JP2009005940A - Medical checkup information management system, and management method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical checkup information management system, and a medical checkup information management method, efficiently conducting medical checkup to an examinee, and decreasing cost on diagnosis. <P>SOLUTION: The management system 1A is provided with a medical checkup information database 21 for storing primary medical checkup information concerning primary medical checkup including diagnostic imaging, and preliminary medical checkup information concerning preliminary medical checkup including diagnostic screening for each examinee, and a management determination part 15 for managing practice of medical checkup to the examinee based on the medical checkup information. The management determination part 15 comprises a determination information memory part 17 for storing a plurality of kinds of determination methods to the preliminary medical checkup to which determination is conducted concerning practice of the primary medical checkup, and selection conditions for selecting a determination method to be applied to the examinee, and a determination method selecting part 18 for referring to at least either the medical checkup information data of the examinee or medical checkup accumulated data, and select a determination method based on the selection conditions. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a screening information management system and a screening information management method for managing screening information about the implementation status of screening for a subject.

  In positron emission tomography (PET), a substance labeled with a radioisotope (RI) that emits positrons (positrons) to a subject is introduced as a tracer, and the positrons emitted from the RI substance are usually In this method, information about a subject is acquired by measuring a pair of γ-rays generated by pair annihilation with electrons in a substance.

In a PET apparatus using such a method, a tracer containing an RI substance is administered to a subject, a pair of γ rays from the RI substance is measured by the above-described method, and the distribution of the RI substance in the body is measured. As a result, a tomographic image of a subject obtained by imaging and quantifying physiological and biochemical information in vivo is obtained, and image diagnosis such as cancer screening or brain examination is performed with reference to the tomographic image. It is possible. In addition to PET examination, CT examination, MRI examination, and the like have been put to practical use as methods for obtaining tomographic images and diagnosing a subject (see Patent Documents 1 and 2).
JP-A-6-347555 JP 2002-136508 A

  According to the image diagnosis such as the above-described PET inspection, CT inspection, and MRI inspection, it is possible to obtain the necessary information by non-invasively acquiring the internal information of the subject. However, in the diagnosis using these tomographic images, there are problems that the apparatus is large and the cost of one diagnosis is high. Such expensive diagnosis costs are particularly problematic when the examination is repeated periodically.

  The present invention has been made to solve the above problems, and provides a screening information management system and a screening information management method capable of efficiently performing screening of a subject and reducing the diagnostic cost. The purpose is to provide.

  In order to achieve such an object, a screening information management system according to the present invention is a screening information management system that manages screening information of a subject, and (1) diagnostic imaging by acquiring a tomographic image of a subject and making a diagnosis. A screening information database that stores, for each subject, screening information data that includes preliminary screening information about primary screening including primary screening and pre-screening including screening diagnosis performed prior to image diagnosis, including (2) preliminary Management judgment means for managing the implementation of the examination for the subject based on the examination information and the main examination information, and (3) the management judgment means is a judgment level with respect to the preliminary examination for making a judgment about the implementation of the main examination. Information storage means storing selection conditions for selecting a plurality of types of determination methods having different values and a determination method to be applied to the subject from the plurality of types of determination methods (4) Refer to at least one of the examination information data of the subject or the examination accumulated data in which the data of a plurality of subjects are accumulated with respect to the examination. And determining method selecting means for selecting a determining method to be applied to the subject.

  In addition, the screening information management method according to the present invention is a screening information management method for managing screening information of a subject, and (a) main screening for the screening including image diagnosis for acquiring a diagnosis by obtaining a tomographic image of the subject. Preliminary screening information about preliminary screening including screening information performed prior to image diagnosis and image diagnosis is input, and screening information data including preliminary screening information and main screening information is stored for each subject in the screening information database An input step; and (b) a management judgment step for managing the implementation of the screening for the subject based on the preliminary screening information and the main screening information. (C) the management determination step makes a determination on the implementation of the main screening. Multiple types of judgment methods with different judgment levels prepared in advance for pre-examination, and judgment methods applied to subjects from multiple types of judgment methods Using the selection condition for selecting, (d) referring to at least one of the examination information data of the subject, or the examination accumulation data in which the data of a plurality of subjects are accumulated with respect to the examination, It has the determination method selection step which selects the determination method applied to a test subject among several types of determination methods.

  In the screening information management system and management method described above, the screening performed on the subject is performed by a simpler method than the screening and the main screening including image diagnosis for obtaining a diagnosis by obtaining a tomographic image. Screening is performed in combination with preliminary screening including diagnosis (hereinafter referred to as screening diagnosis for image diagnosis), and screening information data including preliminary screening information and main screening information is stored in the screening information database for each subject, and screening for the subject is performed. Managing the implementation of This makes it possible to efficiently examine the subject and reduce the diagnostic cost.

  Further, in such a configuration, two or more types of determination methods having different determination levels are prepared for preliminary screening used for determining whether or not to perform the main screening. Then, the screening data including at least one of the screening information data and the screening accumulated data is referred to, and the determination method in the preliminary screening to be applied to the screening subject is selected based on a predetermined selection condition. Thereby, it is possible to accurately evaluate the necessity of performing the main screening for the subject, and to reliably perform the determination on the screening.

  Here, in addition to the above-described screening information database, the management system performs the screening diagnosis performed prior to the image diagnosis and the main screening information about the main screening including the image diagnosis for obtaining a diagnosis by obtaining a tomographic image of the subject. It is preferable to provide a screening information input means used for inputting preliminary screening information for the preliminary screening including.

  In addition, the management system includes a screening execution determination unit that makes a determination regarding the implementation of the main screening based on the result of the preliminary screening performed by the management determination unit applying the determination method selected by the determination method selection unit. It is preferable. Similarly, the management method includes a screening execution determination step in which the management determination step performs a determination on the implementation of the main screening based on the result of the preliminary screening performed by applying the determination method selected in the determination method selection step. It is preferable to have. Thereby, implementation of the medical examination with respect to a test subject can be managed suitably.

  For judgment methods with different judgment levels prepared for pre-examination, multiple types of pre-examination judgment methods determine positive or negative by applying a cutoff value α set with a focus on the sensitivity of the examination. A first determination method for determining by screening diagnosis, and a second determination method for determining by screening diagnosis that determines positive or negative by applying a cutoff value β set by paying attention to the specificity of the test It is preferable.

  In addition, multiple types of judgment methods in preliminary screening are set by focusing on screening diagnostics that apply a cut-off value α that focuses on the sensitivity of the test to determine positive or negative, and on the specificity of the test. It is preferable to include a third determination method in which determination is performed by combining screening diagnosis that determines positive or negative by applying the cut-off value β.

  In addition, regarding the selection of the judgment method in the preliminary examination for the subject, the management system selects the judgment method to be applied to the subject with reference to the previous examination result information extracted from the examination information data by the judgment method selection means. The structure to be used can be used. Similarly, the management method can use a configuration in which the determination method selection step selects a determination method to be applied to the subject with reference to the previous screening result information extracted from the screening information data.

  In addition, the management system can use a configuration in which the determination method selection unit selects a determination method to be applied to the subject with reference to the estimation information of the disease risk derived from the examination accumulated data. Similarly, the management method can use a configuration in which the determination method selection step selects a determination method to be applied to the subject with reference to the estimation information of the disease risk derived from the examination accumulated data.

  As for the details of the specific screening for the subject, the preliminary screening preferably includes at least one of a urine test and a blood test as a screening diagnosis. By carrying out such an examination as a preliminary examination prior to the main examination, it is possible to suitably determine whether or not the main examination is necessary. In addition, this examination preferably includes at least one of PET examination, CT examination, and MRI examination as image diagnosis.

  According to the screening information management system and management method of the present invention, for screening performed on a subject, screening is performed in combination with main screening including image diagnosis and preliminary screening including screening diagnosis, and preliminary screening is performed. Prepare multiple types of judgment methods with different judgment levels, refer to at least one of screening information data or screening accumulation data, and select a judgment method in preliminary screening to be applied to the subject based on a predetermined selection condition Thus, it is possible to efficiently and surely examine the subject and reduce the diagnostic cost.

  DESCRIPTION OF EMBODIMENTS Hereinafter, preferred embodiments of a screening information management system and a screening information management method according to the present invention will be described in detail with reference to the drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted. Further, the dimensional ratios in the drawings do not necessarily match those described.

  FIG. 1 is a block diagram schematically showing a configuration of an embodiment of a screening information management system according to the present invention. FIG. 2 is a flowchart showing the basic concept of the screening information management method executed in the management system shown in FIG.

  Here, the screening information management system 1A shown in FIG. 1 assumes a preliminary screening and a main screening as screenings performed on a subject, and about the implementation status, implementation schedule, and obtained results of those screenings. It is a management system that manages. The main screening is screening including image diagnosis in which a tomographic image of a subject is acquired and diagnosed. Examples of such image diagnosis include PET inspection, X-ray CT (Computed Tomography) inspection, MRI (Magnetic Resonance Imaging) inspection, and the like. Preliminary screening is screening that includes a screening diagnosis that is performed prior to image diagnosis and is used to determine the implementation of the main screening. Examples of such screening diagnosis include urinalysis and blood tests.

  The screening information management system 1A of the present embodiment includes a screening information management device 10, an input unit 50, and an output unit 60. The screening information management apparatus 10 includes a screening data input control unit 11, a management information output control unit 12, a screening database 20, and a management determination unit 15.

  The screening data input control unit 11 controls and executes input of screening data such as screening information of the subject to the management apparatus 10. An input unit 50 is connected to the input control unit 11. In such a configuration, the input unit 50 functions as a screening information input unit used to input screening information regarding the screening of the subject.

  The examination data input to the management apparatus 10 via the input control unit 11 mainly includes examination information data and examination accumulation data. The screening information data is data including screening-related information for individual subjects. As specific screening information data, there are data of main screening information about main screening including image diagnosis and preliminary screening information regarding preliminary screening including screening diagnosis. The examination accumulation data is data in which necessary data such as implementation contents and implementation results are accumulated for a plurality of subjects. Such examination accumulated data may be configured not to be input to the management apparatus 10 if unnecessary.

  The management information output control unit 12 controls and executes output of management information about the examination of the subject stored, managed, or generated in the management device 10 to the outside. An output unit 60 is connected to the output control unit 12. The output unit 60 is management information output means used for outputting management information about the preliminary examination of the subject, the implementation status of the actual examination, the implementation schedule, or the obtained results.

  As the input unit 50 connected to the input control unit 11 of the management device 10, for example, an input device 51 such as a keyboard and a mouse, an external I / F 52 to which an external device 53 is connected, and the like can be used. Here, as the external apparatus 53 connected to the management apparatus 10 via the external I / F 52, for example, an inspection apparatus that performs a predetermined inspection on a subject and outputs data obtained as a result thereof can be cited.

  The output unit 60 connected to the output control unit 12 includes, for example, a display device 61 that displays an output screen for showing management information to the operator, and prints the management information on a paper and outputs it as a document. A printing device 62 or the like can be used. In addition to the management information output screen described above, the display device 61 preferably has a configuration capable of displaying an input screen used when the operator inputs necessary examination information from the input unit 50. Such an input screen may be displayed on a display device different from the output screen.

  Screening data input from the input unit 50 via the screening data input control unit 11 is stored in the screening database 20 in a predetermined data format in the management device 10 as necessary (screening information input step). In the management system 1A of the present embodiment, the screening database 20 includes a screening information database 21 and a screening accumulation database 22.

  The screening information database 21 is a database that stores preliminary screening information and main screening information for screenings that have been performed or are scheduled to be performed on the subjects for each subject. The database 21 includes basic data including personal information such as the subject's name, sex, date of birth, and past medical history information in addition to the screening information data including the preliminary screening information and the main screening information. It is preferable that necessary data such as medical history data is stored.

  The examination accumulation database 22 is a database that stores examination accumulation data in which data of a plurality of subjects are accumulated regarding examination as necessary. Such examination accumulation data is created by, for example, accumulating data such as the contents and results of examinations that have been conducted for multiple subjects at the facility where the examination is performed (hospital, examination center, etc.). Is done. Alternatively, data created by sharing accumulated data among a plurality of facilities may be used as examination accumulated data. Further, the examination accumulation database 22 may be configured not to be provided if unnecessary.

  Further, a management determination unit 15 is provided for the examination data stored in the examination database 20. The management determination unit 15 is a management determination unit that manages the implementation of the screening for the subject based on the preliminary screening information and the main screening information stored in the database 20 (management determination step). The management judgment unit 15 refers to the examination data stored in the database 20 and makes necessary judgments regarding the contents of the examination for the subject, the result of the examination, or the schedule for the future examination. The management information determined by the management determination unit 15 is output from the output unit 60 to the operator via the output control unit 12.

  The management determination unit 15 includes a screening execution determination unit 16, a determination information storage unit 17, and a determination method selection unit 18. The management determination unit 15 makes a necessary determination regarding the implementation of the screening for the subject. That is, the screening for the subject is performed irregularly or periodically with a certain period (examination interval). The management judgment unit 15 makes a judgment on the implementation contents, implementation schedule, etc. of the examination for such a subject.

  The screening execution determination unit 16 is a screening execution determination unit that determines whether or not a test is performed on a subject. This screening execution determination unit 16 determines whether or not to perform this screening based on the result of preliminary screening performed by applying a predetermined determination method (screening determination step). Specifically, the contents of the determination in this case include the necessity of performing the main screening, the necessity of performing the next preliminary screening, or the timing of performing the screening.

  Further, in the present embodiment, the management judgment unit 15 determines the contents of the screening in the preliminary screening including the screening diagnosis (such as urinalysis) performed prior to the image diagnosis (PET inspection, etc.) of the main screening, and the results of the preliminary screening. For the determination based on, a plurality of types of determination methods with different prevalence determination levels are prepared. Specifically, the determination information storage unit 17 of the management determination unit 15 includes determination methods 1, determination methods 2,..., Determination method n as determination methods of n types (n is an integer of 2 or more) having different determination levels. Is stored and prepared in advance (see FIG. 2). In addition, in the determination information storage unit 17, for these n types of determination methods, a predetermined selection condition for selecting one determination method to be applied to the subject from the determination methods 1 to n is prepared. ing.

  The determination method selection unit 18 is a determination method selection unit that selects a determination method to be applied to the subject among the n types of determination methods prepared in the determination information storage unit 17. As shown in FIG. 2, the determination method selection unit 18 controls at least one of the examination information data and the examination accumulation data of the subject from the examination database 20 or input control as examination data necessary for selecting the judgment method. Obtained from the input unit 50 via the unit 11 (step S101).

  Then, the selection unit 18 refers to the acquired examination data, and is a preliminary examination applied to the subject among the determination methods 1 to n based on the selection conditions prepared in the determination information storage unit 17. The determination method is selected (S102, determination method selection step). The selection result of the determination method by the selection unit 18 is output and presented from the output unit 60 to the operator as necessary. In addition, the screening execution determination unit 16 determines whether to perform the main screening based on the result of the preliminary screening performed by applying the determination method selected by the determination method selection unit 18.

  Such a screening information management apparatus 10 stores, for example, a CPU that executes various processes such as screening execution determination processing and determination method selection processing necessary for screening information management, and software programs necessary for processing operations. And a storage device such as an internal memory or an external storage device used for the examination database 20.

  The effects of the screening information management system and the screening information management method according to the above embodiment will be described.

  In the screening information management system 1A and the screening information management method shown in FIG. 1 and FIG. 2, for a screening performed on a subject, a main screening including an image diagnosis for acquiring a tomographic image and performing a diagnosis, and an image Screening is performed in combination with preliminary screening including screening diagnosis performed by a simpler method than diagnosis. In addition, screening information data including preliminary screening information and main screening information is stored in the screening information database 21 of the management device 10 for each subject to manage the screening for the subject. This makes it possible to efficiently examine the subject and reduce the diagnostic cost.

  Furthermore, in such a configuration, two or more types of determination methods having different determination levels are prepared in the determination information storage unit 17 for preliminary screening used for determining whether or not to perform the main screening. Then, the determination method selection unit 18 refers to the examination data including at least one of examination information data or examination accumulation data, and is a preliminary to be applied to the subject who is the subject of the examination based on a predetermined selection condition. Judgment method for screening is selected. Thereby, it is possible to accurately evaluate the necessity of performing the main screening for the subject, and to reliably perform the determination on the screening.

  Here, as the main examination including the image diagnosis, for example, at least one of a PET examination, a CT examination, and an MRI examination is used. The PET test is a test that acquires functional information about blood flow, oxygen metabolism, glucose metabolism, neurotransmitters, etc. by observing the radiation released from the body by putting a radiopharmaceutical containing an RI substance into the body of the subject. is there. In such an inspection method, the cost of one inspection is high, and there is radiation exposure to the subject.

  The X-ray CT examination is an examination in which a subject is irradiated with X-rays and transmitted through the body, and anatomical information of the body tissue is acquired from the difference in transmittance. In such an inspection method, there is radiation exposure to a subject. The MRI examination is an examination for obtaining functional information such as anatomical information of a body tissue and blood volume by applying a strong magnetic field to a subject and observing the state of hydrogen nuclei in the body.

  On the other hand, the screening for the subject can be performed as described above by combining the preliminary screening including the screening diagnosis that can be performed by the simple and inexpensive method as described above and the main screening including the image diagnosis. Can be done efficiently. In addition, by selecting a judgment method in the preliminary screening based on the screening data, the accuracy of evaluation such as the necessity of performing this screening is improved. In addition, by appropriately determining the necessity of conducting this screening in this way, it is possible to minimize radiation exposure due to the screening performed on the subject.

  The screening diagnosis in the preliminary screening preferably includes at least one of a urine test and a blood test. By conducting such an examination as a preliminary examination prior to the main examination, it is possible to suitably determine whether or not the main examination is necessary. In addition, since such preliminary screening is non-invasive, easy, and inexpensive, it is possible to perform repeated testing. Specific examples of urinalysis include urinary protein analysis that analyzes proteins specifically expressed in cancer, and urine pteridine analysis that analyzes the amount of pteridines related to the activity of the immune system due to cancer and infection. And urinary fluorescence analysis, which analyzes by focusing on fluorescent compounds in urine.

  In addition, regarding the preliminary screening for the main screening including the image diagnosis, it is preferable to combine a plurality of types of screening diagnosis in order to improve the accuracy of determining whether or not the main screening is necessary. As a combination of screening diagnosis in this case, for example, there is a method of using a combination of a plurality of types of urinalysis (A urinalysis, B urinalysis, C urinalysis,...) As described above. Alternatively, there is a method using a combination of a urine test and a blood test. In addition, screening diagnosis other than urine test and blood test may be used. The screening diagnosis performed in the preliminary screening will be further described later together with the selection of the determination method in the preliminary screening.

  Further, as described above, it is preferable that the present examination includes at least one of PET examination, X-ray CT examination, and MRI examination as the image diagnosis. In addition, in order to improve the accuracy of the screening for the subject, comprehensive image diagnosis combining PET inspection, CT inspection, and MRI inspection, or comprehensive image diagnosis combining US (ultrasonic) inspection with the above three types of inspections is performed. It may be a medical examination.

  Further, in the management system 1A of the above-described embodiment, the management judgment unit 15 needs to perform or need the main examination based on the result of the preliminary examination performed by applying the judgment method selected by the judgment method selection unit 18. If there is, it is configured to provide a screening execution determination unit 16 that determines whether or not to perform the next screening. Thereby, implementation of the medical examination with respect to a test subject can be managed suitably.

  In addition, regarding the examination to be managed by the management system 1A, it is preferable to comprehensively manage a plurality of examinations (periodic examinations) that are repeatedly performed on the subject at predetermined examination intervals. In this case, the screening information database 21 stores preliminary screening information and main screening information for each of a plurality of screenings periodically performed on the subject. Thereby, it becomes possible to further improve the efficiency as a whole with respect to the examination of the subject performed regularly. As described above, the screening execution interval in the case of performing periodic screening in this manner may be appropriately set as necessary. For example, it may be set to one year.

  The examination information management method in the management system 1A shown in FIG. 1 will be described more specifically. FIG. 3 is a flowchart showing a specific example of the screening information management method executed in the management determination unit 15 of the management apparatus 10.

  In the following, as a plurality of types of determination methods in the preliminary examination prepared in the determination information storage unit 17, a prevalence low level determination method, a prevalence middle level determination method, and a prevalence high level determination method It is assumed that the following three types of determination methods are prepared. As for the disease to be diagnosed in the screening performed on the subject, a description will be given of cancer screening mainly targeting cancer. However, the management system and management method according to the present invention can be similarly applied to various types of screening other than cancer screening.

  In the management method shown in FIG. 3, the determination method selection unit 18 first refers to the medical history data of the subject read from the screening information database 21 and determines whether there is a history of cancer (step S201). Then, if there is a past history, it is determined that the prevalence is high, and the high-level determination method is selected as the determination method in the preliminary examination.

  On the other hand, if there is no past history, it is further determined whether or not the main examination including the image diagnosis is received within a predetermined period (for example, within three years) (S202). If there is a medical history, the screening information data stored in the screening information database 21 is referred to, and the determination method in the preliminary screening is selected from the above-described three types of determination methods based on the corresponding selection conditions. (S203). If there is no medical history, the screening accumulated data stored in the screening accumulation database 22 is referred to, and the determination method in the preliminary screening is similarly selected from the three types of determination methods based on the corresponding selection conditions. (S204).

  When selection of the determination method is completed and preliminary screening is performed, the screening execution determination unit 16 determines whether to perform the main screening based on the preliminary screening result information input via the input control unit 11. . In the specific example shown in FIG. 3, in the low-level determination method and the medium-level determination method, “main examination is performed” for performing image diagnosis, and screening diagnosis is performed again after a predetermined period (for example, three months later). “Re-examination of examination” and “Negative” in which no examination is performed until a predetermined time (for example, the next periodic medical examination time) are determined. Further, in this embodiment, in the high level determination method, one of “execution of main examination” and “re-execution of preliminary examination” is determined, and “negative” is not determined.

  In this embodiment, depending on the presence or absence of the main examination within a predetermined period, the examination data referred to the selection of the judgment method is switched between the examination information data and the examination accumulation data, and the selection method of the judgment method is also set. It is configured to switch. Thereby, the determination method in the preliminary examination which should be applied with respect to a test subject can be selected suitably.

  Moreover, in the said structure, it is good also as a structure which designates or changes the determination method in the next medical examination according to a determination result. As such a configuration, for example, in the flowchart of FIG. 3, when it is determined that “preliminary medical examination is re-executed”, the determination is started from step S204 next time, while when it is determined “negative”, There is a configuration in which determination is started from step S201 next time.

  FIG. 4 is a flowchart showing a method for selecting a determination method based on examination information data (step S203 in FIG. 3). In this method, the determination method selection unit 18 acquires the examination information data of the subject from the examination information database 21 (S301), extracts the previous examination result information, and selects the judgment method by referring to the extracted information (S301). S302). For specific selection conditions, if the screening result is “no abnormality” or “no need for detailed examination”, the low-level judgment method is used. If “follow-up observation” is required, the medium-level judgment method is used. Each of the high-level determination methods is selected as a determination method to be applied to the subject.

  Thus, regarding the selection of the determination method for the subject, a configuration in which the determination method to be applied to the subject can be selected with reference to the previous screening result information extracted from the screening information data can be used. In such a method, for example, as described above, a determination method to be applied to a subject can be suitably selected when the main examination is received within a predetermined period.

  FIG. 5 is a flowchart showing a method of selecting a determination method based on the examination accumulated data (step S204 in FIG. 3). In this method, the determination method selection unit 18 obtains screening accumulation data from the screening accumulation database 22 (S306), derives disease risk estimation information, and refers to it to select a determination method (S307). . For specific selection conditions, a low level determination method is used if the estimated prevalence is a% or less, a medium level determination method is used if the estimated prevalence is a to b%, and an estimated prevalence is b%. If it is above, a high level determination method is each selected as a determination method applied to a test subject (however, a <b).

  As described above, regarding the selection of the determination method for the subject, it is possible to use a configuration in which the determination method applied to the subject is selected with reference to the estimation information of the disease risk derived from the examination accumulated data. In such a method, for example, as described above, a determination method to be applied to a subject can be suitably selected when the main examination is not received within a predetermined period. In addition, a method of referring to the estimation information of the disease risk as described above may be used even when the present examination is being performed.

  In addition, regarding the estimation method of the disease risk in this case, for example, the prevalence rate is determined based on conditions such as sex, age group, time period, etc. based on past examination data, treatment data, etc. for a plurality of subjects accumulated as examination accumulation data. Thus, a method for calculating the estimated prevalence based on the subject's sex, age, screening time, and the like can be used.

  Next, the determination method applied in the preliminary examination will be specifically described. As for the determination methods prepared for the preliminary screening, the determination methods of plural types are determined by screening diagnosis that determines positive or negative by applying a cut-off value α set by paying attention to the sensitivity of the test. It is preferable to include a first determination method and a second determination method in which determination is made by a screening diagnosis in which positive or negative is determined by applying a cutoff value β set by paying attention to the specificity of the test.

  In addition, multiple types of judgment methods in preliminary screening are set by focusing on screening diagnostics that apply a cut-off value α that focuses on the sensitivity of the test to determine positive or negative, and on the specificity of the test. It is preferable to include a third determination method in which determination is performed by combining screening diagnosis that determines positive or negative by applying the cut-off value β.

  As described above, regarding the determination method in the pre-examination, by using separately or in combination with exclusion diagnosis that is diagnosis applied with the cut-off value α and definitive diagnosis that is diagnosis applied with the cut-off value β, For each of a plurality of types of determination methods, a determination method according to the determination level can be suitably configured.

  Here, the exclusion diagnosis applies the cut-off value α set by paying attention to the examination sensitivity as described above. Thus, when it is determined to be negative in a test with high sensitivity, it can be determined that there is almost no doubt. Therefore, such a diagnosis is particularly effective when a true healthy person is identified and excluded from a subject whose prevalence is estimated to be low.

  In the definitive diagnosis, a cutoff value β set by paying attention to the specificity of the test is applied. Thus, when it is determined to be positive by a test with high specificity, it can be determined that there is almost certainly a positive. Therefore, such a diagnosis is particularly effective for a subject who is presumed to have a high prevalence when the true disease is identified and confirmed.

  For example, as shown in FIG. 3, when three types of determination methods are set, as a low level determination method for a subject whose prevalence is estimated to be low, a cut-off value α focusing on examination sensitivity is The cut-off value β focusing on the specificity of the test is applied as a high-level determination method for subjects whose prevalence is estimated to be high while using the first determination method that makes a determination with an applied exclusion diagnosis It is preferable to use the second determination method in which determination is performed with a definite diagnosis. Moreover, it is preferable to use the 3rd determination method which determines by combining an exclusion diagnosis and a definite diagnosis as an intermediate level determination method of those.

  Next, a method for setting the cutoff values α and β applied in the exclusion diagnosis and the definitive diagnosis will be described with reference to FIGS. FIG. 6 is a flowchart showing a setting method of a cutoff value applied to the screening diagnosis.

  In the following, the cut-off value α focused on the sensitivity of the test is set as a cut-off value set so that the sensitivity is 80%, and the cut-off value β focused on the test specificity is 80% specific. A case where the cut-off value is set as follows will be described as an example. In general, for such a cutoff value setting method, it is preferable to set the cutoff values α and β so that the sensitivity and specificity become a predetermined ratio.

  In addition, about the setting of such a cut-off value, the management judgment part 15 of the management apparatus 10 shown in FIG. 1 sets the cut-off value with reference to the data memorize | stored in the examination accumulation | storage database 22. FIG. Can be used. Alternatively, it is possible to use a configuration in which the cutoff value setting process is first executed in the external device and the obtained cutoff value is stored in the determination information storage unit 17.

  In addition, as shown in FIG. 7, the sensitivity and specificity of the test in the screening diagnosis are a positive test result, a test subject having a disease, and a positive test result with respect to the set cutoff value. If there are b subjects without disease, c subjects with negative diagnosis and disease, and d subjects with negative diagnosis and no disease, the sensitivity of the test at that cutoff value (with disease) Of the person who becomes positive) is defined by a / (a + c). The specificity of the test (the rate at which a person without disease becomes negative) is defined by d / (b + d).

  In the setting of the cut-off value, as shown in FIG. 6, first, necessary examination accumulated data is acquired (S501), and a test used for screening diagnosis for which a cut-off value is to be set (for example, a urine test by a predetermined method) ), The distribution of the test values for a plurality of subjects is analyzed for each case of presence / absence of illness (S502). Then, with reference to the distribution of the test value for the subject with illness, a cut-off value α with a sensitivity of 80% is calculated for the exclusion diagnosis (S503). Further, with reference to the distribution of test values for subjects without disease, a cut-off value β with a specificity of 80% is calculated for a definite diagnosis (S504).

  FIG. 8 is a diagram illustrating a method for setting the cutoff value α in the exclusion diagnosis. Here, as shown in the graph (a) of FIG. 8, the cut-off value α serving as a threshold for positive / negative determination is set to α = 6 with reference to the distribution of test values for the subject with disease. . In this example, as shown in the table (b) of FIG. 8, a cut-off value α with a sensitivity of 80% that can make 8 out of 10 cancer patients positive is set. Further, the specificity at this time is 70%.

  FIG. 9 is a diagram illustrating a method for setting the cutoff value β in the definitive diagnosis. Here, as shown in the graph (a) of FIG. 9, the cut-off value β serving as a threshold value for the positive / negative determination is set to β = 8 with reference to the distribution of the test values for the subject without disease. . In this example, as shown in the table (b) of FIG. 9, a cut-off value β with a specificity of 80% that can make 8 out of 10 healthy persons negative is set. Further, the sensitivity at this time is 40%.

  Next, a plurality of types of determination methods prepared for the preliminary examination will be described with reference to FIGS. Here, as in the example shown in FIG. 3, it is assumed that three types of determination methods, ie, a low level determination method, a medium level determination method, and a high level determination method are prepared as a plurality of types of determination methods. Will be described.

  FIG. 10 is a diagram illustrating an example of a plurality of types of determination methods in preliminary examination, in which determination method (a) is an example of a low level determination method, determination method (b) is an example of a medium level determination method, The determination method (c) shows an example of a high level determination method. The determination method in the present embodiment is a determination method in the case where a preliminary screening is performed by combining a plurality of types of screening diagnosis.

  In this embodiment, the low level determination method (a) uses a method (first determination method) in which a plurality of exclusion diagnoses to which the cut-off value α is applied are performed and a determination is made regarding the implementation of the main examination. . Specifically, as a result of performing a plurality of exclusion diagnoses as preliminary examinations, if all are positive, it is determined that “main examination is performed” in which image diagnosis is performed. If it is partially positive / negative, it is determined that the screening diagnosis is performed again after a predetermined period of time and “preliminary screening re-execution”. Further, if all are negative, it is determined as “negative” in which a medical examination is not performed until a predetermined time.

  Further, in the high level determination method (c), a method (second determination method) in which a plurality of definitive diagnoses to which the cut-off value β is applied is performed and determination regarding the implementation of the main examination is performed. Specifically, as a result of performing a plurality of definitive diagnoses as preliminary examinations, if even one diagnosis is positive, it is determined that “main examination is performed” in which image diagnosis is performed. Moreover, if all are negative, it is determined that “preliminary screening re-execution” is performed again after a predetermined period.

  In addition, in these intermediate-level determination methods (b), a plurality of exclusion diagnoses to which the cut-off value α is applied and a definite diagnosis to which the cut-off value β is applied are performed, respectively. A determination method (third determination method) is used. Specifically, as a result of performing a plurality of exclusion diagnoses and a plurality of definitive diagnoses as a preliminary examination, if one diagnosis is positive as a result of the definitive diagnosis, an image diagnosis is performed regardless of the result of the exclusion diagnosis. “Implementation”.

  Further, if the results of the definitive diagnosis are all negative, and if the results of the exclusion diagnosis are all positive, it is determined that “main screening is performed” in which image diagnosis is performed. Further, if the result of the exclusion diagnosis is partly positive / negative, it is determined that “preliminary screening re-execution” in which the screening diagnosis is performed again after a predetermined period. If the results of the exclusion diagnosis are all negative, it is determined as “negative” in which the examination is not performed until a predetermined time.

  FIG. 11 is a diagram illustrating another example of a plurality of types of determination methods in preliminary screening, in which determination method (a) is an example of a low level determination method, and determination method (b) is an example of a medium level determination method. The determination method (c) shows an example of a high level determination method. The determination method in the present embodiment is a determination method in the case where preliminary screening is performed by combining two types of screening diagnosis.

  In the present embodiment, in the low level determination method (a), two types of exclusion diagnosis are performed: exclusion diagnosis 1 to which the cut-off value α1 is applied and exclusion diagnosis 2 to which the cut-off value α2 is applied. A method is used to make a judgment about the implementation of a medical examination. Specifically, as a result of performing two types of exclusion diagnosis as a preliminary screening, if both are positive, it is determined that “main screening is performed” in which image diagnosis is performed. If one is positive and the other is negative, it is determined that “preliminary screening re-execution” in which the screening diagnosis is performed again after a predetermined period. Moreover, if both are negative, it will determine with "negative" not performing a medical examination until predetermined time.

  Further, in the high level determination method (c), two types of definitive diagnoses, that is, a definitive diagnosis 1 to which the cut-off value β1 is applied and a definitive diagnosis 2 to which the cut-off value β2 is applied, are performed, and the main examination is performed. The method of making a determination on is used. Specifically, as a result of performing two types of definitive diagnoses as preliminary screening, if both are positive, or one is positive and the other is negative, it is determined that “main screening is performed” in which image diagnosis is performed. Moreover, if both are negative, it will determine with "preliminary screening re-execution" which performs a screening diagnosis again after a predetermined period.

  Moreover, in these intermediate level determination methods (b), two types of diagnosis are performed: one type of exclusion diagnosis to which the cutoff value α is applied, and one type of definitive diagnosis to which the cutoff value β is applied. Thus, a method for making a determination about the implementation of this examination is used. Specifically, as a result of two types of diagnosis as a preliminary screening, if the result of the definitive diagnosis is positive, it is determined that “the actual screening is performed” in which the image diagnosis is performed regardless of the result of the exclusion diagnosis. If the result of the definitive diagnosis is negative and the result of the exclusion diagnosis is positive, it is determined that the screening diagnosis is performed again after a predetermined period of time and “preliminary screening is performed again”. If the result of the exclusion diagnosis is negative, it is determined as “negative” in which the medical examination is not performed until a predetermined time.

  The examination information management system and management method according to the present invention are not limited to the above-described embodiments and configuration examples, and various modifications are possible. For example, the specific hardware configuration of the examination information management system is not limited to the configuration shown in FIG. 1, and various configurations may be used.

  In addition, the plurality of types of determination methods prepared for the preliminary examination are three types in the above configuration example, but two types or four or more types of determination methods may be prepared. Moreover, about the specific content of each determination method, you may use the various determination methods from which the determination level about prevalence differs in addition to the example shown to FIG. 10, FIG. In addition to the methods shown in FIGS. 3 to 5, specifically, various methods may be used as the determination method selection method.

  In addition, regarding the screening accumulated data, regarding the estimation of the disease risk shown in FIG. 5, in the above embodiment, the prevalence data is confirmed based on conditions such as sex, age group, and time period from the past screening data. The estimated prevalence rate is calculated. For example, as shown in FIG. 12, a prevalence table for each sex, age group, time period, etc. may be prepared as the examination accumulation data.

  INDUSTRIAL APPLICABILITY The present invention can be used as a screening information management system and a screening information management method that can efficiently perform screening of a subject and reduce the diagnostic cost.

It is a block diagram which shows the structure of one Embodiment of a screening information management system. It is a flowchart which shows the basic concept of the screening information management method. It is a flowchart which shows an example of a screening information management method. It is a flowchart which shows the selection method of the determination method by examination information data. It is a flowchart which shows the selection method of the determination method by the examination accumulation data. It is a flowchart which shows the setting method of the cutoff value applied to a screening diagnosis. It is a figure shown about the sensitivity and specificity in screening diagnosis. It is a figure which shows the setting method of cutoff value (alpha) in an exclusion diagnosis. It is a figure which shows the setting method of cutoff value (beta) in definite diagnosis. It is a figure which shows an example of the multiple types of determination method in a preliminary | backup examination. It is a figure which shows the other example of the multiple types of determination method in a preliminary | backup examination. It is a figure which shows the table of prevalence prepared as examination accumulation data.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 1A ... Examination information management system, 10 ... Examination information management apparatus, 11 ... Examination data input control part, 12 ... Management information output control part, 15 ... Management judgment part, 16 ... Examination execution judgment part, 17 ... Decision information storage part, DESCRIPTION OF SYMBOLS 18 ... Determination method selection part, 20 ... Examination database, 21 ... Examination information database, 22 ... Examination accumulation database, 50 ... Input part, 51 ... Input device, 52 ... External I / F, 53 ... External device, 60 ... Output part 61 ... Display device, 62 ... Printing device.

Claims (10)

A screening information management system for managing screening information of a subject,
Examination information data including main examination information about main examination including image diagnosis for obtaining tomographic images of a subject and performing diagnosis, and preliminary examination information about preliminary examination including screening diagnosis performed prior to the image diagnosis, A screening information database stored for each subject;
Based on the preliminary screening information and the main screening information, management judgment means for managing the implementation of the screening for the subject,
The management judgment means includes
Selection conditions for selecting a plurality of types of determination methods with different determination levels and a determination method to be applied to the subject from the plurality of types of determination methods for the preliminary screening for performing the determination on the implementation of the main screening Stored determination information storage means;
Refer to at least one of the examination information data of the subject or examination accumulation data in which data of a plurality of subjects are accumulated regarding the examination, and the preliminary examination is based on the selection condition, among the plurality of types of determination methods And a determination method selection means for selecting a determination method to be applied to the subject.   The plurality of types of determination methods in the preliminary screening include a first determination method in which determination is performed by a screening diagnosis in which positive or negative is determined by applying a cut-off value α set by paying attention to sensitivity of the test, The screening information management according to claim 1, further comprising: a second determination method in which determination is made by a screening diagnosis in which positive or negative is determined by applying a cutoff value β set by paying attention to the specificity of the screening system.   The determination methods of the plurality of types in the preliminary screening are set by focusing on screening diagnostics for determining positive or negative by applying a cut-off value α set by focusing on the sensitivity of testing, and on the specificity of testing The screening information management system according to claim 1, further comprising a third determination method for performing determination by combining screening diagnosis for determining positive or negative by applying the cut-off value β.   The determination method selection means selects the determination method to be applied to the subject with reference to the previous examination result information extracted from the examination information data. The screening information management system described in the section.   The determination method selection means selects the determination method to be applied to the subject with reference to estimation information of a disease risk derived from the examination accumulated data. The screening information management system described in the section. A screening information management method for managing screening information of a subject,
Input pre-examination information about pre-examination including pre-examination including pre-examination including pre-examination for pre-examination including pre-examination including pre-examination for the pre-examination including the pre-examination of the pre-examination including the main diagnosis including pre-examination. Screening information input step for storing information and screening information data including the main screening information for each subject in the screening information database;
Based on the preliminary screening information and the main screening information, the management judgment step for managing the implementation of the screening for the subject,
The management judging step includes
In order to select a plurality of types of determination methods with different determination levels prepared in advance and a determination method to be applied to the subject from the plurality of types of determination methods for the preliminary screening for performing the determination on the implementation of the main screening Using the selection conditions of
Refer to at least one of the examination information data of the subject or examination accumulation data in which data of a plurality of subjects are accumulated regarding the examination, and the preliminary examination is based on the selection condition, among the plurality of types of determination methods A screening information management method comprising: a determination method selection step of selecting a determination method to be applied to the subject.   The plurality of types of determination methods in the preliminary screening include a first determination method in which determination is performed by a screening diagnosis in which positive or negative is determined by applying a cut-off value α set by paying attention to sensitivity of the test, The screening information management of Claim 6 including the 2nd determination method which determines by the screening diagnosis which judges the positive or negative by applying the cutoff value (beta) set paying attention to the specificity of the screening Method.   The determination methods of the plurality of types in the preliminary screening are set by focusing on screening diagnostics for determining positive or negative by applying a cut-off value α set by focusing on the sensitivity of testing, and on the specificity of testing The screening information management method according to claim 6, further comprising a third determination method in which determination is performed by combining screening diagnosis for determining positive or negative by applying the cut-off value β.   The determination method selection step refers to the previous screening result information extracted from the screening information data, and selects the determination method to be applied to the subject. The screening information management method described in the section.   10. The determination method selection step of selecting the determination method to be applied to the subject with reference to disease risk estimation information derived from the examination accumulated data. The screening information management method described in the section.

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