System for managing adverse events associated with treatment, method for managing adverse events associated with treatment, and program

Abstract

[Problem] To make it possible to present actions to be taken in response to adverse events associated with treatment. [Solution] A system for managing adverse events associated with treatment, the system comprising: an acquisition unit that acquires vital information of a patient and subjective symptom information relating to a subjective symptom of the patient; a classification unit that classifies adverse events associated with treatment and the severity of the adverse events on the basis of at least one of the vital information and the subjective symptom information; a determination unit that determines an action to be taken by the patient, according to the adverse event and the severity; and an output unit that outputs action information indicating the action.

Description

Treatment-associated adverse event management system, treatment-associated adverse event management method and program

[0001] The present invention relates to a system for managing adverse events associated with treatment, a method for managing adverse events associated with treatment, and a program therefor.

[0002] Patent Document 1 discloses, as an example of treatment, a device that displays side effects that may occur due to a drug.

[0003] Japanese Patent Application Laid-Open No. 2004-185196

[0004] However, adverse events such as complications do not necessarily occur as a result of treatment, and symptoms vary from patient to patient, leaving patients unsure of how to respond.

[0005] The present invention has been made in view of the above background, and aims to provide a technology that can suggest actions to be taken in response to adverse events associated with treatment.

[0006] The main invention of the present invention for solving the above problem is a system for managing adverse events associated with treatment, comprising: an acquisition unit that acquires vital information of a patient and subjective symptom information related to the patient's symptoms; a classification unit that classifies the adverse event associated with the treatment and the severity of the adverse event associated with the treatment based on at least one of the vital information and the subjective symptom information; a decision unit that decides an action to be taken by the patient depending on the adverse event associated with the treatment and the severity; and an output unit that outputs behavioral information indicating the behavior.

[0007] Other problems and solutions disclosed in this application will be made clear in the section on preferred embodiments of the invention and the drawings.

[0008] According to the present invention, it is possible to suggest actions to be taken in response to adverse events associated with treatment.

[0009] It is a diagram showing an example of the overall configuration of a management system for adverse events accompanying treatment. It is a diagram showing an example of the hardware configuration of a management server 2. It is a diagram showing an example of the software configuration of a management server 2. It is a diagram explaining the operation of the management server 2.

[0010] <Summary of the Invention> The details of embodiments of the present invention will be listed and described below. The present invention has, for example, the following configuration: [Item 1] A treatment-associated adverse event management system comprising: an acquisition unit that acquires vital information of a patient and subjective symptom information related to the patient's subjective symptoms; a classification unit that classifies a treatment-associated adverse event and the severity of the adverse event based on at least one of the vital information and the subjective symptom information; a decision unit that determines an action to be taken by the patient in accordance with the adverse event and the severity; and an output unit that outputs behavioral information indicating the behavior. [Item 2] A treatment-associated adverse event management system according to item 1, wherein the classification unit classifies the severity of a predetermined treatment-associated adverse event based on at least two of the vital information and the subjective symptom information. [Item 3] The treatment-associated adverse event management system according to Item 2, wherein the acquisition unit acquires a second degree of the subjective symptom, and the classification unit classifies the vital information into a first degree and classifies the severity based on the vital information, the subjective symptom information, and the first and second degrees. [Item 4] The treatment-associated adverse event management system according to Item 1, wherein the acquisition unit acquires the degree of the subjective symptom, and when the subjective symptom indicates the adverse event, the classification unit classifies the severity according to the degree. [Item 5] The treatment-associated adverse event management system according to Item 1, comprising a storage unit that stores the behavioral information in association with the degree, and the determination unit reads out the behavioral information corresponding to the classified severity from the storage unit. [Item 6] The treatment-associated adverse event management system according to Item 1, wherein the acquisition unit acquires the symptom information by displaying information on the presence or absence and severity of the subjective symptoms on a patient terminal and allowing the patient to select one of the subjective symptoms.[Item 7] A method for managing adverse events associated with treatment, characterized in that a computer executes the steps of: acquiring vital information of a patient and subjective symptom information related to the patient's symptoms, classifying adverse events associated with treatment and the severity of the adverse events based on at least one of the vital information and the subjective symptom information, determining an action to be taken by the patient depending on the adverse events and the severity, and outputting behavioral information indicating the action. [Item 8] A program for causing a computer to execute the steps of: acquiring vital information of a patient and subjective symptom information related to the patient's symptoms, classifying adverse events associated with treatment and the severity of the adverse events based on at least one of the vital information and the subjective symptom information, determining an action to be taken by the patient depending on the adverse events and the severity, and outputting behavioral information indicating the action.

[0011] <System Overview> The following describes a management system for adverse events such as complications associated with treatment according to one embodiment of the present invention. The management system for adverse events such as complications associated with treatment according to this embodiment classifies the severity of adverse events such as complications associated with treatment based on vital signs and subjective symptom information acquired from the patient, and suggests actions the patient should take in response to adverse events such as complications associated with treatment according to the severity. Adverse events include complications, side effects, and the like. Adverse events include dangerous events caused by side effects of medication, such as when a patient becomes unsteady due to a side effect of medication and falls. Adverse events also include injuries caused by side effects of medication, such as when a patient becomes unsteady due to a side effect of medication and falls, resulting in injury. Adverse events also include dangerous events that may occur to patients during treatment. For example, adverse events may include cases where a coexisting disease or chronic condition worsens during treatment, even if there is no direct causal relationship with the treatment. For example, an adverse event may include a patient suffering from heart failure and constipation straining during bowel movements, which puts strain on the heart and causes heart failure symptoms. Adverse events may also include the development of bedsores due to complete immobility in patients who require bed rest.

[0012] 1 is a diagram showing an example of the overall configuration of a management system for adverse events such as complications associated with treatment. The management system for adverse events such as complications associated with treatment of this embodiment includes a management server 2. The management server 2 is communicably connected to a patient terminal 1 and a medical institution terminal 3 via a communication network. The communication network 3 is, for example, the Internet, and is constructed using a public telephone network, a mobile phone network, a wireless communication path, Ethernet (registered trademark), or the like.

[0013] The patient terminal 1 is a computer operated by a patient, and may be, for example, a smartphone, a tablet computer, or a personal computer.

[0014] The medical institution terminal 3 is a computer operated by a medical professional such as a doctor or a nurse. The medical institution terminal 3 may be, for example, a smartphone, a tablet computer, or a personal computer.

[0015] The management server 2 may be a general-purpose computer such as a workstation or a personal computer, or may be logically realized by cloud computing.

[0016] <Management Server> FIG. 2 is a diagram illustrating an example of the hardware configuration of the management server 2. Note that the illustrated configuration is an example, and other configurations may also be used. The management server 2 includes a CPU 201, memory 202, storage device 203, communication interface 204, input device 205, and output device 206. The storage device 203 stores various data and programs, and is, for example, a hard disk drive, solid state drive, or flash memory. The communication interface 204 is an interface for connecting to a communication network, and is, for example, an adapter for connecting to Ethernet (registered trademark), a modem for connecting to a public telephone network, a wireless communication device for wireless communication, or a USB (Universal Serial Bus) connector or RS232C connector for serial communication. The input device 205 is, for example, a keyboard, mouse, touch panel, button, microphone, or the like for inputting data. The output device 206 is, for example, a display, printer, speaker, or the like for outputting data. Each functional unit of the management server 2 described below is realized by the CPU 201 reading a program stored in the storage device 203 into the memory 202 and executing it, and each storage unit of the management server 2 is realized as part of the storage area provided by the memory 202 and the storage device 203.

[0017] 3 is a diagram illustrating an example of the software configuration of the management server 2. The management server 2 includes a behavior storage unit 231, a vital information storage unit 232, an acquisition unit 211, a classification unit 212, a determination unit 213, and an output unit 214.

[0018] The behavioral memory unit 231 stores behavioral information in association with adverse events such as complications associated with treatment and the severity of the adverse events such as complications associated with treatment. Adverse events such as complications associated with treatment include subjective symptoms themselves, such as physical condition, mood, shortness of breath, motivation, shortness of breath, mood, fatigue, lethargy, pain, diarrhea, nausea, vomiting, rash, high blood pressure, numbness, and convulsions. Adverse events such as complications associated with treatment also include physical symptoms associated with mental states such as autonomic dysfunction that do not match subjective symptoms. The severity of adverse events such as complications associated with treatment can be, for example, three levels: mild, moderate, and severe, but is not limited to these levels and may be two levels or four or more levels. The behavioral information is information indicating actions that the patient should take. The actions that the patient should take can be three types: wait-and-see, self-care, and contacting a medical institution (telephone solicitation), but are not limited to these levels and may include one or two of these, or other actions. Self-care may include specific self-care content. For example, information on self-care published in clinical practice guidelines may be included in the behavioral information.

[0019] The acquisition unit 211 acquires vital information of the patient and subjective symptom information related to the patient's subjective symptoms. The vital information may be, for example, blood pressure, body temperature, etc. The vital information may be input by the patient to the patient terminal 1 and received from the patient terminal 1, or the vital information may be acquired from a measuring device. The subjective symptoms may include physical condition, mood, shortness of breath, motivation, shortness of breath, good mood, fatigue, lethargy, pain, diarrhea, nausea, vomiting, rash, numbness, palpitations, sweating, swelling, shortness of breath, chills, cough, etc. The acquisition unit 211 also acquires the degree of subjective symptoms (hereinafter referred to as the subjective symptom degree or second degree). The subjective symptom degree may be, for example, three levels: mild, moderate, and severe, but is not limited thereto and may be two levels or four or more levels. The acquisition unit 211 can acquire subjective symptom information by displaying information regarding the presence or absence of subjective symptoms and the degree of subjective symptoms on the patient terminal 1 and allowing the patient to select an option. The acquisition unit 211 can prepare options according to the degree of subjective symptoms. For example, regarding the degree of shortness of breath, the acquisition unit 211 can provide to the patient terminal 1 a mild option of "shortness of breath, but no hindrance to daily life," a medium option of "shortness of breath that hindrance to climbing stairs, cleaning, going out, etc.", and a severe option of "shortness of breath and wheezing," and allow the patient to select one of these options.

[0020] The vital information storage unit 232 stores vital information. The vital information storage unit 232 can store vital information in association with the patient and the date (or date and time). The acquisition unit 211 can register the acquired vital information in the vital information storage unit 232 in association with the patient and the acquisition date. The vital information can include, for example, body temperature, blood pressure, weight, activity level (e.g., measured values ​​obtained by a three-axis or six-axis acceleration sensor), oxygen saturation, etc. In addition to these, any values ​​measured on the body of the patient can also be included.

[0021] The classification unit 212 classifies the severity of adverse events such as complications associated with treatment. The classification unit 213 can classify the severity of adverse events such as complications associated with treatment based on at least one of vital sign information and subjective symptom information.

[0022] The classification unit 212 can classify the vital information into degrees (hereinafter referred to as vital degrees or first degrees). The vital degree can also be, for example, three levels: mild, moderate, and high. However, the present invention is not limited to these levels and may be two levels or four or more levels. The classification unit 212 can classify, for example, a systolic blood pressure of 135 or more and less than 160 as mild, 160 or more and less than 180 as moderate, and 180 or more as high. The classification unit 212 can also refer to the vital information storage unit 232 and classify the systolic blood pressure into mild, moderate, or high if it continues for a predetermined period of time (e.g., two days, five days, etc.) or more. If the classification unit 212 cannot classify the vital information, the classification unit 212 can not use the vital information in information processing.

[0023] When the vital sign information or subjective symptom information indicates an adverse event such as a complication associated with treatment itself (for example, physical condition, mood, shortness of breath, motivation, shortness of breath, good mood, fatigue / lethargy, pain, diarrhea, nausea, vomiting, rash, high blood pressure, numbness, convulsions, etc.), the classification unit 212 can classify the severity of the adverse event such as a complication associated with treatment based only on either the vital sign information or the subjective symptom information. In this case, the vital sign information or the subjective symptom information can be regarded as an adverse event such as a complication associated with treatment, and the degree of vital sign or the degree of subjective symptom can be regarded as the degree of the adverse event such as a complication associated with treatment.

[0024] For adverse events such as complications associated with a given treatment where the vital sign information or subjective symptom information does not indicate the adverse event itself, the classification unit 212 can classify the adverse event such as a complication associated with a treatment and its severity based on at least two of the vital sign information and the subjective symptom information. In this case, the classification unit 212 can classify the severity based on the vital sign information, the subjective symptom information, and the first and second degrees. For example, if shortness of breath is mild and fatigue / lethargy is moderate, anemia can be classified as severe. Note that the classification unit 212 can determine the type and severity of the adverse event such as a complication associated with a treatment by following a decision tree prepared using the type and degree of vital sign information and / or subjective symptom information.

[0025] The decision unit 213 can decide the action that the patient should take depending on the adverse events such as complications associated with the treatment and their severity. The decision unit 213 can read out action information corresponding to the classified adverse events such as complications associated with the treatment and their severity from the action storage unit 231.

[0026] The output unit 214 outputs behavioral information indicating behaviors that the patient should take depending on the symptoms of adverse events such as complications associated with treatment. The main unit 215 can transmit the behavioral information read by the determination unit 213 to the patient terminal 1. The output unit 214 can also transmit the classification results by the classification unit 212 to the medical institution terminal 1 depending on the severity of adverse events such as complications associated with treatment. For example, for adverse events such as complications associated with advanced treatment, the output unit 214 can transmit to the medical institution terminal 1 the type and severity of the adverse event such as a complication associated with treatment, as well as the vital sign information, subjective symptom information, and subjective symptom level used for the classification. The output unit 214 may transmit these to the medical institution terminal 1 when the severity of the adverse event such as a complication associated with treatment is equal to or greater than a predetermined threshold (which may differ depending on the adverse event such as a complication associated with treatment).

[0027] <Operation> FIG. 4 is a diagram illustrating the operation of the management server 2.

[0028] The management server 2 acquires vital information, subjective symptom information, and subjective symptom level from the patient terminal 1 (S301), and classifies the vital information into vital level (S302).

[0029] The management server 2 determines the adverse events such as complications associated with the treatment and the degree of the adverse events such as complications associated with the treatment based on the vital sign information, the symptom information, the vital sign level, and the symptom level (S303). Here, the management server 2 can determine the adverse events such as complications associated with the treatment and the degree of the adverse events such as complications associated with the treatment using, for example, a decision tree.

[0030] The management server 2 reads out behavioral information corresponding to adverse events such as complications associated with the treatment and the severity of the adverse events such as complications associated with the treatment from the behavior memory unit 231 (S304), and transmits the read out behavioral information to the patient terminal 1 (S305).

[0031] If the degree of adverse events such as complications associated with treatment is equal to or greater than a predetermined threshold (S306: YES), the management server 2 can transmit the adverse events such as complications associated with treatment and the degree of adverse events such as complications associated with treatment, as well as vital signs, symptom information, and the degree of subjective symptoms to the medical institution terminal 3 (S307).

[0032] As described above, the management system for adverse events such as complications associated with treatment in this embodiment can determine the complications and other adverse events associated with treatment and their severity based on the patient's vital signs and symptom information, and can suggest actions that the patient should take accordingly.

[0033] Although the present embodiment has been described above, the above embodiment is intended to facilitate understanding of the present invention and is not intended to limit the present invention. The present invention may be modified or improved without departing from the spirit thereof, and equivalents thereof are also included in the present invention.

[0034] 1 Patient terminal 2 Management server 3 Medical institution terminal

Claims

1. An acquisition unit that acquires the patient's vital information and subjective symptom information regarding the subjective symptoms of the patient; a classification unit that classifies an adverse event associated with treatment and the severity of the adverse event based on at least one of the vital information and the subjective symptom information; a determination unit that determines an action to be taken by the patient according to the adverse event and the severity; and an output unit that outputs action information indicating the action. A harmful event management system associated with treatment, characterized by comprising the above components.

2. The harmful event management system associated with treatment according to claim 1, wherein the classification unit classifies the severity based on at least two of the vital information and the subjective symptom information for a predetermined adverse event associated with the treatment. A harmful event management system associated with treatment, characterized by the above.

3. The harmful event management system associated with treatment according to claim 2, wherein the acquisition unit acquires a second degree of the subjective symptom, and the classification unit classifies the vital information into a first degree and classifies the severity based on the vital information, the subjective symptom information, and the first and second degrees. A harmful event management system associated with treatment, characterized by the above.

4. The harmful event management system associated with treatment according to claim 1, wherein the acquisition unit acquires the degree of the subjective symptom, and the classification unit classifies the severity according to the degree when the subjective symptom indicates an adverse event associated with the treatment. A harmful event management system associated with treatment, characterized by the above.

5. The harmful event management system associated with treatment according to claim 1, further comprising a storage unit that stores the action information in association with the degree, and the determination unit reads out the action information corresponding to the classified severity from the storage unit. A harmful event management system associated with treatment, characterized by the above.

6. The harmful event management system associated with treatment according to claim 1, wherein the acquisition unit acquires the subjective symptom information by causing the patient to select information regarding the presence and degree of the subjective symptom by displaying it on a patient terminal. A harmful event management system associated with treatment, characterized by the above.

7. A method for managing adverse events associated with treatment, characterized in that a computer executes steps of: obtaining vital information of a patient and subjective symptom information regarding the subjective symptoms of the patient; classifying adverse events associated with treatment and the severity of the adverse events based on at least one of the vital information and the subjective symptom information; determining actions to be taken by the patient according to the adverse events and the severity; and outputting action information indicating the actions.

8. A program for causing a computer to execute steps of: obtaining vital information of a patient and subjective symptom information regarding the subjective symptoms of the patient; classifying adverse events associated with treatment and the severity of the adverse events based on at least one of the vital information and the subjective symptom information; determining actions to be taken by the patient according to the adverse events and the severity; and outputting action information indicating the actions.

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