Information processing system, information processing apparatus, information processing method, and program

Abstract

To precisely evaluate adverse events.SOLUTION: The information processing system includes a clinical laboratory test value extraction unit that extracts a clinical laboratory test value for a drug, a specification unit that specifies a worst value of the clinical laboratory test value or an average value of the clinical laboratory test value for each clinical laboratory test item during a prescription period of the drug, a grade determination unit that determines one of a plurality of grades based on the worst value of the clinical laboratory test value or the average value of the clinical laboratory test value, and an evaluation unit that evaluates whether or not there is an adverse event according to the one of the plurality of grades.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an information processing system, an information processing device, an information processing method, and a program. [Background technology]

[0002] Adverse events such as side reactions and adverse effects caused by pharmaceuticals are evaluated in clinical trials conducted by public institutions.

[0003] For example, Non-Patent Document 1 discloses the "ICH International Medical Terminology Japanese Edition (MedDRA / J)," a glossary that adds Japanese to the English version of MedDRA, which is widely used in drug regulation in Japan.

[0004] Furthermore, for example, Non-Patent Document 2 discloses the Common Terminology Criteria for Adverse Events (CTCAE). [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] "MedDRA (Medical Dictionary for Regulatory Activities)", [online], Japanese Maintenance Organization, [searched July 1, 2024], Internet<URL: https: / / www.jmo.pmrj.jp / > [Non-patent document 2] "Common Terminology Criteria for Adverse Events (CTCAE) version 5.0", [online], JCOG (Japan Clinical Oncology Group), [searched July 1, 2024], Internet<URL: https: / / jcog.jp / doctor / tool / ctcaev5 / > Summary of the Invention [Problem to be solved by the invention]

[0006] Adverse events are often assessed by the name of the injury or illness. This name is determined and recorded by the doctor, which can result in the adverse events being underestimated. Thus, there was a problem in that adverse events could not be evaluated precisely.

[0007] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an information processing system, an information processing device, an information processing method, and a program that are capable of precisely evaluating adverse events. [Means for solving the problem]

[0008] In order to solve the above-mentioned problems, one aspect of the present invention is an information processing system comprising: a clinical test value extraction unit that extracts clinical test values ​​for a pharmaceutical; an identification unit that identifies the worst value of the clinical test value or the average value of the clinical test value for each clinical test item during the prescription period of the pharmaceutical; a grade determination unit that determines which of multiple grades the pharmaceutical falls under based on the worst value of the clinical test value or the average value of the clinical test value; and an evaluation unit that evaluates whether or not the event is an adverse event depending on which of the multiple grades the pharmaceutical falls under.

[0009] Another aspect of the present invention is an information processing device that includes a clinical test value extraction unit that extracts clinical test values ​​for a pharmaceutical product, an identification unit that identifies the worst value of the clinical test value or the average value of the clinical test value for each clinical test item during the prescription period of the pharmaceutical product, a grade determination unit that determines which of multiple grades the clinical test value belongs to based on the worst value of the clinical test value or the average value of the clinical test value, and an evaluation unit that evaluates whether or not the event is an adverse event depending on which of the multiple grades the event belongs to.

[0010] Another aspect of the present invention is an information processing method executed by a computer, comprising: a clinical test value extraction step of extracting clinical test values ​​for a drug; an identification step of identifying the worst value of the clinical test value or the average value of the clinical test value for each clinical test item during the prescription period of the drug; a grade determination step of determining which of multiple grades the event belongs to based on the worst value of the clinical test value or the average value of the clinical test value; and an evaluation step of evaluating whether or not the event is an adverse event depending on which of the multiple grades the event belongs to.

[0011] Another aspect of the present invention is a program that causes a computer to execute the following steps: a clinical test value extraction step of extracting clinical test values ​​for a drug; an identification step of identifying the worst clinical test value or the average clinical test value for each clinical test item during the prescription period of the drug; a grade determination step of determining which of multiple grades the drug belongs to based on the worst clinical test value or the average clinical test value; and an evaluation step of evaluating whether the drug belongs to an adverse event depending on which of the multiple grades the drug belongs to. [Effects of the Invention]

[0012] As described above, according to the present invention, adverse events can be precisely evaluated. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a system configuration diagram showing an example of the configuration of an information processing system SYS according to a first embodiment of the present invention. [Figure 2] 1 is a block diagram showing an example of the configuration of an information processing device 100 according to the present embodiment. [Figure 3] FIG. 10 is a diagram showing an example of a grade determination criterion in the information processing system SYS according to the present embodiment. [Figure 4] 1 is a block diagram showing an example of the configuration of an electronic medical record information management device 200 according to this embodiment. [Figure 5] 10 is a flowchart showing an example of information processing in the information processing system SYS according to the present embodiment. [Figure 6] 10A and 10B are diagrams showing an example of an output image in the information processing system SYS according to the present embodiment. [Figure 7] 1 is a hardware configuration diagram showing an example of a hardware configuration of an information processing device 100 according to the present embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0014] (First embodiment) A first embodiment of the present invention will be described below with reference to the drawings.

[0015] The information processing system SYS is a system that acquires temperature measurement information as tag information from a temperature-measuring tag attached to a prescription drug, acquires prescription drug information, acquires detailed drug information for the prescription drug based on the prescription drug information, and determines the management status of the prescription drug based on the tag information and the detailed drug information associated with the tag information. The information processing system SYS will be described in more detail.

[0016] FIG. 1 is a system configuration diagram showing an example of the configuration of an information processing system SYS according to the first embodiment of the present invention. The information processing system SYS includes an information processing device 100 and an electronic medical record information management device 200. The information processing device 100 and the electronic medical record information management device 200 are connected to each other via a network NW so that they can communicate with each other.

[0017] The information processing device 100 is a server device that evaluates adverse events based on clinical test values ​​for pharmaceuticals. Pharmaceuticals include approved drugs, unapproved drugs, biological products, vaccines, drug-medical device combination products, and supplements. Adverse events are any undesirable or unintended signs, symptoms, illnesses, etc. caused by side reactions or adverse effects of pharmaceuticals.

[0018] The information processing device 100 extracts clinical test value information for pharmaceuticals from the electronic medical record information managed by the electronic medical record information management device 200. The clinical test value information is information on clinical test values ​​for each test item, such as blood tests and urine tests. The information processing device 100 identifies the worst clinical test value or the average clinical test value for the clinical test item during the prescription period of the pharmaceutical. The information processing device 100 determines which of multiple grades the event falls under based on the worst clinical test value or the average clinical test value. The information processing device 100 evaluates whether the event is an adverse event or not depending on which of the multiple grades the event falls under.

[0019] The electronic medical record information management device 200 is a server device that manages electronic medical record information. The electronic medical record information is managed for each patient and includes at least the administered medicines and the clinical test values ​​for each clinical test item before and after the medication period (prescription period). The electronic medical record information management device 200 outputs the clinical test value information included in the electronic medical record information to the information processing device 100 in response to a request from the information processing device 100.

[0020] Next, the configuration of the information processing device 100 will be described in detail.

[0021] FIG. 2 is a block diagram showing an example of the configuration of the information processing device 100 according to this embodiment. The information processing device 100 includes a communication unit 110, an input unit 120, an output unit 130, a control unit 140, and a storage unit 150.

[0022] The communication unit 110 has a function of communicating with other devices in the information processing system SYS, such as the electronic medical record information management device 200, via a network. The communication unit 110 outputs various information and signals received from other devices to the control unit 140. The communication unit 110 also transmits various information and signals output from the control unit 140 to other devices.

[0023] The input unit 120 is an input device such as a mouse, a keyboard, a touch panel, a power button, and a setting button.

[0024] The output unit 130 is an output device such as a display unit, a speaker, or the like.

[0025] The control unit 140 has a function of controlling the information processing device 100 . The control unit 140 includes a laboratory test value extraction unit 141 , an identification unit 142 , a grade determination unit 143 , an adverse event determination unit 144 , and a statistics unit 145 .

[0026] The laboratory test value extraction unit 141 sends a request for electronic medical record information to the electronic medical record information management device 200 via the communication unit 110 and the network, and extracts the drug administration period and laboratory test values ​​for the administration period from the electronic medical record information. The administration period is the period from the administration start date to a predetermined period after the administration end date. The predetermined period is, for example, 30 days.

[0027] The predetermined period may be 60 days or may be set based on the half-life of the drug in the blood.

[0028] The identification unit 142 identifies the worst or average clinical test value for each clinical test item during the prescription period of the drug. The prescription period is the period from the day after the medication start date to a predetermined period after the medication ends. The worst clinical test value for each clinical test item is the highest or lowest clinical test value determined for each clinical test item. For example, in the case of white blood cell count, platelet count, anemia (hemoglobin count or hemoglobin concentration), neutrophil count, etc., the lowest clinical test value during the prescription period is the worst value. Furthermore, for example, in the case of aspartate aminotransferase, alanine aminotransferase, etc., the highest clinical test value during the prescription period is the worst value.

[0029] In addition, if there are multiple types of units for clinical test values ​​for each clinical test item, i.e., if the units are not unified, the identification unit 142 may unify the units by converting the units into one of the units for each clinical test item.

[0030] The grade determination unit 143 determines which of multiple grades the AE is based on the worst or average clinical test value. Here, the multiple grades are, for example, five grades based on CTCAE v5.0: Grade 1, Grade 2, Grade 3, Grade 4, and Grade 5. Grade 1 corresponds to mild or no symptoms, mild symptoms, clinical or laboratory findings only, or no treatment required. Grade 2 corresponds to moderate symptoms, or requiring minimal / local / non-invasive treatment, or age-appropriate limitations in activities of daily living other than self-care. Grade 3 corresponds to severe or medically significant but not immediately life-threatening symptoms, or requiring hospitalization or prolonged hospitalization, or limitations in activities of daily living other than self-care. Grade 4 corresponds to life-threatening symptoms or requiring emergency treatment. Grade 5 corresponds to death due to AE.

[0031] Here, an AE is any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease observed during a treatment or procedure. AEs here are not necessarily related to the treatment or procedure. That is, AEs include both those that are determined to be causally related and those that are not. AEs are defined to uniquely represent specific medical events and are used in medical records, reports, and scientific analyses.

[0032] The grade determination unit 143 determines which of a plurality of grades the clinical test result falls into depending on which of the criteria the worst clinical test result or the average clinical test result falls into. The criteria will be described with reference to FIG.

[0033] FIG. 3 is a diagram showing an example of the grade determination criteria in the information processing system SYS according to this embodiment. As shown in the figure, the judgment criteria are criteria that correspond to the CTCAEv5.0 Term Japanese, test value items (clinical test value items), standard values ​​for Grade 1 or higher, standard values ​​for Grade 3 or higher, units of the test value items, and notes for each CTCAEv5.0 MedDRAv20.1 Code.

[0034] Here, test value items with the remarks "male" and "female" indicate the reference values ​​for males and females, respectively. The remarks "baseline" and "B" are values ​​set based on the amount of change in laboratory test values ​​from before the evaluation period. The laboratory test values ​​from before the evaluation period are, for example, the amount of change from the laboratory test values ​​on the first day of administration of a drug.

[0035] The illustrated criteria are merely an example and are not limiting, and any criteria may be used as long as each clinical test item is associated with a criteria value for each grade.

[0036] 2, the adverse event determination unit 144 determines whether or not an adverse event has occurred depending on which of a plurality of grades the worst or average clinical test value is. For example, the adverse event determination unit 144 determines that an adverse event has occurred if the grade is Grade 2 or higher, i.e., Grade 2, Grade 3, Grade 4, or Grade 5.

[0037] The statistical unit 145 performs statistical processing for each adverse event to generate statistical information. Specifically, the statistical unit 145 calculates the number of people who have experienced the adverse event and the ratio of the number of people who have experienced the adverse event to the number of clinical tests for each grade, and generates an output image in the form of a graph such as a pie chart or a bar graph, or a table.

[0038] The storage unit 150 stores a grade determination result 151, an adverse event determination result 152, and statistical information 153.

[0039] The grade determination result 151 is the result of the grade determination by the grade determination unit 143 .

[0040] The adverse event determination result 152 is a determination result of whether or not an adverse event has occurred by the adverse event determination unit 144. The adverse event determination result 152 is associated with the grade determination result 151.

[0041] The statistical information 153 is generated by the statistics unit 145. The statistical information 153 is associated with the grade determination result 151.

[0042] Next, the electronic medical record information management device 200 will be described.

[0043] FIG. 4 is a block diagram showing an example of the configuration of the electronic medical record information management device 200 according to this embodiment. The electronic medical record information management device 200 includes a communication unit 210, an input unit 220, an output unit 230, a control unit 240, and a storage unit 250.

[0044] The communication unit 210 has a function of communicating with other devices in the information processing system SYS, for example, the information processing device 100, via a network. The communication unit 210 outputs various information and various signals received from the other devices to the control unit 240. The communication unit 210 also transmits various information and various signals output from the control unit 240 to the other devices.

[0045] The input unit 220 is an input device such as a mouse, a keyboard, a touch panel, a power button, and a setting button.

[0046] The output unit 230 is an output device such as a display unit, a speaker, or the like.

[0047] The control unit 240 has a function of controlling the electronic medical record information management device 200.

[0048] The storage unit 250 stores electronic medical record information 251. The electronic medical record information 251 is electronic medical record information for each patient.

[0049] Next, the flow of information processing will be described.

[0050] FIG. 6 is a flowchart showing an example of information processing in the information processing system SYS according to this embodiment.

[0051] In step S101, the information processing device 100 extracts clinical test value information from the electronic medical record information managed by the electronic medical record information management device 200. Thereafter, the information processing device 100 executes the process of step S102.

[0052] In step S102, the information processing device 100 identifies the worst clinical test value or the average clinical test value during the prescription period for each clinical test item. Thereafter, the information processing device 100 executes the process of step S103.

[0053] In step S103, the information processing device 100 determines which grade of the worst or average clinical test value during the prescription period belongs to based on the worst or average clinical test value for each clinical test item and the criteria. Next, the information processing device 100 executes the process of step S104.

[0054] In step S104, the information processing device 100 determines whether the grade corresponding to the worst clinical test value or the average clinical test value during the prescription period is Grade 1. If the grade corresponding to the worst clinical test value or the average clinical test value during the prescription period is Grade 1 (YES in step S104), the information processing device 100 determines that it is not an adverse event and terminates the processing in Fig. 5. On the other hand, if the grade corresponding to the worst clinical test value or the average clinical test value during the prescription period is not Grade 1 (NO in step S104), the information processing device 100 executes the processing in step S105.

[0055] In step S105, the information processing device 100 determines that the event is an adverse event. The information processing device 100 stores the adverse event and the clinical test items determined to be an adverse event as adverse event determination results in the storage unit 150. The information processing system SYS ends the processing related to FIG. 5.

[0056] Next, the output image will be described.

[0057] FIG. 6 is a diagram showing an example of an output image in the information processing system SYS according to this embodiment. The example shown is an output image in which the number of people (number of patients) who experienced adverse events and the ratio of the number of people who experienced the adverse events to the number of clinical tests for each grade are output in table format for each adverse event when rituximab and belimumab are administered for systemic lupus erythematosus (SLE), a designated intractable disease. The output image also includes the number of patients who experienced each adverse event and the ratio of the number of patients to the number of clinical tests for each grade for each adverse event in the RTX group (n=21) and the BEL group (n=43). The RTX group (n=21) is an example of a group of subjects diagnosed with systemic lupus erythematosus who were administered rituximab (RTX), where n represents the number of subjects. The BEL group (n=43) is an example of subjects diagnosed with total visible lupus erythematosus who were administered belimumab (BEL).

[0058] The output image may be in a graph format instead of a table format.

[0059] Next, the hardware configuration of the information processing device 100 will be described.

[0060] FIG. 7 is a hardware configuration diagram showing an example of the hardware configuration of the information processing device 100 according to this embodiment. The information processing device 100 is composed of a CPU 101, a drive unit 102, a storage medium 103, an input unit 104, an output unit 105, a ROM (Read Only Memory) 106, a RAM (Random Access Memory) 107, an auxiliary storage unit 108, and an interface unit 109.

[0061] The CPU 101, drive unit 102, input unit 104, output unit 105, ROM 106, RAM 107, auxiliary storage unit 108, and interface unit 109 are interconnected via a bus. The CPU 101 referred to here refers to a processor in general, and includes not only a device called a CPU in the narrow sense, but also, for example, a GPU, a DSP, etc. Furthermore, the CPU 101 referred to here is not limited to being realized by a single processor, but may be realized by combining multiple processors of the same or different types.

[0062] The CPU 101 controls the electronic medical record information management device 200 by reading and executing programs stored in the auxiliary storage unit 108, ROM 106, and RAM 107, and by reading various data stored in the auxiliary storage unit 108, ROM 106, and RAM 107 and writing the various data to the auxiliary storage unit 108 and RAM 107. The CPU 101 also reads various data stored in the storage medium 103 via the drive unit 102 and writes the various data to the storage medium 103. The storage medium 103 is a portable storage medium such as a magneto-optical disk, a flexible disk, or a flash memory, and stores various data. The drive unit 102 is a device that reads and writes data from and to a storage medium 103 such as an optical disk drive, a flexible disk drive, or a flash memory.

[0063] The input unit 104 is an input device such as a mouse, a keyboard, a touch panel, a power button, a setting button, and an infrared receiver. The output unit 105 is an output device such as a display unit, a speaker, or the like. The ROM 106 and RAM 107 store programs for operating the various functional units of the information processing device 100 and various data.

[0064] The auxiliary storage unit 108 is a hard disk drive, a flash memory, or the like, and stores programs for operating each functional unit of the information processing device 100 and various data. The interface unit 109 has a communication interface and is connected to the network NW or other devices in the information processing system SYS by wire or wirelessly.

[0065] For example, the communication unit 110 in the functional configuration of the information processing device 100 in FIG. 2 described above corresponds to the interface unit 109 in FIG. 7, the input unit 120 in FIG. 2 corresponds to the input unit 104 in FIG. 7, the output unit 130 in FIG. 2 corresponds to the output unit 105 in FIG. 7, the control unit 140 in FIG. 2 corresponds to the CPU 101 in FIG. 7, and the memory unit 150 in FIG. 2 corresponds to the memory medium 103, ROM 106, RAM 107, and auxiliary memory unit 108 in FIG. 7.

[0066] As described above, the information processing system SYS according to this embodiment includes a clinical test value extraction unit 141 that extracts clinical test values ​​for pharmaceuticals, an identification unit 142 that identifies the worst clinical test value for each clinical test item during the prescription period of the pharmaceutical or the average value of the clinical test values, a grade determination unit 143 that determines which of multiple grades the pharmaceutical falls under based on the worst clinical test value or the average value of the clinical test values, and an evaluation unit (adverse event determination unit 144) that evaluates whether or not the event is an adverse event depending on which of the multiple grades the pharmaceutical falls under.

[0067] In this way, adverse events can be quantitatively evaluated using the laboratory test values ​​in the electronic medical record information, allowing for precise evaluation of adverse events and accurate assessment of the incidence rate of adverse events.

[0068] The embodiments of the present invention have been described in detail above with reference to the drawings, but the specific configuration is not limited to that described above, and various design changes can be made within the scope of the gist of the present invention.

[0069] The program running on the information processing device 100 according to one aspect of the present invention may be a program that controls one or more processors, such as a central processing unit (CPU), to implement the functions described in the above-described embodiments and modifications of the present invention (a program that causes a computer to function). The term "computer" as used herein also includes quantum computers. Information handled by each of these devices may be temporarily stored in random access memory (RAM) during processing, and then stored in various storage devices, such as flash memory and hard disk drives (HDDs), and may be read, modified, or written by the CPU or the like as needed.

[0070] Note that part or all of the information processing device 100 in each of the above-described embodiments and modifications may be realized by a computer having one or more processors. In this case, the information processing device 100 may be realized by recording a program for realizing the control function on a computer-readable recording medium, and reading and executing the program recorded on the recording medium into a computer system.

[0071] The term "computer system" used here refers to a computer system built into the information processing device 100, and includes hardware such as an OS and peripheral devices. The term "computer-readable recording medium" refers to portable media such as flexible disks, optical magnetic disks, ROMs, and CD-ROMs, as well as storage devices such as hard disks built into the computer system.

[0072] Furthermore, the term "computer-readable recording medium" may include a medium that dynamically stores a program for a short period of time, such as a communication line when transmitting a program via a network such as the Internet or a communication line such as a telephone line, or a medium that stores a program for a fixed period of time, such as volatile memory within a computer system that serves as a server or client in such a case. The program may also be one that realizes part of the above-mentioned functions, or one that can realize the above-mentioned functions in combination with a program already stored in the computer system.

[0073] Furthermore, part or all of the information processing device 100 in each of the above-described embodiments and modifications may be realized as an LSI, which is typically an integrated circuit, or as a chipset. Furthermore, each functional block of the information processing device 100 in each of the above-described embodiments and modifications may be individually formed into a chip, or part or all of the functional blocks may be integrated into a chip. Furthermore, the integrated circuit method is not limited to LSI, and may be realized using a dedicated circuit and / or a general-purpose processor. Furthermore, if an integrated circuit technology that replaces LSI emerges due to advances in semiconductor technology, it is also possible to use an integrated circuit based on that technology.

[0074] While the embodiments and modifications have been described above in detail with reference to the drawings as one aspect of the present invention, the specific configuration is not limited to the embodiments and modifications, and design changes within the scope of the present invention are also included. Furthermore, various modifications of one aspect of the present invention are possible within the scope of the claims, and embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the present invention. Furthermore, configurations in which elements described in the above embodiments and modifications are substituted with elements that achieve the same effect are also included. [Explanation of symbols]

[0075] 100 Information processing device 101 CPU 102 Drive section 103 Storage medium 104 Input section 105 Output section 106 ROM 107 RAM 108 Auxiliary storage 109 Interface section 110 Communications Department 120 Input section 130 Output section 140 Control Unit 141 Clinical Test Value Extraction Unit 142 Specific part 143 Grade Judging Department 144 Adverse Event Assessment Unit 145 Statistics Department 150 Storage section 151 Grade Determination Results 152 Adverse Event Assessment Results 153 Statistics 200 Electronic medical record information management device 210 Communications Department 220 Input section 230 Output section 240 Control Unit 250 Storage section 251 Electronic Medical Record Information NW Network SYS Information Processing System

Claims

1. a clinical test value extraction unit that extracts clinical test values ​​for pharmaceuticals; an identification unit that identifies the worst value or the average value of the clinical test values ​​for each clinical test item during the prescription period of the drug; a grade determination unit that determines which grade of a plurality of grades the clinical test value belongs to based on the worst value of the clinical test value or the average value of the clinical test value; an evaluation unit that evaluates whether or not an event is an adverse event depending on which of the multiple grades the event is; An information processing system comprising:

2. The prescription period is a predetermined period from the day after the start date of administration of the drug to the end date of administration of the drug, The information processing system according to claim 1 .

3. a clinical test value extraction unit that extracts clinical test values ​​for pharmaceuticals; an identification unit that identifies the worst value or the average value of the clinical test values ​​for each clinical test item during the prescription period of the drug; a grade determination unit that determines which grade of a plurality of grades the clinical test value belongs to based on the worst value of the clinical test value or the average value of the clinical test value; an evaluation unit that evaluates whether or not an event is an adverse event depending on which of the multiple grades the event is; An information processing device comprising:

4. 1. A computer-implemented information processing method, comprising: A clinical test value extraction step of extracting clinical test values ​​for the drug; a specifying step of specifying the worst value or the average value of the clinical test value for each clinical test item during the prescription period of the drug; a grading step of determining which of a plurality of grades the patient belongs to based on the worst value of the clinical test values ​​or the average value of the clinical test values; an evaluation step of evaluating whether or not the event is an adverse event depending on which of the multiple grades the event is; An information processing method comprising:

5. On the computer, A clinical test value extraction step of extracting clinical test values ​​for the drug; a specifying step of specifying the worst value or the average value of the clinical test value for each clinical test item during the prescription period of the drug; a grading step of determining which of a plurality of grades the patient belongs to based on the worst value of the clinical test values ​​or the average value of the clinical test values; an evaluation step of evaluating whether or not the event is an adverse event depending on which of the multiple grades the event is; A program to execute.

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