JP7017779B2 - Molecular test support device and program - Google Patents

Description

The present invention relates to a molecular test support device and a program.

Pathology is a discipline that connects morphology-based clinical medicine and basic medicine. In recent years, morphological information preparation and organization for using the accumulation results of typical cases for pathological diagnosis and its education are maturing. Based on this pathology, there is a pathological diagnosis in which lesion tissue or cells collected from a patient by surgery or biopsy are observed under a microscope to make a diagnosis.
Conventionally, as a technique for supporting this pathological diagnosis, for example, in Patent Document 1, when there is an image to be inspected, an operator (for example, a pathologist) is made to select an organ to be inspected, and the image to be inspected. On the other hand, a technique for performing image processing by applying a detection algorithm specialized for an organ is disclosed.

Japanese Unexamined Patent Publication No. 2012-73179

By the way, pathological diagnosis has a field called molecular pathological diagnosis. In molecular pathological diagnosis, for example, lesion tissue or cells collected by surgery or biopsy from a cancer patient are observed under a microscope to make a diagnosis, and the protein or genetic abnormality of the cancer cells of the patient is examined. As a result, it is possible to select a drug and a treatment method that are expected to be effective for the patient.
There are many test items in such molecular pathological diagnosis. For this reason, clinical practice guidelines, guides, guidelines, etc. for selecting a test item suitable for diagnosis from among these many test items are presented. For example, there are more than 500 types of clinical practice guidelines, guides, guidelines, etc. regarding tumors, including organ types, tumor types, and treatment policy types. In addition, a plurality of test items are listed in each clinical practice guideline, guideline, guideline, and the like. The pathologist must know the appropriate test items for the diseased tissues and cells of various organs. In order to select an appropriate test item, it takes a lot of time to refer to the clinical practice guidelines, and there are situations in which additional tests are forced due to lack of test items or inappropriate selection. In order to solve such a situation, a technique for reducing the time and effort of a pathologist to select an examination item is desired.

However, in the case of the above-mentioned conventional technique, the diagnosis is supported when the inspection item has already been selected and the inspection target image has been obtained, and the inspection item selection work is not supported. That is, there is a problem that the above-mentioned conventional technique cannot reduce the labor of selecting inspection items.

The present invention has been made to solve the above problems, and an object of the present invention is to provide a molecular test support device and a program capable of reducing the labor of selecting test items.

In one embodiment of the present invention, an option presentation unit that presents a plurality of organ names of the human body to the operator as options, and a diagnosis performed by the operator in response to the organ names being presented as options by the option presentation unit. Immunohistochemical staining of the test specimen based on the selection operation reception unit that accepts the organ name selection operation that selects the organ name of the test specimen and the organ name indicated by the organ name selection operation accepted by the selection operation reception unit. A test item that extracts recommended test items recommended for the test sample to be diagnosed from a plurality of test items stored in advance as test items for molecular tests including diagnosis by diagnosis or genetic analysis. It is a molecular inspection support device including an extraction unit and an inspection item presentation unit that presents the recommended inspection item extracted by the inspection item extraction unit.

Further, in one embodiment of the present invention, in the above-mentioned molecular test support device, the option presentation unit further presents a plurality of classification names of the appearance findings of the test specimen to the operator as options, and the selection operation reception unit. Further accepts the classification name selection operation for selecting the classification name performed by the operator, and the inspection item extraction unit receives the organ name and the classification name selection operation indicated by the organ name selection operation received by the selection operation reception unit. The recommended inspection items are extracted based on the classification name indicated by.

Further, in one embodiment of the present invention, in the above-mentioned molecular inspection support device, the inspection item presenting unit displays a plurality of the recommended inspection items when there are a plurality of the recommended inspection items extracted by the inspection item extraction unit. Display a list.

Further, in one embodiment of the present invention, in the above-mentioned molecular inspection support device, the selection operation reception unit selects an inspection item to be inspected from the recommended inspection items presented by the inspection item presentation unit. Further provided is an order information generation unit that further accepts the target selection operation and generates inspection order information for the inspection item of the inspection order target received by the selection operation reception unit.

Further, in one embodiment of the present invention, in the above-mentioned molecular test support device, the option presentation unit indicates whether the test result of the test item is negative or positive with respect to the test item presented by the test item presentation unit. The option is presented for each inspection item, and the selection operation reception unit further accepts a diagnosis result selection operation for selecting a diagnosis result option presented by the inspection item presentation unit, and the inspection presented by the inspection item presentation unit. Further provided is a diagnosis result information generation unit that generates diagnosis result information based on the item and the diagnosis result selection operation received by the selection operation reception unit.

Further, one embodiment of the present invention further includes a determination guideline presentation unit that presents a determination guideline for the inspection result of the molecular inspection in the above-mentioned molecular inspection support device.

Further, in one embodiment of the present invention, a computer provided with a terminal device presents an option presentation step in which a plurality of organ names of the human body are presented to the operator as options, and an organ name is presented as an option in the option presentation step. The selection operation acceptance step that accepts the organ name selection operation that selects the organ name of the test specimen to be diagnosed performed by the operator according to the situation, and the organ name indicated by the organ name selection operation accepted in the selection operation acceptance step. Based on this, it is recommended to carry out the diagnosis target test sample from among multiple test items stored in advance as test items for molecular tests including diagnosis by immunohistochemical staining of test specimens or diagnosis by genetic analysis. It is a program for executing an inspection item extraction step for extracting recommended inspection items and an inspection item presentation step for presenting the recommended inspection items extracted in the inspection item extraction step.

According to the present invention, it is possible to provide a molecular test support device and a program capable of reducing the labor of selecting test items.

It is a figure which shows an example of the appearance structure of the molecular inspection support apparatus of this embodiment. It is a figure which shows an example of the functional structure of the molecular inspection support apparatus of this embodiment. It is a figure which shows an example of the operation of the molecular inspection support apparatus of this embodiment. It is a figure which shows an example of the option presented by the option presentation part of this embodiment.

[Embodiment]
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a diagram showing an example of the appearance configuration of the molecular inspection support device 10 of the present embodiment. The molecular test support device 10 is a device including a computer such as a mobile terminal such as a smart phone or a tablet, or a desktop type or notebook type personal computer. In the present embodiment, the case where the molecular test support device 10 is a terminal device such as a smart phone will be described as an example.

[Functional configuration of molecular test support device]
FIG. 2 is a diagram showing an example of the functional configuration of the molecular test support device 10 of the present embodiment. The molecular inspection support device 10 includes a control unit 100, a storage unit 200, an operation detection unit TP, a display unit DSP, and a communication unit TC.
The operation detection unit TP includes, for example, a touch panel and the like, and detects the operation of the operator U. In this example, the operator U is a pathologist.
The display unit DSP includes, for example, a liquid crystal display, and displays an image under the control of the control unit 100.
The communication unit TC communicates with an external device by wire or wirelessly.

The storage unit 200 stores information used for the calculation of the control unit 100. Information on the determination guideline GL is stored in advance in the storage unit 200. Here, the determination guideline GL is a selection criterion for a test item of a molecular test and a diagnostic standard for a test result of the test item. The information of the determination guideline GL is created based on the information published in the clinical practice guidelines issued by each medical society, and is stored in the storage unit 200, for example.
The control unit 100 includes, for example, a CPU (Central Processing Unit) and performs various operations. The control unit 100 presents the option presentation unit 110, the selection operation reception unit 120, the inspection item extraction unit 130, the inspection item presentation unit 140, the ordering information generation unit 150, the diagnosis result information generation unit 160, and the determination guideline. A unit 170 is provided as a software function unit.

The option presentation unit 110 presents the plurality of organ names ON of the human body to the operator U as option CHs.
The selection operation reception unit 120 detects the selection operation SO performed by the operator U on the operation detection unit TP. The selection operation SO performed by the operator U on the operation detection unit TP includes an organ name selection operation SO-ON, a classification name selection operation SO-CN, an order target selection operation SO-OT, and a diagnosis result selection operation. There is SO-D.
The selection operation reception unit 120 accepts only the selection operation SO among various operations for the operation detection unit TP. For example, the selection operation reception unit 120 does not accept the character input operation.

When the selection operation reception unit 120 receives the organ name selection operation SO-ON, the inspection item extraction unit 130 extracts the recommended inspection item RDI based on the organ name ON selected by the operator U.
The inspection item presentation unit 140 presents the recommended inspection item RDI extracted by the inspection item extraction unit 130. In this example, the "presentation" is a display to the display unit DSP. In the case of this example, the inspection item presentation unit 140 displays the recommended inspection item RDI on the display unit DSP.

When the selection operation reception unit 120 accepts the order target selection operation SO-OT, the order information generation unit 150 generates the inspection order information TO for the inspection item ODI of the inspection order target selected by the operator U. The order information generation unit 150 outputs the generated inspection order information TO to an external device (for example, an inspection order system; not shown) via the communication unit TC.
When the selection operation reception unit 120 accepts the diagnosis result selection operation SO-D, the diagnosis result information generation unit 160 has the inspection item DI presented by the inspection item presentation unit 140 and the diagnosis result selection received by the selection operation reception unit 120. The diagnosis result information DR is generated based on the operation SO-D. The diagnosis result information generation unit 160 outputs the generated diagnosis result information DR to an external device (for example, a medical certificate creation system; not shown) via the communication unit TC.
The determination guideline presentation unit 170 presents the determination guideline GL of the test result IR of the molecular test.
Next, an example of the operation of the molecular test support device 10 will be described with reference to FIG.

[Operation of molecular test support device]
FIG. 3 is a diagram showing an example of the operation of the molecular inspection support device 10 of the present embodiment.
(Step S10) The option presentation unit 110 presents the option CH to the operator U by displaying the organ name ON and the classification name CN on the display unit DSP. Here, an example of the option CH presented by the option presentation unit 110 will be described with reference to FIG.

FIG. 4 is a diagram showing an example of the option CH presented by the option presentation unit 110 of the present embodiment. In this example, the organ name ON includes head and neck, lung, esophagus, intestinal tract, liver, biliary tract, pancreas, kidney, lower urinary tract, male reproductive organs, female reproductive organs, mammary gland, endocrine system, skin, bone / joint, soft part, Includes muscles, peripheral nerves, central nerves, eyes, oral cavity, blood vessels, heart, and blood.
That is, the option presentation unit 110 presents the plurality of organ names ON of the human body to the operator U as option CHs.

Further, in this example, the classification name CN includes benign, malignant-epithelial, malignant-non-epithelial, and malignant-hematological systems as tumor classification 1 (1 according to Roman numbers in the figure), and tumor classification 2 (malignant-hematological). In the figure, 2) according to Roman numbers include primary, metastatic, recurrent, and ectopic, respectively. The classification name CN is the name of the appearance findings (for example, findings by a microscope or an image) of the inspection specimen SP.
That is, the option presentation unit 110 further presents the plurality of classification name CNs of the appearance findings of the inspection specimen SP to the operator U as the option CH.

The operator U selects the organ name ON of the test specimen TSP to be diagnosed from among the plurality of organ names ON displayed on the display unit DSP. That is, the operator U selects the organ name ON of the test specimen TSP to be diagnosed according to the organ name ON being presented as the option CH by the option presentation unit 110. The selection operation SO for selecting the organ name ON of the test specimen TSP to be diagnosed is referred to as an organ name selection operation SO-ON.
Further, the operator U selects the classification name CN that matches the appearance findings of the test specimen TSP to be diagnosed from the plurality of classification name CNs displayed on the display unit DSP. The selection operation SO for selecting the classification name CN is referred to as a classification name selection operation SO-CN.

(Step S20) Returning to FIG. 3, the selection operation reception unit 120 receives the organ name selection operation SO-ON for selecting the organ name ON of the test specimen TSP to be diagnosed performed by the operator U. Further, the selection operation reception unit 120 further accepts the classification name selection operation SO-CN for selecting the classification name CN performed by the operator U.
The selection operation reception unit 120 may receive the classification name selection operation SO-CN after receiving the organ name selection operation SO-ON.

(Step S30) The inspection item extraction unit 130 extracts the recommended inspection item RDI based on the content indicated by the selection operation SO received in step S20. Here, the inspection item DI is a type of inspection performed on the inspection specimen SP when the inspection specimen SP is subjected to a molecular inspection. This molecular test includes diagnosis by immunohistochemical staining or diagnosis by genetic analysis. Further, the recommended inspection item RDI is an inspection item DI recommended to be carried out for the inspection specimen TSP to be diagnosed by the determination guideline GL among a plurality of types of inspection item DIs. As described above, the determination guideline GL is stored in the storage unit 200. This determination guideline GL includes information in which the recommended test item RDI is associated with the organ name ON and the classification name CN. That is, when the determination guideline GL is searched using the organ name ON or the classification name CN as a search key, the recommended test item RDI associated with the organ name ON or the classification name CN is extracted. The inspection item extraction unit 130 is stored in the storage unit 200 using the organ name ON indicated by the organ name selection operation SO-ON and the classification name CN indicated by the classification name selection operation SO-CN as search keys. Search for the judgment guideline GL. The inspection item extraction unit 130 extracts the inspection item DI obtained as a result of the search as the recommended inspection item RDI.

That is, the test item extraction unit 130 includes a diagnosis by immunohistochemical staining of the test sample SP or a diagnosis by gene analysis based on the organ name ON indicated by the organ name selection operation SO-ON received by the selection operation reception unit 120. From a plurality of test item DIs stored in advance as test item DIs for molecular tests, the recommended test item RDI recommended for the test sample TSP to be diagnosed is extracted.
Further, the inspection item extraction unit 130 extracts the recommended inspection item RDI based on the classification name CN indicated by the classification name selection operation SO-CN received by the selection operation reception unit 120.
The inspection item extraction unit 130 may extract the recommended inspection item RDI by using only the organ name ON as the search key without using the classification name CN as the search key.

(Step S40) The inspection item presentation unit 140 presents the recommended inspection item RDI extracted by the inspection item extraction unit 130 (FIG. 4). Here, there are generally a plurality of recommended test item RDIs corresponding to the test specimen SP of a certain organ. In the example of FIG. 4, among the recommended test item RDI, there are 7 recommended test item RDI by immunohistochemical staining and 3 recommended test item RDI by gene analysis.
The inspection item presentation unit 140 displays a list of a plurality of recommended inspection item RDIs when there are a plurality of recommended inspection item RDIs to be extracted by the inspection item extraction unit 130.
The operator U selects the inspection item DI to be actually inspected, that is, the inspection item ODI to be ordered for inspection, from among these recommended inspection item RDIs. The operation of selecting the inspection item ODI of the inspection order target by the operator U is referred to as an order target selection operation SO-OT.

(Step S50) The selection operation reception unit 120 receives the order target selection operation SO-OT by the operator U. That is, the selection operation reception unit 120 further accepts the order target selection operation SO-OT that selects the inspection item ODI to be inspected from the recommended inspection item RDI presented by the inspection item presentation unit 140.

(Step S60) The order information generation unit 150 generates the inspection order information TO for the inspection item ODI of the inspection order target received by the selection operation reception unit 120. The order information generation unit 150 outputs the generated inspection order information TO to the inspection order system (not shown) via the communication unit TC.
(Step S110) When the inspection ordering system receives the inspection order information TO from the molecular inspection support device 10, the inspection ordering system is directed to an organization that carries out the molecular inspection (for example, a molecular inspection department in a hospital or a company that provides a molecular inspection service). , Notify that there was an order and the inspection item DI of the molecular inspection. Further, the operator U (for example, a pathologist) submits the test specimen TSP to be diagnosed to the tissue to be subjected to the molecular test. When a molecular test is performed on the test specimen TSP in the tissue to be subjected to the molecular test and the test result IR of the molecular test is obtained, the test result IR is notified to the molecular test support device 10. Here, the test result IR does not include the diagnosis result of the doctor.

(Step S70) The option presentation unit 110 presents an option CH for each test item DI as to whether the doctor should determine that the test result IR is negative or positive. In other words, for the inspection item DI presented by the inspection item presentation unit 140, the option presentation unit 110 presents the option CH of whether the inspection result IR of the inspection item DI is negative or positive for each inspection item DI. do. As an example, the option presentation unit 110 displays a “negative” operation icon and a “positive” operation icon for each test item DI included in the test result IR.
Test result Judgment as to whether IR is negative or positive is a diagnosis result by a doctor. That is, the option presentation unit 110 prompts the doctor (for example, a pathologist) who is the operator U to give the diagnosis result to the test result IR that does not include the diagnosis result. The selection operation SO of the diagnosis result option CH by this doctor is referred to as a diagnosis result selection operation SO-D. That is, the selection operation reception unit 120 receives the diagnosis result selection operation SO-D for selecting the option CH of the diagnosis result presented by the inspection item presentation unit 140.

(Step S80) The diagnosis result information generation unit 160 generates the diagnosis result information DR based on the inspection item DI presented by the inspection item presentation unit 140 and the diagnosis result selection operation SO-D received by the selection operation reception unit 120. do. The diagnosis result information generation unit 160 outputs the generated diagnosis result information DR to the medical certificate creation system (not shown).
(Step S210) When the medical certificate creation system receives the diagnosis result information DR from the molecular test support device 10, it generates medical certificate data and ends a series of operations.

[Summary of embodiments]
As described above, the molecular test support device 10 of the present embodiment is based on the organ name ON selected by the organ name selection operation SO-ON by the operator U, and is selected from a plurality of test item DIs for the molecular test. , The recommended test item RDI suitable for the test sample TSP to be diagnosed is extracted.
Therefore, according to the molecular inspection support device 10, it is possible to reduce the labor of selecting the inspection item DI as compared with the case of manually selecting the inspection item DI for the molecular inspection.

Further, the molecular test support device 10 can perform all operations only by the selection operation SO. Here, it is conceivable to set the organ name ON and the classification name CN to a free description type and manually input them using a keyboard or a touch panel. However, when the organ name ON or the classification name CN is manually input by free description, it may not be possible to extract an appropriate recommended test item RDI due to typographical errors or fluctuations in the notation. On the other hand, according to the molecular test support device 10 of the present embodiment, since all the operations are performed only by the selection operation SO, the notation does not fluctuate and typographical errors (misselection) are unlikely to occur. Therefore, the molecular test support device 10 can reduce the frequency of extracting inappropriate recommended test item RDI, so that the labor of selecting the test item DI can be reduced.

Further, the molecular test support device 10 can narrow down the recommended test item RDI by the classification name CN in addition to the organ name ON. As a result, the number of recommended inspection items RDI is reduced as compared with the case where the recommended inspection item RDI is not narrowed down by the classification name CN. Therefore, it is possible to reduce the trouble of narrowing down the inspection item ODI to be ordered by the operator U.

Further, when the molecular inspection support device 10 has a plurality of recommended inspection item RDIs, the molecular inspection support device 10 displays a list of these recommended inspection item RDIs. Therefore, the operator U can easily grasp the recommended inspection item RDI at first glance, and can reduce the trouble of narrowing down the inspection item ODI to be ordered for inspection.

Further, the molecular inspection support device 10 includes an ordering information generation unit 150 that places an order for an inspection item ODI selected by the operator U through a communication line. According to the molecular test support device 10, it is possible to reduce the trouble of ordering the molecular test by the operator U.

Further, the molecular test support device 10 includes a diagnosis result information generation unit 160. The diagnosis result information generation unit 160 provides a user interface that allows the operator U to select whether the test result IR is negative or positive. Even when a test is performed on a plurality of test item DIs, the operator U can generate the diagnosis result information DR only by operating the "negative" operation icon or the "positive" operation icon. .. Therefore, according to the molecular test support device 10, it is possible to reduce the labor of generating the diagnosis result as compared with the case where the diagnosis result is handwritten or created in the free input format.

Further, the molecular test support device 10 includes a determination guideline presentation unit 170, and has a display function of the determination guideline GL. According to the molecular test support device 10, the operator U can reduce the trouble of searching for necessary information from the literature of the clinical practice guideline.

Although the embodiments of the present invention have been described in detail with reference to the drawings, the specific configuration is not limited to this embodiment and can be appropriately modified without departing from the spirit of the present invention. .. The configurations described in the above-described embodiments may be combined.

The device and each part included in the device in the above embodiment may be realized by dedicated hardware, or may be realized by a memory and a microprocessor.

The device and each part of the device are composed of a memory and a CPU (Central Processing Unit), and the function is realized by loading and executing a program for realizing the function of each part of the device and the device in the memory. It may be something to make.

Further, by recording a program for realizing the functions of the device and each part of the device on a computer-readable recording medium, and having the computer system read and execute the program recorded on the recording medium, the control unit is executed. You may perform the processing by each part provided with. The term "computer system" as used herein includes hardware such as an OS and peripheral devices.

Further, the "computer system" includes the homepage providing environment (or display environment) if the WWW system is used.
Further, the "computer-readable recording medium" refers to a portable medium such as a flexible disk, a magneto-optical disk, a ROM, or a CD-ROM, and a storage device such as a hard disk built in a computer system. Further, a "computer-readable recording medium" is a communication line for transmitting a program via a network such as the Internet or a communication line such as a telephone line, and dynamically holds the program for a short period of time. In that case, it also includes those that hold the program for a certain period of time, such as the volatile memory inside the computer system that is the server or client. Further, the above-mentioned program may be for realizing a part of the above-mentioned functions, and may be further realized by combining the above-mentioned functions with a program already recorded in the computer system.

10 ... Molecular test support device, 110 ... Option presentation unit, 120 ... Selection operation reception unit, 130 ... Inspection item extraction unit, 140 ... Inspection item presentation unit, 150 ... Order information generation unit, 160 ... Diagnosis result information generation unit, 170 … Judgment guideline presentation section

Claims (7)

An option presentation unit that presents the names of multiple organs in the human body to the operator as options,
A selection operation reception unit that accepts an organ name selection operation for selecting an organ name of a test sample to be diagnosed by an operator in response to an organ name presented as an option by the option presentation unit.
A plurality of test items stored in advance as test items for molecular tests including diagnosis by immunohistochemical staining of test specimens or diagnosis by genetic analysis based on the organ name indicated by the organ name selection operation received by the selection operation reception unit. An inspection item extraction unit that extracts recommended inspection items recommended for the inspection sample to be diagnosed from the inspection items, and an inspection item extraction unit.
An inspection item presentation unit that presents the recommended inspection item extracted by the inspection item extraction unit, and an inspection item presentation unit.
A molecular test support device equipped with. The option presentation unit further presents a plurality of classification names of the appearance findings of the inspection sample to the operator as options.
The selection operation reception unit further accepts the classification name selection operation for selecting the classification name performed by the operator.
The inspection item extraction unit extracts the recommended inspection item based on the organ name indicated by the organ name selection operation received by the selection operation reception unit and the classification name indicated by the classification name selection operation according to claim 1. The described molecular test support device. The molecular inspection support device according to claim 1 or 2, wherein the inspection item presenting unit displays a list of a plurality of the recommended inspection items when there are a plurality of the recommended inspection items extracted by the inspection item extraction unit. The selection operation reception unit further accepts an order target selection operation for selecting an inspection item to be inspected from the recommended inspection items presented by the inspection item presentation unit.
The molecular inspection support device according to any one of claims 1 to 3, further comprising an order information generation unit for generating inspection order information for inspection items subject to inspection order received by the selection operation reception unit. The option presentation unit presents options for each test item whether the test result of the test item is negative or positive for the test item presented by the test item presentation unit.
The selection operation reception unit further accepts a diagnosis result selection operation for selecting a diagnosis result option presented by the inspection item presentation unit.
Claims 1 to 4 further include a diagnosis result information generation unit that generates diagnosis result information based on the inspection items presented by the inspection item presentation unit and the diagnosis result selection operation received by the selection operation reception unit. The molecular test support device according to any one of the above. The molecular test support device according to any one of claims 1 to 5, further comprising a judgment guideline presentation unit that presents a judgment guideline for the test result of the molecular test. For the computer installed in the terminal device,
An option presentation step that presents the names of multiple organs of the human body to the operator as options,
In the option presentation step, the selection operation acceptance step for accepting the organ name selection operation for selecting the organ name of the test sample to be diagnosed performed by the operator in response to the organ name being presented as an option, and the selection operation acceptance step.
A plurality of test items stored in advance as test items for molecular tests including diagnosis by immunohistochemical staining of test specimens or diagnosis by genetic analysis based on the organ name indicated by the organ name selection operation received in the selection operation reception step. The inspection item extraction step for extracting the recommended inspection items recommended for the inspection sample to be diagnosed from the inspection items of
An inspection item presentation step that presents the recommended inspection item extracted in the inspection item extraction step, and an inspection item presentation step.
A program to execute.

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