Side effect management system, side effect management server, and side effect management server program
The side effect management system effectively classifies and manages side effects using patient terminals and servers, enabling early detection and appropriate responses to support safe continuation of cancer drug therapy.
Patent Information
- Application Number
- PCT/JP2024/046270
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-29
- Filing Date
- 2024-12-26
- Publication Date
- 2025-07-03
AI Technical Summary
Patients with cancer struggle to distinguish between symptoms associated with the disease and side effects of drug therapy, and medical institutions face challenges in managing side effects outside the hospital, leading to inadequate care.
A side effect management system comprising a patient terminal and a management server that acquires vital data and subjective symptoms, classifies patients into groups based on these data, and determines appropriate coping actions using a unique algorithm, which are then output to the patient and medical staff.
Enables early detection and management of side effects, allowing patients to safely continue drug therapy while minimizing side effect severity through informed actions.
Smart Images

Figure JP2024046270_03072025_PF_FP_ABST
Abstract
Description
Side effect management system, side effect management server, and side effect management server program
[0001] The present invention relates to a side effect management system, a side effect management server, and a side effect management server program.
[0002] There is a technology that suggests what side effects may occur depending on the user's condition and the medication used for treatment (see Patent Document 1).
[0003] Patent Publication No. 2016-134132
[0004] However, patients are unable to distinguish between cancer-related symptoms and side effects of drug therapy, and are unsure of the level and timing of treatment, or how to properly communicate this to medical professionals, making it difficult to balance treatment with daily life.In addition, it is difficult for medical institutions to grasp the patient's condition outside the hospital, and side effects may not be managed appropriately.
[0005] The present invention has been made in view of the above background, and aims to provide a technique that can suggest ways to deal with side effects.
[0006] The main invention of the present invention for solving the above problem is a side effect management system including a patient terminal and a management server, wherein the management server is characterized by comprising: an acquisition unit that acquires the patient's vital data and subjective symptoms caused by side effects of the anticancer drug used by the patient from the patient terminal; a processing unit that acquires a judgment result of the countermeasure action that the patient should take in response to the subjective symptoms based on the vital data and the subjective symptoms; and an output unit that outputs the countermeasure action to the patient terminal.
[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 ways to deal with side effects.
[0009] Fig. 1 is a diagram showing an example of the overall configuration of a side effect management system. Fig. 2 is a diagram showing an example of the hardware configuration of the management server 2. Fig. 3 is a diagram showing an example of the software configuration of the management server 2. Fig. 4 is a diagram explaining information managed by the patient behavior management unit 231 regarding side effects in which the subjective symptoms are the side effects themselves. Fig. 5 is a diagram explaining information managed by the patient behavior management unit 231 regarding side effects in which the subjective symptoms are not the side effects themselves. Fig. 6 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 below. The present invention has, for example, the following configuration. [Item 1] A side effect management system including a patient terminal and a management server, wherein the management server comprises: an acquisition unit that acquires, from the patient terminal, vital data of a patient and subjective symptoms caused by side effects of an anticancer drug used by the patient; a processing unit that acquires, based on the vital data and the subjective symptoms, a determination result of a countermeasure action to be taken by the patient for the subjective symptoms; and an output unit that outputs the countermeasure action to the patient terminal. [Item 2] The system described in Item 1, wherein the acquisition unit acquires the subjective symptoms by displaying the presence or absence of the subjective symptoms and the state of the subjective symptoms on the patient terminal and allowing the patient to select one. [Item 3] The system described in Item 2, wherein the processing unit comprises: a classification unit that classifies the patient into a predetermined patient group based on the vital data and the subjective symptoms; and a determination unit that determines the countermeasure action according to the classified patient group. [Item 4] The system according to item 3, wherein the classification unit evaluates the state of the acquired subjective symptoms using a predetermined degree, and classifies the patient into a patient group by applying a predetermined weighting to the vital data, the evaluated degree, or a combination thereof. [Item 5] The system according to item 3 or item 4, further comprising a patient behavior management unit that associates and manages the coping action for each patient group, and the determination unit determines the coping action for the patient belonging to the classified patient group by referring to the patient behavior management unit. [Item 6] The side effect management system according to item 1, wherein the output unit outputs the coping action to a predetermined institution that manages the patient.[Item 7] A side effect management server configured to be able to communicate with a patient terminal, comprising: an acquisition unit that acquires, from the patient terminal, vital data of a patient and subjective symptoms caused by side effects of an anticancer drug taken by the patient, a processing unit that acquires, based on the vital data and the subjective symptoms, a determination result of a countermeasure action that the patient should take for the subjective symptoms, and an output unit that outputs an action based on the determination result to the patient terminal. [Item 8] A side effect management server program that causes a side effect management server configured to be able to communicate with a patient terminal to function as: an acquisition unit that acquires, from the patient terminal, vital data of a patient and subjective symptoms caused by side effects of an anticancer drug taken by the patient, a processing unit that acquires, based on the vital data and the subjective symptoms, a determination result of a countermeasure action that the patient should take for the subjective symptoms, and an output unit that outputs an action based on the determination result to the patient terminal. [Item 9] A side effect management method using a patient terminal and a side effect management server, wherein the patient terminal acquires from the patient vital data and subjective symptoms caused by side effects of an anticancer drug used by the patient, and the management server executes the following steps: acquiring the vital data and the subjective symptoms from the patient terminal; performing processing to acquire a determination result of countermeasure action that the patient should take in response to the subjective symptoms based on the vital data and the subjective symptoms; and outputting an action based on the determination result to the patient terminal.
[0011] <System Overview> The following describes a side effect management system according to one embodiment of the present invention. The side effect management system of this embodiment uses a unique algorithm to determine the corrective action that the patient should take based on the subjective symptoms and vital signs data entered by the patient, and based on the results, the program provides and shares information with the patient and medical professionals. This enables early detection of side effects caused by the anticancer drugs used by patients, supports patients in independently managing side effects, and supports doctors in responding to side effects early, allowing drug therapy to be continued safely while preventing side effects from becoming more severe.
[0012] 1 is a diagram showing an example of the overall configuration of a side effect management system. The side effect management system 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 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 showing an example of the software configuration of the management server 2. The management server 2 includes a patient behavior management unit 231, a vital sign storage unit 232, a subjective symptom storage unit 233, an acquisition unit 211, a processing unit 212, and an output unit 213. The processing unit 212 includes a classification unit 221 and a determination unit 222.
[0018] The patient behavior management unit 231 associates and manages countermeasure actions for each patient group. The patient behavior management unit 231 can be implemented as a storage unit that stores content (which may be text data, or one or more data including still images, moving images, audio, etc.) for explaining countermeasure actions to patients. The content can also be stored in an external database, and the patient behavior management unit 231 can be implemented as a functional unit that accesses the external database to acquire the content.
[0019] Patient groups can be sorted, for example, by side effects and / or vital signs, as described below. Side effects refer to harmful and unintended reactions to medications. While side effects can occur in all patients, they do not necessarily occur. Side effects vary from individual to individual, and symptoms can range from mild to severe. Specific side effects include, but are not limited to, fatigue, shortness of breath, fever, dry cough, anemia, interstitial pneumonia, etc., and can include common side effects listed in the package insert of the target anticancer drug. Side effects can include subjective symptoms themselves, such as fatigue, shortness of breath, fever, dry cough, etc. Side effects can include symptoms that do not match subjective symptoms, such as anemia and interstitial pneumonia. Side effects that do not match subjective symptoms can be identified by vital signs or a combination of vital signs and subjective symptoms. Vital signs are information obtained from a patient's vital activities and are also referred to as biometric information or vital signs. Specific examples of vital data include, but are not limited to, blood pressure, body temperature, pulse rate, respiration, weight, body fat, etc., and may include other information such as blood tests and urine tests. The degree of side effects can be classified into three levels, for example, mild, moderate, and severe, but is not limited to these and may also be classified into two levels or four or more levels.
[0020] The coping action is information indicating the action that a patient should take when a side effect occurs. The coping action can be classified into three types: wait-and-see, self-care, and contacting a medical institution (telephone recommendation). However, the coping action is not limited to these and may include one or two of these, or may include other actions. Self-care may include specific self-care content. For example, it may include information on self-care published in a "Manual for Dealing with Serious Adverse Reactions." In this embodiment, the coping action includes a type of coping action (coping action type) and an explanation of the coping action (coping action details). The coping action type may be set to "wait-and-see," "self-care," or "telephone recommendation." When the coping action type is "wait-and-see," the coping action details may not be set, or may be set to "wait-and-see," "rest and live daily life," or the like. When the coping action type is "self-care," information indicating the type of self-care to be performed is set in the coping action. When the coping action type is "telephone recommendation," the coping action details may not be set, or may be set to "contact a hospital," or the like. The patient behavior management unit 231 can store the corrective behavior type and the corrective behavior details in association with information specifying the patient group and information indicating the side effect.
[0021] The patient behavior management unit 231 can store coping actions for side effects in which the subjective symptoms or vital data are the side effects themselves, with the degree of subjective symptoms being treated as a patient group. Figure 4 is a diagram explaining information managed by the patient behavior management unit 231 for side effects in which the subjective symptoms are the side effects themselves. As shown in Figure 4, for subjective symptoms such as fatigue and malaise, the degree of subjective symptoms is set as a patient group, and coping action types and coping actions corresponding to the degree of subjective symptoms are set for each side effect.
[0022] For example, regarding fatigue and lethargy, if the degree of subjective symptoms is "mild," the response action can be set to "wait and see," if the degree is "moderate," "self-care" and "ensure adequate rest," and if the degree is "severe," "recommend a phone call."
[0023] For example, for shortness of breath, if the subjective symptom level is "mild," the response action can be set to "wait and see," and if the level is "moderate" or "severe," the response action can be set to "recommend a phone call."
[0024] For example, regarding fever, if the level of vital data (hereinafter referred to as vital level) is "mild," the response action can be set to "wait and see," and if it is "moderate" or "severe," the response action can be set to "recommend a call."
[0025] For example, for dry cough, if the subjective symptom level is "mild," the response action can be set to "wait and see," and if the symptom level is "moderate" or "severe," the response action can be set to "recommend a call."
[0026] The patient behavior management unit 231 can store countermeasures for side effects for which the subjective symptoms or vital data are not the side effects themselves as countermeasures corresponding to patient groups classified based on a single subjective symptom level, a combination of multiple subjective symptom levels, a single vital sign level, a combination of multiple vital sign levels, or a combination of one or more subjective symptom levels and one or more vital sign levels. Figure 5 is a diagram explaining information managed by the patient behavior management unit 231 for side effects for which the subjective symptoms are not the side effects themselves. In this case, the classification of patient groups is determined by applying a predetermined weighting to a single subjective symptom level, a combination of multiple subjective symptom levels, a single vital sign level, a combination of multiple vital sign levels, or a combination of one or more subjective symptom levels and one or more vital sign levels using a unique algorithm.
[0027] As shown in FIG. 5 , for example, for anemia, if the subjective symptom level of “shortness of breath” is “severe” or “moderate,” “telephone recommendation” can be set; if fatigue / lethargy is “severe,” “telephone recommendation” can be set; if palpitations are “severe,” “telephone recommendation” can be set; if shortness of breath is “mild” and “fatigue / lethargy” are “moderate,” “telephone recommendation” can be set; if shortness of breath is “mild” and “palpitations” are “moderate,” “telephone recommendation” can be set; and for other combinations of subjective symptom level and / or vital signs level, “wait and see” can be set as a countermeasure action.
[0028] For example, for interstitial pneumonia, if the vital sign level of "fever" is "severe" or "moderate," "recommend a phone call," if "shortness of breath" is "severe" or "moderate," "recommend a phone call," if "dry cough" is "severe" or "moderate," "recommend a phone call," if "fever" is "mild" and "shortness of breath" is "mild," "recommend a phone call," if "fever" is "mild" and "dry cough" is "mild," "recommend a phone call," if "shortness of breath" is "mild" and "dry cough" is "mild," and for other combinations of subjective symptom level and / or vital sign level, the response action can be set to "wait and see."
[0029] The vital sign storage unit 232 stores vital sign data acquired from a patient. The vital sign data may include, for example, blood pressure (systolic blood pressure and / or diastolic blood pressure), body temperature, etc. The vital sign storage unit 232 may store the vital sign data in association with the patient and the date (or time and date).
[0030] The subjective symptom storage unit 233 stores subjective symptoms acquired from the patient. The subjective symptoms may include fatigue, lethargy, shortness of breath, fever, dry cough, etc. The subjective symptom storage unit 233 may also store the degree of subjective symptoms (hereinafter referred to as the subjective symptom degree). The subjective symptom storage unit 233 may store the subjective symptoms and the subjective symptom degree in association with the patient and the date (or date and time). The subjective symptom degree may be, for example, classified into three levels: mild, moderate, and severe, but is not limited thereto, and may be two levels or four or more levels.
[0031] The acquisition unit 211 acquires vital data and subjective symptoms of the patient. The acquisition unit 211 can receive the vital data and subjective symptoms input by the patient to the patient terminal 1 from the patient terminal 1. The acquisition unit 211 may acquire vital data from a measuring device. The acquisition unit 211 can acquire the subjective symptoms, for example, by displaying the presence or absence of subjective symptoms and the state of the subjective symptoms on the patient terminal 1 and having the patient select one. The acquisition unit 211 can register the acquired vital data in the vital data storage unit 232 and the subjective symptom storage unit 233 in association with the patient and the acquisition date.
[0032] The acquisition unit 211 can also acquire the degree of subjective symptoms. The acquisition unit 211 can acquire the subjective symptom information by displaying information on the presence or absence of subjective symptoms and the degree of subjective symptoms on the patient terminal 1 and allowing the patient to select one of the information.
[0033] The acquisition unit 211 can prepare options according to the severity of each subjective symptom.
[0034] For example, the acquisition unit 211 can provide the patient terminal 1 with the following options regarding the degree of fatigue and lethargy: "Feeling tired and lethargic, but it does not interfere with daily life" as a mild option; "Feeling tired and lethargic, and it interferes with cooking, cleaning, washing, going out, etc." as a medium option; and "Feeling tired and lethargic, and it interferes with eating, changing clothes, using the toilet, bathing, etc." as a severe option, and allow the patient to select one of these.
[0035] For example, the acquisition unit 211 can provide the patient terminal 1 with a mild option regarding the degree of shortness of breath, with "slight shortness of breath" as a medium option, "even slight movement makes me short of breath, which makes it difficult to cook, clean, do laundry, go out, etc." as a medium option, and "even slight movement or even at rest makes it difficult to eat, change clothes, use the toilet, bathe, etc." as a severe option, and allow the patient to select one of these.
[0036] For example, the acquisition unit 211 can provide the patient terminal 1 with a mild option regarding the severity of dry cough: "slight cough"; "coughing, or symptoms interfering with cooking, cleaning, laundry, going out, etc."; and "severe coughing, or symptoms interfering with eating, changing clothes, using the toilet, bathing, etc." as severe options, and allow the patient to select one of these.
[0037] The processing unit 212 acquires a determination result of a countermeasure action that the patient should take in response to the subjective symptoms based on the vital data and the subjective symptoms. The processing unit 212 may include a classification unit 221 and a determination unit 222.
[0038] The classification unit 221 can classify patients into patient groups based on the vital data and subjective symptoms. The classification unit 221 can evaluate the degree of the acquired subjective symptoms and classify patients into patient groups by applying a predetermined weight to the vital data, the evaluated degree, or a combination thereof.
[0039] When the subjective symptom is a side effect itself, the classification unit 221 can determine the patient group based on the degree of the subjective symptom (mild, moderate, severe).
[0040] If the subjective symptoms are not side effects themselves, the classification unit 221 can determine the patient group based on the subjective symptoms and / or vital data.
[0041] The classification unit 221 can classify the vital data into degrees (hereinafter referred to as vital degrees). The vital degrees can 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. For example, the classification unit 221 can classify the vital degree of "high blood pressure" as follows: a systolic blood pressure of 135 or more but less than 160 as mild, a systolic blood pressure of 160 or more but less than 180 as moderate, and a systolic blood pressure of 180 or more as high. For example, the classification unit 221 can classify the vital degree of "fever" as follows: a body temperature of 37 to 37.4 degrees Celsius as mild, a body temperature of 37.5 to 37.9 degrees Celsius as moderate, and a body temperature of 38.0 degrees Celsius or higher as high. The classification unit 212 can also refer to the vital information storage unit 232 and classify the vital degree of "high blood pressure" as mild, moderate, or high if the systolic blood pressure in the above categories continues for a predetermined period of time (e.g., two days, five days, etc.) or more. If the classification unit 212 cannot perform these classifications, it can prevent the vital information from being used in information processing.
[0042] The determination unit 222 determines a countermeasure action according to the classified patient group. The determination unit 222 can determine a countermeasure action for a patient belonging to the classified patient group by referring to the patient behavior management unit 231. When the subjective symptom is a side effect itself, the determination unit 222 can determine a countermeasure action by reading out the subjective symptom and the countermeasure action corresponding to the degree of the subjective symptom from the patient behavior management unit 231.
[0043] The output unit 213 outputs the countermeasure action to the patient terminal 1. The output unit 213 can output the countermeasure action to a predetermined institution that manages the patient. The output unit 213 can transmit information for identifying the patient, subjective symptoms, the degree of subjective symptoms, vital data, and the judgment result of the countermeasure action to the medical institution terminal 3. The output unit 214 may transmit the degree of side effect and / or the degree of vital signs to the medical institution terminal 3 when the degree of side effect and / or the degree of vital signs is equal to or greater than a predetermined threshold (which may differ depending on the side effect).
[0044] <Operation> FIG. 6 is a diagram illustrating the operation of the management server 2.
[0045] 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).
[0046] The management server 2 classifies the patients into patient groups based on the vital information, subjective symptom information, vital level, and subjective symptom level (S303).
[0047] The management server 2 acquires the side effects and the corrective actions corresponding to the patient group from the patient behavior management unit 231 (S304), and transmits the acquired corrective actions to the patient terminal 1 (S305).
[0048] The management server 2 can transmit information for identifying the patient, side effects, coping actions, vital data, subjective symptoms, and the degree of subjective symptoms to the medical institution terminal 3 (S306). Note that the management server 2 may transmit this information only for a specific patient group to the medical institution terminal 3.
[0049] As described above, the side effect management system of this embodiment can estimate side effects based on the patient's vital data and subjective symptoms, and can suggest actions that the patient should take accordingly.
[0050] 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.
[0051] 1 Patient terminal 2 Management server 3 Medical institution terminal
Claims
1. A side effect management system including a patient terminal and a management server, wherein the management server comprises: an acquisition unit that acquires from the patient terminal the patient's vital data and subjective symptoms caused by side effects of an anticancer drug used by the patient; a processing unit that acquires, based on the vital data and the subjective symptoms, a judgment result of the countermeasure action that the patient should take in response to the subjective symptoms; and an output unit that outputs the countermeasure action to the patient terminal.
2. A side effect management system according to claim 1, wherein the acquisition unit acquires the subjective symptoms by displaying the presence or absence of the subjective symptoms and the state of the subjective symptoms on the patient terminal and allowing the patient to select one of the symptoms.
3. A side effect management system according to claim 2, wherein the processing unit comprises: a classification unit that classifies the patient into a predetermined patient group based on the vital data and the subjective symptoms; and a judgment unit that judges the countermeasure action according to the classified patient group.
4. A side effect management system according to claim 3, characterized in that the classification unit evaluates the acquired state of subjective symptoms using a predetermined degree, and classifies the patient into a patient group by applying a predetermined weighting to the vital data, the evaluated degree, or a combination of these.
5. A side effect management system according to claim 3 or 4, further comprising a patient behavior management unit that associates and manages the countermeasure actions for each patient group, and the judgment unit refers to the patient behavior management unit to judge the countermeasure action for the patients belonging to the classified patient group.
6. A side effect management system according to claim 1, wherein the output unit outputs the countermeasure action to a specified institution that manages the patient.
7. A side effect management server configured to be capable of communicating with a patient terminal, comprising: an acquisition unit that acquires from the patient terminal the patient's vital data and subjective symptoms caused by side effects of an anticancer drug used by the patient; a processing unit that acquires a judgment result of the countermeasure action that the patient should take in response to the subjective symptoms based on the vital data and the subjective symptoms; and an output unit that outputs an action based on the judgment result to the patient terminal.
8. A side effect management server program that causes a side effect management server configured to be able to communicate with a patient terminal to function as: an acquisition unit that acquires from the patient terminal the patient's vital data and subjective symptoms caused by side effects of an anticancer drug used by the patient; a processing unit that acquires a judgment result regarding the countermeasure action that the patient should take in response to the subjective symptoms based on the vital data and the subjective symptoms; and an output unit that outputs an action based on the judgment result to the patient terminal.
9. A side effect management method using a patient terminal and a side effect management server, characterized in that the patient terminal acquires from the patient the patient's vital data and subjective symptoms caused by side effects of an anticancer drug used by the patient, and the management server executes the following steps: acquiring the vital data and the subjective symptoms from the patient terminal; performing a process to acquire a judgment result of the countermeasure action that the patient should take in response to the subjective symptoms based on the vital data and the subjective symptoms; and outputting an action based on the judgment result to the patient terminal.
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