures are for understanding the present invention, and the application of the present invention is not limited to such embodiments. In the following, it goes without saying that an alarm notified to a telemedicine center or the like is also included in the information processing result according to the present invention.

FIG. 1 is a diagram showing a configuration example of a system to which a clinical data analysis processing method according to the present invention is applied.

As an embodiment, a spirometer or a peak flow meter (hereinafter, these are collectively referred to as a respiratory function test device) 10 for measuring expiration and inspiration to obtain clinical data of an asthmatic patient 1 and a respiratory information processing device 2 is connected through a communication network as communication means, more specifically, for example, through the Internet 3.

Here, the respiratory function test apparatus 10 can use, as an example, a product provided by Enact Products, Inc. of the United States whose basic principle is described in the above-mentioned Japanese Patent Publication No. 10-500958.

The respiratory function test apparatus 10 has a communication function for connecting to a telephone line, and can automatically connect to a registered telephone number on the respiratory information processing apparatus 2 side. Alternatively, a URI (Uniform Responder) of the respiratory information processing device 2 side is connected to the provider by telephone through the Internet 3 according to the present invention.
It is also possible to provide a function to automatically connect to ource Identifier).

By the operation of the patient 1, the respiratory function test apparatus 10 outputs, as clinical data, the measurement data of the expiration and inspiration, which are the measurement data converted into digital signals, together with the time stamp data of the measurement time.

Therefore, as described above, the measurement data is sent to the respiratory information processing apparatus 2 together with a signal for identifying a patient through the communication means, that is, the telephone line or the Internet 3 or the like. Here, the respiratory information processing device 2 is connected to the respiratory function testing devices 10 of a plurality of patients through the Internet 3 as a central device.

In FIG. 1, clinical data received by the respiratory information processing device 2 is classified into clinical data for each patient and is temporarily stored. After that, the clinical data for each patient is analyzed and evaluated based on the signal for identifying the patient.

The evaluation result is stored and registered for each patient. The stored and registered clinical data is analyzed and evaluated later, a clinical risk is scored in accordance with the evaluation, information processing is performed in the order of clinical urgency, and an operation for obtaining the information result is performed. At this time, if abnormal data is detected due to the clinical urgency, an alarm is generated, and the telemedicine center 4 and the medical terminal 5 where the nurse is on standby,
It is possible to prompt a medical treatment plan. At the same time, the alarm can be explicitly output to a processing device such as a facsimile or a personal computer on the patient 1 side.

A medical terminal 5 used by a medical worker such as a doctor or a nurse is also connected to the respiratory information processing apparatus 2 by a telephone line, and can be automatically connected to a registered telephone number on the respiratory information processing apparatus 2 side. can do. Alternatively, the personal computer 5a can be configured to have a function of making a telephone connection to a provider and automatically connecting to a URI (Uniform Resource Identifier) of the respiratory information processing apparatus 2 through the Internet 3.

In this case, of the above information processing results, those relating to the same patient can be made accessible by a plurality of medical terminals at the same time or at different times. That is, referring to FIG. 1, when there are a plurality of medical terminals 5, the information processing result of the same patient is accessed from the plurality of medical terminals, and a plurality of medical terminals in the medical terminal 5 and the telemedic center 4 are accessed. Accessing the information processing result of the same patient from this example is an example of this.

The above-mentioned various information input from the medical terminal can be added to the output at the medical terminal. The information is transmitted to the respiratory information processing apparatus 2 and then to the other medical terminals 5. I can do it. The flow can be illustrated by FIG.

In FIG. 8, the clinical data obtained by the respiratory function test performed by the respiratory function test apparatus 101 is transmitted to the respiratory information processing apparatus 102, where the clinical data is accumulated, analyzed, evaluated, and evaluated for clinical risk. Information processing such as scoring of degrees and sorting of clinical data in order of clinical urgency is performed, and the information processing result is obtained.

The information processing result is output to each medical terminal.
The example of FIG. 8 illustrates a case where output is performed at three medical terminals 103a, b, and c.

The input information from the medical terminal 103a is directly displayed on the display 104a of the medical terminal 103a, transmitted to the respiratory information processing apparatus 102, and transmitted to the other medical terminals 103b and c, and the display 1
04b and c are displayed.

A treatment control plan is created in advance, and is output to each medical terminal as a part of the information processing result. In this treatment control plan, for example, only information input from the medical terminal 103a by a specific doctor using the specific medical terminal 103a can be reflected.

Table 1 and FIG. 3 are examples of the information processing results described above.

Table 1 is a list of clinical data and patient names arranged in order of clinical urgency. Clinical data
PEF, FEV1, PEF / OEF, and intraday variability are shown. In this list, only the information of the patient selected by the information on the patient (patient name or the like) transmitted from the medical terminal to the respiratory information processing apparatus in advance is listed.

FIG. 3 is a diagram showing the transition of data for 30 days, with the horizontal axis representing the change of the parameter of the measured value of a certain patient. FIG. 3A shows the measured PEF and the measured PEF against the patient's own best value as certified by the physician.
If the ratio of F is up to 80%, the green region I is less than 80%.
Determined to be in III.

Then, the yellow region II and the red region II
When it is in I, the exhalation ability is in a reduced state,
Routine medical treatment is required. Therefore, in such a case, it is determined that a warning from the doctor of the telemedicine center 4 and the medical terminal 5 should be displayed on the patient 1 side.

FIG. 3B shows the change of FEV1 (the meaning of which will be described later). FEV1 in the morning and afternoon is measured, and there is a problem if the way of exhalation does not have a certain tendency. Therefore, when the difference between the downward and upward directions of FEV1 exceeds a predetermined value, it is determined that there is an abnormality.

FIG. 3C shows the transition of the measured value of the daily fluctuation rate of the measured value. The daily fluctuation rate is obtained from the ratio between the maximum and minimum values of the morning and afternoon measurements. If the daily fluctuation rate exceeds 20%, it is determined to be abnormal.

FIG. 3D shows a column for displaying information input from the medical terminal as a remark. 3A to 3D are displayed side by side on the display.

FIG. 9 shows a specific example of a treatment control plan.

In this example, the peak flow value (ie, PE
F) is selected as a display indicating the patient's health condition, and the usage of the drug is displayed accordingly. Specific examples of reflecting the information input from the medical end into the treatment control plan include selection of a coping method of the treatment control plan, modification thereof, and addition thereto. For example, changing the type and amount of the medicine to be used.

Tables 1, 3, 9 and the like may be switched and displayed on the display, or may be displayed simultaneously. For example, by using a personal computer and pointing and clicking the patient name in Table 1 using a mouse, the display can be switched to the screens of FIGS. 3 and 9.

In the above description, FEV1 means the cumulative expiratory volume from zero second to one second. For example, in the graph shown in FIG. The PEF can be defined as the expiratory flow rate on the horizontal axis in FIG.
1, the maximum expiratory flow rate (point X in FIG. 11). In addition, the intraday fluctuation rate is a maximum value of PEFmax and a minimum value of PEFmin for a plurality of PEFs on the same day.
2 (PEFmax-PEFmin) / (PEFmax + PEFmin)
Can be defined as Furthermore, the method of determining OEF can be determined by any method.However, PEEF determined from the measurement of expiratory flow at a specialty hospital or the like can be used as OEF, and this can be appropriately corrected using clinical data within a certain period Alternatively, the PEF under a certain condition can be calculated by the respiratory information processing apparatus, and this can be used as the OEF.

FIG. 2 is a block diagram showing an example of the configuration of the respiratory information processing apparatus 2. It has a respiratory information reception processing function unit 20 and a periodic output processing function unit 21 mainly controlled by execution of a software program.

Further, a reception log information database 22, a cumulative respiratory information database 23,
It has a patient basic information database 24, a doctor basic information database 25, and a nurse basic information database 26.
In addition, the case card information database 27 necessary for the clinical trial
Can also be added.

When the clinical data obtained by the respiratory function test apparatus 10 operated by the patient 1 is received by the respiratory information processing apparatus 2, the respiratory information reception processing function unit 20
Is checked for clinical validity. Then, it is output as a normalized record to the periodic output processing device 21 via the cumulative respiratory information database 23, and further stored in the patient basic information database 24.

Here, the received clinical data includes a signal (ID) for identifying a patient as measurement value information and a time stamp indicating the measurement time. Therefore, the respiratory information reception processing function unit 20 can determine, for each patient, whether or not the measurement value is transmitted at a predetermined timing.

That is, the respiratory information reception processing function unit 20
Receives the clinical data, checks the patient ID and the time stamp belonging to the clinical data, and stores them in the patient basic information database 24 via the cumulative respiratory information database 23.

By accessing the patient basic information database 24 for each patient on a regular basis, non-examination of clinical data is detected, and preventive measures against non-examination are taken as follows. That is, (1) If there is no communication from the patient in the respiratory information processing apparatus 2 during a specific period, the respiratory information reception processing function unit 20 generates an alarm. (2) If the respiratory information processing device 2 has not transmitted clinical data from a patient up to a predetermined number of times a day, for example, twice a day, the respiratory information reception processing function unit 20 issues an alarm. appear. (3) The clinical data for a certain period has been collectively transmitted from the patient to the respiratory information processing apparatus 2, but if a part of the clinical data is missing, the respiratory information reception processing function unit 20 generates an alarm. (4) If no long-term clinical data has been transmitted to the respiratory information processing apparatus 2, the respiratory information reception processing function unit 2
0 generates an alarm.

In any of the above cases, when an alarm is generated from the respiratory information reception processing function unit 20, the alarm is sent by specifying the patient name corresponding to the telemedicine center 4. Thereby, the telemedicine center 4 can notify the relevant patient 1 and instruct that the collection and transmission of clinical data is performed by a predetermined regular operation of the respiratory function test apparatus 10.

In such a case, the notification to the patient 1 is provided by providing the telemedicine center 4 with an automatic notification function means or by a doctor or a nurse via telephone.

Next, data error processing of the clinical data received by the respiratory information reception processing function unit 20 is performed.

Here, in order to understand the embodiment of the present invention,
The parameters of the clinical data obtained from the respiratory function test apparatus 10 by operating the patient 1 will be described.

[0092] The respiratory function test apparatus 10 uses PEF and FEV.
1 is obtained.

When a doctor's diagnosis is made, the PEF is measured for each patient, and the patient's basic information database 24
Registered in.

FIG. 4 is a processing flow (measurement value validity check) at the time of receiving a measurement value for each patient performed by the respiratory information reception processing function unit 20. FIG. 5 is a processing flow (measurement value trend analysis) when the measurement value for each patient is received by the respiratory information reception processing function unit 20.

In FIG. 4, the measurement records of the patient are read from the received data in descending order of the measurement time (processing step P).
1). At this time, the measurement time of the first record is recorded in the time transfer file of the respiratory information reception processing function unit 20.

If the measurement data is final (processing step P
2: Y), a record temporarily stored in the cumulative respiratory information database 23 is output, and at the same time, an error alarm for a problem detected in data verification is output (processing step P3).

If the data is not final, if the PEF is less than or equal to the predetermined value Tα or if the FEV1 is more than or equal to the predetermined value Tβ, there is a high possibility that the measurement data is erroneous due to incomplete measurement. . Therefore, the record in this case is deleted. At the same time, the counter value of the number of errors is increased (processing step P5). As described above, data based on the deficiency at the time of measurement is deleted in advance.

Then, the ratio PEF% of PEF to OEF
It is determined whether (ie, PEF / OEF) is less than or equal to RZ%, for example, 60%. If it is not more than RZ%, a red alarm is output (processing step P7).

If the time stamp of the data is within the same time zone, for example, within 30 minutes (processing step P11: Y),
Increment the counter value of the number of times in the same time zone (processing step P
9). If the data is the maximum value in the same time zone, the data is temporarily stored in the respiratory information reception processing function unit 20 as a record to be updated (processing step P1).
0). This is because only the record having the maximum value in the same time zone is recorded as valid.

Further, in the processing step P8, if the time is not the same time zone, the record temporarily stored in the temporary file of the respiratory information reception processing function unit 20 is output. At this time, if an error has occurred a predetermined number of times, for example, three times, an alarm is output (processing step P11). The alarm at this time is also notified to the telemedicine center 4.

Next, the number of error records is initialized.
At the same time, the same time zone is set, the maximum value is recorded, and the record is temporarily stored (processing step P12).

FIG. 5 is a processing flow following the processing step P3 in FIG. In particular, the processing after storing the normalized record in the cumulative respiratory information database 23.

For each patient, the cumulative respiratory information database 2
3 is read out (processing step P13).

If the data is not the last but after the time S (processing step P14: N), the ratio PEF% of the PEF to the registered OEF of the patient is the yellow area I
I (see FIG. 3A).
15). That is, when PEF% is greater than YZ (yellow zone parameter)% and equal to or less than GZ (green zone parameter)% (for example, greater than 60% and 80%).
%), The yellow zone number counter is increased (processing step P16).

Then, the yellow zone number counter is set to 2
If it does not come after the S time, the process P
18 outputs a yellow alarm. Next, the yellow zone number counter is reset and initialized (processing step P19).

Note that the green zone parameter corresponds to the above-mentioned normal set value, and the yellow zone parameter corresponds to the above-mentioned caution set value.

When such a yellow alarm is output (processing step P18), the telemedicine center 4 is also notified, and the predetermined processing is notified to the patient automatically or through a nurse.

FIG. 6 is a flowchart of daily batch processing in the respiratory information reception processing function unit 20.

Cumulative respiratory information database 2 for each patient
3 is read out (processing step P20). Next, when the data is the last (processing step P21: Y),
The processing for the patient is ended (processing step P22). Alternatively, when the data processing time is earlier than one week (W), the number of measurements is 0, so that the data is unbalanced (processing step P21: Y), and an illegal alarm is output (processing step P22). ) To end the batch processing for the patient.

When the illegal alarm is output, it is notified to the telemedicine center 4, which prompts the patient 1 to periodically measure data.

In the processing step P21, if the measured data is not the last but the processing time of the data is within one week (processing step P21: N), the measurement number counter is incremented (processing step P23).

When the measurement data is on the same day (processing step P24: Y), the maximum value and the minimum value are updated (processing step P25).

If the measurement data is not the same day (processing step P24: N), it is determined whether there is a valid maximum value and a minimum value satisfying a predetermined condition (processing step P26). If there is a valid maximum value and minimum value (processing step P26: Y), it is determined whether the daily fluctuation% shown in FIG. 3C is larger than a predetermined value V% (processing step P27).

When the daily fluctuation% is smaller than V% (processing step P27: N), the number of fluctuation abnormalities is initialized (processing step P28). When the daily fluctuation% is equal to or more than V% (processing step P27: Y), the fluctuation abnormality counter is increased (processing step P29).

When the fluctuation abnormality counter counts three times, a fluctuation alarm is output (processing step P30).
The maximum value and the minimum value are initialized (processing step P31).

On the other hand, if there is no valid maximum value and minimum value in the processing step P26, it is determined whether or not the maximum value and the minimum value are unbalanced (processing step P3).
2). The maximum value and the minimum value are unbalanced when 1
This is the case where measurements are taken twice or more a day. If it is unbalanced, the number of times of unbalance is increased (processing step P33). Then, when the maximum value and the minimum value are not unbalanced and when the number of times of imbalance increases, the number of fluctuation abnormalities is initialized (processing step P34).

FIG. 7 shows the OEF for each patient in the above description.
5 is a processing flow for certifying the following.

The patient records are retrieved from the cumulative respiratory information database 23 in descending order of the measurement time (processing step P4).
0). It is determined whether the extracted data is the last one or the processing time is before the predetermined date (XD).

When the data is final or the processing time is before a predetermined date (xD) (processing step P41:
Y), if there is a PEF sample number (processing step P42: Y),
The average value thereof is calculated by the cumulative value / the number of samples (processing step P43). Next, a variance value is obtained (processing step P4).
4). This variance value is obtained by (counter value / number of samples− (average value) ² ).

Further, a 3SD value which is three times the square root of the variance is calculated (processing step P45). This 3SD
Based on the value calculation, a self-best value (that is, OEF) is calculated (processing step P46), and the OEF recognition for the patient is completed (processing step P46-1).

On the other hand, in the processing step P41, if the data is not final and the processing time is within the predetermined date (xD) (processing step P41: N), the sample number counter is increased (processing step P47). Then, the accumulated value for calculating the average value is updated (processing step P48). Then, the process returns to the processing step P40.

In the above description of the embodiment, the clinical data of an asthmatic patient is measured by the respiratory function test apparatus 10,
A method and system for receiving and analyzing over a network has been described. However, the present invention is not limited to this,
The method for processing clinical data, which is a feature of the present invention, can also be applied to the analysis of clinical data related to other diseases.

The following summarizes the present invention.

(Supplementary Note 1) The step of measuring the clinical data of the patient by the apparatus for testing respiratory function based on expiration / inspiration, and the step of communicating means for transmitting the measured clinical data to the respiratory information together with a signal for identifying the patient. Transmitting to the device, the respiratory information processing device performs information processing including at least one of the following (a) to (d), and obtaining the information processing result: (a) the clinical information for each patient The process of storing data. (B) analyzing and evaluating the accumulated clinical data; (C) a process of scoring the clinical risk according to the evaluation result of the clinical data. (D) a process of rearranging the clinical data in the order of clinical urgency in consideration of the clinical risk. The respiratory information processing apparatus transmits the information processing result to one or more medical terminals, and the medical terminal determines the information processing result and information input from any of the medical terminals. And outputting a clinical data analysis method.

(Supplementary Note 2) The respiratory information processing apparatus may include:
A treatment control plan including contents indicating a patient's health condition classified according to the patient's health condition and a coping method including a method of using the drug corresponding thereto, and as a part of the information processing result 3. The clinical data analysis processing method according to claim 1, wherein the treatment control plan is included.

(Supplementary Note 3) The information input from any one of the medical terminals may include the information for performing one of selection of a coping method of the treatment control plan, modification of the coping method, and addition to the method, or 3. The clinical data analysis processing method according to 2.

(Supplementary Note 4) When either the information processing result or the information input from the medical terminal is updated, the medical terminal determines whether the past information processing result and the past information input from the medical terminal have been updated. 4. The clinical data analysis processing method according to any one of supplementary notes 1 to 3, further comprising a step of outputting the data.

(Supplementary Note 5) Supplementary notes 1 to 5, including a step of transmitting information input from the medical terminal to the respiratory information processing apparatus and transmitting the information to the medical terminal and / or another medical terminal therefrom. 5. The clinical data analysis processing method according to any one of 4.

(Supplementary Note 6) The respiratory information processing apparatus may include:
The step of transmitting the information processing result to one or more medical terminals is started based on a transmission request signal of an information processing result transmitted from the medical terminal to the respiratory information processing apparatus. 6. The clinical data analysis processing method according to any one of supplementary notes 1 to 5.

(Supplementary Note 7) The transmission request signal includes a password for enabling the respiratory information processing apparatus to transmit the information processing result to a medical terminal. The clinical data analysis processing method according to supplementary note 6.

(Supplementary Note 8) The password is different for each patient, and the password determines contents of the information processing result which can be transmitted to the medical terminal by the respiratory information processing apparatus. , The clinical data analysis processing method described in Supplementary Note 7.

(Supplementary note 9) Any one of Supplementary notes 1 to 8, characterized in that a signal can be encrypted at the time of transmission and a decryption process of the encrypted signal can be performed at the time of reception. Clinical data analysis processing method.

(Supplementary Note 10) Measuring means for measuring clinical data of a patient, information processing means for performing at least one of the following (a) to (d) information processing and obtaining the information processing result, (a) patient Processing for accumulating the clinical data every time. (B) analyzing and evaluating the accumulated clinical data; (C) a process of scoring the clinical risk according to the evaluation result of the clinical data. (D) a process of rearranging the clinical data in the order of clinical urgency in consideration of the clinical risk. 1 or 2 having output means for outputting the information processing result
A clinical system including the above medical terminal, communication means for transmitting the clinical data from the measurement means to the information processing means, and communication means for transmitting the information processing result from the information processing means to the medical terminal. A data analysis processing system, wherein any of the medical terminals has an input device capable of outputting to the one or more medical terminals.

(Supplementary Note 11) Further, there is provided communication means for transmitting an input signal from the medical terminal to the information processing means, and the input signal is transmitted to one or more medical terminals via the information processing means. 11. The clinical data analysis processing system according to supplementary note 10, wherein the clinical data analysis processing system is transmitted to the clinical data analysis system.

(Supplementary Note 12) The clinical data analysis processing system according to supplementary note 10 or 11, wherein the information processing means can accumulate a plurality of information processing results updated with time.

(Supplementary note 13) The clinical data analysis processing system according to supplementary note 12, wherein the one or more medical terminals can output the plurality of information processing results.

(Supplementary Note 14) The respiratory function testing apparatus has signal encryption processing means, and the respiratory information processing apparatus and the medical terminal use signal encryption processing means and decryption of an encrypted signal. 14. The clinical data analysis processing system according to any one of supplementary notes 10 to 13, further comprising a processing unit.

(Supplementary Note 15) A computer program for causing a computer and / or a computer system to execute each step in the clinical data analysis processing method according to Supplementary Notes 1 to 9.

(Supplementary Note 16) A computer-readable recording medium recording a program for causing a computer and / or a computer system to execute each step in the clinical data analysis processing method according to Supplementary Notes 1 to 9.

[0140]

As described above, according to the embodiment of the present invention with reference to the drawings, the present invention collects and analyzes measurement data, that is, clinical data, so that not only physicians but also patients can be more efficiently and actively involved. It is possible to provide a clinical data analysis processing method and system capable of providing feedback and providing more comprehensive and dynamic information. That is, according to the present invention, it is possible to establish a system that can easily determine from the detection of an abnormality in the acquisition of clinical data by a patient to the evaluation of the analysis result of the clinical data with a predetermined standard. As a result, the analysis results can be fed back to the patient accurately, the onset / change of the patient's condition can be detected in advance, and the dosage adjustment, the selection of an appropriate drug, and the treatment by a physician when and when necessary. Proper control of receiving and the like makes it possible to control and eliminate symptoms and improve respiratory function.

[0141]

[Table 1]

[Brief description of the drawings]

FIG. 1 is a diagram showing a configuration example of a system to which a clinical data analysis processing method according to the present invention is applied.

FIG. 2 is a block diagram illustrating a configuration example of a respiratory information processing apparatus 2.

FIG. 3 is a diagram showing a change in a parameter of a measurement value of a certain patient on a horizontal axis with a day.

FIG. 4 is a processing flow (measurement value validity check) at the time of receiving a measurement value for each patient performed by the respiratory information reception processing function unit 20;

FIG. 5 is a processing flow (measurement value trend analysis) at the time of receiving a measurement value for each patient performed by the respiratory information reception processing function unit 20;

FIG. 6 is a flowchart of daily batch processing in the respiratory information reception processing function unit 20;

FIG. 7 is a processing flow for certifying the maximum peak flow value (PEF) for each patient.

FIG. 8 is a diagram showing how information from a medical terminal is transmitted to another medical terminal via a respiratory information processing device.

FIG. 9 is a diagram showing the contents of a control plan.

FIG. 10 is a graph showing a temporal cumulative value of the expiratory volume.

FIG. 11 is a graph for determining a maximum expiratory flow rate.

[Explanation of symbols]

 Reference Signs List 1 patient 10 peak flow meter (respiratory function testing device) 2 respiratory information processing device 3 communication network (Internet) 4 telemedicine center 5 medical terminal (doctor) 5a personal computer 101 respiratory function testing device 102 respiratory information processing device 103a, 103b, 103c medical terminal 104a, 104b, 104c display

Claims (2)

[Claims] A step of measuring clinical data of a patient by an apparatus for testing respiratory function based on expiration / inspiration, wherein a communication means transmits the measured clinical data to a respiratory information processing apparatus together with a signal for identifying a patient. Transmitting, the respiratory information processing device performs information processing including at least one of the following (a) to (d), and obtaining an information processing result: (a) transmitting the clinical data for each patient Processing to accumulate. (B) analyzing and evaluating the accumulated clinical data; (C) a process of scoring the clinical risk according to the evaluation result of the clinical data. (D) a process of rearranging the clinical data in the order of clinical urgency in consideration of the clinical risk. The respiratory information processing apparatus transmits the information processing result to one or more medical terminals, and the medical terminal determines the information processing result and information input from any of the medical terminals. And outputting a clinical data analysis method. 2. The treatment control according to claim 1, wherein the respiratory information processing apparatus includes a content indicating a patient's health condition classified according to the patient's health condition and a coping method including a method of using a drug corresponding thereto. The clinical data analysis processing method according to claim 1, further comprising a plan, wherein the treatment control plan is included as a part of the information processing result.