Condition change detection system, condition change detection program, and vital data supplementation method

Abstract

This invention provides a condition change detection system, a condition change detection program, and a vital data supplementation method that can accurately detect changes in a subject's condition while suppressing a decrease in detection accuracy even when data is missing. [Solution] The condition change detection system 100 is configured to include a biological information measuring device 101 that measures the vital signs of a subject and a host device 200 that manages the condition changes of each subject. The host device 200 mainly consists of a storage unit 201, an input unit 202, a control unit 203, an output unit 204, and a communication unit 205. In this case, the control unit 203 includes a pre-processing unit 203a that processes the acquired vital data into a state suitable for detection, an index calculation unit 203b that calculates biological indicators using the processed data, a change detection unit 203c that detects changes in the subject's condition based on the calculated biological indicators, and a condition notification unit 203d that notifies the changes in condition.

Description

Technical Field

[0001] A subject state change detection system, a subject state change detection program, and a vital data complementation method for complementing defects occurring in a plurality of vital data obtained by the detection system, which detect changes in a subject's condition based on a vital index for evaluating changes in vital data acquired from a subject over time.

Background Art

[0002] Conventionally, there has been a subject state change detection system for determining changes in a subject's condition based on a vital index calculated using vital data representing a subject's vital signs. For example, Patent Document 1 below discloses an abnormality notification device (subject state change detection system) that estimates a patient's state based on a vital index (vital sign) such as the slope of a moving average or an approximate straight line calculated for the patient's heart rate or respiratory rate.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

[0004] However, in the subject state change detection system described in Patent Document 1 above, it is not assumed that there are defects such as omissions or outliers in a part of the data set consisting of a plurality of measurement values used for calculating the vital index. Therefore, when such a defect occurs, there is a problem that it is difficult to accurately detect changes in the subject's condition.

[0005] The present invention has been made to address the above problems, and an object thereof is to provide a subject state change detection system, a subject state change detection program, and a vital data complementation method for complementing defects occurring in a plurality of vital data obtained by the detection system, which can accurately detect changes in a subject's condition while suppressing a decrease in detection accuracy even when there are defects in the data. [Overview of the project]

[0006] To achieve the above objective, the present invention features a condition change detection system for detecting changes in a subject's condition, comprising: vital sign acquisition means for continuously or intermittently acquiring vital data representing the subject's vital signs; data preprocessing means for processing the acquired vital data into a state suitable for the detection; index calculation means for calculating a biometric index using the processed data; and change detection means for performing the detection based on the biometric index. The data preprocessing means, in the event that some vital data is missing, compensates for the missing portion with supplementary data created using vital data acquired in a predetermined period immediately preceding the missing portion.

[0007] According to this, the condition change detection system is configured to supplement missing portions of vital data (hereinafter also referred to as "missing data") with supplemental data created by a data preprocessing means using vital data acquired during a predetermined period immediately preceding the loss. Therefore, the condition change detection system calculates biometric indicators from the vital data supplemented with supplemental data that reflects the subject's condition immediately before the loss, and determines changes in the subject's condition based on these biometric indicators. This allows for accurate detection of changes in the subject's condition while suppressing a decrease in detection accuracy.

[0008] Here, "missing data" refers to cases where, in vital data consisting of multiple measurements (data), some of the measurements were not acquired and are therefore missing, or where the acquired measurements are unsuitable as data to be used when detecting changes in the subject's condition (hereinafter referred to as "changes in condition") (hereinafter referred to as "abnormal values").

[0009] Another feature of the present invention is that, in the condition change detection system, the supplementary data consists of biometric indicators calculated using vital data acquired during a predetermined period immediately preceding the data loss.

[0010] According to this, the condition change detection system consists of biometric indicators calculated using vital data acquired during a predetermined period immediately preceding the loss of supplemental data. Therefore, the condition change detection system can calculate the biometric indicators that constitute the supplemental data using an indicator calculation means, simplifying the biometric indicator calculation process in the data preprocessing means and enabling efficient creation of supplemental data.

[0011] Another feature of the present invention is that, in the condition change detection system, the vital sign acquisition means is comprised of a wearable terminal attached to the subject's body to acquire the subject's vital data, and the data preprocessing means compensates for the loss of vital data that occurs during non-wearing periods when the subject is not wearing the wearable terminal.

[0012] According to this, the condition change detection system is configured to compensate for the loss of vital data that occurs during non-wearing periods when the subject is not wearing the wearable device, using data preprocessing means. Therefore, even when a non-wearing period occurs due to the subject removing the wearable device, the condition change detection system can detect changes in the subject's condition while ensuring the subject's freedom in daily life.

[0013] Situations in which the subject may remove the wearable device include when the subject lies down, such as when sleeping or napping; when the subject gets wet, such as when washing hands or taking a bath; or when charging the wearable device.

[0014] Another feature of the present invention is that, in the condition change detection system, the data preprocessing means processes the acquired vital data into a state suitable for detecting changes in the subject's condition by removing unreliable data contained in the vital data.

[0015] According to this, the condition change detection system is configured to process vital data used for calculating biometric indicators into a state suitable for detecting changes in the subject's condition by removing unreliable data (i.e., abnormal values) contained in the vital data acquired by the data preprocessing means. Therefore, when the condition change detection system performs removal processing to remove abnormal values ​​prior to processing the completion of missing parts, it can perform completion processing not only on missing measurement values ​​but also on abnormal values, thereby improving the reliability of the vital data after completion processing.

[0016] On the other hand, if abnormal value removal is performed after the interpolation process, the condition change detection system can remove abnormal values ​​based on abnormal value judgment criteria set based on the entire vital data after the interpolation process, thereby improving the reliability of the vital data after the interpolation process.

[0017] Another feature of the present invention is that the condition change detection system further includes a condition notification means that notifies when the condition of the subject has changed in response to detection by the change detection means.

[0018] According to this, the condition change detection system is further configured to include a condition notification means that notifies the subject of a change in condition when a change in the subject's condition is detected by the change detection means. Therefore, the condition change detection system can quickly notify the subject of a change in condition even if the subject is unaware of the change in their condition (has no subjective symptoms) or is unable to call for help. In addition, the condition change detection system can notify people at a distance of the subject's change in condition.

[0019] Furthermore, the present invention can be implemented not only as a system for detecting changes in patient condition, but also as a program for detecting changes in patient condition and a method for supplementing vital data.

[0020] Specifically, the condition change detection program is a condition change detection program that causes a computer device to perform a process to detect changes in the condition of a subject, and causes the computer device to perform a vital sign acquisition step of continuously or intermittently acquiring vital data representing the subject's vital signs, a data preprocessing step of processing the acquired vital data into a state suitable for the detection, an index calculation step of calculating a biometric index using the processed data, and a change detection step of performing the detection based on the biometric index, wherein if some of the vital data is missing in the data preprocessing step, the missing portion may be filled in with supplementary data created using vital data acquired in a predetermined period immediately preceding the missing portion.

[0021] According to this, the condition change detection program can be expected to have the same effects as the condition change detection system invention described above.

[0022] Furthermore, the vital data completion method is a vital data completion method for completing missing data included in vital data representing the vital signs of a subject used in a condition change detection system for detecting changes in the subject's condition. The condition change detection system comprises vital acquisition means for continuously or intermittently acquiring vital data, data preprocessing means for processing the acquired vital data into a state suitable for the detection, index calculation means for calculating a biometric index using the processed data, and change detection means for performing the detection based on the biometric index. The data preprocessing means may complete the missing portion with completion data created using vital data acquired in a predetermined period immediately preceding the loss.

[0023] According to this, the method for supplementing vital data can be expected to have similar effects and advantages to the invention of the condition change detection system described above. [Brief explanation of the drawing]

[0024] [Figure 1] This is a schematic diagram illustrating the overall configuration of a substance change detection system according to an embodiment of the present invention. [Figure 2] It is a block diagram showing an outline of a control system in the body change detection system shown in FIG. 1. [Figure 3] It is a flowchart showing the flow of processing of the body change detection program. [Figure 4] It is a flowchart showing the flow of processing of the data recording subprogram. [Figure 5] It is a graph showing in time series the measured values of the pulse of the subject acquired at 10-minute intervals by the communication unit in the host device in the 24 hours from 0:00 on May 11 to 0:00 on May 12 (current time). [Figure 6] It is a flowchart showing the flow of processing of the data preprocessing subprogram. [Figure 7] It is an explanatory diagram schematically showing the relationship between the moving average value (mA) for the most recent 3 hours and the outlier determination criteria (mA + 20 and mA - 20) set based on the moving average value in the graph shown in FIG. 5. [Figure 8] It is a graph showing processed data in which missing data consisting of outliers (measured value at 18:00 on May 11) and missing data (a plurality of measured values from 22:10 on May 11 to 0:00 on May 12) in the graph shown in FIG. 5 are respectively replaced with complementary data. [Figure 9] It is a flowchart showing the flow of processing of the change determination subprogram. [Figure 10] (A) and (B) respectively show a biological index and a determination criterion for detecting a change in the condition of the subject in the graph shown in FIG. 8. (A) is an explanatory diagram schematically showing the relationship between the moving average value (MA) for the most recent 3 hours and the determination criterion for the moving average (reference value (MA)) determined according to the subject. (B) is an explanatory diagram schematically showing the relationship between the slope of the approximate straight line (LA) for the most recent 24 hours and the determination criterion for the slope of the approximate straight line (reference value (LA)). [Figure 11] It is a flowchart showing the flow of processing of the re-examination subprogram.

Mode for Carrying Out the Invention

[0025] (Configuration of the condition change detection system 100) Hereinafter, an embodiment of the substance change detection system according to the present invention will be described with reference to the drawings. Figure 1 is a schematic diagram showing the overall configuration of the substance change detection system 100 according to an embodiment of the present invention. Figure 2 is a block diagram illustrating the schematic of the control system in the substance change detection system 100 shown in Figure 1. Note that the figures referenced in this specification are schematic representations, with some components exaggerated to facilitate understanding of the present invention. Therefore, the dimensions and ratios between components may differ.

[0026] This condition change detection system 100 is a detection device for detecting changes in a subject's condition using vital data acquired from the subject. In this embodiment, the condition change detection system 100 is used by a provider of home medical care to remotely monitor the subject's condition. Here, vital data is information representing vital signs, and is a digitalized version of the subject's vital sign measurements that can be electronically stored, managed, and analyzed.

[0027] Furthermore, the term "target person" refers to a person or animal other than a person (for example, a dog or cat) whose condition changes are monitored using the condition change detection system 100. Specifically, the target person includes the elderly, people with disabilities, patients, people with dementia, insomnia or heatstroke or other symptoms that interfere with daily life, people who require follow-up observation after illness, people undergoing rehabilitation (hereinafter referred to as "rehabilitation"), healthy people who receive health management, pregnant women, newborns, disaster victims, or athletes. Follow-up observation refers to regularly checking the condition or the effectiveness of treatment and monitoring changes in condition or progression of symptoms.

[0028] Furthermore, a provider refers to a person who performs medical acts or acts equivalent to medical acts on a subject, such as a doctor, nurse, pharmacist, or nutritionist. Home medical care refers to a provider visiting the subject's residence (for example, their home, nursing home, or group home) to provide medical examinations, treatment, rehabilitation, or health management.

[0029] This condition change detection system 100 is mainly composed of a biological information measuring device 101 and a host device 200, respectively.

[0030] The biometric information measuring device 101 is a terminal device for measuring the vital signs of a subject. In this embodiment, the biometric information measuring device 101 is a known wristwatch-type wearable terminal that can measure the vital signs of a subject while being worn on the subject's wrist. This biometric information measuring device 101 mainly comprises a measuring unit 102, a control unit 103, and a communication unit 105.

[0031] The measurement unit 102 outputs vital data of the subject measured at predetermined intervals to the control unit 103 according to instructions from the control unit 103. In this embodiment, the measurement unit 102 measures the pulse rate (number of pulses per minute in the arteries of each part of the subject) and blood oxygen saturation (hereinafter simply referred to as "oxygen saturation") every second as vital signs of the subject. The interval for measuring vital signs can be set as appropriate. In this case, the measurement unit 102 may also measure parameters such as respiratory rate, heart rate (number of heartbeats per minute), blood pressure, body temperature, weight, blood glucose level, or activity level as vital signs in addition to the subject's vital signs described above. This measurement unit 102 corresponds to the vital sign acquisition means according to the present invention.

[0032] The control unit 103 is composed of a microcomputer consisting of a CPU, ROM, RAM, etc., and controls various operations of the biological information measuring device 101 by executing a control program pre-recorded in a storage device such as ROM. Specifically, the control unit 103 controls the operations of the measurement unit 102 and the communication unit 105 according to the control program and instructions from the host device 200, which will be described later.

[0033] The communication unit 105 is an electrical circuit that sends and receives information to and from the host device 200 via the Internet network in accordance with instructions from the control unit 103. In this embodiment, the communication unit 105 transmits the most recently acquired vital data of the subject to the host device 200 every 10 minutes in accordance with instructions from the control unit 103. The interval at which vital signs are transmitted to the host device 200 (hereinafter referred to as the "transmission interval") can be set as appropriate.

[0034] This biological information measuring device 101 includes a power supply unit (not shown) that supplies power to each part that consumes electricity within the biological information measuring device 101, an operation unit (not shown) for inputting instructions to the biological information measuring device 101, and a display unit (not shown) for displaying the results of the operation and the acquired vital data of the subject. However, these are not directly related to the present invention, so their descriptions are omitted.

[0035] The host device 200 is a computer device that receives vital data from each subject transmitted from each biometric information measuring device 101 and manages changes in each subject's condition. In this embodiment, it is composed of a personal computer (so-called PC). Here, the management of changes in the subject's condition by the host device 200 refers to the process of monitoring and recording changes in the subject's condition and notifying the provider and supporters of changes in the subject's condition. Here, supporters refer to people who support the subject's life, such as family members, relatives, friends, caregivers who care for the subject, or neighbors who live near the subject.

[0036] This host device 200 is mainly composed of a storage unit 201, an input unit 202, a control unit 203, an output unit 204, and a communication unit 205.

[0037] The memory unit 201 is a storage device that stores the condition change detection program and the OS (operating system) for operating the host device 200, and is composed of, for example, an HDD, SSD, ROM, or RAM. This condition change detection program is a computer program that processes the vital data of the subject received from the biological information measuring device 101 into a format suitable for detecting changes in the subject's condition, calculates biological indicators, and detects changes in the subject's condition based on the calculated biological indicators.

[0038] Furthermore, the memory unit 201 records interview information for confirming the subject's actual condition when a change in the subject's condition is detected. In this embodiment, the interview information consists of information asking about the subject's current state, including questions asking whether there has been a change in the subject's condition, questions asking about the specific content of subjective symptoms, and answers to those questions (specifically, answers expressed as multiple-choice options).

[0039] Specifically, questions to inquire about changes in the subject's condition include: "We detected an abnormality in vital signs. Have you noticed any changes in your physical condition? 1. Yes 2. No." Questions to inquire about the specific nature of subjective symptoms include: "What are your symptoms? ·Loss of appetite ·Fever ·Shortness of breath ·Stomach ache ·Other," "What is your temperature?", "Are you lethargic?", or "Are you able to eat?".

[0040] Here, biometric indicators are indices used to evaluate fluctuations in vital data over time. Specifically, these include moving averages, slopes of approximation lines, standard deviations, coefficients of variation, or correlation coefficients calculated for each parameter such as pulse rate and oxygen saturation. Biometric indicators may also include the difference or percentage change obtained by comparing the values ​​of each of the aforementioned indicators or measured vital signs between the past and the present.

[0041] The input unit 202 is an input device for receiving operations from the provider to the host device 200, and in this embodiment, it consists of a keyboard and a mouse. The input unit 202 outputs instructions to the control unit 203 according to the operation.

[0042] The control unit 203 executes the calculation of the subject's biological indicators and the detection of changes in their condition by running the condition change detection program. Specifically, the control unit 203 includes a pre-processing unit 203a, an indicator calculation unit 203b, a change detection unit 203c, and a condition notification unit 203d, all of which are activated by the execution of the condition change detection program.

[0043] The preprocessing unit 203a creates processed data by processing the unprocessed vital data (hereinafter also referred to as "raw data") received from the communication unit 105 for each subject into a state suitable for detecting changes in condition. Specifically, the preprocessing unit 203a performs noise detection processing to detect abnormal values ​​contained in the raw data and data completion processing to complete missing parts of the raw data (abnormal values ​​or missing measurements) using completion data. In this case, the preprocessing unit 203a creates the processed data at the time interval (i.e., the transmission interval; hereinafter referred to as the "scheduled reception interval") at which the vital data of the subject is scheduled to be received via the communication unit 205. This preprocessing unit 203a corresponds to the data preprocessing means according to the present invention.

[0044] Here, an abnormal value is a value that deviates from the range considered normal for the measurement of a subject's vital signs. For example, an abnormal value may occur due to the biological information measuring device 101 not being properly attached to the subject, the subject's body movement during measurement, a decrease in the battery level of the biological information measuring device 101, ambient environmental factors that interfere with measurement such as temperature, humidity, or electromagnetic waves, or a malfunction of the biological information measuring device 101.

[0045] In this embodiment, the preprocessing unit 203a sets an abnormal value determination criterion that serves as a standard for determining abnormal values ​​using the biometric indicators calculated by the indicator calculation unit 203b, and detects abnormal values ​​included in the raw data for each parameter based on this criterion. In this case, the indicator calculation unit 203b calculates the moving averages of pulse rate and oxygen saturation over the past 3 hours as biometric indicators for setting the abnormal value determination criterion. The preprocessing unit 203a then sets the abnormal value determination criterion by considering pulse rate measurements that are ±20 or more in absolute value from the calculated moving average value of pulse rate and oxygen saturation measurements that are -10% or more in absolute value from the calculated moving average value of oxygen saturation as abnormal values.

[0046] Furthermore, if an abnormal value is detected in the noise detection process or if vital data could not be received at a predetermined time (in this embodiment, at a predetermined 10-minute interval), the preprocessor 203a determines that there is a gap in the raw data. The preprocessor 203a then fills in the missing portion of the raw data with supplementary data consisting of biological indices calculated by the index calculation unit 203b. Specifically, the preprocessor 203a creates processed data by filling in the missing data using supplementary data consisting of a moving average of the three hours immediately preceding the missing measurement value (i.e., the average value for the three hours from the time the last vital data was acquired to three hours prior).

[0047] The index calculation unit 203b calculates the subject's biometric indicators for each vital sign parameter using raw data or processed data created by the preprocessing unit 203a. Specifically, the index calculation unit 203b calculates biometric indicators for setting abnormal value judgment criteria and biometric indicators constituting supplementary data for each parameter of pulse rate and oxygen saturation using raw data, in accordance with instructions from the preprocessing unit 203a. The index calculation unit 203b also calculates biometric indicators for determining changes in the subject's condition for each parameter of pulse rate and oxygen saturation using processed data. This index calculation unit 203b corresponds to the index calculation means according to the present invention.

[0048] In this embodiment, the index calculation unit 203b uses the processed data to calculate the biometric index that constitutes the complementary data for each parameter of pulse rate and oxygen saturation, the moving average for the most recent 3 hours, the slope of the approximate straight line for the most recent 24 hours and the most recent 48 hours, and the standard deviation for the most recent 3 hours, the most recent 24 hours and the most recent 48 hours, respectively.

[0049] The change detection unit 203c determines whether or not there has been a change in the condition of each subject based on the individual biological indicators calculated by the indicator calculation unit 203b. In this case, the change detection unit 203c determines the change in the subject's condition at scheduled reception intervals (10-minute intervals in this embodiment).

[0050] Specifically, the change detection unit 203c determines that a subject's condition has changed if the moving average over the past three hours exceeds a predetermined standard value corresponding to each subject, and the standard deviation over the past three hours is within a predetermined range (in this embodiment, the standard deviation of pulse rate is within 10 and the standard deviation of oxygen saturation is within 5). This change detection unit 203c corresponds to the change detection means according to the present invention.

[0051] Furthermore, the change detection unit 203c determines that the subject's condition has changed if the slope of the approximate straight line over the most recent 24 hours exceeds a predetermined reference value (0.04 in this embodiment) and the standard deviation over the most recent 24 hours is within a predetermined range (same as the predetermined range for the standard deviation over the most recent 3 hours). Furthermore, the change detection unit 203c determines that the subject's condition has changed if the slope of the approximate straight line over the most recent 48 hours exceeds a predetermined reference value (0.02 in this embodiment) and the standard deviation over the most recent 48 hours is within a predetermined range (same as the predetermined range for the standard deviation over the most recent 3 hours).

[0052] Furthermore, the change detection unit 203c determines that the subject's condition requires observation if the slope of the approximate straight line over the most recent 24 hours is less than the predetermined reference value and is located near the predetermined reference value. In this embodiment, the vicinity of the predetermined reference value refers to the case where 0.02 < slope of the approximate straight line over the most recent 24 hours < 0.04.

[0053] In this case, the change detection unit 203c re-evaluates the condition of a subject that it has determined to be in a state requiring observation, based on the latest processing data after a certain period of time has elapsed. In this embodiment, the change detection unit 203c determines that the condition of the subject has changed if, three hours after the determination that the subject is in a state requiring observation, the slope of the approximate straight line for the most recent 24 hours is greater than or equal to the slope of the approximate straight line for the most recent 24 hours at the time of the determination.

[0054] When the change detection unit 203c detects a change in the subject's condition, the condition notification unit 203d notifies the provider and support staff that the subject's condition has changed, and also transmits medical interview information to the support staff. Specifically, in response to the change detection unit 203c detecting a change in the subject's condition, the condition notification unit 203d transmits notification information to the provider terminal 300 and the support staff terminal 400, respectively, indicating that a change in the subject's condition has been detected.

[0055] Furthermore, the condition notification unit 203d transmits pre-recorded medical interview information to the supporter terminal 400. This condition notification unit 203d corresponds to the condition notification means according to the present invention. In this case, the notification information and medical interview information may consist of, for example, text data, audio data, image data, or video data individually, or a combination thereof.

[0056] The output unit 204 is an output device for outputting the vital data of a subject received from the biological information measuring device 101, in accordance with instructions from the control unit 203. This output unit 204 mainly consists of a display screen 204a. This display screen 204a is a display device for displaying the vital data of a subject received via the communication unit 205 in the form of an image (e.g., a table or graph) in accordance with instructions from the control unit 203. In this embodiment, the display screen 204a is composed of a liquid crystal display.

[0057] The communication unit 205 is an electrical circuit that transmits and receives information between each biometric information measuring device 101, each provider terminal 300, and each supporter terminal 400 via the Internet NW in accordance with instructions from the control unit 203. In this embodiment, the communication unit 205 transmits notification information to the provider terminal 300 and the supporter terminal 400, respectively, in accordance with instructions from the condition notification unit 203d, and also transmits medical interview information to the supporter terminal 400.

[0058] The provider terminal 300 is a display device that receives notification information transmitted from the host device 200 and presents the content of the notification information to the provider. In this embodiment, it is configured as a smartphone. Here, a smartphone is a mobile phone equipped with an operating system for portable computers, and can perform various processes such as communication, data processing, image processing, and audio processing by operating its LCD display screen.

[0059] Therefore, the provider terminal 300 is configured to include an input unit 302 consisting of a liquid crystal touch panel and a microphone, a control unit 303 consisting of a microcomputer, an output unit 304 consisting of a liquid crystal display and a speaker, and a communication unit 305 for communicating with the host device 200 via the Internet NW. In this embodiment, the provider terminal 300 receives notification information transmitted from the communication unit 205, displays text data on the liquid crystal display indicating that a change in the subject's condition has been detected, and also outputs it as sound through the speaker.

[0060] The supporter terminal 400 is a communication device that receives medical questionnaire information transmitted from the host device 200, presents the contents of the questionnaire to the supporter, and transmits the answers to the questionnaire to the host device 200. It is configured in substantially the same way as the provider terminal 300. Therefore, for the supporter terminal 400, the explanation of the parts common to the provider terminal 300 will be omitted, and only the parts that differ will be explained. In this embodiment, the supporter terminal 400 receives medical questionnaire information transmitted from the communication unit 205, displays the contents of the questionnaire for confirming the actual condition of the subject with the supporter as text data on the liquid crystal display, and also outputs it as audio through the speaker.

[0061] (Operation of the condition change detection system 100) Next, the operation of the condition change detection system 100 configured in this way will be explained. In this embodiment, the condition change detection system 100 is used when a medical professional (provider) remotely monitors the condition of a patient (subject) receiving care at home. First, the attachment of the biological information measuring device 101 will be explained. The provider prepares a biological information measuring device 101 for each subject.

[0062] In this case, the control unit 103 of the biological information measuring device 101 is pre-configured to communicate with the host device 200 and to set the operating patterns of each part of the biological information measuring device 101. The communication settings for the control unit 103 and the operating pattern settings for each part are performed by connecting the host device 200 via the Internet network.

[0063] Next, the subject attaches the prepared biometric information measuring device 101 to their wrist. In this case, the subject attaches the biometric information measuring device 101 with its power turned ON. This completes the attachment of the biometric information measuring device 101. Of course, if the subject is unable to attach the biometric information measuring device 101 themselves, a support person may assist or act on their behalf in attaching the device 101.

[0064] On the other hand, the provider on the host device 200 configures the host device 200 for communication with each biometric information measuring device 101 and for collecting vital data (measured values) of the subject from each biometric information measuring device 101. In this embodiment, the provider sets the vital sign parameters so that the biometric information measuring device 101 measures pulse rate and oxygen saturation, respectively, and sets the transmission interval so that the vital data for each parameter is sent to the host device 200 at 10-minute intervals. This allows the operation of the condition change detection system 100 to begin.

[0065] Subsequently, the provider performs an input operation to the host device 200 to start measuring the subject's vital data using the biological information measuring device 101. In accordance with the provider's operation, the control unit 203 in the host device 200 executes the condition change detection program shown in Figure 3 in step S100 to start operating the condition change detection system 100.

[0066] Specifically, the control unit 203 controls the operation of the communication unit 205 to instruct the biological information measuring device 101 to start measuring vital data via the Internet network. In response to this instruction, the control unit 103 in the biological information measuring device 101 controls the operation of the measurement unit 102 to measure the subject's vital data for each of the set parameters. In this embodiment, the measurement unit 102 measures the subject's pulse rate and oxygen saturation every second as parameters.

[0067] Next, the control unit 103 periodically transmits the measured vital data of the subject to the host device 200 based on a pre-set transmission interval. In this embodiment, the control unit 103 controls the operation of the communication unit 105 to transmit to the host device 200 every 10 minutes one of the most recently measured values ​​for each parameter of pulse rate and oxygen saturation, which are measured every second by the measurement unit 102, as a set of vital data.

[0068] Next, in step S102, the control unit 203 instructs the start of execution of the data recording subprogram. This data recording subprogram is for recording a dataset consisting of the subject's vital data in the storage unit 201 for calculating biometric indicators used when determining the subject's condition. Specifically, in step S200, the control unit 203 starts the execution of the data recording subprogram shown in Figure 4, records the start time of the execution in the storage unit 201, and proceeds to step S202.

[0069] Next, in step S202, the control unit 203 executes a reception interval elapsed determination process. This reception interval elapsed determination process determines whether a predetermined time has elapsed since the start of execution of the data recording subprogram or since the last time this reception interval elapsed determination process was performed. In this embodiment, the predetermined time is the time interval at which the host device 200 is scheduled to receive the subject's vital data, i.e., the scheduled reception interval (10 minutes).

[0070] Specifically, the control unit 203 continues to determine "No" in this determination process until the transmission interval is reached, whichever is shorter: the start time of step S200 or the time elapsed since the last "Yes" determination in this reception interval elapsed determination process. The control unit 203 then returns to step S202. On the other hand, when the elapsed time reaches the transmission interval, the control unit 203 determines "Yes" in this determination process, records the time of the "Yes" determination in the storage unit 201, and proceeds to step S204.

[0071] Next, in step S204, the control unit 203 determines whether or not the subject's vital data has been acquired. Specifically, if the communication unit 205 has received the subject's vital data from the biological information measuring device 101, the control unit 203 determines "Yes" in this determination process and proceeds to step S206. If the determination result is "No", the control unit 203 may repeat this determination process until it determines "Yes" for a predetermined time (for example, 2 minutes), or it may store the determination result until the predetermined time has elapsed and then determine whether or not the subject's vital data has been acquired based on the stored determination result.

[0072] Next, in step S206, the control unit 203 records the vital data of the subject received via the communication unit 205 and the time of reception of this vital data as unprocessed raw data in the storage unit 201. Then, the control unit 203 returns to step S202. On the other hand, in step S204, if the communication unit 205 did not receive the vital data of the subject, the control unit 203 determines "No" and proceeds to step S208.

[0073] Next, in step S208, the control unit 203 records the current time as the time when vital data of the subject could not be received (non-reception time), and records information indicating that the measured values ​​are missing, along with the non-reception time, as missing data in the storage unit 201. Then, the control unit 203 proceeds to step S210. This process of recording raw data or missing data in the storage unit 201 corresponds to the vital data acquisition step according to the present invention.

[0074] Next, in step S210, the control unit 203 executes a predetermined time T1 elapsed determination process. This predetermined time T1 elapsed determination process determines whether a predetermined time T1 has elapsed since the control unit 203 started executing the data recording subprogram or since the last time vital data of the subject was received. In this embodiment, the predetermined time T1 is 3 hours, but it is not limited to this and can be set appropriately according to the type of disease the subject is suffering from, the subject's condition, or the subject's living environment.

[0075] Specifically, the control unit 203 determines "No" and returns to step S202 if the shorter of the time elapsed since the start time of step S200 or the most recent reception time in step S206 is less than the predetermined time T1. In this embodiment, as shown in Figure 5, the control unit 203 determines "No" because the elapsed time since the most recent reception time in step S206 (May 11, 22:00) is 2 hours. On the other hand, if the elapsed time is equal to or greater than the predetermined time T1, the control unit 203 determines "Yes" and proceeds to step S212.

[0076] Next, in step S212, the control unit 203 notifies the provider and the supporter that the subject's vital data has not been received properly, and sends a message to the supporter prompting them to confirm whether the biometric information measuring device 101 is in a state where it can operate properly. In this embodiment, the message prompting confirmation includes information such as whether the biometric information measuring device 101 is attached to the subject, whether the biometric information measuring device 101 is attached correctly, whether the battery level of the biometric information measuring device 101 is sufficient, whether the measurement environment (temperature, humidity, or electromagnetic waves, etc.) is appropriate, whether the biometric information measuring device 101 is showing any malfunctions, or whether the subject is moving during measurement.

[0077] In this case, if the control unit 203 determines in step S210 that the subject's vital data has not been received for a predetermined time T1, it sends error information indicating that the vital data has not been received properly to the provider terminal 300 and the supporter terminal 400, respectively. The control unit 203 also sends a message prompting confirmation to the supporter terminal 400. Then, the control unit 203 returns to step S202. This data recording subprogram, which repeatedly performs the processes in steps S200 to S212, is always running while the condition change detection program is being executed.

[0078] Next, in step S104 of the condition change detection program, the control unit 203 determines whether the amount of data that will definitely be used in the data preprocessing subprogram in the next step S106 is stored in the storage unit 201, and whether the raw data is sufficient. In this embodiment, the control unit 203 determines whether the raw data consists of at least 3 hours' worth of data.

[0079] Specifically, if the raw data recorded in the storage unit 201 does not include 3 hours' worth of data, the control unit 203 continues to determine "No" in this determination process until 3 hours' worth of raw data is recorded in the storage unit 201, and returns to step S104. On the other hand, if the raw data includes 3 hours' worth of data, the control unit 203 determines "Yes" in this determination process and proceeds to step S106.

[0080] Next, in step S106, the control unit 203 executes a data preprocessing subprogram. This data preprocessing subprogram performs noise detection processing to detect abnormal values ​​contained in the raw data and data completion processing to fill in missing portions (missing data) in the raw data after the noise detection processing.

[0081] Specifically, the control unit 203 starts executing the data preprocessing subprogram shown in Figure 6 in step S300 and proceeds to step S302. In this case, the control unit 203 repeatedly executes this data preprocessing subprogram at scheduled reception intervals (10-minute intervals in this embodiment). The process of executing this data preprocessing subprogram corresponds to the data preprocessing step.

[0082] Next, in step S302, the control unit 203 performs noise detection processing to detect abnormal values ​​contained in the raw data. This noise detection processing consists of the following substeps 1 to 3.

[0083] Substep 1: First, the control unit 203 (indicator calculation unit 203b) calculates biometric indicators for each parameter to set the criteria for determining abnormal values. In this embodiment, the control unit 203 (indicator calculation unit 203b) calculates the most recent 3-hour moving average for each parameter, pulse rate and oxygen saturation, as the biometric indicators for setting the criteria for determining abnormal values.

[0084] In this embodiment, as shown in Figure 5, the raw data was most recently received at 10:00 PM on May 11th, and the measurement data for the most recent 1 hour and 50 minutes, from 10:10 PM on the same day to 12:00 AM on May 12th, is missing. Therefore, the control unit 203 (index calculation unit 203b) calculates a moving average for the most recent 3 hours (from 7:00 PM on May 11th to 10:00 PM on the same day), excluding the missing portion, for each parameter of pulse rate and oxygen saturation.

[0085] Substep 2: Next, the control unit 203 (preprocessing unit 203a) sets abnormal value judgment criteria for each parameter using the biometric indicators calculated in substep 1. In this embodiment, as shown in Figure 7, the control unit 203 (preprocessing unit 203a) sets a judgment criterion that a pulse rate measurement (absolute value) is abnormal if it is ±20 or more of its moving average value (mA) (illustrated, blacked-out portion). The control unit 203 (preprocessing unit 203a) also sets a judgment criterion that an oxygen saturation measurement (absolute value) is abnormal if it is -10% or more of its moving average value.

[0086] These criteria for determining abnormal values ​​can be appropriately set depending on the length or time period of the raw data used to calculate the biometric indicators, the type of disease the subject is suffering from, the subject's physical condition, the subject's living environment, or the provider's circumstances.

[0087] Substep 3: Next, the control unit 203 (preprocessing unit 203a) determines whether the measured value included in the raw data is an abnormal value. Specifically, if the measured value meets the abnormal value determination criteria for each parameter set in substep 2, the control unit 203 determines that the measured value is an abnormal value and records the information indicating that the measured value is an abnormal value in the storage unit 201 along with the raw data. In this embodiment, the control unit 203 (preprocessing unit 203a) determines that the measured value at 18:00 on May 11 is an abnormal value because it is below the lower limit of the abnormal value determination criteria (mA-20).

[0088] On the other hand, the control unit 203 determines "No" if the measured value does not meet the abnormal value determination criteria. After the noise detection process is completed, the control unit 203 proceeds to step S304. The control unit 203 may omit the noise detection process for measured values ​​that have already been determined to be abnormal by the noise detection process.

[0089] Next, in step S304, the control unit 203 performs data completion processing to fill in any missing parts in the raw data after the noise detection process (hereinafter referred to as "labeled data"). This data completion processing consists of the following substeps 1 to 4.

[0090] Substep 1: First, the control unit 203 (preprocessing unit 203a) identifies missing data included in the labeled data. Specifically, if the labeled data includes missing data from step S208 of the data recording subprogram, the control unit 203 (preprocessing unit 203a) identifies the missing data as data to be processed for completion. Also, if the labeled data includes abnormal values ​​determined in step S302, the control unit 203 (preprocessing unit 203a) identifies the abnormal values ​​as missing data. On the other hand, if the labeled data does not contain any missing data or abnormal values, the control unit 203 (preprocessing unit 203a) proceeds to step S306.

[0091] In this embodiment, the control unit 203 (preprocessing unit 203a) identifies multiple missing data points (data from 10:10 PM on May 11th to 12:00 AM on May 12th) and an abnormal value (18:00 PM on May 11th) included in the labeled data as missing data points. In this case, if the missing data points and / or abnormal values ​​are consecutive in time, the control unit 203 (preprocessing unit 203a) identifies each consecutive missing data point and / or abnormal value as a single missing data point. Specifically, the control unit 203 (preprocessing unit 203a) identifies the abnormal value as a first missing data point and identifies the multiple consecutive missing data points as a single second missing data point.

[0092] Substep 2: Next, the control unit 203 (indicator calculation unit 203b) creates supplementary data to fill in the missing data. Specifically, the control unit 203 (indicator calculation unit 203b) calculates moving averages for pulse rate and oxygen saturation, which are bioindicators that constitute the supplementary data, over a predetermined time immediately preceding the missing data. The predetermined time can be set as appropriate depending on the type of disease the subject is suffering from, the subject's condition, or the subject's living environment.

[0093] In this embodiment, the control unit 203 (index calculation unit 203b) calculates a moving average over the three hours immediately preceding the first missing data (from 16:50 on May 11th to 19:50 on the same day) as a biometric index for the first supplementary data to supplement the first missing data. The control unit 203 (index calculation unit 203b) also calculates a moving average over the three hours immediately preceding the second missing data (from 19:00 on May 11th to 22:00 on the same day) as a biometric index for the second supplementary data to supplement the second missing data. Through these calculation processes, the first and second supplementary data can be created, respectively.

[0094] Substep 3: Next, the control unit 203 (preprocessing unit 203a) completes each missing data identified in substep 1 with the completion data created in substep 2. In this embodiment, as shown in Figure 8, the control unit 203 (preprocessing unit 203a) completes the missing portion of the labeled data by replacing the first missing data with the first completion data. The control unit 203 also completes the other missing portions of the labeled data by replacing each of the multiple missing data (12 in this embodiment) contained in the second missing data with the second completion data. These processes complete the data completion process for the labeled data. After that, the control unit 203 proceeds to step S306.

[0095] Next, in step S306, the control unit 203 records the labeled data that does not contain missing data, or the labeled data that has been processed in step S304, as processed data in the storage unit 201. Here, the processed data is a dataset for calculating biometric indicators used when determining changes in the subject's condition. After that, the control unit 203 proceeds to step S308.

[0096] Next, in step S308, the control unit 203 terminates the execution of the data preprocessing subprogram and returns to step S108 of the condition change detection program.

[0097] Next, in step S108, the control unit 203 executes a change determination subprogram. This change determination subprogram detects changes in the subject's condition based on biological indicators calculated using the processed data created by the data preprocessing subprogram. Specifically, the control unit 203 starts executing the change determination subprogram shown in Figure 9 in step S400 and proceeds to step S402.

[0098] Next, in step S402, the control unit 203 performs a sudden change determination process to determine whether the subject's condition has changed in a short period of time, or whether there is a sudden change in condition. This sudden change determination process consists of the following substeps 1 and 2.

[0099] Substep 1: First, the control unit 203 (indicator calculation unit 203b) calculates biometric indicators for each parameter to determine whether or not there has been a change in condition in a short period of time. In this embodiment, the control unit 203 (indicator calculation unit 203b) uses processed data to calculate the moving average and standard deviation of pulse rate and oxygen saturation over the past 3 hours as biometric indicators, respectively. The process of calculating these biometric indicators corresponds to the indicator calculation step according to the present invention.

[0100] Substep 2: Next, the control unit 203 (change detection unit 203c) determines whether or not there has been a change in the subject's condition based on the biometric indicators calculated in substep 1. In this embodiment, if the moving average value over the past 3 hours exceeds a predetermined standard value set in advance for each subject by the provider, and the standard deviation over the past 3 hours is less than or equal to a predetermined standard value in the standard deviation, the control unit 203 (change detection unit 203c) determines that the subject's condition has changed and proceeds to step S414. This process of detecting a change in the subject's condition based on the biometric indicators calculated in substep 1 corresponds to the change detection step according to the present invention.

[0101] In this embodiment, the predetermined reference values ​​in standard deviation are 10 for the standard deviation of pulse rate and 5 for the standard deviation of oxygen saturation, but these reference values ​​can be set as appropriate. On the other hand, as shown in Figure 10(A), the control unit 203 (change detection unit 203c) determines "No" if the moving average value over the last 3 hours is less than or equal to the predetermined reference value in the moving average (indicated, reference value (MA)) or if the standard deviation over the last 3 hours exceeds the predetermined reference value in standard deviation, and proceeds to step S404.

[0102] Next, in step S404, the control unit 203 determines whether the predetermined time T2 elapsed determination process (step S502) of the re-examination subprogram, which will be described later in step S418, is currently being executed. In this case, if the control unit 203 is executing the predetermined time T2 elapsed determination process, it determines "Yes" to this determination process and proceeds to step S420. On the other hand, if the control unit 203 is not executing the predetermined time T2 elapsed determination process, it determines "No" to this determination process and proceeds to step S406.

[0103] Next, in step S406, the control unit 203 determines whether the amount of data that will definitely be used in the first period condition determination process in the next step S408 is stored in the storage unit 201, thereby determining the sufficiency of the processing data. In this embodiment, the control unit 203 determines whether the processing data consists of at least 24 hours' worth of data. In this case, if the processing data recorded in the storage unit 201 does not include 24 hours' worth of data, the control unit 203 determines "No" in this determination process and proceeds to step S428, ending the execution of the change determination subprogram and returning to step S110 of the condition change detection program. On the other hand, if the processing data includes 24 hours' worth of data, the control unit 203 determines "Yes" in this determination process and proceeds to step S408.

[0104] Next, in step S408, the control unit 203 performs a first period condition determination process to determine whether the subject's condition has changed during a first period that is longer than the period (short time) in the sudden change determination process of step S402. This first period condition determination process consists of the following substeps 1 and 2.

[0105] Substep 1: First, the control unit 203 (indicator calculation unit 203b) calculates biometric indicators for each parameter to determine whether or not there has been a change in condition during the first period, using the processed data. In this embodiment, the control unit 203 (indicator calculation unit 203b) calculates the slope and standard deviation of the approximate straight line, respectively, using the processed data for the most recent 24 hours for pulse rate and oxygen saturation, as biometric indicators.

[0106] Substep 2: Next, the control unit 203 (change detection unit 203c) determines whether or not there has been a change in the subject's condition based on the biometric indicators calculated in substep 1. Specifically, as shown in Figure 10(B), the control unit 203 (change detection unit 203c) determines "Yes" if the slope of the approximate straight line (LA) for the most recent 24 hours exceeds a predetermined reference value (shown, reference value (LA)) for that slope, and the standard deviation for the most recent 24 hours is less than or equal to a predetermined reference value for the standard deviation, and proceeds to step S414.

[0107] In this embodiment, the predetermined reference value for the slope of the approximate line is 0.04, and the predetermined reference value for the standard deviation is the same as the predetermined reference value for the standard deviation in step S402. On the other hand, the control unit 203 (change detection unit 203c) determines "No" if the slope of the approximate line over the most recent 24 hours falls below the predetermined reference value for that slope, or if the standard deviation over the most recent 24 hours exceeds the predetermined reference value for the standard deviation, and proceeds to step S410.

[0108] Next, in step S410, the control unit 203 determines whether the amount of data that will definitely be used in the second period condition determination process in the next step S412 is stored in the storage unit 201, thereby determining the sufficiency of the processing data. In this embodiment, the control unit 203 determines whether the processing data consists of data for at least 48 hours. In this case, if the processing data recorded in the storage unit 201 does not include data for 48 hours, the control unit 203 determines "No" in this determination process, proceeds to step S428, terminates the execution of the change determination subprogram, and returns to step S110 of the condition change detection program. On the other hand, if the processing data includes data for 48 hours, the control unit 203 determines "Yes" in this determination process and proceeds to step S412.

[0109] Next, in step S412, the control unit 203 performs a second period condition determination process to determine whether the subject's condition has changed during the second period, which starts at the same time as the first period in step S408 and is longer than the first period. This second period condition determination process consists of the following substeps 1 and 2.

[0110] Substep 1: First, the control unit 203 (indicator calculation unit 203b) calculates biometric indicators for each parameter to determine whether or not there has been a change in condition during the second period, using the processed data. In this embodiment, the control unit 203 (indicator calculation unit 203b) calculates the slope and standard deviation of the approximate straight line, respectively, using the processed data for the most recent 48 hours for pulse rate and oxygen saturation, as biometric indicators.

[0111] Substep 2: Next, the control unit 203 (change detection unit 203c) determines whether or not there has been a change in the subject's condition based on the biometric indicators calculated in substep 1. Specifically, the control unit 203 (change detection unit 203c) determines that the subject's condition has changed and "Yes" if the slope of the approximate straight line for the most recent 48 hours exceeds a predetermined reference value for that slope, and the standard deviation for the most recent 48 hours is less than or equal to a predetermined reference value for the standard deviation, and proceeds to step S414. In this embodiment, the predetermined reference value for the slope of the approximate straight line is 0.02, and the predetermined reference value for the standard deviation is the same as the predetermined reference value for the standard deviation in step S402.

[0112] Next, in step S414, the control unit 203 (condition notification unit 203d) notifies the provider that the subject's condition has changed and transmits medical interview information to the supporter. Specifically, if the control unit 203 (condition notification unit 203d) determines that the subject's condition has changed in at least one of steps S402, S408, or S412, it transmits notification information indicating that a change in the subject's condition has been detected to the provider terminal 300 and the supporter terminal 400, respectively. The control unit 203 (condition notification unit 203d) also transmits medical interview information pre-recorded in the storage unit 201 to the supporter terminal 400.

[0113] In this case, the support worker who receives the medical questionnaire information operates the input unit 402 of the support worker terminal 400 to input the answers to the questionnaire and transmits the answers to the provider terminal 300 via the Internet NW. The provider who receives these answers decides on the treatment to be given to the subject by considering the subject's vital data (raw data) included in the notification information received from the host device 200 and the answers received from the support worker terminal 400.

[0114] On the other hand, the control unit 203 (change detection unit 203c) determines "No" if the slope of the approximate straight line for the most recent 48 hours falls below the predetermined reference value for that slope, or if the standard deviation for the most recent 48 hours exceeds the predetermined reference value for the standard deviation, and proceeds to step S416.

[0115] Next, in step S416, the control unit 203 (change detection unit 203c) determines whether the subject's condition is in a state requiring observation. Here, a state requiring observation means a state in which the subject's condition needs to be reassessed after a predetermined period of time. Specifically, if the slope of the approximate straight line for the most recent 24 hours is outside a predetermined range, the control unit 203 (change detection unit 203c) determines "No" as the subject's condition does not require observation, proceeds to step S428, terminates the execution of the change determination subprogram, and returns to step S110 of the condition change detection program. In this embodiment, the predetermined range is the range in which the slope of the approximate straight line for the most recent 24 hours is greater than 0.02 and less than 0.04.

[0116] On the other hand, the control unit 203 (change detection unit 203c) determines "Yes" if the slope of the approximate straight line for the most recent 24 hours is within the predetermined range, as this indicates that the subject's condition requires observation. The control unit 203 (change detection unit 203c) also records the time at which the "Yes" determination was made (hereinafter referred to as the "observation start time") in the storage unit 201 and proceeds to step S418.

[0117] Next, in step S418, the control unit 203 instructs the start of execution of the re-examination subprogram. In this case, after instructing the start of execution of the re-examination subprogram in step S418, the control unit 203 proceeds to step S428 and returns to step S110 of the condition change detection program. Therefore, the control unit 203 then executes the processing of the condition change detection program (data preprocessing subprogram and change determination subprogram) while simultaneously executing the processing of the re-examination subprogram. First, the execution process of the re-examination subprogram will be explained.

[0118] This re-examination subprogram re-evaluates the condition of subjects whose condition was determined to require observation in step S416 of the change determination subprogram after a certain period of time. Specifically, the control unit 203 starts the execution of the re-examination subprogram shown in Figure 11 in step S500, records the execution start time in the storage unit 201, and proceeds to step S502.

[0119] Next, in step S502, the control unit 203 executes a predetermined time T2 elapsed determination process. This predetermined time T2 elapsed determination process determines whether a predetermined time T2 (3 hours in this embodiment) has elapsed since the control unit 203 determined in step S416 that the person is in a state requiring observation. This predetermined time T2 can be set appropriately according to the type of disease the person is suffering from, the person's condition, or the person's living environment.

[0120] Specifically, the control unit 203 determines "No" if the elapsed time from the observation start time in step S416 is less than the predetermined time T2, and returns to step S502. On the other hand, the control unit 203 determines "Yes" if the elapsed time is equal to or greater than the predetermined time T2, and proceeds to step S504.

[0121] Next, in step S504, the control unit 203 performs a re-determination process to determine whether the condition of the subject, which was determined to require observation in step S416, remains poor even after the predetermined time T2 of step S502 has elapsed. This re-determination process consists of the following substeps 1 and 2.

[0122] Substep 1: First, the control unit 203 (indicator calculation unit 203b) calculates a biometric indicator for each parameter to determine whether or not there has been a change in condition during the first period, similar to substep 1 of step S408 of the change determination subprogram.

[0123] Substep 2: Next, the control unit 203 (change detection unit 203c) determines whether or not there has been a change in the subject's condition based on the biometric indicators calculated in substep 1. Specifically, if the slope of the approximate straight line for the most recent 24 hours is greater than or equal to the slope of the approximate straight line for the most recent 24 hours calculated in step 408, the control unit 203 (change detection unit 203c) determines that the subject's condition is poor and determines "Yes," then proceeds to step S506.

[0124] Next, in step S506, the control unit 203 (condition notification unit 203d) notifies the provider that the subject's condition is poor, in substantially the same manner as in step S414 of the change determination subprogram, and transmits questionnaire information to the support staff. Specifically, if the control unit 203 (condition notification unit 203d) determines in substep 2 of step S504 that the subject's condition is poor, it transmits notification information to the provider terminal 300 and the support staff terminal 400, respectively, and transmits questionnaire information to the support staff terminal 400. The response of the support staff upon receiving the questionnaire information and the response of the provider upon receiving the notification information and the support staff's response are the same as the response after step S414, so the explanation is omitted.

[0125] On the other hand, if the slope of the approximate straight line for the most recent 24 hours is smaller than the slope of the approximate straight line for the most recent 24 hours calculated in step 408, the control unit 203 (change detection unit 203c) determines that the subject's condition has improved at the time of step 416 and determines "No", then proceeds to step S508.

[0126] Next, in step 508, the control unit 203 terminates the execution of the re-examination subprogram, proceeds to step S428 of the change determination subprogram, and returns to step S110 of the condition change detection program.

[0127] Next, we will describe each process of the condition change detection program (data preprocessing subprogram and change determination subprogram) which is executed in parallel with the re-examination subprogram. After step S418, in step 428, the control unit 203 terminates the execution of the change determination subprogram and returns to step S110 of the condition change detection program.

[0128] Next, in step S110, the control unit 203 determines whether or not to terminate the execution of the condition change detection program. In this embodiment, since the control unit 203 has not received an instruction from the provider to terminate the program execution, it determines "No" to continue the execution of the condition change detection program and returns to step S106. In other words, the control unit 203 continues to detect changes in the subject's condition.

[0129] Next, the control unit 203 executes the data preprocessing subprogram in the same manner as the process in step S106 described earlier, and then proceeds to step S108. Next, in step S108, the control unit 203 executes the change determination subprogram as described above, and proceeds to step S404 via steps S400 and S402.

[0130] Next, in step S404, the control unit 203 determines whether the predetermined time T2 elapsed determination process (step S502) of the re-examination subprogram in step S418 is currently being executed. In this case, the control unit 203 determines "Yes" because the predetermined time T2 elapsed determination process is currently being executed, and proceeds to step S420.

[0131] Next, in step S420, the control unit 203 performs a first period condition determination process, which is substantially the same as the first period condition determination process in step S408, to determine whether or not the subject's condition has changed during the first period. Therefore, regarding the first period condition determination process in step S420, the explanation of the parts that are common with the determination process in step S408 will be omitted, and only the parts that differ will be explained.

[0132] Specifically, in substep 2 of step S420, the control unit 203 (change detection unit 203c) determines "No" if the slope of the approximate straight line for the most recent 24 hours falls below the predetermined reference value for that slope, or if the standard deviation for the most recent 24 hours exceeds the predetermined reference value for the standard deviation, and proceeds to step S422.

[0133] Next, in step S422, the control unit 203 performs a second period condition determination process, which is substantially the same as the second period condition determination process in step S412, to determine whether or not the subject's condition has changed during the second period. Therefore, regarding the second period condition determination process in step S422, the explanation of the parts that are common with the determination process in step S412 will be omitted, and only the parts that differ will be explained.

[0134] Specifically, in substep 2 of step S422, the control unit 203 (change detection unit 203c) determines "No" if the slope of the approximate straight line for the most recent 48 hours falls below the predetermined reference value for that slope, or if the standard deviation for the most recent 48 hours exceeds the predetermined reference value for the standard deviation, and proceeds to step S424.

[0135] Next, in step S424, the control unit 203 (change detection unit 203c) determines whether the subject's condition is in a state requiring observation, which is substantially the same as the observation-requiring state determination process in step S416. Therefore, regarding the observation-requiring state determination process in step S424, the explanation of the parts common to the determination process in step S416 will be omitted, and only the parts that differ will be explained.

[0136] Specifically, in step S424, the control unit 203 (change detection unit 203c) determines "Yes" if the slope of the approximate straight line for the most recent 24 hours is within the predetermined range, indicating that the subject's condition requires observation. The control unit 203 (change detection unit 203c) also records the time at which "Yes" was determined in the storage unit 201 and proceeds to step S426.

[0137] Next, in step S426, the control unit 203 instructs the start of execution of the re-examination subprogram, similar to step S418. In this case, as already explained in step S418, the control unit 203 executes the processing of the condition change detection program (data pre-processing subprogram and change determination subprogram) while simultaneously executing the processing of the re-examination subprogram.

[0138] Therefore, the control unit 203 repeatedly executes the first period condition determination process, the second period condition determination process, the condition requiring observation determination process, and the re-examination subprogram in steps S420 to S426 until the currently running re-examination subprogram is completed or the execution of the condition change detection program is interrupted, thereby continuing to determine the change in the subject's condition.

[0139] However, in step S110, the control unit 203 determines "Yes" to terminate the execution of the condition change detection program if the provider has given an instruction to terminate the program execution, and proceeds to step S112. Then, in step S112, the control unit 203 terminates the execution of the condition change detection program.

[0140] As can be understood from the above description of operation, according to the above embodiment, the condition change detection system 100 is configured to compensate for the missing portion with supplementary data created by the control unit 203 (pre-processing unit 203a) using vital data acquired in a predetermined period immediately before the loss. Therefore, the condition change detection system 100 can detect changes in the subject's condition based on biometric indicators calculated from processed data compensated with supplementary data that reflects the subject's condition immediately before the loss, thereby suppressing a decrease in detection accuracy and enabling accurate detection of changes in the subject's condition.

[0141] Furthermore, the present invention is not limited to the embodiments described above, and various modifications are possible as long as they do not depart from the purpose of the present invention. In the description of each modified example, the same reference numerals are used for parts that are the same as in the embodiments described above, and redundant descriptions are omitted.

[0142] For example, in the above embodiment, the condition change detection system 100 is comprised of a wristwatch-type wearable terminal that is attached to the subject's wrist as the biometric information measuring device 101. However, the biometric information measuring device 101 is not limited to this embodiment as long as it is a device that can acquire the subject's vital signs. For example, the biometric information measuring device 101 can also be comprised of a ring-type wearable terminal, a wristband-type wearable terminal, a thermometer, a blood pressure monitor, a scale, a body composition analyzer, a pulse oximeter, a blood glucose meter for measuring blood glucose, or a sheet-type measuring device that is placed under a lying subject to measure the subject's body movements.

[0143] Furthermore, in the above embodiment, the condition change detection system 100 is configured such that the control unit 203 (index calculation unit 203b) calculates the moving average of pulse rate and oxygen saturation for the three hours immediately preceding the missing data as biometric indicators that constitute the supplementary data. With this configuration, the condition change detection system 100 can detect changes in the subject's condition based on biometric indicators calculated from processed data supplemented with supplementary data that reflects the subject's condition immediately before the missing data, thereby enabling accurate detection of changes in the subject's condition while suppressing a decrease in detection accuracy.

[0144] Therefore, the biometric indicators that constitute the supplementary data can be any data that reflects the condition of the subject near the missing portion, and are not limited to the above embodiment. For this reason, the biometric indicators that constitute the complete data can be, for example, the median, mode, maximum, or minimum values ​​for each parameter during a predetermined period before and after the missing data. In this case, the predetermined period can be appropriately set according to the subject's age, living environment, type of disease, severity of disease, health status, treatment content, or whether or not the subject has a chronic disease.

[0145] Furthermore, in the above embodiment, the condition change detection system 100 is composed of biometric indicators calculated using vital data acquired in a predetermined period immediately preceding the data loss. According to this, the condition change detection system 100 can calculate the biometric indicators constituting the supplementary data using the indicator calculation unit 203b, simplifying the biometric indicator calculation process in the preprocessing unit 203a and enabling efficient creation of supplementary data. However, the condition change detection system 100 can also be composed of data other than the aforementioned biometric indicators for the supplementary data.

[0146] Specifically, the supplementary data may consist only of the last value obtained in the raw data before the missing data (for example, the value at 5:50 PM on May 11th in the above embodiment) or the first value obtained in the raw data after the missing data (the value at 6:10 PM on the same day). Alternatively, the supplementary data may consist of values ​​that can be connected by a straight line (linear function) or a curve (a function of two or more elements) between the values ​​obtained before and after the period of missing data.

[0147] Furthermore, in the above embodiment, the condition change detection system 100 is configured so that the preprocessor 203a compensates for missing vital data (specifically, missing data after 10pm on May 11th) that occurs during non-wearing periods when the subject is not wearing the wearable device. This allows the condition change detection system 100 to detect changes in the subject's condition while ensuring the subject's freedom in daily life, even when non-wearing periods occur due to sleep, bathing, etc. However, the condition change detection system 100 may also be configured so that the control unit 203 does not compensate for missing vital data that occurs during non-wearing periods, but instead uses processed data in which only abnormal values ​​have been compensated to detect changes in the subject's condition.

[0148] Furthermore, in the above embodiment, the state change detection system 100 is configured to perform a interpolation process in which, after the preprocessing unit 203a detects unreliable data (abnormal values) contained in the raw data, the abnormal values ​​are replaced with interpolation data. As a result, the state change detection system 100 performs abnormal value detection processing prior to interpolation processing of missing data, so that interpolation processing can be performed not only on missing data but also on abnormal values, thereby improving the reliability of the processed data.

[0149] However, the condition change detection system 100 may be configured to detect and remove unreliable data (abnormal values) contained in the raw data after the preprocessing unit 203a has performed a interpolation process in which missing data is replaced with interpolated data. In this case, the condition change detection system 100 can remove abnormal values ​​contained in the processed data based on an abnormal value judgment criterion set based on the entire processed data after the interpolation process for missing data, thereby improving the reliability of the processed data.

[0150] Furthermore, in the above embodiment, the condition change detection system 100 is configured such that the preprocessing unit 203a detects unreliable data (abnormal values) contained in the raw data and performs a removal process to remove abnormal values ​​from the raw data. However, the condition change detection system 100 can be configured without performing the removal process.

[0151] Furthermore, in the above embodiment, the condition change detection system 100 is configured to notify the caregiver that the subject's condition has changed when a change in the subject's condition is detected, and to transmit medical interview information to the caregiver. This allows the condition change detection system 100 to prompt the caregiver to confirm the subject's actual condition through the notification information and medical interview information. However, the condition change detection system 100 may be configured to omit the transmission of notification information and / or medical interview information to the caregiver.

[0152] Furthermore, in the above embodiment, the condition change detection system 100 is configured to include a condition notification unit 203d that notifies the subject of a change in condition in response to the detection of a change in the subject's condition by the change detection unit 203c. With this configuration, the condition change detection system 100 can quickly notify the subject of a change in condition in response to the detection of a change in the subject's condition, even if the subject is unaware of a change in their condition (has no subjective symptoms) or is unable to call for help. The condition change detection system 100 can also notify people at a distance of a change in the subject's condition. However, the condition change detection system 100 can be configured without the condition notification unit 203d.

[0153] Furthermore, in the above embodiment, the condition change detection system 100 is configured such that the control unit 203 determines the change in the subject's condition through a sudden change determination process, a first period condition determination process, a second period condition determination process, a state requiring observation determination process, and a first period re-determination process. However, the condition change detection system 100 is not limited to the determination method in the above embodiment, as long as it is configured to determine the change in the subject's condition using raw data. For example, the condition change detection system 100 may be configured to determine the change in the subject's condition using any one of the determination methods in the above embodiment, or it may be configured to determine the change in the subject's condition using a method other than the determination method in the above embodiment. [Explanation of symbols]

[0154] 100...Condition change detection system, 101...Biological information measuring device, 102...Measurement unit, 103...Control unit, 105...Communication unit, 200...Host device, 201...Storage unit, 202...Input unit, 203...Control unit, 203a...Preprocessing unit, 203b...Index calculation unit, 203c...Change detection unit, 203d...Condition notification unit, 204...Output unit, 204a...Display screen, 205...Communication unit, 300...Provider terminal, 302...Input unit, 303...Control unit, 304...Output unit, 305... Communications Department, 400...Supporter terminal, 402...Input unit, NW...Internet.

Claims

1. A system for detecting changes in the condition of a subject, A vital signs acquisition means for continuously or intermittently acquiring vital data representing the vital signs of the subject, A data preprocessing means for processing the acquired vital data into a state suitable for detection, An index calculation means for calculating a biometric index using the processed data, The system includes a change detection means that performs the detection based on the aforementioned biometric indicators, The aforementioned data preprocessing means is A condition change detection system characterized by supplementing the missing portion of vital data with supplementary data created using vital data acquired during a predetermined period immediately preceding the missing portion, if a portion of the vital data is missing.

2. In the condition change detection system described in claim 1, The aforementioned supplementary data is A system for detecting changes in physical condition, characterized in that it consists of the biometric indicators calculated using vital data acquired during a predetermined period immediately preceding the loss.

3. In the condition change detection system described in claim 1, The aforementioned vital sign acquisition means is It consists of a wearable device that is attached to the body of the subject to acquire the subject's vital data, The aforementioned data preprocessing means is A system for detecting changes in a person's condition, characterized by compensating for the loss of vital data that occurs during periods when the person is not wearing the wearable device.

4. In the condition change detection system described in claim 1, The aforementioned data preprocessing means is A system for detecting changes in a patient's condition, characterized by processing the vital data to a state suitable for detection by removing unreliable data included in the acquired vital data.

5. In the condition change detection system described in claim 1, further, A condition change detection system characterized by comprising a condition notification means that notifies that the condition of the subject has changed in response to the detection by the change detection means.

6. A condition change detection program that causes a computer device to perform a process to detect changes in the condition of a subject, The aforementioned computer device, A vital signs acquisition step involves continuously or intermittently acquiring vital data representing the vital signs of the subject, A data preprocessing step for processing the acquired vital data into a state suitable for detection, An index calculation step of calculating a biometric using the processed data, The system performs a change detection step that performs the detection based on the aforementioned biometric indicators. The aforementioned data preprocessing step is: A condition change detection program characterized by supplementing the missing portion of the vital data with supplementary data created using vital data acquired during a predetermined period immediately preceding the missing portion, if a portion of the vital data is missing.

7. A vital data completion method for completing missing data included in vital data representing the vital signs of a subject used in a condition change detection system for detecting changes in the subject's condition, The aforementioned condition change detection system is A vital signs acquisition means for continuously or intermittently acquiring the aforementioned vital data, A data preprocessing means for processing the acquired vital data into a state suitable for detection, An index calculation means for calculating a biometric index using the processed data, The system includes a change detection means that performs the detection based on the aforementioned biometric indicators, A vital data supplementation method characterized in that the data preprocessing means supplements the missing portion with supplemental data created using vital data acquired during a predetermined period immediately preceding the missing portion.

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