TW200917148A - Medical examination information management system and method - Google Patents
Medical examination information management system and method Download PDFInfo
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- TW200917148A TW200917148A TW097124432A TW97124432A TW200917148A TW 200917148 A TW200917148 A TW 200917148A TW 097124432 A TW097124432 A TW 097124432A TW 97124432 A TW97124432 A TW 97124432A TW 200917148 A TW200917148 A TW 200917148A
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- G16H30/00—ICT specially adapted for the handling or processing of medical images
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- G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
- G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
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Abstract
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200917148 九、發明說明: 【發明所屬之技術領域】 次本發明係關於對受試驗者實施檢診之實施狀況等的檢診 責訊進行管理的檢診資訊管理系統、及檢診資訊管理方 法。 【先前技術】 正電子斷層攝影法(PET : p〇sitr〇n Emissi〇n 丁〇则砂咖) 係扣如下方法:將由對受試驗者放出陽電子(正電子)之放 门位元素(RI)所標識的物質投入作為示蹤劑,測量從 RI物質放出之陽電子與通常物質中之電子成對湮滅所生成 的一對7線,藉此取得受試驗者之資訊。 使用有上述方法之ΡΕΤ裝置係對受試驗者投與含有幻物 質之示蹤劑,利用上述方法測量來自RI物質的一對r線, 攸而測定RI物質之體内分布。藉此,可取得使生物體内的 生理學、生化學之資訊實現圖像化、定量化的受試驗者之 斷層圖像,並可參照該斷層圖像而進行癌檢診或者腦檢查 等圖像診斷。又,作為取得斷層圖像並對受試驗者進行診 斷之方法’除PET檢查之外,CT (Computed Tomography, 電月1^ 斷層掃描)檢查、MRI (Magnetic Resonance Imaging, 磁振造影)檢查等亦得以實用化(參照專利文獻1、2)。 專利文獻1:日本專利特開平6_347555號公報 專利文獻2 :日本專利特開2002· 136508號公報 【發明内容】 發明所欲解決之問題 132466.doc 200917148 根據上述的PET檢查、CT檢查及MRI檢查等圖像診斷, 可於非入侵之情況下取得受試驗者之内部資訊並進行必要 的診斷。然而,在利用有該等斷層圖像之診斷中,存在如 下問題:裝置為大型,且一次之診斷費用高額。上述高額 的診斷費用在定期反覆進行檢診之情況下特別成為問題。 本發明係為解決上述問題點而研製者,其目的在於提供 一種可對受試驗者有效地進行檢診、從而降低其診斷費用 的檢診資訊管理系統及檢診資訊管理方法。 解決問題之技術手段 為達成上述目的,本發明之檢診資訊管理系統之特徵在 於,其係對受試驗者之檢診資訊進行管理者,該檢診資訊 管理系統具備:(1)檢診資訊資料庫,其針對每一位受試驗 者記憶檢診資訊資料*該檢診資訊資料包括:含有取得受 試驗者之斷層圖像並進行診斷之圖像診斷之本檢診的本檢 診資訊、及含有於圖像診斷前所進行的診斷之預備檢診的 預備檢診資訊;以及(2)管理判斷機構,其根據預備檢診資 訊及本檢診資訊,對受試驗者進行檢診實施之管理;且(3) 上述管理判斷機構具有判定資訊記憶機構,其中記憶有在 對本檢診之實施進行判定的預備檢診中,用以適用於受試 驗者之判定法。 又,本發明之檢診資訊管理方法之特徵在於,其係對受 試驗者之檢診資訊進行管理者,該檢診資訊管理方法包 括:(a)檢診資訊輸入步驟,其輸入如下資訊,即,含有取 得受試驗者之斷層圖像並進行診斷之圖像診斷之本檢診的 132466.doc 200917148 本檢診資訊、及含有於圖像診斷前所進行的診斷之預備檢 診的預備檢診資訊,並針對每一位受試驗者,將包含預備 檢診貢訊及本檢診資訊之檢診貧訊貧料記憶於檢診育訊貧 料庫中;以及(b)管理判斷步驟,其根據預備檢診資訊及本 檢診資訊,對受試驗者進行檢診實施之管理;且(c)於上述 管理判斷步驟中,在對本檢診之實施進行判定之預備檢診 中,使用預先準備的適用於受試驗者之判定法。 於上述的檢診資訊管理系統及管理方法中,關於對受試 驗者所實施的檢診,係將以下檢診組合而進行檢診,即, 含有取得斷層圖像並進行診斷之圖像診斷的本檢診、及含 有藉由較圖像診斷更簡易之方法所進行之診斷(以下,稱 為相對於圖像診斷之篩選診斷)的預備檢診,並針對每一 位受試驗者,將含有預備檢診資訊及本檢診資訊之檢診資 訊資料記憶於檢診資訊資料庫中,以對受試驗者進行檢診 實施之管理。藉此,能對受試驗者有效地進行檢診,從而 可降低其診斷費用。 進而,於上述構成中,對於在是否實施本檢診之判定等 中所使用的預備檢診,將適用於受試驗者之判定法預先準 備於記憶機構中。藉此,對於受試驗者實施本檢診之必要 性等可進行適當的評價,從而對於檢診之實施能夠可靠地 進行判定。 更具體而言,本發明之檢診資訊管理系統之特徵在於, 其係對受試驗者之檢診資訊進行管理者,該檢診資訊管理 系統具有:(1)檢診資訊資料庫,其針對每一位受試驗者記 132466.doc 200917148 憶檢診資訊貢料’該檢診貧訊貧料包括.含有取得受試驗 者之斷層圖像並進行診斷之圖像診斷之本檢診的本檢診資 訊、及含有於圖像診斷前所進行的篩選診斷之預備檢診的 預備檢診資訊;以及(2)管理判斷機構,其根據預備檢診資 訊及本檢診資訊,對受試驗者進行檢診實施之管理;且上 述管理判斷機構具有(3)判定資訊記憶機構,其中記憶有在 對本檢診之實施進行判定之預備檢診中,判定標準不同的 複數種類之判定法、及用以從上述複數種類之判定法中選 擇適用於受試驗者之判定法的選擇條件;以及(4)判定法選 擇機構,其參照受試驗者之檢診資訊資料、或者儲存有檢 診中複數個受試驗者之資料的檢診儲存資料之至少一者, 根據選擇條件,對於預備檢診,於複數種類之判定法中選 擇適用於受試驗者的判定法。 又,本發明之檢診資訊管理方法之特徵在於,其係對受 試驗者之檢診資訊進行管理者,該檢診資訊管理方法包 括:(a)檢診資訊輸入步驟,其輸入如下資訊:含有取得受 試驗者之斷層圖像並進行診斷之圖像診斷之本檢診的本檢 診資訊、及含有於圖像診斷前所進行之篩選診斷之預備檢 診的預備檢診資訊,並針對每一位受試驗者,將包含預備 檢診貧訊及本檢診資訊之檢診賁訊資料記憶於檢診貧訊資 料庫中;以及(b)管理判斷步驟,其根據預備檢診資訊及本 檢診資訊,對受試驗者進行檢診實施之管理;且上述管理 判斷步驟包括判定法選擇步驟,(c)其在對本檢診之實施進 行判定之預備檢診中,使用預先準備的判定標準不同之複 132466.doc 200917148 數種類之判定法、及用以從上述複數種類之判定法中選擇 適用於受試驗者之判定法的選擇條件,(d)並參照受試驗者 之檢診資訊資料、或者儲存有檢診之複數個受試驗者之資 料的檢診儲存資料之至少一者,根據選擇條件,對於預備 檢診,於複數種類之判定法中選擇適用於受試驗者之判定 法。 於上述的檢診資訊管理系統及管理方法中,關於對受試 驗者所實施的檢診,係將以下檢診組合而進行檢診,即, 含有取得斷層圖像並進行診斷之圖像診斷的本檢診、及含 有藉由較圖像診斷更簡易之方法所進行之診斷(相對於圖 像診斷之筛選診斷)的預備檢診,並針對每一位受試驗 者’將含有預備檢診資訊及本檢診資訊之檢診資訊資料記 憶於檢診資訊資料庫中,以對受試驗者進行檢診實施之管 理。藉此,能對受試驗者有效地進行檢診,從而可降低其 診斷費用。 進而,於上述構成中,對於在是否實施本檢診之判定等 中所使用的預備檢診,準備判定標準互不相同的兩種以上 之判定法。並且,參照含有檢診資訊資料或者檢診儲存資 料之至少一者的檢診資料,根據特定之選擇條件,選擇可 適用於作為檢診對象之受試驗者的預備檢診中之判定法。 藉此,對於受試驗者實施本檢診之必要性等可進行精度良 好的評價,從而對於檢診之實施能夠可靠地進行判定。 或者,本發明之檢診資訊管理系統之特徵在於,其係對 受試驗者之檢診資訊進行管理者,該檢診資訊管理系統具 132466.doc -10- 200917148 備:(1)檢診資訊資料庫,其對於每一位受試驗者記憶檢診 資訊資料,該檢診資訊資料包括:含有取得受試驗者之斷 層圖像並進行診斷之圖像診斷之本檢診的本檢診資訊、及 含有於圖像診斷前所進行的診斷之預備檢診的預備檢診資 訊;以及(2)管理判斷機構,其根據預備檢診資訊及本檢診 資訊,對受試驗者進行檢診實施之管理;且(3)上述管理判 斷機構具有:判定資訊記憶機構’其中記憶有在對本檢診 之實施進行判定之預備檢診中,適用於受試驗者之判定 法;以及檢診實施判定機構,其根據應用判定法所進行的 預備檢診之結果,對本檢診之實施進行判定;(4)預備檢診 中之判定法係將除外診斷及確定診斷加以組合而進行判定 之判定法,上述除外診斷係應用著眼於檢查之靈敏度所設 定之截斷值α來判斷陽性或陰性之診斷,上述確定診斷係 應用著眼於檢查之特異度所設定之截斷值β來判斷陽性或 陰性之診斷。 又,本發明之檢診資訊管理方法之特徵在於,其係對受 試驗者之檢診資訊進行管理者,該檢診資訊管理方法包 括:(a)檢診資訊輸入步驟,其輸入如下資訊,即,含有取 得受試驗者之斷層圖像並進行診斷之圖像診斷之本檢診的 本檢診資訊、及含有於圖像診斷前所進行的診斷之預備檢 診的預備檢診資訊,並針對每一位受試驗者,將包含預備 檢診資訊及本檢診資訊之檢診資訊資料記憶於檢診資訊資 料庫中;以及(b)管理判斷步驟,其根據預備檢診資訊及本 檢診資訊,對受試驗者進行檢診實施之管理;(c)上述管理 132466.doc -11 - 200917148 判斷步驟包括檢診實施判定步驟,其在對本檢診之實施進 行判定之預備檢診中,使用預先準備的適用於受試驗者之 判定法,並根據應用判定法所進行的預備檢診之結果,對 本檢診之實施進行判定,(d)預備檢診中之判定法係將除外 診斷及確定診斷加以組合而進行判定之判定法,上述除外 診斷係應用著眼於檢查之靈敏度所設定之截斷值α來判斷 陽性或陰性之診斷,上述確定診斷係應用著眼於檢查之特 異度所設定之截斷值β來判斷陽性或陰性之診斷。 於上述的檢診資訊管理系統及管理方法中,關於對受試 驗者所實施的檢診,係將以下檢診組合而進行檢診,即, 含有取得斷層圖像並進行診斷之圖像診斷的本檢診、及含 有藉由較圖像診斷更簡易之方法所進行之診斷(相對於圖 像診斷之篩選診斷)的預備檢診,並針對每一位受試驗 者,將含有預備檢診資訊及本檢診資訊之檢診資訊資料記 憶於檢診資訊資料庫中,以對受試驗者進行檢診實施之管 理。藉此,能對受試驗者有效地進行檢診,從而可降低其 診斷費用。 進而,於上述構成中,作為在是否實施本檢診之判定等 中所使用之預備檢診之判定法,使用的是將以下診斷組合 之複合判定法,即,應用著眼於檢查之靈敏度的截斷值(X 來判斷陽性或陰性之除外診斷、以及應用著眼於檢查之特 異度之截斷值β來判斷陽性或陰性之確定診斷。藉此,對 於受試驗者實施本檢診之必要性等可進行精度良好的評 價,從而對於檢診之實施能夠可靠地進行判定。 132466.doc •12- 200917148 關於對受試驗者之具體的檢診内容而言,預備檢診中, 篩選診斷較好的是含有尿檢查及血液檢查之至少一者。將 上述檢查在本檢診之前作為預備檢診而實施,藉此可對是 否實施本檢診等適當地進行判定。又,本檢診中,較好的 是含有PET檢查、CT檢查及MRI檢查中之至少一者作為圖 像診斷。 發明之效果 根據本發明之檢診資訊管理系統及管理方法,對於對受 試驗者所實施的檢診,將含有圖像診斷之本檢診與含有篩 選診斷之預備檢診組合而進行檢診,並且對於是否實施本 檢診之判定等中所使用之預備檢診,將適用於受試驗者之 判定法預先準備於記憶機構中,藉由該構成,能對受試驗 者有效且可靠地進行檢診,從而可降低其診斷費用。 更具體而言,關於對受試驗者所實施的檢診,係將含有 圖像診斷之本檢診與含有筛選診斷之預備檢診組合而進行 檢診,並且對於預備檢診,準備判定標準不同的複數種類 之判定法,並參照檢診資訊資料或者檢診儲存資料之至少 一者,根據特定之選擇條件,選擇適用於受試驗者的預備 檢診中之判定法,藉此能對受試驗者有效且可靠地進行檢 診,從而可降低其診斷費用。 或者,關於對受試驗者所實施的檢診,係將含有圖像診 斷之本檢診與含有篩選診斷之預備檢診組合而進行檢診, 並且作為預備檢診中之判定法,使用的是將以下診斷組合 之複合判定法,即,應用著眼於檢查之靈敏度的截斷值α 132466.doc -13- 200917148 來判斷陽性或者陰性之除外診斷、以及應用著眼於檢查之 特異度的截斷值β來判斷陽性或陰性之確定診斷,藉此能 對受試驗者有效且可靠地進行檢診,從而可降低其診斷費 用。 【實施方式】 以下,參照圖式,對本發明之檢診資訊管理系統及檢診 資訊管理方法之較佳實施形態進行詳細地說明。再者,於 圖式之說明中,對於相同要素附以相同符號,省略重複的 說明。又,圖式之尺寸比率未必與說明對象一致。 圖1係概略表示本發明之檢診資訊管理系統之第1實施形 態之構成的方塊圖。又,圖2係表示圖1所示之管理系統中 所實施的檢診資訊管理方法之基本概念之流程圖。 此處,圖1所示之檢診資訊管理系統1Α係將預備檢診與 本檢診假設為對受試驗者所實施的檢診’並對該等檢診之 實施狀況、實施預定及所得之結果等進行管理之管理系 統。所謂本檢診,係指含有取得受試驗者之斷層圖像並進 行診斷的圖像診斷之檢診。作為上述圖像診斷之例,可列 舉PET檢查、X線CT (Computed Tomography,電腦斷層掃 描)檢查、MRI (Magnetic Resonance Imaging,磁振造影) 檢查等。又,所謂預備檢診,係指含有於圖像診斷前所進 行的用於對本檢診之實施進行判定之筛選診斷的檢診。作 為上述篩選診斷之例,可列舉尿檢查、血液檢查等。 本實施形態之檢診資訊管理系統1A之構成為具備檢診資 訊管理裝置1 0、輸入部50及輸出部60。又,檢診資訊管理 132466.doc -14- 200917148 裝置〇具有.檢沴資料輸入控制部丨丨、管理資訊輸出控制 部12、檢診資料庫20及管理判斷部15。 檢診資料輸入控制部n對將受試驗者之檢診資訊等檢診 資:向管理裝置10中之輸入加以控制、實行。於該輸入控 制部11上,連接有輸入部5〇。於該構成中,輸入部5〇係作 為用於對文式驗者之檢诊資訊進行輸入的檢診資訊輸入機 構而發揮功能。。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 [Prior Art] The positron emission tomography (PET: p〇sitr〇n Emissi〇n Ding, the sand coffee) is the following method: the element (RI) of the positive electron (positron) is released from the subject. The identified substance is used as a tracer to measure a pair of 7 lines generated by the annihilation of the positive electrons emitted from the RI substance and the electrons in the normal substance, thereby obtaining the information of the subject. Using the above-described method, the subject is administered a tracer containing a phantom substance to the subject, and a pair of r lines from the RI substance are measured by the above method, and the in vivo distribution of the RI substance is measured. In this way, a tomographic image of a subject who can image and quantify the physiology and biochemistry information in the living body can be obtained, and a cancer examination or a brain examination can be performed by referring to the tomographic image. Like diagnosis. In addition, as a method of obtaining a tomographic image and diagnosing a subject, in addition to PET examination, CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) examination are also performed. It has been put into practical use (refer to Patent Documents 1 and 2). Patent Document 1: Japanese Laid-Open Patent Publication No. Hei. No. Hei. No. Hei. No. Hei. No. Hei. No. Hei. No. Hei. No. Hei. No. Hei. No. Hei. Image diagnosis, which can obtain the internal information of the subject and make necessary diagnosis without non-invasion. However, in the diagnosis using such tomographic images, there is the following problem: the device is large, and the diagnostic cost at one time is high. The above-mentioned high diagnostic costs are particularly problematic in the case of regular and repeated examinations. The present invention has been made in order to solve the above problems, and an object of the present invention is to provide a medical examination information management system and a medical examination information management method which can effectively perform examinations for a subject and thereby reduce the diagnosis cost thereof. Technical Solution to Problem In order to achieve the above object, the medical information management system of the present invention is characterized in that it is a manager for the examination information of the subject, and the inspection information management system has: (1) inspection information a database for each of the subjects to memorize the medical information*. The medical information includes: the medical examination information including the diagnosis of the image of the subject and the diagnosis of the diagnosis, And pre-examination information for the preliminary examination of the diagnosis performed prior to the diagnosis of the image; and (2) the management judgment institution, which performs the examination and examination on the subject according to the preliminary examination information and the examination information. Management (3) The above-mentioned management judgment means has a judgment information memory means for memorizing the judgment method applicable to the subject in the preliminary examination for judging the execution of the examination. Further, the method for managing a medical examination information of the present invention is characterized in that it is a manager for the examination information of the subject, and the management method for the inspection information includes: (a) a step of inputting the medical information, which inputs the following information, In other words, 132466.doc 200917148, which contains the diagnosis of the image of the subject and the diagnosis of the diagnosis, and the pre-examination of the pre-examination of the diagnosis performed before the diagnosis of the image. Diagnostic information, and for each subject, memorize the poor and poor materials containing the pre-examination of the tribute and the information of the pharmacy in the quarantine library; and (b) the management judgment step, The management of the examination and the implementation of the examination according to the preliminary examination information and the examination information; and (c) in the above-mentioned management judgment step, in the preliminary examination for determining the implementation of the examination, the use of the advance The prepared judgment method is applicable to the subject. In the above-mentioned inspection information management system and management method, the examination performed by the subject is performed by a combination of the following examinations, that is, an image diagnosis in which a tomographic image is acquired and diagnosis is performed. This examination, and a preliminary examination containing a diagnosis by a method that is easier to diagnose by image (hereinafter referred to as screening diagnosis with respect to image diagnosis), and for each subject, will contain The pre-examination information and the information on the inspection information of this inspection information are stored in the inspection information database to manage the examination and implementation of the subjects. Thereby, the subject can be effectively examined, thereby reducing the cost of diagnosis. Further, in the above configuration, the determination method applied to the subject is prepared in advance in the memory mechanism for the preliminary examination used in the determination of whether or not the examination is performed. In this way, it is possible to appropriately evaluate the necessity of performing the examination, and the like, and it is possible to reliably determine the implementation of the examination. More specifically, the medical information management system of the present invention is characterized in that it is a manager for the examination information of the subject, and the inspection information management system has: (1) a medical information database for the examination, which is directed to Each subject is recorded 132466.doc 200917148 Recalling the medical information tribute 'The consultation is poor. The inspection includes the examination that contains the image of the patient's tomogram and the diagnosis of the diagnosis. Diagnostic information and pre-examination information for pre-examination of screening diagnoses performed prior to image diagnosis; and (2) management judgment agency, which conducts test on the subject based on the pre-examination information and the review information The management of the inspection implementation; and the above-mentioned management judgment organization has (3) a judgment information memory mechanism in which a judgment method for determining a plurality of types of different criteria in the preliminary examination for determining the implementation of the examination is used, and Selecting a selection condition suitable for the subject's judgment method from the plurality of types of determination methods; and (4) determining the method selection means, referring to the subject's examination information, or There Detection and Diagnosis in at least one of the plurality of stored diagnostic information by detecting the data of the test subject, according to a selection condition, ready for FDD, in the determination of multiple types selected optional method suitable for determining the test method of the subject. Further, the method for managing a medical examination information according to the present invention is characterized in that it is a manager for the examination information of the subject, and the management method for the inspection information includes: (a) a step of entering the inspection information, which inputs the following information: The medical examination information including the diagnosis of the image of the subject and the imaging diagnosis of the diagnosis, and the preliminary examination information of the preliminary examination including the screening diagnosis performed before the image diagnosis, and Each of the subjects will be kept in the check-up information database containing the information on the pre-examination of the poor and the information on the check-up; and (b) the management judgment step based on the preliminary check-up information and The inspection information is used to manage the examination and implementation of the subject; and the management judgment step includes a determination method selection step, and (c) the pre-preparation determination is used in the preliminary examination for determining the implementation of the examination. The standard is different. The method of determining the number of types and the selection condition for selecting the judgment method applicable to the subject from the above-mentioned plural types of judgment methods, (d) and referring to At least one of the test information of the tester or the test and storage data storing the data of the plurality of test subjects of the test subject is selected according to the selection condition, and the test for the plural type is selected for the preliminary test. The judgment of the subject. In the above-mentioned inspection information management system and management method, the examination performed by the subject is performed by a combination of the following examinations, that is, an image diagnosis in which a tomographic image is acquired and diagnosis is performed. This examination, and a pre-examination of the diagnosis (diagnostic diagnosis based on image diagnosis) by means of a simpler method than image diagnosis, and will include a preliminary examination for each subject The information on the information and the information on the medical examinations are stored in the medical information database for the management of the examination and implementation of the subjects. Thereby, the subject can be effectively examined, thereby reducing the cost of diagnosis. Further, in the above-described configuration, two or more determination methods are prepared for the preliminary examinations used in the determination of whether or not to perform the examination. Further, with reference to the medical examination data including at least one of the medical examination information and the medical examination and storage materials, the determination method in the preliminary examination which can be applied to the subject who is the subject of the examination is selected according to the specific selection conditions. In this way, it is possible to perform a highly accurate evaluation of the necessity of performing the examination, and the like, and it is possible to reliably determine the implementation of the examination. Alternatively, the inspection information management system of the present invention is characterized in that it is a manager of the examination information of the subject, and the inspection information management system has 132466.doc -10- 200917148 Preparation: (1) Inspection information a database for each of the subjects to memorize the information of the examination, the inspection information includes: the examination information including the examination for obtaining a tomographic image of the subject and performing diagnostic imaging diagnosis, And pre-examination information for the preliminary examination of the diagnosis performed prior to the diagnosis of the image; and (2) the management judgment institution, which performs the examination and examination on the subject according to the preliminary examination information and the examination information. (3) The above-mentioned management judging means has: a judgment information storage means "which stores a judgment method suitable for the subject in the preliminary examination for judging the implementation of the examination; and a judgment implementation judgment means, It judges the implementation of this examination according to the results of the preliminary examination conducted by the application judgment method; (4) The judgment method in the preliminary examination combines the exclusion diagnosis and the determination diagnosis In the determination method for judging, the above-mentioned exclusion diagnosis system uses a cutoff value α set by the sensitivity of the examination to judge a positive or negative diagnosis, and the above-described determination diagnosis is judged by using the cutoff value β set by the specificity of the examination. Positive or negative diagnosis. Further, the method for managing a medical examination information of the present invention is characterized in that it is a manager for the examination information of the subject, and the management method for the inspection information includes: (a) a step of inputting the medical information, which inputs the following information, In other words, the medical examination information including the diagnosis of the image of the subject and the imaging diagnosis of the diagnosis, and the preliminary examination information including the preliminary examination for the diagnosis performed before the image diagnosis, and For each subject, the information on the pre-examination information and the information on the inspection information will be stored in the inspection information database; and (b) the management judgment step, based on the preliminary inspection information and the inspection Diagnostic information, management of the examination and implementation of the subject; (c) Management 132462.doc -11 - 200917148 The judgment step includes a review and implementation determination step, which is in the preliminary examination for judging the implementation of the examination. Use the pre-prepared judgment method applicable to the subject, and judge the implementation of the examination according to the results of the preliminary examination conducted by the application judgment method. (d) Judgment in the preliminary examination The method of judging a combination of the diagnosis and the determination of the diagnosis, the above-mentioned exclusion diagnosis is based on the cutoff value α set by the sensitivity of the examination to determine a positive or negative diagnosis, and the above-mentioned determination diagnosis is applied to the examination. The cut-off value β set by the specificity is used to judge the diagnosis of positive or negative. In the above-mentioned inspection information management system and management method, the examination performed by the subject is performed by a combination of the following examinations, that is, an image diagnosis in which a tomographic image is acquired and diagnosis is performed. This review, and a pre-examination of the diagnosis (diagnostic diagnosis based on image diagnosis) with a simpler method than image diagnosis, and for each subject, will contain pre-examination information. The information on the examination of the inspection information is stored in the inspection information database to manage the examination and implementation of the subject. Thereby, the subject can be effectively examined, thereby reducing the cost of diagnosis. Furthermore, in the above-described configuration, the determination method of the preliminary examination used in the determination of whether or not the present examination is performed is a combination determination method in which the following diagnosis is combined, that is, the application is focused on the sensitivity of the examination. The value (X is used to determine the positive or negative exclusion diagnosis, and the cut-off value β of the specificity of the examination is used to determine the positive or negative determination. Therefore, the necessity of performing the examination for the subject can be performed. Accurate evaluation makes it possible to reliably judge the implementation of the examination. 132466.doc •12- 200917148 For the specific examination contents of the subjects, in the preliminary examination, the screening diagnosis is better. At least one of the urine test and the blood test is performed as a preliminary test before the present examination, thereby appropriately determining whether or not to perform the test, etc. Further, in the present examination, it is preferable It is an image diagnosis including at least one of a PET examination, a CT examination, and an MRI examination. Effect of the invention According to the examination information management system and management method of the present invention, For the examination performed by the subject, the examination including the image diagnosis and the preliminary examination including the screening diagnosis are performed, and the preliminary examination used in the determination of whether or not to perform the examination is performed. In the diagnosis, the judgment method applicable to the subject is prepared in advance in the memory mechanism, and by this configuration, the subject can be effectively and reliably examined, and the diagnosis cost can be reduced. More specifically, The examination conducted by the subject is a combination of the examination including the image diagnosis and the preliminary examination including the screening diagnosis, and the determination of the plural type of the determination criteria is prepared for the preliminary examination. And referring to at least one of the inspection information material or the examination and storage data, according to the specific selection conditions, selecting a judgment method suitable for the subject's preliminary examination, thereby enabling the subject to perform the test effectively and reliably The examination will reduce the cost of the diagnosis. Or, the examination for the subject will include the examination of the image diagnosis and the preliminary examination with the screening diagnosis. The diagnosis is performed in combination with the diagnosis, and as the determination method in the preliminary examination, the composite determination method using the following combination of diagnosis, that is, the cutoff value α 132466.doc -13 - 200917148 focusing on the sensitivity of the examination is used. A positive or negative exclusion diagnosis, and a cut-off value β that focuses on the specificity of the examination to determine a positive or negative determination diagnosis, can effectively and reliably perform a diagnosis on the subject, thereby reducing the diagnosis cost. [Embodiment] Hereinafter, preferred embodiments of the medical examination information management system and the medical examination information management method of the present invention will be described in detail with reference to the drawings, and in the description of the drawings, the same elements are attached. The same reference numerals are given to the first embodiment of the medical examination information management system of the present invention. Further, Fig. 2 is a flow chart showing the basic concept of the inspection information management method implemented in the management system shown in Fig. 1. Here, the medical information management system 1 shown in FIG. 1 assumes that the preliminary examination and the current examination are assumed to be the examinations performed by the subject, and the implementation status, implementation schedule, and income of the examinations are performed. The management system that manages the results. The term "this examination" refers to a diagnosis that includes an image diagnosis that obtains a tomographic image of a subject and performs diagnosis. Examples of the above image diagnosis include PET examination, X-ray CT (Computed Tomography) examination, MRI (Magnetic Resonance Imaging) examination, and the like. In addition, the preliminary examination refers to a diagnosis including screening diagnosis for determining the implementation of the examination before the diagnosis of the image. Examples of the above screening diagnosis include urine test, blood test, and the like. The medical examination information management system 1A of the present embodiment is configured to include a medical examination management device 10, an input unit 50, and an output unit 60. Further, the inspection information management 132466.doc -14- 200917148 device has the inspection data input control unit, the management information output control unit 12, the examination database 20, and the management determination unit 15. The examination data input control unit n controls and executes the input of the examination information such as the examination information of the subject to the management device 10. An input unit 5 is connected to the input control unit 11. In this configuration, the input unit 5 functions as a review information input means for inputting the examination information of the style examiner.
作為經由輸入控制部U而輸入至管理裝置1〇的檢診資 料,主要有檢診資訊資料與檢診储存資料。檢診資訊資料 係含有各個受試驗者之檢診相關資訊的資料。具體的檢診 貝訊資料有.含有圖像診斷之本檢診的本檢診資訊之資 料、及含有篩選診斷之預備檢診的預備檢診資訊之資料。 又,檢诊儲存資料係對於複數個受試驗♦,儲存有檢診之 實施内容、實施結果等必要資料的資料。亦可構成為,對 於上述檢診储存資料,只要*需要,則不輸人至管 10中。 管理資訊輸出控制部12對於管理裝置10中記憶、管理或 者生成的受試驗者之檢診的㈣資訊向外部之輪出加以控 制、實仃。對於該輸出控制部12,連接有輸出部60。輸出 。刚係用於對受試驗者之預備檢診、本檢診之實施狀況、 實她預疋、或者所得之結果等之管理資訊進行輸出的管理 資訊輸出機構。 作為連接於管理裝置1G之輸人控制部_輸人部5〇,可 使用例如鍵盤或滑氣等輸入裝置51、連接有外部裝置㈣ 132466.doc 200917148 作為經由外部I/F52而連接於管理裝 可舉出例如一種檢查裝置,其對受試 ,並輸出檢查結果所得之資料。 外部I/F52等。此處, 置10的外部裴置53, 驗者進行特定之檢查 又,作為連接於輸出控制部12之輸出部6〇,可使用例如 對操作者顯示用以呈現管理資訊之輸出畫面的顯示裝置 理貝訊印刷於紙面上並作為檔案而輸出的印刷裝 置62等。x,對於顯示裝置61 ’較好的構成為,除上述的 管理資訊之輸出畫面以外’可顯示在將必要的檢診資訊從 輸入部5G向操作者輸人時所使用的輸人晝面。再者,對於 、Γ衿入畫面,亦可構成為,顯示在與輸出晝面不同的顯 示裝置中。As the inspection materials input to the management device 1 via the input control unit U, there are mainly the inspection information materials and the examination and storage materials. The check-up information is information that contains information about the examinations of each subject. Specific examinations The information of the Bayesian information includes the information of this examination and the information of the pre-examination of the pre-examination of the screening diagnosis. In addition, the inspection and storage data is for a plurality of tests ♦, and stores the necessary information such as the implementation contents and implementation results of the examination. It may also be configured such that, for the above-mentioned inspection and storage materials, as long as *required, the person is not admitted to the tube 10. The management information output control unit 12 controls the actual (4) information of the examination of the subject who is memorized, managed, or generated in the management device 10 to the external rotation. An output unit 60 is connected to the output control unit 12. Output. A management information output mechanism that is used to output management information such as the pre-test of the subject, the status of implementation of the test, the actual results, or the results obtained. As the input control unit_input unit 5 connected to the management device 1G, an input device 51 such as a keyboard or a slippery air, and an external device (4) 132466.doc 200917148 can be connected to the management device via the external I/F 52. For example, an inspection device that tests the test and outputs the data obtained by the inspection result can be cited. External I/F52, etc. Here, the external device 53 of the 10 is placed, and the examiner performs a specific inspection. Further, as the output unit 6 connected to the output control unit 12, for example, a display device for displaying an output screen for presenting management information to the operator can be used. A printing device 62 that is printed on a paper surface and output as a file. x is preferable in that the display device 61' is configured to display an input face used when the necessary review information is input from the input unit 5G to the operator, in addition to the above-described management information output screen. Further, the screen may be displayed in a different display device than the output screen.
對於從輸入部50經由檢診資料輸入控制部u所輸入之檢 診資料,於㈣裝置10中,視需要㈣特定之資料形式儲 2於檢診資料庫20中(檢診資訊輸入步驟),本實施形態之 s理系統1A中,檢診資料庫2G之構成為具有檢診資訊資料 庫21與檢診儲存資料庫22。 檢診資訊資料庫2丨係針對每一位受試驗者,對受試驗者 已實施的或者預定實施的檢診之預備檢診資訊及本檢診資 訊進行記憶之資料庫。又,對於該資料庫21而言,較好的 疋除包含預備檢诊資訊及本檢診資訊之檢診資訊資料以 外’還儲存有包含受試驗者之姓名、性別、出生年月曰等 個人資訊之基本資料、以及包含受試驗者之既往資訊的病 歷資料等必要資料。 檢診儲存資料庫22係視需要而對儲存有檢診之複數個受 132466.doc •16- 200917148 試驗者之資料的檢診儲存資料進行記憶之資料庫。上述檢 #儲存資料藉由如下方法而製作:例如在進行檢診之設施 (醫院、檢診中心等)中,將之前對複數個受試驗者所實施 的檢診之實施内容、實施結果等資料進行儲存。或者,亦 "T使用藉由使複數個設施間丘有棟在眘祖品癌m t 一 u 1虿储存貝枓而製作的資料來 作為檢診儲存資料。又,噹蛤吟 、 邊檢沴儲存資料庫22亦可構成 為,只要無需則不設置。The inspection data input from the input unit 50 via the examination data input control unit u is stored in the examination database 20 (in the inspection information input step) in the (4) device 10 as needed (4). In the semaphore system 1A of the present embodiment, the inspection database 2G is configured to include the examination information database 21 and the examination storage database 22. The Inspection Information Library 2 is a database for each subject to be tested for the pre-examination information of the examinations that have been carried out or scheduled for the trial and the information of the examination. In addition, for the database 21, it is better to remove the information including the pre-examination information and the medical information of the medical examination, and also include the name, sex, date of birth, etc. of the subject. The basic information of the information, as well as the medical information including the past information of the subject. The check-up repository 22 is a database that stores a plurality of check-ups stored in the 132466.doc •16-200917148 tester as needed. The above-mentioned inspection #storage data is produced by the following methods: for example, in the facilities (hospitals, inspection centers, etc.) where the examination is conducted, the contents of the implementation of the examinations and the results of the implementation of the examinations performed on the plurality of subjects before Save it. Or, it is used as a medical examination and storage data by making a number of facilities in the village of Mt. Further, the storage and storage of the database 22 may be configured so as not to be provided as long as it is unnecessary.
又,對於儲存於該檢診資料庫2〇中的檢診資料設置有 管理判斷部15。該管理判斷部15係根據資料庫2〇中所記憶 之預備檢診資訊及本檢”訊,對受試驗者進行檢診實施 之官理的管理判斷機構(管理判斷步驟)。管理判斷部15參 照記憶於資料庫20中的檢診資料,對於受試驗者的檢診之 實施内容、實施結果、或者今後檢診之實施預定進行必要 的判斷。又,經管理判斷部15所判斷之管理資訊經由輸出 控制部12 ’從輸出部6〇向操作者輸出。 管理判斷部15具有:檢診實施判定部16、判定資訊記憶 部17及判定法選擇部18。管理判斷部15對於受試驗者的檢 診之實施進行必要的判斷。即,對受試驗者之檢診係不定 期地實施、或者於固定期間(檢診實施間隔)定期地實施。 管理判斷部1 5對於上述受試驗者的檢診之實施内容、實施 預定等進行判斷。 檢診實施判定部16係對於受試驗者的檢診之實施進行判 定之檢診實施判定機構。該檢診實施判定部16根據應用特 定之判定法所進行的預備檢診之結果,對本檢診之實施進 132466.doc 17 200917148 行判定(檢診實施判定步驟)。關於此時的判定内容,具體 而5,可列舉是否實施本檢診、是否實施下一次的預備檢 6乡、或者其等檢診之實施時間等。 又,於本實施形態中,對管理判斷部丨5而言,對於包含 在本檢診之圖像診斷(PET檢查等)以前所進行的篩選診斷 (尿檢查等)之預備檢診中的檢診内容、以及基於預備檢診Further, the management determination unit 15 is provided for the examination materials stored in the examination database. The management judging unit 15 is a management judging unit (management judging step) for performing an examination of the subject according to the preliminary examination information and the current examination information stored in the database 2 (management determination step). The management judging unit 15 With reference to the examination data stored in the database 20, it is necessary to make necessary judgments on the implementation contents of the examination of the subject, the implementation results, or the implementation schedule of the future examination. Further, the management information judged by the management judgment unit 15 The output is controlled by the output control unit 12' from the output unit 6 to the operator. The management determination unit 15 includes a diagnosis execution determination unit 16, a determination information storage unit 17, and a determination method selection unit 18. The management determination unit 15 is for the subject. The examination is carried out in a necessary manner. That is, the examination of the subject is performed irregularly or periodically during the fixed period (inspection interval). The management judgment unit 1 checks the above-mentioned subjects. The examination execution execution determination unit 16 is a diagnosis execution determination unit that determines the implementation of the examination of the subject. The determination unit 16 determines the execution of the examination according to the result of the preliminary examination by the application-specific determination method, and determines (the examination execution determination step). The content of the determination at this time is specifically 5 In addition, in the present embodiment, the management determination unit 丨5 is included in the present invention, whether or not the present examination is carried out, whether or not the next preliminary inspection is performed, or the implementation time of the examination is performed. Examination of diagnostic imaging (PET examination, etc.) Previous screening examinations (urine examinations, etc.) in the preliminary examinations, and based on preliminary examinations
之結果的判定,準備罹病率之判定標準不同的複數種類之 判定法。具體而言,於管理判斷部15之判定資訊記憶部17 中6己憶並預先準備有判定標準不同的n種類0為2以上之 整數)之判定法:判定法i、判定法2.....判定法n(參照圖 2)。又,於判定資訊記憶部17中,對於該等η種類之判定 法,準備預先決定之選擇條件,用以從判定法丨〜判定法η 中選擇適用於受試驗者的一個判定法。 判定法選擇部18係在判定f訊記憶部17所準備的η種類 之判定法中’選擇可適用於受試驗者之判定法的判定法選 =機構。如圖2所示,判定法選擇部18將受試驗者之檢診 ^ Λ貝料、或者檢診料資料之至少-者作為用以選擇判 疋去之必要的檢診資料’並從檢诊資料庫2G或者經由輸入 控制部11而從輸入部50取得(步驟si〇i)。The determination of the result is a determination method of a plurality of types in which the criteria for determining the rate of rickets are different. Specifically, the determination information storage unit 17 of the management determination unit 15 recalls that the n-type 0 having a different determination criterion is an integer of 2 or more in advance: the determination method i, the determination method 2... .. determination method n (refer to Figure 2). Further, the determination information storage unit 17 prepares a predetermined selection condition for the determination method of the η type, and selects one of the determination methods applicable to the subject from the determination method 判定 to the determination method η. The determination method selection unit 18 selects a determination method selection means that is applicable to the judgment method of the subject in the determination method of the η type prepared by the f-memory unit 17. As shown in FIG. 2, the determination method selection unit 18 uses at least one of the examiner's examination, the sputum, or the inspection materials as the necessary examination information for selecting the sputum and the inspection. The database 2G is acquired from the input unit 50 via the input control unit 11 (step si〇i).
’選擇部18參照所取得之檢診資料,根據判定資訊 2部17所準備的選擇條件,對判定法卜判定法种適用 p試驗者的預備檢料m加㈣ G =步驟)。該選擇部18之判定法之選擇結果視需要-自輸出⑽向操作者輸出、提示。又,檢診實施判定部16 132466.doc -18- 200917148 根據應用判疋法選擇部丨8巾所選擇的判定法*進行的預備 檢診之結果,對本檢診之實施進行判定。 >上述檢診資訊管理裝置聞如可藉由以下部分而構成: 檢β貝afl f理中執行必要的檢診實施判定處理及判定法選 擇處理等錢處理之CPU、記憶有處理動作中必要的各軟 體程式等之ROM、以及檢診資料庫2()中使用的内部記憶體 或者外部記憶裝置等記憶裝置。The selection unit 18 refers to the acquired examination data, and based on the selection conditions prepared by the determination information 2 unit 17, applies the preliminary sample m of the p tester to the determination method determination method (4) G = step). The selection result of the determination method of the selection unit 18 is outputted and presented to the operator as needed from the output (10). Further, the inspection execution determination unit 16 132466.doc -18- 200917148 determines the execution of the examination based on the result of the preliminary examination by the determination method* selected by the application selection method. > The above-mentioned inspection information management device can be configured as follows: It is necessary to perform a necessary processing such as a checkup execution determination process and a determination method selection process, etc. The ROM of each software program, and the internal memory or external memory device used in the inspection database 2 ().
* X下對上述實施形態之檢診資訊管理系統及檢診資訊 ^理方法之效果進行說明。 於圖1及圖2所示的檢診資訊管理系統】A及檢診資訊管理 方法中,關於對受試驗者所實施之檢診,係將以下檢診組 ^而進行檢診,即,含有取得斷層圖像並進行診斷之圖像 診斷的本檢診、及含有藉由較圖像診斷更簡易之方法所進 行之篩選診斷的預備檢診。λ,針對每一位受試驗者,將 含有預備檢診資訊及本檢診資訊之檢診資訊資料記憶於管 理裝置10之檢診資訊倾庫21中,以對受試驗者進行檢診 實施之管理。藉此,能對受試驗者有效地進行檢診,從而 可降低其診斷費用。 進而,於上述構成中,對於在是否實施本檢診之判定等 中所使用的預備檢診,於判定資訊記憶部17中,準備判定 標準互不相同的兩種以上之判定法。然後,於μ法選= 部18中,參照含有檢診資訊資料或者檢診儲存資料之至少 一者的檢診資料,根據特定之選擇條件, 夕 擇可適用於成 為檢鉍對象之受試驗者的預備檢診中 巧疋在。藉此,對 132466.doc -19· 200917148 於受試驗者實施本檢診之必要性等可進行精度良好的評 價,從而對於檢診之實施能夠可靠地進行判定。 此處,作為含有圖像診斷之本檢診,使用例如PET檢 查、CT檢查及MRI檢查中之至少一者。PET檢查係將含有 RI物質的放射性藥劑輸入到受試驗者之體内,觀察從體内 放出的放射線,藉此取得血流量、氧代謝、葡萄糖代謝、 神經傳達物質等的功能資訊之檢查。該檢查方法中,一次 之檢查費用高額,而且受試驗者會遭受放射線暴露。 又,X線CT檢查係對受試驗者照射X線並使其穿透體 内,根據其穿透率之不同而取得體内組織解剖學的資訊之 檢查。於上述檢查方法中,受試驗者會遭受放射線暴露。 又,MRI檢查係對受試驗者提供強磁場並觀察體内氫原子 核之狀態,藉此取得體内組織解剖學之資訊及血液量等的 功能資訊之檢查。 相對於此,如上所述,將含有以簡易且便宜之方法可實 施的筛選診斷之預備檢診、與含有圖像診斷之本檢診組合 而進行檢診,藉此可如上所述,對受試驗者有效地進行檢 診。又,根據檢診資料而選擇預備檢診中之判定法,以此 提高對本檢診實施之必要性等之評價精度。而且,如此對 本檢診實施之必要性準確地進行判斷,從而可將對受試驗 者實施檢診而導致的放射線暴露抑制為最小限度。 作為預備檢診中之筛選診斷,較好的是含有尿檢查及血 液檢查中之至少一者。將該檢查作為在本檢診之前的預備 檢診而實施,藉此可對是否實施本檢診適當地進行判斷。 132466.doc -20- 200917148 又,由於上述預備檢診為非入侵、簡易且便宜,從而可實 施反覆檢查。作為尿檢查之具體例,可列舉:尿蛋白質分 析法,其係對癌中呈異常表現之蛋白質等進行分析;尿喋 啶類分析法,其係對與癌或感染症所引起的免疫系統之活 性相關的喋咬類之量進行分析;以及尿螢光分析法等,其 係著眼於尿中之螢光化合物而進行分析。 又,對相對於含有圖像診斷之本檢診的預備檢診而言, 將複數種類之篩選診斷加以組合而實施,此在提高是否實 施本檢診之判斷精度方面較佳。作為此時篩選診斷之組 合,有如下方法:例如,將上述複數種類之尿檢查(A尿檢 查、B尿檢查、C尿檢查、…)組合而使用,或者將尿檢查 與血液檢查組合而使用。又,亦可利用尿檢查、血液檢查 以外之篩選診斷。關於在預備檢診中進行的篩選診斷,與 預備檢診中之判定法之選擇加以結合後,於以下描述。 又,對於本檢診而言,如上所述,作為圖像診斷,較好 的是含有PET檢查、X線CT檢查及MRI檢查中之至少一 者。又,為提高對受試驗者之檢診之精度,亦可將PET檢 查、CT檢查及MRI檢查組合之綜合圖像診斷、或者將上述 三種類之檢查再與US(超音波)檢查組合之綜合圖像診斷作 為本檢診。 又,上述實施形態之管理系統1A可設有如下構成,即, 於管理判斷部1 5中設置檢診實施判定部1 6,該檢診實施判 定部1 6係根據應用判定法選擇部1 8中所選擇之判定法而進 行的預備檢診之結果,對本檢診之實施、或者必要時下一 132466.doc -21 - 200917148 可對受試驗者適當地進行 次檢診之實施進行判定。藉此 檢♦實施之管理。* The effect of the inspection information management system and the inspection information method of the above embodiment will be described under X. In the inspection information management system A and the inspection information management method shown in FIG. 1 and FIG. 2, the examination for the subject is performed by the following inspection group, that is, including This examination for obtaining a tomographic image and performing diagnostic imaging diagnosis, and a preliminary examination including screening diagnosis by a method that is easier than image diagnosis. λ, for each subject, the medical information containing the preliminary examination information and the medical examination information is stored in the examination information dump 21 of the management device 10 to perform the examination and examination on the subject. management. Thereby, the subject can be effectively examined, thereby reducing the cost of diagnosis. Further, in the above-described configuration, the determination information storage unit 17 prepares two or more determination methods in which the determination criteria are different from each other in the preliminary examination used in the determination of whether or not the present examination is performed. Then, in the μ method selection unit 18, referring to the examination data including at least one of the inspection information material or the examination and storage data, according to the specific selection condition, the selection can be applied to the subject who is the subject of the examination. The preparatory examination is clever. Therefore, it is possible to perform an accurate evaluation on the necessity of performing the examination on the subject, such as 132466.doc -19· 200917148, and it is possible to reliably judge the implementation of the examination. Here, as the present examination including image diagnosis, at least one of a PET test, a CT test, and an MRI test is used. In the PET examination, a radioactive drug containing an RI substance is introduced into a subject, and radiation emitted from the body is observed, thereby obtaining functional information such as blood flow, oxygen metabolism, glucose metabolism, and nerve communication substance. In this inspection method, the inspection cost is high at one time, and the subject is exposed to radiation. Further, the X-ray CT examination irradiates the subject with X-rays and penetrates the body, and obtains information on the anatomy of the body in accordance with the difference in the transmittance. In the above inspection method, the subject is exposed to radiation. Further, the MRI examination provides a strong magnetic field to the subject and observes the state of the hydrogen nucleus in the body, thereby obtaining information on the information of the anatomy of the body and the function information of the blood volume. On the other hand, as described above, the preliminary examination including the screening diagnosis which can be performed by the simple and inexpensive method is combined with the present examination including the image diagnosis, and the diagnosis can be performed as described above. The subject is effectively examined. In addition, the judgment method in the preliminary examination is selected based on the examination data, thereby improving the evaluation accuracy of the necessity of performing the examination and the like. Further, by accurately determining the necessity of the present examination, it is possible to minimize radiation exposure caused by the examination of the subject. As the screening diagnosis in the preliminary examination, it is preferred to include at least one of a urine test and a blood test. This examination is carried out as a preliminary examination before the examination, so that it is possible to appropriately judge whether or not to perform the examination. 132466.doc -20- 200917148 In addition, since the above-mentioned preliminary examination is non-invasive, simple and inexpensive, it is possible to carry out repeated examinations. Specific examples of the urine test include a urine protein analysis method for analyzing a protein which is abnormally expressed in cancer, and a urinary acridine analysis method for an immune system caused by cancer or an infection. The amount of activity-related bites is analyzed; and urinary fluorescence analysis or the like is performed by focusing on fluorescent compounds in urine. Further, it is preferable to combine a plurality of kinds of screening diagnoses with respect to the preliminary examination for the present examination including the image diagnosis, and it is preferable to improve the judgment accuracy of the present examination. As a combination of screening diagnosis at this time, there is a method in which, for example, a plurality of types of urine tests (A urine test, B urine test, C urine test, ...) are used in combination, or a urine test and a blood test are used in combination. . In addition, screening tests other than urine tests and blood tests can also be used. The screening diagnosis performed in the preliminary examination is combined with the selection of the judgment method in the preliminary examination, and is described below. Further, as for the examination, as described above, it is preferable to include at least one of a PET test, an X-ray CT test, and an MRI test as an image diagnosis. In addition, in order to improve the accuracy of the examination of the subject, it is also possible to combine the comprehensive image diagnosis of the PET examination, the CT examination and the MRI examination, or the combination of the above three types of examinations with the US (ultrasonic) examination. Image diagnosis is used as this examination. Further, the management system 1A of the above-described embodiment may be configured such that the management determination unit 1 is provided with a diagnosis execution determination unit 1 6 which is based on the application determination method selection unit 18 The results of the preliminary examination conducted by the judgment method selected in the above may be carried out for the implementation of this examination or, if necessary, the next inspection of the subject. This will be used to check the implementation of the management.
又,關於本管理系統1A對管理對象之檢診,較好的是, 试驗者每隔特定之檢診實施間隔反覆實施的複數次檢 (定期檢β )進行綜合的管理。於此情形時,檢診資訊資 料庫21中’記憶㈣受試驗者定期實施的錢次檢診中各 典的預備檢5乡f訊及本檢診資訊。藉此,對於定期實施的 ::驗者之檢診,可進一步提高其整體效率。關於如此進 仃疋期檢5乡時的檢診實施間㊣,可視需要而適當設定,但 亦可設為例如1年間隔。 對於圖i所示之管理系、㈣之檢診資訊管理方法,將進 2具體的說明。圖3係表示管理裝置1〇之㈣判斷部15 中實仃的檢診資訊管理方法之一具體例的流程圖。 備以下說明巾’作為判定資訊記憶部17所準備的預 ^之複數種類之判定法’準備有如下三種類之 低標準判定法、羅病率中標準判定法及羅病率 疋法。又,關於對受試驗者實施的檢診中成為診 ^ ^病’將對主^以癌作為診斷對象之癌檢診進行 於窟檢:疋’本發明之管理系統及管理方法亦可同樣適用 於癌檢移以外之各種各樣的檢診。 檢:!二示之管理方法中,判定法選擇㈣首先參照從 是庫21中讀出的受試驗者之病歷資料,判斷-❹者(步驟S2G1)。接著,若為有癌病史者,、 病率高,從而選擇高標準判定法作為預備檢診中 I32466.doc -22- 200917148 之判定法。 另 ’▲無既往病史時’則進一步判斷於 内(例如3年以内)含有圖像診斷之本檢診是否已= (2) ’、、、後,右有受診經歷,則參照記憶於檢診資訊資 料庫21中之訊資料,根據對應的選擇條件,從上述 種類之判疋法中選擇預備檢診中之判定法(S203)。又, 右‘、’、又歷’則參照記憶於檢診儲存資料庫22中之檢誇 儲存資料,根據對應的選擇條件,同樣從三種類之判定: 中選擇預備檢診中之判定法(S2〇4)。In addition, it is preferable that the management system 1A checks the management target, and the tester performs comprehensive management for a plurality of inspections (periodical inspections) which are repeatedly performed at intervals of the specific examination execution interval. In this case, in the inspection information database 21, the memory (4) of the pre-examination of the code examinations and the inspection information of the samples in the regular examinations conducted by the subjects. In this way, the overall efficiency of the inspection can be further improved for the regular inspection of the examinee. In the case of the inspection, the implementation of the inspection at the time of the 5th inspection is appropriately set as needed, but it may be set to, for example, a one-year interval. For the management system shown in Figure i and (4) the inspection information management method, a detailed description will be given. Fig. 3 is a flow chart showing a specific example of a method of managing the medical examination information in the (4) determining unit 15 of the management device 1 . The following descriptions are prepared as the determination method of the plural type of the pre-form prepared by the information storage unit 17. The following three types of low-standard determination methods, the standardization method for the disease rate, and the disease rate method are prepared. In addition, in the examination of the subject, it is diagnosed as a diagnosis. The cancer examination for the diagnosis of the cancer is carried out in the examination: 疋' The management system and management method of the present invention are equally applicable. Various examinations other than cancer screening. In the management method of the second method, the selection of the determination method (4) first refers to the medical record data of the subject read from the library 21, and judges the latter (step S2G1). Then, if there is a history of cancer, and the disease rate is high, the high standard judgment method is selected as the judgment method of I32466.doc -22- 200917148 in the preliminary examination. In addition, ' ▲ no previous medical history' is further judged within (for example, within 3 years) whether the examination containing the image diagnosis has been = (2) ', ,, and after the right, there is a diagnosis, then refer to the memory for the examination The information in the information database 21 selects the determination method in the preliminary examination from the above-described types of judgments according to the corresponding selection conditions (S203). Moreover, the right ', ', and the calendar' refer to the stored data stored in the inspection and storage database 22, and the judgment method in the preliminary examination is also selected from the three types of judgments according to the corresponding selection conditions ( S2〇4).
在判疋法之選擇結束、預備檢診實施後,檢診實施判定 部16根據經由輸入控制部u所輸入的預備檢診之結果資 汛,對本檢診之實施進行判定。於圖3所示之具體例中, 低榼準判定法及中標準判定法分別判定進行圖像診斷之 「實施本檢診」、於特定期間後(例如3個月後)再次進行篩 選診斷之「再實施預備檢診」'以及直至特定時期(例如 下一個定期檢診時期)為止未檢診之「陰性」中之任— 者。又,於本實施例中,高標準判定法判定「實施本檢 診」及「再實施預備檢診」中之任一者,對於「陰性」不 作判定。 本實施例中’設為如下構成:根據於特定期間内本檢診 有無受診,將判定法之選擇中參照的檢診資料以檢診資訊 資料與檢診儲存資料進行轉換、合併,從而對判定法之選 擇條件進行轉換。藉此,可適當地選擇可適用於受試驗者 的預備檢診中之判定法。 132466.doc •23- 200917148 又’於上述構成中,亦可構成為,根據判定結果而指定 或者變 Λ 下一次檢珍中之判定法。作為上述構成,例如於 圖3之流程圖中,當判定我「$由 幻疋為再實施預備檢診」時,下一 次會從步驟S204開始判定 Ώ W疋’另-方面,當判定為「陰性」 時,下一次會從步驟S2〇1開始判定。 圖4係表示檢診資訊資 姜J疋法之選擇方法的流程圖 (圖3之步驟S203)。續大、土 ώ !( 亥方去中,判定法選擇部18從檢診資 成貝料庫21中取得受試驗者之檢診資訊資料⑻叫並抽 出前-次之檢診結果資訊’再參照該檢診結果資訊進行判 定法之選擇(S3G2)。對於具體的選擇條件^言,分別 檢診結果為「益里當 十土、 *' 」或者無品精查」時之低標準判定 法、「要經過觀察」時之中標準判定法、「要精查」時之 高標準判定法,並將其料適用於受試驗者之判定法。 如此Μ於對文δ式驗者之判定法之選擇,可採用如下構 成:參照從檢診資訊資料中抽出的前-次之檢診結果資 訊’選擇制於受試驗者的判定法。上述方法中,例如备 如上所述於特定期間内本檢診受診等情況下,可適當地^ 擇適用於受試驗者之判定法。 圖5係表示檢診儲存資料之判定法之選擇方法的流程圖 (圖次3之步驟S2G4)。該方法中,#】定法選擇部職檢診儲 存資料庫22中取得檢診儲存資料(請6),導出疾病風險之 推定資訊並參照該推定資訊❿進行车丨$法之選擇 (S307)對於具體的選擇條件而言,分別選擇推定罹病率 為a/〇以下時之低標準判定法、推定罹病率為以〜bQ/。時之中 132466.doc -24- 200917148 ==定法、推定羅病率為⑽以上時之高標準判定法, /、作為適用於受試驗者之判定法(其中,a<b)。 如:’關於對受試驗者之判定法之選擇,可採 照從檢診儲存資料導出的疾病風險之推定資訊二 =於受試驗者之判定法。上述方法中,例如當如上; 特定期間内本檢診未受診等情況下,可適當選擇適用 使用上當本檢診受診之情況下,亦可 述 > …、疾病風險之推定資訊的方法。 又’關於此時的疾病風險之推定方法,可使用如下方 去.例如,根據作為檢診儲存資料而儲存的複數 者之過去的檢診資料、治療資料等,按性別、年代、時: 等條件確認罹病率之資料, 時月 m K㈣並根據受試驗者之性別、年代 及檢診時期等而計算上述推定罹病率。 對i備欠=預備檢料適用之判定法進行具體說明。關於 、=檢;所準備之判定法,較好的是,複數種類之判定 法包括.第1判定法,其係在應用著眼於檢查之靈敏度所 設定之截斷值α來判斷陽性或陰 敏度所 ' &丨王 < 師選#斷中進行判 疋’以及第2判定法,里传在廡田从 -定之一在應者眼於檢查之特異度所 截斷值陶斷陽性或陰性之筛選診斷令進行判 疋0 又’較好的是,預備檢沴φ ν 之硬數種類之判定法包括第 3判定法,其係將如下筛選診斷加以組合而進二 用者眼於檢查之靈敏度所設定之截斷值時判斷陽 性或陰性之篩選診斷、以及座 + 辦以及應用者眼於檢查之特異度所設 132466.doc -25- 200917148 疋之截斷值β來判斷陽性或陰性之篩選診斷。 如此,對於預備檢診中之判定法,可將應用截斷值以之 ^斷ρ除外θ斷、與應用截斷值p之診斷即確定診斷分開 使用或者組合使用,藉此對於複數種類之判定法中之每一 、,去而。可適虽地構成與其判定標準相對應之判定 法。 μ $處,除外診斷係如上所述應用著眼於檢查之靈敏度所 叹疋之截斷值α者。如必匕’當在靈敏度高的檢查中判斷為 陰性時’則可基本無誤地判斷為陰性。因@,上述診斷對 於推定為罹病率低的受試驗者’在將真正健康者識別並去 除之情況下特別有效。 又,確定診斷係應用著眼於檢查之特異度所設定之截斷 值β者 > 此,當在特異度高的檢查中判斷為陽性時,則 可基本無誤地判斷為陽性。因此,上述診斷對於推定為罹 ^丙率㈣钱驗者,在_並確以正㈣After the completion of the selection of the judgment method and the execution of the preliminary examination, the examination and execution execution determination unit 16 determines the execution of the examination based on the result of the preliminary examination input by the input control unit u. In the specific example shown in FIG. 3, the low-level determination method and the medium-standard determination method respectively determine the "implementation of the present examination" for performing image diagnosis, and perform the screening diagnosis again after a specific period (for example, three months later). "Re-execution of the "pre-examination"" and "negative" in the "negative" that has not been examined until a certain period of time (for example, the next regular inspection period). Further, in the present embodiment, the high standard determination method determines that either "execution of the examination" and "re-preparation of the preliminary examination" is determined, and "negative" is not determined. In the present embodiment, the configuration is as follows: based on whether or not the examination is conducted during the specific period, the examination information referred to in the selection of the determination method is converted and combined with the inspection information and the examination and storage data, thereby determining The selection conditions of the law are converted. Thereby, the determination method applicable to the preliminary examination of the subject can be appropriately selected. 132466.doc •23- 200917148 Further, in the above configuration, the determination method in the next inspection may be specified or changed according to the determination result. As the above configuration, for example, in the flowchart of FIG. 3, when it is determined that "$ is a re-preparation check by the illusion," the next time, the next step is to determine ΏW疋' in the step S204, and when it is determined as " When it is negative, the next time it will be judged from step S2〇1. Fig. 4 is a flow chart showing a method of selecting a medical examination method (step S203 of Fig. 3).续续,土ώ! (In the case of Haifang, the judgment method selection unit 18 obtains the examiner's medical information (8) from the test capital into the shell storehouse 21 and extracts the previous-time check-up result information' The selection of the judgment method is based on the information of the inspection result (S3G2). For the specific selection conditions, the low-standard judgment method when the result of the examination is "Yili Dangdang, *'" or no product inspection" The standard judgment method and the high standard judgment method in the case of "to be observed", and apply the material to the judgment method of the subject. The selection may be carried out by selecting a pre-test result information extracted from the medical examination information to select a method for determining the subject. In the above method, for example, the present invention is prepared for a specific period as described above. In the case of a medical examination or the like, the judgment method applicable to the subject can be appropriately selected. Fig. 5 is a flowchart showing a method of selecting a method for checking the stored data (step S2G4 of Fig. 3). , #]The law selects the departmental inspection and storage database 22 Check the stored information (please 6), derive the presumptive information of the disease risk and refer to the presumptive information to select the ruling method (S307). For the specific selection conditions, select the estimated ricket rate as a/〇. The low standard judgment method and the presumed rickets rate are the high standard judgment method when the ratio of ~bQ/ is 132466.doc -24- 200917148 ==, and the estimated disease rate is (10) or more, /, as applicable to The tester's judgment method (where a<b). For example: 'About the choice of the testee's judgment method, the presumptive information of the disease risk derived from the examination and storage data may be taken. In the above method, for example, as described above, in the case where the examination is not performed in a specific period, the method of applying the above-mentioned medical examination may be appropriately selected, and the method of estimating the disease risk may be described. In addition, the method of estimating the disease risk at this time can be used, for example, according to the past, the examination data, the treatment data, etc. of the plurals stored as the medical examination data, by gender, age, and time. The conditions for confirming the rate of morbidity, etc., are calculated according to the sex, age, and period of examination of the subject, and the above-mentioned presumed rickets rate is calculated according to the testee's gender, age, and examination period. Preferably, the determination method of the plural type includes the first determination method, which is to determine the positive or negative sensitivity by applying the cutoff value α set by the sensitivity of the inspection. ' &丨王<师选# Interruption in the judgment and the second judgment method, the transcript of the positive or negative value of the cut-off value of the specificity of the eye in the examination It is preferable to select a diagnostic order to determine 0. It is preferable that the determination method of the hard type of the preliminary inspection 沴 ν includes the third determination method, which combines the following screening diagnoses into the eyes of the second user. Screening diagnosis for positive or negative determination of the cut-off value set by sensitivity, and screening accuracy of 132466.doc -25- 200917148 截 cut-off value β to determine the specificity of the test. . In this way, for the determination method in the preliminary examination, the application of the cutoff value may be separated from the θ, and the diagnosis may be used separately or in combination with the application of the cutoff value p, thereby determining the plural type of judgment. Every one, go. It may be appropriate to form a judgment corresponding to its criterion. At the μ$, the diagnostics are applied as described above with the cutoff value α of the sensitivity of the inspection. If it is judged as "negative in the high-sensitivity test", it can be judged to be negative without any error. Because of @, the above diagnosis is particularly effective in the case where the subject who is presumed to have a low rickets rate is recognized and removed by the real healthy person. Further, it is determined that the diagnostic system applies the cutoff value β set by the specificity of the examination. > When it is judged to be positive in the examination with high specificity, it is judged to be positive without any error. Therefore, the above diagnosis is presumed to be 罹 丙 rate (four) money tester, in _ and indeed positive (four)
有效。 1⑴ 例如 θ 虽如圖3所示設定三種類之判定法時,較好的 吏用第1判疋法作為用於推定為罹病率低的受試驗者 :低標準衫法,該第1料法係、在應用著眼於檢查之靈 :之截斷值α的除外診斷中進行判定,並且使用第2判定 厂於推定為羅病率高的受試驗者之高標準判定法, St定法係編著眼於檢查之特異度之截斷值β的確 定又’較好的是’❹將除外珍斷及確 4 5而進行判定之第3判定法作為上述兩個判定法 132466.doc • 26 - 200917148 之中間的中標準判定法。 其次,對於除外診斷及確定診斷中應用之截斷值α、p之 設定方法,使用圖6〜圖9加以說明。圖6係表示應用於筛選 診斷之截斷值之設定方法的流程圖。effective. 1(1) For example, when θ is used to determine three types of judgment methods as shown in Fig. 3, it is preferable to use the first judgment method as a subject for estimating a low rickets rate: a low standard jersey method, the first method The determination is made in the exclusion diagnosis in which the cut-off value α is applied to the inspection spirit, and the high-standard judgment method is adopted in the second judgment factory, and the St-determination method is written. The determination of the cut-off value β of the specificity of the inspection is 'better', and the third judgment method that judges the exclusion and the determination is determined as the middle of the above two determination methods 132466.doc • 26 - 200917148 Medium standard judgment method. Next, a method of setting the cutoff values α and p applied in the exclusion diagnosis and the determination diagnosis will be described with reference to Figs. 6 to 9 . Fig. 6 is a flow chart showing a method of setting a cutoff value applied to the screening diagnosis.
U 以下ϋ眼於檢查《靈敏度的截料使靈敏度 達嶋而設定之截斷值,將著眼於檢查之特異度的截斷: β作為使特異度達8〇%而設定之截斷值,以此為例加以說 明。-般而t,關於上述截斷值之設定方〉去,較好的是以 使靈敏度、特異度達到特定比例之方式來設㈣斷值:、 再者,關於上述截斷值之設定,可採用如下構成.在圖 1所示之管理裝置10之管理判斷部15中,參照檢珍儲存資 料庫22中所記憶的資料而進行截斷值之設^。或者 用如下構成:於外部裝置中先進行截斷值之設定處理:: 將所獲得之截斷值記憶於判定資訊記憶部17中。 又’關於篩選診斷中的檢查之靈敏度及特異度 所示’料所収之截斷值,當以下情況時,^ 果為陽性,患疾的受試驗去盔 /斯、-口 , 指者為认,診斷結果為陽性,益 病的Μ驗者為b人;診斷結果為陰性,患病的 為I以及診斷結果為陰性,無病的受試 仏者 上述截斷值時的檢查之靈敏度(患病者中呈陽性^人時: 由a/(a+c)而定義。又,檢查之 t例)藉 比例)藉由d/(b+d)而定義。—、丄病者中呈陰性之 如圖6所示,於截斷值之設定中 取侍必要的檢 132466.doc -27- 200917148 診儲存資料(讀),,然後針對患病/無病之情形分別分析 欲設定截斷值之篩料斷所制之檢查⑼如,特定方法 之尿檢查)中的以複數個受試驗者為對象之檢查值之分布 (々S502)。接者’參照患病之受試驗者的檢查值之分布,計 算除外診斷之靈敏度為㈣之截斷值叫如)。又,參照無 病的受試驗者之檢查值之分布,計算確定診斷之特異^ 8〇0/。之截斷值 p(S5〇4)。 、 圖8係表示除外診斷中之截斷值α之設定方法的示圖。此 處,如圖8之圖表⑷所示,參照患病之受試驗者的檢查值 之分布’將成為陽性/陰性之判斷之臨限值的截斷值a設定 為6於該例中,如圖8之表⑼所示,設定可使癌患者 10人中之8人為陽性的靈敏度嶋之截斷值a。又,此時的 特異度達70%。 圖9係表示確定診斷中之截斷值β之設定方法的示圖。此 處如圖9之圖表⑷所*,參照無病之受試驗者的檢查值 之/刀布’將成為陽性/陰性之判斷之臨限值的截斷值p設定 為β 8於邊例中,如圖9之表⑻所示,設定可使健康者 中之8人為陰性的特異度8〇%之截斷值ρ。又,此時的 靈敏度達40%。 其次,關於對預備檢診所準備的複數種類之判定法,使 用圖1〇圖11加以說明。此處,如圖3所示之例,準備低 标準判疋去、中標準判定法及高標準判定法該三種類之判 疋法作為複數種類之判定法,對其具體例加以說明。 圖10係表示預備檢診中的複數種類之判定法之一例的示 132466.doc • 28 - 200917148 圖,判疋法(a)表示低標準 標準判定法之例,又,判定:之^’判定法W表示中 本實施例中之判定法成為不问標準判定法之例。 行預備檢診時之判定^ 數種類之筛選診斷組合而進 本實施例令,於低標準判定法⑷中 數次實施應用有截斷值α之除外診斷,對本複 行判定(第1判定法)。具 本檢衫之實施進 次除外診斷後,結果若作為預備檢診’進行複數 之「實施本檢診」。又=:,則判定為進行圖像診斷 Γ為於特Γ:後再次進彳二選;=陽:實=備則 二行:診為陰性,則判定為直至特定時期為: 又,於高標準判定法中, 應用有載斷值β之確定4 法,複數次實施 ϋ =疋法)。具體而言,作為預備檢診,進行複數次確定! 斷後,結果即便有一次診斷為陽性(均為陽性 = :為广㈣定為進行圖像診斷之「=二 為㈣,㈣定為於特定㈣後再次 進仃師選珍斷之「再實施預備檢診」。 人 使用如=^個料法之巾間的巾標㈣定法⑻中, 斷用 分別複數次實施應用有截斷值CC之除料 斷,應用錢斷值卩之確定賴,㈣本檢診之實施進: Ή第3判定法)。具體而言,作為預備檢診,進行複數a 除外診斷及複數次確定㈣後,若確定輯之結果十較 132466.doc -29- 200917148 ^一次:::陽性,定為進行圖 #」,而與除外診斯 —义實施本檢 、〜果無闕。 田確〜斷之結果均為陰 均為陽性,則判定為進行圖像珍斷::斷之結果 又,若除外診斷之結果為—都、 實細本檢診」。 特定期間後再次進行筛::陽性·:性’則判定為於 為正未進行檢診之「陰^ 為陰性’則判定為直至特定時期 圖η係表示預備檢診中的複數種 示圖,判定法矣-V 』疋法之其他例的 j疋法⑷表確標準判定法之例 中標準判定法之例,又 丨疋法(b)表示 例。本奋η, 士 〜法⑷表示高標準判定法之 本…i中之判定法成為將 進行預備檢診時之判定法。 <師“斷組合而 :實施例t,於低標準判定法⑷中 :=Γα1之除外診斷-及應用有截斷值= 定1體ζ1之除外診斷’對本檢診之實施進行判 後二=二Γ為預備檢診,進行兩種類之除外診斷 施本檢診」。又,二=為進仃圖像診斷之「實 判定為於特定期間後再次進行筛選診斷=生= :」。又’結果若兩者均為陰性,則判定為:::= 為止未進行檢診之「陰性」。 I至特疋時期 又’於高標準判定法⑷中,使用如 截斷值—斷〗、及應用有截斷值β2:= 132466.doc •30- 200917148 兩種類之確定診斷, 言,作為預備檢診,進行二之Λ施進行判定。具體而 者均為陽性,或者確定診斷後,結果若兩 進行圖像診斷之「實施本㈣ ^者為陰性,則判定為 性’則判定為於特定期間德:二又,結果若兩者均為陰 預備檢診」。 a 人進仃蒒選診斷之「再實施 使用如下方:兩:二定法之中間的"票準判定法附, 應用有截斷值有^^的一種除外診斷、及 診之實施進行判定。且體^斷該兩種類之診斷,對本檢 類之診斷後,若確〜1 ,作為預備檢診,進行兩種 像診斷之「實施本::斷之結果為陽性’則判定為進行圖 又,在確定診斷之,果;而與除外診斷之結果無關。 性,則判定為於料性時,若除外診斷之結果為陽 預備檢= :::後再次進行筛選診斷之「再㈣ 至特定時期為止未進行檢診之「^」為陰性,則判定為直 本發明之檢診資訊管理 」 實施形態及構成例,其可方法並非限定於上述 資訊管理系統之具體二卩㈣形。例如’對於檢診 非限於圖^所示^ 構成,可使用各種構成,而並 構二!於對預備撿診所準備的複數種類之判定法,上述 之判定法之構成。又, 員次者四種類以上 10、圖11所示之例 丨固判定法之具體内容,除圖 例从外,亦可使㈣罹轉之以標準不 132466.doc •31 200917148 同的各種判定 >丰。v ' 又’關於判定法之選擇方法,除圖3〜圖 不之方法以外,具體而言還可使用各種方法。 又一,對於檢診儲存資料而言,於上述實施例中,關於圖 5所不之疾病風險之推定,係根據過去的檢診資料等,按 性=、年代、時期等條件確認罹病率之f料,並計算上述 推定罹病帛,但例如亦可如圖12所示預先準備按性別、 年代、時期等的罹病率之表以作為檢診儲存資料。U The following is a cut-off value that is set by checking the sensitivity of the interception to make the sensitivity reach ,, and will focus on the cut-off of the specificity of the inspection: β is a cut-off value set to make the specificity reach 8〇%, for example. Explain. In general, t is set to the setting value of the above-mentioned cutoff value. It is preferable to set the sensitivity and the specificity to a specific ratio. (4) The value of the cutoff value is further set as follows: In the management determination unit 15 of the management device 10 shown in FIG. 1, the data stored in the verification storage database 22 is referred to and the cutoff value is set. Alternatively, the setting process of the cutoff value is first performed in the external device:: The obtained cutoff value is stored in the judgment information storage unit 17. In addition, the sensitivity and specificity of the examination in the screening diagnosis are shown as the cut-off value of the material. When the following conditions are true, the result is positive, and the disease is tested by the helmet/s, and the mouth is recognized. The diagnosis result is positive, the tester of the disease is b person; the diagnosis result is negative, the disease is I and the diagnosis result is negative, and the sensitivity of the test when the disease-free test subject is cut off (in the case of the patient) When positive ^ people: defined by a / (a + c). In addition, the t example of the inspection) is defined by d / (b + d). -, the negative of the rickets as shown in Figure 6, in the cut-off value set to take the necessary inspection 132466.doc -27- 200917148 diagnosis storage data (read), and then for the disease / disease-free situation The distribution of the inspection values (see S502) for a plurality of subjects in the examination (9), for example, the urine test of the specific method, in which the cut-off value is to be set is analyzed. The pick-up refers to the distribution of the test values of the affected subject, and the sensitivity of the exclusion diagnosis is (4), and the cut-off value is called). Further, the specificity of the diagnosis is determined by referring to the distribution of the test values of the disease-free subjects. The cutoff value p(S5〇4). FIG. 8 is a diagram showing a method of setting the cutoff value α in the exclusion diagnosis. Here, as shown in the graph (4) of Fig. 8, the cutoff value a of the threshold value of the judgment of the positive/negative judgment of the distribution of the test value of the subject is set to 6 in this example, as shown in the figure. As shown in Table 9 (9), the cutoff value a of the sensitivity 可使 which can make 8 of 10 cancer patients positive is set. Moreover, the specificity at this time is 70%. Fig. 9 is a diagram showing a method of setting the cutoff value β in the diagnosis. Here, as shown in the graph (4) of Fig. 9, the cutoff value p of the threshold value of the judgment/the negative cloth of the test value of the disease-free tester is set to be β 8 in the side example, such as As shown in the table (8) of Fig. 9, the cutoff value ρ of the specificity of 8〇% which is negative for 8 of the healthy persons is set. Also, the sensitivity at this time is 40%. Next, the determination method of the plural types prepared for the preliminary inspection clinic will be described using FIG. 1 and FIG. Here, as an example shown in Fig. 3, the three types of judgment methods of the low standard judgment, the medium standard judgment method, and the high standard judgment method are prepared as a plural type judgment method, and a specific example thereof will be described. Fig. 10 is a diagram showing an example of a determination method of a plural type in a preliminary examination. 132466.doc • 28 - 200917148. The judgment method (a) indicates an example of a low standard criterion determination method, and further, determination: The method W indicates that the determination method in the present embodiment is an example in which the standard determination method is not required. In the case of the screening diagnosis of the type of judgment at the time of the preliminary examination, the order of the present invention is applied, and the exclusion diagnosis using the cutoff value α is applied several times in the low standard judgment method (4), and the determination of the second line is performed. ). After the implementation of this check-up shirt is excluded, the result will be “pre-tested as a preliminary check-up”. Also =:, it is judged that the image diagnosis is a special feature: after the second selection; = yang: real = regular two lines: the diagnosis is negative, it is determined that until a specific period is: In the standard judgment method, the method of determining the load value β is applied, and the ϋ = 疋 method is performed plural times. Specifically, as a preliminary examination, a plurality of determinations are made! After the break, the result is diagnosed as positive only once (all positive =: wide (four) is determined as image diagnosis "= two is (four), (four) is specified as specific (4) After re-entering the teacher's choice, the "pre-practice inspection" will be carried out. The person uses the towel label (4) in the towel method (4), and the application of the cut-off value CC is repeated. The material is broken, and the application of the value of the money is determined. (4) The implementation of this inspection is: Ή3rd judgment method). Specifically, as a preliminary examination, after the plural a exclusion diagnosis and the multiple determinations (4), if the result of the determination is more than 132466.doc -29- 200917148 ^ once::: positive, it is determined to carry out the map #", and Execution of this test with the exception of the diagnosis, the fruit is innocent. If the result of the field is positive and the result of the break is positive, then it is judged that the image is judged: the result of the break is again. If the result of the diagnosis is excluded, the result is a diagnosis. After a certain period of time, the screen is again screened: "Positive:: Sex" is determined to be "negative" in the case where the test is not performed, and it is determined that the figure η indicates a plurality of types in the preliminary examination. The other method of judging the method of 矣-V 疋 ( ( ( ( 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 V V V The judgment method in the standard judgment method is the judgment method when the preliminary examination is to be performed. <The division is broken and combined: Example t, in the low standard judgment method (4): = 除外α1 exclusion diagnosis - and application There is a cut-off value = the diagnosis of the 1st body ζ1's diagnosis. After the judgment of the implementation of this test, the second test is a preliminary check-up, and two types of diagnostic tests are excluded. In addition, the second value is "the actual diagnosis is that the screening diagnosis is repeated after a specific period = raw = :". In addition, if both of the results are negative, it is judged as "negative" in which no examination is performed until:::=. From the I to the special period, in the high standard judgment method (4), the use of the cut-off value - break, and the application of the cut-off value β2: = 132466.doc • 30- 200917148 two kinds of certain diagnosis, words, as a preliminary check , the second is performed to determine. Specifically, all of them are positive, or after the diagnosis is confirmed, if the results of the two methods of image diagnosis are "negative", then it is judged as "sexual" and then determined to be in a specific period: two again, the result if both Prepare for the vaginal examination." a person's selection diagnosis is "re-implementation using the following side: two: the middle of the second method of the "quote queuing method attached, the use of a cut-off value of ^^, a diagnosis, and the implementation of the diagnosis. The diagnosis of the two types of the body is broken. If the diagnosis of the test is confirmed, if it is =1, as a preliminary examination, the "implementation: the result of the break is positive" is judged as the progress of the two types of diagnosis. In the case of determining the diagnosis, it is irrelevant to the result of the exclusion diagnosis. If it is judged to be in the nature of the condition, if the result of the exclusion diagnosis is positive for the positive test =::, then the screening diagnosis is repeated (four) to specific In the case where the "^" that has not been inspected for a period of time is negative, it is determined that the "inspection information management of the present invention" is an embodiment and a configuration example, and the method is not limited to the specific shape of the information management system. For example, 'for the examination, it is not limited to the composition shown in Fig. ^, and various configurations can be used, and the second is constructed! The judgment method of the above-mentioned determination method in the judgment method of the plural type prepared for the preparatory clinic. In addition, the details of the four types of members are 10 or more, and the specific content of the method for determining the tamping method shown in Fig. 11 can be changed to the standard without the standard. 132466.doc • 31 200917148 ; Feng. v ' Further' Regarding the selection method of the determination method, in addition to the method of Fig. 3 to Fig. 3, various methods can be specifically used. In addition, for the examination and storage of the data, in the above-mentioned embodiment, the estimation of the disease risk of FIG. 5 is based on the past examination data, etc., and the ricket rate is confirmed according to the conditions of sex, age, and period. In addition, the above-mentioned presumed rickets are calculated, but for example, a table of morbidity rates by sex, age, period, and the like may be prepared in advance as a check-up storage data.
以下,對本發明之檢診資訊管理系統及檢診資訊管理方 法作進一步說明。 &對本發明的檢診資訊管理系統及管理方法之第2實施形 態加以說明。此處’本實施形態之檢診資訊管理系統之概 略構成係基本上與第丨實施形態中圓丨所示之構成相同。 又,於檢診資訊管理裝置1G中,關於檢診資料輸入控制部 11、官理資訊輸出控制部丨2及檢診資料庫2〇之構成,參照 圖1如上所述。 管理判斷部15具有檢診實施判定部16與判定資訊記憶部 17。管理判斷部15對受試驗者實施檢診進行必要的判斷。 即,對受試驗者之檢診不定期地或者於固定期間(檢診實 施間隔)定期地實施。管理判斷部15對上述受試驗者的檢 #之實施内容、實施預定等進行判斷。 檢診實施判定部16係對受試驗者實施檢診進行判定之檢 δ乡實鉍判疋機構。該檢診實施判定部〗6根據應用特定之判 定法所進行的預備檢診之結果’對本檢診之實施進行判定 (檢診實施判定步驟)。關於此時之判定内容,具體而言可 132466.doc • 32- 200917148 列舉是否實施本檢診、是否實施下一次預備檢診'或者 該等檢診之實施時期等。 判定資訊記憶部17係在用以對實施本檢診進行判定之預 備檢診中,記憶有適用於受試驗者之判定法的判定資訊記 憶機構。本實施形態之管理系統以中,於該判定資訊記憶 邛17中,對根據含有在本檢診之圖像診斷(ρΕτ檢查等)之 月'J所進行的篩選診斷(尿檢查等)之預備檢診中的檢診内 谷、及預備檢診之結果所進行的判定,準備有將以下診斷 加以組σ而進行判定之判^法,%,應用著眼於檢查之靈 敏度所疋之截斷值α來判斷陽性或陰性之篩選診斷即除 外診斷、及應用著眼於檢查之特異度所設定之截斷值㈣ 判斷1%性或陰性之篩選診斷即確定診斷。 此處’除外診斷係如上所述應用著眼於檢查之靈敏度所 «又疋之截斷值α者。如此,當在靈敏度高的檢查中判斷為 陰性夺貝J可基本無誤地判斷為陰性。因此,上述診斷對 於推定為羅病率低的受試驗者,在將真正健康者識別並去 除之情況下特別有效。 又,確定診斷係應用著眼於檢查之特異度所設定之截斷 值β者士〇此’备在特異度高的檢查中判斷為陽性時,則 可基ί無誤地判斷為陽性。因此,上述診斷對於推定為罹 病率兩的受試驗者,在識別並確定真正疾病之情況下特別 有效。而且’將上述除外診斷與確定診斷組合而使用,藉 可對本檢》乡實施之必要性等進行精度良好的評價。再 者’關於筛選診斷中的檢查之靈敏度及特異度,於第!實 132466.doc -33- 200917148 施形態中,參照圖7如上所述。 圖1 3係表示將除外診斷及確定診斷組合而進行判定的預 備檢診中之判定法之例圖。圖13所示之判定法(a)表示實施 以下兩種類之診斷,即,應用有截斷值α的一種類之除外 診斷及應用有截斷值β的一種類之確定診斷,並對本檢診 之實施進行判定。具體而言,作為預備檢診,進行一種類 之除外診斷及一種類之確定診斷後,若確定診斷之結果為 陽性,則判定為進行圖像診斷之「實施本檢診」,而與除 外診斷之結果無關。又,在確定診斷之結果為陰性時,若 除外診斷之結果為陽性,則判定為於特定期間後(例如3個 月後)再次進行篩選診斷之「再實施預備檢診」。又,若 除外診斷之結果為陰性,則判定為直至特定時期(例如下 一次定期檢診時期)為止未進行檢診之「陰性」。 又,圖13所示之判定法(b)表示分別複數次實施應用有 截斷值α之除外診斷、及應用有截斷值β之確定診斷,以對 本檢診之實施進行判定。具體而言,作為預備檢診,進行 複數種類之除外診斷及複數種類之確定診斷後,若確定診 斷之結果中即便有一次診斷為陽性(均為陽性、或者一部 分為陽性•陰性),則判定為「實施本檢診」,而與除外 診斷之結果無關。又’在確定診斷之結果均為陰性時》若 除外診斷之結果均為陽性,則判定為「實施本檢診」。 又,若除外診斷之結果為一部分陽性•陰性,則判定為 「再實施預備檢診」。又,若除外診斷之結果均為陰性, 則判定為「陰性」。 132466.doc •34- 200917148 ,又,本實施形態之管理系統1A中,於管理判斷部15中, 對2備檢移而吕,準備有包含如上所述之將除外診斷與 確定診:組合之判定法的羅病率之判定標準不同的複數種 類之判定法。具體而言,於判定資訊記憶部^中,準備有 判定標準不同的„種類(11為2以上之整數)之判定法。又於 判定資訊記憶部17中,準備有對於上述η種類之判定法預 先決定之選擇條件,該選擇條件用以從上述η種類之判定 法中選擇適用於受試驗者之一種判定法。 ,管理判斷部!5對應於上述〇種類之判定法而具有判定法 選擇Μ 8判疋法選擇部! 8取得受試驗者之檢診資訊資料 或者檢診健存資料之至少一者,將其作為用以選擇判定法 之檢診資料。然後,選擇部18參照已取得之檢診資料,根 據記憶部17中所準備之選擇條件,於η種類之判定法中選 擇適用於受試驗者的預備檢診中之判定法。選擇㈣的判 定法之選擇結果視需要,從輸出部6〇向操作者輸出、提 :。又,檢診實施判定部16根據應用選擇部18所選擇之判 =法而進行的預備檢診之結果,對本檢診之實施進行判 定。 上述檢診資訊管理裝置1G例如可藉由以下部分而構成: 檢診資訊管理中執行必要的檢診實施判定處料各種處理 之CPU、記憶有處理動作中必要的各軟體程式等之職、 以及檢診資料庫20中使用的内部記憶體或者外部記憶裝置 等記憶裝置。 < 以下,對上述實施形態之檢診資訊管理系統及檢診資訊 132466.doc -35· 200917148 管理方法之效果進行說明。 於圖1及圖1 3所示之檢診資訊管理系統1A及檢診資訊管 理方法中,關於對受試驗者所實施之檢診,係將以下檢診 組合而進行檢診,即,含有取得斷層圖像並進行診斷之圖 像診斷的本檢診、及含有藉由較圖像診斷更簡易之方法所 進行之韩選診斷的預備檢診。又,針對每一位受試驗者, 將含有預備檢診資訊及本檢診資訊之檢診資訊資料記憶於 管理裝置1 0之檢診資訊資料庫21中,以對受試驗者進行檢 診實施之管理。藉此,能對受試驗者有效地進行檢診,從 而可降低其診斷費用。 進而,於上述構成中,作為在是否實施本檢診之判定等 中所使用之預備檢診之判定法,於判定資訊記憶部1 7中, 準備有將以下診斷組合之複合判定法,即,應用著眼於檢 查之靈敏度之截斷值α來判斷陽性或陰性之除外診斷、及 應用著眼於檢查之特異度之截斷值β來判斷陽性或陰性之 確定診斷。藉此,對於受試驗者實施本檢診之必要性等可 進行精度良好的評價,從而對於檢診之實施能夠可靠地進 行判定。 此處,作為含有圖像診斷之本檢診,使用有例如PET檢 查、CT檢查及MRI檢查中之至少1者。對於上述檢查而 言,將如上所述含有藉由簡易且便宜之方法可實施之篩選 診斷的預備檢診、與含有圖像診斷之本檢診組合而進行檢 診,由此可對受試驗者有效地進行檢診。又,於預備檢診 中使用將除外診斷與確定診斷加以組合之判定法,由此提 132466.doc -36- 200917148 高對本檢診實施之必要性等之評價精度。又,如此對本檢 診實施之必要性準確地進行判斷,從而可將對受試驗者實 施檢診而導致的放射線暴露抑制為最小限度。 作為預備檢診中之篩選診斷,較好的是含有尿檢查及血 液檢查中之至少一者。將上述檢查作為在本檢診之前的預 備檢診而實施,藉此可對是否實施本檢診適當地進行判 斷。關於尿檢查之具體例等,如以上第1實施形態中所 述。又,對相對於含有圖像診斷之本檢診的預備檢診而 言,將複數種類之篩選診斷加以組合而實施,此在提高是 否實施本檢診之判斷精度方面較佳。作為此時篩選診斷之 組合之例,如以上第1實施形態中所述。 又,本檢診中,如上所述,圖像診斷較好的是含有PET 檢查、X線CT檢查及MRI檢查中之至少1者。又,為提高對 受試驗者之檢診之精度,亦可將由PET檢查、CT檢查及 MRI檢查組合之綜合圖像診斷、或者將上述三種類之檢查 再與US(超音波)檢查組合之綜合圖像診斷作為本檢診。 又,於上述實施形態中,對於預備檢診而言,於判定資 訊記憶部17中,準備有判定標準不同的複數種類之判定 法,並於判定法選擇部1 8中,參照含有檢診資訊資料或者 檢診儲存資料之至少一者的檢診資料,根據特定之選擇條 件,選擇可適用於成為檢診對象之受試驗者的預備檢診中 之判定法。藉此,可根據受試驗者之檢診資料,對於受試 驗者實施本檢診之必要性等進行適當的評價。 又,上述實施形態之管理系統1A設為如下構成,即,於 132466.doc -37· 200917148 管理判斷部1 5中設置有檢診實施判定部1 6,該檢診實施判 定部1 6係根據應用特定之判定法所進行的預備檢診之結 果,對本檢診之實施、或者必要要時下一次檢診之實施進 行判定。藉此,可對受試驗者適當地進行檢診實施之管 理。 又,關於本管理系統1A對管理對象之檢診,較好的是, 對受試驗者每隔特定之檢診實施間隔反覆實施的複數次檢 診(定期檢診)進行綜合的管理。於此情形時,檢診資訊資 料庫2 1中,記憶有對受試驗者定期實施的複數次檢診中各 自之預備檢診資訊及本檢診資訊。藉此,對於定期實施的 受試驗者之檢診,可進行一步提高其整體效率。關於如此 定期進行檢診時的檢診實施間隔,可視需要而適當設定, 但亦可設為例如1年間隔。 關於對預備檢診所準備之判定法,如圖13之判定法(a)所 示,可採用如下構成:預備檢診中之判定法可根據除外診 斷之結果中的陽性/陰性及確定診斷之結果中的陽性/陰性 之組合,對本檢診之實施進行判定。藉此,可對本檢診之 實施適當地進行判定。 或者,如圖13之判定法(b)所示,預備檢診之判定法可 採用如下構成:使用複數次除外診斷作為除外診斷,使用 複數次確定診斷作為確定診斷,並且根據複數次除外診斷 之結果中的所有陽性/一部分陽性•陰性/所有陰性、及複 數次確定診斷之結果中的所有陽性/一部分陽性•陰性/所 有陰性之組合,對本檢診之實施進行判定。如此,藉由分 132466.doc -38- 200917148 別複數次使用除外診斷及確定診斷,可提高對本檢診實施 之判定精度。 ' 以下對圖1所示之管理系統以、及管理系統丨八之檢診資 訊管理方法作進一步具體的說明。首先,對適用於除外診 斷及確定診斷之截斷值α、β之設定方法加以說明。本實施 形態之截斷值之設定方法、設定處理之實行構成等係與以 上第1實施形態中參照圖6〜圖9所說明之設定方法等相同。 如以上參照圖6所述,於截斷值之設定中,首先,取得 必要的檢診儲存資料(S501),然後針對患病/無病之情形, 分別分析用於篩選診斷之檢查(例如尿檢查)中的以複數個 受試驗者為對象之檢查值之分布(S5〇2)。接著,參照串病 之受試驗者的檢查值之分布,計算除外診斷之靈敏度為 80%之截斷值a(S503)。又,參照無病的受試驗者之檢查值 之分布,計算確定診斷之特異度為8〇%之截斷值β (s5〇4)。 在除外診斷之截斷值《之設定中,於圖8所示之例中,參 照患病的受試驗者之檢查值之分布,將成為陽性/陰性之 判斷之臨限值的截斷值a設定為a=6。於該例中,設定可 使癌患者10人中之8人為陽性的靈敏度8〇%之截斷值a。 又,在確定診斷之截斷值β之設定中,於圖9所示之例中, 參照無病的受試驗者之檢查值之分布,將成為陽性/陰性 之判斷之臨限值的截斷值β設定為ρ=8。於該例中,設定可 使健康者10人中之8人為陰性的特異度8〇%之截斷值β。 其次,對判定資訊記憶部17中準備有複數種類之判定法 時的檢診資訊管理方法進行具體說明。圖14係表示於管理 132466.doc •39- 200917148 裝置1 〇之管理判斷邱 體例的流程圖。中實行的檢診資訊管理方法之-具 再者Μ下,準備低標準判定法、中標準判定法、及高 標準判定法該三種類之 。 疋法作為預備檢診中之複數種類 '疋、、。又’關於對受試驗者實施的檢診中成為診斷對 之疾,,將對主要以癌作為診斷對象之癌檢診進行說 疋本發明之管理系統及管理方法亦可同樣適用於 癌檢移以外之各種各樣的檢診。 於圖14所7F之官理方法中’判定法選擇部18首先來昭從 檢診資訊資料庫21中讀出的受試驗者之病歷資料,判斷盆 疋否為有癌病史者(步驟S7〇1)。接著,若為有癌病史者, 則判斷羅病率高,從而選擇高標準判定法作為預備檢診中 之判定法。 另方面’當無既往病史時,則進一步判斷於特定期間 内(例如3年以内)含有圖像診斷之本檢^否已受診 (5702) 。接著,若有受診經歷,則參照受試驗者之檢診資 訊資料,從上述三種類之判定法中選擇預備檢診之判定法 (5703) 。X,若無受診經歷,則參照檢診儲存資料,同樣 從三種類之判定法中選擇預備檢診中之判定法(s7〇4)。 在判定法之選擇結束、預備檢診實施後,檢診實施判定 部16根據經由輸入㈣部n所輸入的預備檢診之結果資 訊,對本檢診之實施進行判定n4所示之具體例中, 低‘準判定法及中標準判定法分別判定上述的「實施本檢 診」、「再實施預備檢診」、以及「陰性」令之任一者。 132466.doc -40- 200917148 又,於本實施例中 「再實施預備檢診 定。 高標準判定法判定「實施本檢診」及 中之任-纟,對於「陰性」不作判 本實施例中’設為如下構成:根據特定期間内本檢 無受診’將判u之選擇中參照的檢診f料及判定法 擇條件進行轉換。藉此,可適t地選擇能㈣於受試驗者 的預備檢診中之判定法n上述構成中,亦可構成為 根據判定結果而指定或者變更下—次檢珍中之判定法。作 為上述構纟’例如於圖14之流程圖中,當判U「再實施 預備檢診」時,下一次會從步驟”⑽開始判定,另一方 面,當判定為「陰性」時’下一次會從步驟s7〇i開始判 定。 關於檢診資訊資料之判定法之選擇方法,可參照第1實 施形態中圖4所示之流程圖(圖14之步驟S7〇3)。如圖々所 示,於對受試驗者之判定法之選擇時參照前一次檢診結果 資訊之構成中’例如以上所述當在特定期間内本檢診受診 等情況下,可適當選擇適用於受試驗者之判定法。 關於檢診儲存資料之判定法之選擇方法,可參照第1實 施形態中圖5所示之流程圖(圖14之步驟S7〇4)。如圖5所 示,於對受試驗者之判定法之選擇時參照疾病風險推定資 訊之構成中,例如以上所述當在特定期間内本檢診未受診 等情況下,可適當選擇適用於受試驗者之判定法。又,當 本檢診受診之情況下,亦可使用參照疾病風險推定資訊I 方法。 132466.doc -41 - 200917148 又 • g於此時的疾病風險之推定方法,可使用如 法.例如,根據作為檢診儲存資料而儲存 者之過去的檢診資料、治療資料等,按性別、年代 等條件確認羅病率之資料,並根據受試驗者之性別、年代 及檢診時期等而計算上述推定罹病率。 其次,對麵備檢料㈣之料法料 明=於對預備檢診所準備之判定法,採用如下構成= :疋貝=憶部17中’如上所述準備將除外診斷與確定診 斷加以組合之一種類之判定法。於此 夕 示之構成中的判定法選擇部18β、0’’"、、需圖1所 或者’亦可採用如下構成:於判定資訊記憶部17中 備,有將除外診斷與確定診斷加以組合之判定法令之至小 一種類的判定標聿;^ π μ ^ ,疋才不丰不同的複數種類之列定法。於此情卅 作為,體例’可採用如下判定法之構成,即,將複數 ㈣之判定法各自之除外診斷與衫診斷 判定,並且其組合互不相同。 。而進仃 又,於上述構成中,關於複數種類之判定法中含有的— 確定診斷之一者的判定法,=2為僅含有除外診斷或者 於此情形時,複數種二Π擴法之選擇範圍。 述的除外診斷及確定診斷組合而進㈣定之判i法=上 還包括利用應用著眼於檢查之靈敏度所設定之截斷:卜, ::診斷進行判定之判定法、及利用應用;二= 截斷值卩的確定診斷進行判定之判定法。 132466.doc •42- 200917148 如此,對於預備檢診中之判定法,可將應用截斷值以之 診斷即除外診斷、與應用截斷值β之診斷即確定診斷分開 使用或者組合使用,藉此對於複數種類之判定法中之每一 判定法而言,可適當地構成與其判定標準相對應之 法。 心 例如,當如圖14所示設定有3類判定法時,較好的是, 使用除外診斷之判定法作為用於推定罹,料低的受試驗者 =低標準判定法,並且使用確定診斷之取法作為用於推 定罹病率高的受試驗者之高標準判定法。又,作為上述兩 個判定法之中間的中標準判定法,較好的是設為如下、籌 成:使用除外診斷與確定診斷加以組合之判定法,對本檢 診之實施進料細研究。或者,亦可分別將除外診斷與: ,診斷組合而構成,並且根據上述組合之診斷數、診斷内 谷等’準備判定標準不同的三種類之判定法,以作為低標 準判定法、中標準判定法及高標準判定法。Hereinafter, the inspection information management system and the inspection information management method of the present invention will be further described. & A second embodiment of the inspection information management system and management method of the present invention will be described. Here, the outline configuration of the medical examination information management system of the present embodiment is basically the same as the configuration shown by the circle in the second embodiment. Further, in the examination information management device 1G, the configuration of the examination data input control unit 11, the official information output control unit 丨2, and the examination database 2A is as described above with reference to Fig. 1 . The management determination unit 15 includes a diagnosis execution determination unit 16 and a determination information storage unit 17. The management determination unit 15 makes a necessary judgment on the examination of the subject. In other words, the examination of the subject is performed irregularly or periodically during the fixed period (inspection interval). The management determination unit 15 determines the content of the execution of the test subject, the execution schedule, and the like. The examination and execution execution determination unit 16 is a method for determining the diagnosis of the subject. The inspection execution determination unit 6 judges the execution of the examination based on the result of the preliminary examination performed by the application-specific determination method (the examination execution determination step). Specifically, the content of the judgment at this time may be 132466.doc • 32- 200917148, and whether or not to implement the examination, whether to carry out the next preparatory examination, or the implementation period of such examinations. The determination information storage unit 17 stores a determination information recording means for applying the judgment method of the subject in the preparatory examination for determining the examination. In the management system of the present embodiment, in the determination information memory unit 17, the preparation for screening diagnosis (urine examination, etc.) based on the month 'J containing the image diagnosis (ρΕτ check, etc.) of the present examination is performed. In the case of the inspection of the intestines in the examination, and the judgment of the results of the preliminary examination, the judgment is made by grouping the following diagnosis into the group σ, and the % is applied to the cutoff value α of the sensitivity of the examination. The screening diagnosis to determine positive or negative is to exclude the diagnosis, and to use the cut-off value set by the specificity of the examination (4) to determine the diagnosis of 1% or negative screening diagnosis. Here, the 'exclusion diagnosis system' applies the sensitivity of the inspection as described above. Thus, when it is judged as a negative in the high-sensitivity examination, it can be judged to be negative without any error. Therefore, the above diagnosis is particularly effective for a subject who is presumed to have a low rate of morbidity, in the case where a true healthy person is recognized and removed. Further, it is determined that the diagnostic system uses a cut-off value set by the specificity of the examination, and if it is judged to be positive in the examination with high specificity, it can be judged as positive by mistake. Therefore, the above diagnosis is particularly effective for a subject estimated to have two morbidity rates in the case of identifying and determining a true disease. Further, the combination of the above-mentioned exclusion diagnosis and the determination diagnosis is used, and the accuracy of the implementation of the hometown of the inspection can be accurately evaluated. Further, the sensitivity and specificity of the examination in the screening diagnosis are as described above with reference to Fig. 7 in the form of Fig. 7 . Fig. 1 is a view showing an example of a determination method in a preliminary examination for judging a combination of an exclusion diagnosis and a determination diagnosis. The determination method (a) shown in Fig. 13 indicates that the diagnosis of the following two types is performed, that is, a type of exclusion diagnosis using the cutoff value α and a certain type of diagnosis having the cutoff value β applied, and the implementation of the examination is performed. Make a decision. Specifically, as a preliminary examination, after performing a type of exclusion diagnosis and a certain type of diagnosis, if it is determined that the result of the diagnosis is positive, it is determined that the "implementation of the examination" for image diagnosis is performed, and the diagnosis is excluded. The result is irrelevant. When the result of the diagnosis is negative, if the result of the exclusion diagnosis is positive, it is determined that the "pre-review" is performed again after the specific period (for example, three months later). In addition, if the result of the exclusion diagnosis is negative, it is determined that the "negative" is not performed until the specific period (for example, the next regular inspection period). Further, the determination method (b) shown in Fig. 13 indicates that the exclusion diagnosis using the cutoff value α and the determination diagnosis using the cutoff value β are performed plural times to determine the implementation of the examination. Specifically, as a preliminary examination, after performing a plurality of types of exclusion diagnosis and a certain type of diagnosis, if it is determined that one of the diagnosis results is positive (all positive, or a part is positive • negative), it is determined It is "implementation of this examination" and has nothing to do with the results of the exclusion diagnosis. In addition, if the result of the diagnosis is negative, if the result of the exclusion diagnosis is positive, it is judged as "implementation of this examination". In addition, if the result of the exclusion diagnosis is a part of positive/negative, it is judged as "re-preparation check". Moreover, if the result of the exclusion diagnosis is negative, it is judged as "negative". 132466.doc • 34- 200917148 Further, in the management system 1A of the present embodiment, the management determination unit 15 prepares for the second inspection, and prepares the combination of the exclusion diagnosis and the determination diagnosis as described above. The judgment method of the plural type in which the judgment criteria of the judging method are different. Specifically, in the determination information storage unit, a determination method of "the type (11 is an integer of 2 or more) having different determination criteria is prepared. Further, in the determination information storage unit 17, a determination method for the above-described η type is prepared. a predetermined selection condition for selecting a determination method suitable for the subject from the determination method of the η type. The management determination unit 5 has a determination method corresponding to the determination method of the above-described 〇 type. 8 疋 疋 选择 选择 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 The examination data is selected according to the selection conditions prepared in the memory unit 17, and the determination method in the preliminary examination for the subject is selected in the determination method of the η type. The selection result of the selection method of (4) is selected as needed. The part 6〇 outputs to the operator, and the inspection execution determination unit 16 performs the inspection based on the result of the preliminary examination performed by the judgment method selected by the application selection unit 18. The above-mentioned inspection information management device 1G can be configured, for example, by performing the necessary inspections in the examination information management, determining the CPUs for various processes, and memorizing the software programs necessary for the processing operations. And a memory device such as an internal memory or an external memory device used in the examination database 20. <The effect of the management method of the above-described embodiment of the inspection information management system and the inspection information 132466.doc -35· 200917148 In the examination information management system 1A and the examination information management method shown in FIG. 1 and FIG. 13 , the examination performed on the subject is performed by the following examinations, that is, the examination is performed. This examination includes a diagnosis of an image for obtaining a tomographic image and a diagnostic diagnosis, and a preliminary examination including a Korean diagnosis by a method that is easier to diagnose than the image. Further, for each subject The medical information containing the pre-examination information and the medical information of the medical examination is stored in the medical information database 21 of the management device 10 to perform the inspection and implementation of the test subject. In this way, the subject can be effectively examined, and the diagnosis cost can be reduced. Further, in the above configuration, the determination method for the preliminary examination used in the determination of whether or not to perform the examination is used. In the determination information storage unit 17, a composite determination method that combines the following diagnostic combinations, that is, a cut-off value α that focuses on the sensitivity of the examination, is used to determine the positive or negative exclusion diagnosis, and the specificity of the application-oriented inspection is applied. The cut-off value β is used to determine a positive or negative diagnosis. This allows the subject to perform an accurate evaluation of the necessity of performing the examination, and can reliably determine the implementation of the examination. As the present examination including image diagnosis, at least one of a PET test, a CT test, and an MRI test is used. In the above-described examination, a preliminary examination including a screening diagnosis which can be performed by a simple and inexpensive method, and a combination of the examinations including the image diagnosis are performed as described above, whereby the subject can be examined. Conduct an effective examination. In addition, in the preliminary examination, the judgment method combining the exclusion diagnosis and the determination diagnosis is used, thereby raising the accuracy of the evaluation of the necessity of the examination and the like. Further, by accurately determining the necessity of the present examination, it is possible to minimize radiation exposure caused by the examination of the subject. As the screening diagnosis in the preliminary examination, it is preferred to include at least one of a urine test and a blood test. The above examination is carried out as a pre-examination check before the examination, so that it is possible to appropriately judge whether or not to perform the examination. Specific examples of the urine test and the like are as described in the first embodiment. Further, it is preferable to combine a plurality of kinds of screening diagnoses with respect to the preliminary examination of the present examination including the image diagnosis, and it is preferable to improve the accuracy of the determination of whether or not the examination is performed. An example of a combination of screening diagnoses at this time is as described in the first embodiment above. Further, in the present examination, as described above, it is preferable that at least one of the PET examination, the X-ray CT examination, and the MRI examination is included in the image diagnosis. In addition, in order to improve the accuracy of the examination of the subject, a comprehensive image diagnosis combined with PET examination, CT examination and MRI examination, or a combination of the above three types of examinations and US (ultrasonic) examination may be combined. Image diagnosis is used as this examination. Further, in the above-described embodiment, the determination information storage unit 17 prepares a plurality of types of determination methods having different determination criteria, and the determination method selection unit 18 refers to the inclusion of the examination information. The examination data of at least one of the data or the examination and storage data is selected according to the specific selection conditions, and the determination method in the preliminary examination that can be applied to the subject who is the subject of the examination is selected. By this, it is possible to appropriately evaluate the necessity of the test subject to perform the test based on the test materials of the subject. In addition, the management system 1A of the above-described embodiment is configured to provide a diagnosis execution determination unit 1 6 in the management determination unit 15 of 132466.doc -37· 200917148, and the inspection execution determination unit 16 is based on The results of the preliminary examination conducted by the specific judgment method are used to determine the implementation of this examination or, if necessary, the next inspection. Thereby, the subject can be appropriately administered for the examination and implementation. In addition, it is preferable that the management system 1A conducts a comprehensive examination of a plurality of examinations (periodic examinations) that are repeatedly performed at intervals of a specific examination. In this case, the check-up information database 21 records the preliminary check-up information and the check-up information in the plurality of check-ups performed regularly by the subject. In this way, for the regular examination of the test subject, the overall efficiency can be improved in one step. In this way, the inspection execution interval at the time of regular inspection may be appropriately set as needed, but may be, for example, a one-year interval. As for the judgment method for the preparation of the preparatory examination clinic, as shown in the judgment method (a) of Fig. 13, the following configuration can be adopted: the judgment method in the preliminary examination can be based on the positive/negative in the result of the exclusion diagnosis and the result of the diagnosis. The combination of positive/negative in the determination of the implementation of this examination. Thereby, the judgment of the implementation of this examination can be appropriately determined. Alternatively, as shown in the determination method (b) of FIG. 13, the determination method of the preliminary examination may be constituted by using a plurality of exclusion diagnoses as the exclusion diagnosis, using the plurality of determination diagnoses as the determination diagnosis, and according to the plurality of exclusion diagnoses. The combination of all positive/partial positives/negative/all negatives and multiple positive/partial positive•negative/all negative combinations in the results of the diagnosis determines the implementation of this test. In this way, by using 132466.doc -38- 200917148, the use of the exclusion diagnosis and the determination of the diagnosis can improve the accuracy of the judgment of the implementation of this examination. The following is a more detailed description of the management system shown in Figure 1 and the management information management method of the management system. First, a method of setting the cutoff values α and β applicable to the exclusion diagnosis and the determination of the diagnosis will be described. The setting method of the cutoff value and the configuration of the setting process in the present embodiment are the same as those in the above-described first embodiment as described with reference to Figs. 6 to 9 . As described above with reference to FIG. 6, in the setting of the cutoff value, first, the necessary examination and storage data is acquired (S501), and then the examination for screening diagnosis (for example, urine examination) is separately analyzed for the diseased/no disease situation. The distribution of the test values for a plurality of subjects (S5〇2). Next, with reference to the distribution of the test values of the subject of the cross-sectional disease, the cut-off value a of the sensitivity of the exclusion diagnosis of 80% is calculated (S503). Further, with reference to the distribution of the test values of the disease-free subjects, the cut-off value β (s5〇4) which determines the specificity of the diagnosis to be 8〇% is calculated. In the setting of the cut-off value of the excluded diagnosis, in the example shown in FIG. 8, the cutoff value a of the threshold value of the positive/negative judgment is set to the reference value of the test value of the test subject. a=6. In this example, a cutoff value a of 8 % sensitivity which is positive for 8 out of 10 cancer patients is set. Further, in the setting of the cutoff value β for determining the diagnosis, in the example shown in FIG. 9, the cutoff value β of the threshold value of the positive/negative judgment is set with reference to the distribution of the test value of the disease-free subject. It is ρ=8. In this example, a cut-off value β of 8% specificity which is negative for 8 out of 10 healthy persons is set. Next, the inspection information management method when the determination information storage unit 17 prepares a plurality of types of determination methods will be specifically described. Figure 14 is a flow chart showing the management of the device in the management of 132466.doc • 39- 200917148. In the case of the management information management method implemented in the middle, there are three types of the low standard judgment method, the medium standard judgment method, and the high standard judgment method. The sputum method is used as a plural type in the preliminary examination. In addition, it is said that the diagnosis and treatment of the subject is a diagnosis of cancer, and the management system and the management method of the present invention are also applicable to cancer detection. Various kinds of examinations other than those. In the method of the method of 7F of Fig. 14, the 'determination method selection unit 18 first determines the medical record data of the subject read from the examination information database 21, and determines whether the pelvic sputum is a cancer history (step S7〇). 1). Next, if it is a person with a history of cancer, it is judged that the rate of morbidity is high, and the high standard judgment method is selected as the determination method in the preliminary examination. On the other hand, when there is no past medical history, it is further judged whether the examination containing the image diagnosis within a certain period (for example, within 3 years) has been diagnosed (5702). Next, if there is a medical experience, the pre-examination judgment method (5703) is selected from the above three types of judgment methods with reference to the subject's examination information. X. If there is no experience of consultation, refer to the examination and storage data, and select the judgment method in the preliminary examination from the three types of judgment methods (s7〇4). After the completion of the selection of the determination method and the execution of the preliminary examination, the examination and execution execution determination unit 16 determines the execution of the examination based on the result information of the preliminary examination input by the input (four) unit n. The low 'quasi-determination method and the medium-standard judgment method respectively determine any of the above-mentioned "implementation of this examination", "re-implementation of preliminary examination", and "negative" order. 132466.doc -40- 200917148 In addition, in the present embodiment, "the preliminary examination is performed again. The high-standard judgment method determines that "the implementation of this inspection" and the middle-of-the-ninth, and the "negative" is not judged in the embodiment. 'Set as follows: According to the fact that there is no diagnosis in the specific period of time, the test material and the judgment method selected in the selection of the judgment are converted. In this way, the determination method in the preliminary examination of the subject can be appropriately selected (n). In the above configuration, the determination method in the next-time verification may be specified or changed according to the determination result. As the above configuration, for example, in the flowchart of Fig. 14, when U is "re-prepared for preliminary examination", the next determination is made from the step "(10), and on the other hand, when the determination is "negative", the next time. The decision will be started from step s7〇i. For the selection method of the judgment method for the examination information, refer to the flowchart shown in Fig. 4 in the first embodiment (step S7〇3 of Fig. 14). As shown in Fig. ,, in the case of the selection of the judgment method of the subject, the information of the previous examination result information is referred to, for example, as described above, when the examination is conducted within a specific period, etc., it may be appropriately selected and applied. The judgment of the subject. For the selection method of the judgment method for checking the stored data, reference may be made to the flowchart shown in Fig. 5 in the first embodiment (step S7〇4 of Fig. 14). As shown in FIG. 5, in the case of selecting the judgment method of the subject, reference is made to the constitution of the disease risk estimation information. For example, when the examination is not performed within a certain period of time, the selection may be appropriately applied to the subject. The judge's judgment method. In addition, in the case of this examination, the reference disease risk estimation information I method can also be used. 132466.doc -41 - 200917148 • The method for estimating the risk of disease at this time can be used, for example, according to the past inspection data, treatment data, etc. of the depositor as a check-up storage data, by gender, The age and other conditions confirm the information of the disease rate, and calculate the presumed rickets rate based on the sex, age and inspection period of the subject. Secondly, the material preparation method for the opposite preparation (4) is as follows: In the judgment method for the preparatory inspection clinic, the following composition is used: : Mussel = Recalling section 17 'As described above, one of the combination of the exclusion diagnosis and the determination diagnosis is prepared. The method of judging the type. The determination method selection unit 18β, 0''", and FIG. 1 or 'in the configuration of the present embodiment may be configured as follows: the determination information storage unit 17 is provided with the exclusion diagnosis and the determination diagnosis. The combination of the judgment of the decree to the small class of the criteria; ^ π μ ^, 疋 is not a different type of complex number. In this case, the constitution may adopt a configuration in which the exclusion diagnosis of each of the plural (four) determination methods and the shirt diagnosis determination are made, and the combinations thereof are different from each other. . Further, in the above configuration, regarding the determination method of one of the diagnoses included in the determination method of the plural type, =2 is the selection containing only the exclusion diagnosis or in this case, the plural kinds of two expansion methods range. The above-mentioned exclusion diagnosis and determination of the diagnosis combination (4) The determination of the method i also includes the use of the application to focus on the sensitivity of the inspection of the cutoff: Bu, :: diagnosis to determine the judgment method, and the use of application; two = cutoff value The determination method for determining the diagnosis of 卩. 132466.doc •42- 200917148 In this way, for the judgment method in the preliminary examination, the application of the cut-off value can be diagnosed, that is, the diagnosis is excluded, and the diagnosis of the application of the cut-off value β, that is, the diagnosis is used separately or in combination, thereby Each of the determination methods of the type may appropriately constitute a method corresponding to the determination criterion. For example, when three types of judgment methods are set as shown in FIG. 14, it is preferable to use the judgment method of the exclusion diagnosis as the subject for estimating the sputum, the low tester = the low standard judgment method, and the use of the determination diagnosis The method is adopted as a high standard judgment method for estimating a subject having a high rate of rickets. Further, as the middle standard determination method in the middle of the above two determination methods, it is preferable to carry out a detailed study on the implementation of the present examination by using a determination method in which a combination of the exclusion diagnosis and the determination diagnosis is used. Alternatively, it is also possible to combine the exclusion diagnosis with the diagnosis and the diagnosis, and to determine the three types of determination criteria such as the number of diagnoses and the diagnosis of the inner valley, etc., as the low standard judgment method and the medium standard judgment. Law and high standard judgment method.
其次,使關15、圖16,對預備檢診所準備的複數種類 之判定法進行說明。此處,如上所述準備低標準判定法、 中=準判定法及高標㈣定法該三種類之心法,並對其 具體例加以說明…對於三種類之判定法,以如下構成 為例進行說明,即,使用除外診斷之判定法作為低標準判 定法’使用確定診斷之判定㈣為高標準^法,並且使 用除外診斷與確定診斷組合之判定法作為中標準判定法。 圖15係預備檢診中的複數種類之判定法之—例的示圖, 判定法⑷表⑽料判m,料法(咐*中標準 132466.doc •43- 200917148 判定法之例,又,判定法⑷表示高標準判定法之例。 施例中之判定法成為將複數種類之篩選診斷組合而進行預 備檢診時之狀法。關於該等判定法之具體内纟,與第! 實施形‘4中圖1G所示之判定法⑷〜⑷相同。 於本實施例中,低標準判定法⑷使用如下方法:複數次 實施應料錢值W除外輯,對本檢診之實施進行判 定。又,高標準判定法⑷使用如下方法:複數次實施應用 有截斷值β之確定診斷’對本檢診之實施進行判定。又, 上述兩個判定法之中間的中標準判定法⑻係與本實施形態 中的圖13之狀法(b)相同,使用分別複數次實施除外 及確定診斷之方法。Next, the determination method of the plural type prepared by the preparatory inspection clinic will be described in the case of the gates 15 and 16. Here, as described above, the three types of mind methods of the low standard determination method, the medium=quasi-determination method, and the high standard (four) method are prepared, and specific examples thereof are described. For the three types of determination methods, the following configuration is taken as an example. Description, that is, the judgment method using the exclusion diagnosis is used as the low standard judgment method 'the determination using the determination diagnosis (4) is the high standard method, and the judgment method using the exclusion diagnosis and the determination diagnosis combination is used as the medium standard judgment method. Fig. 15 is a diagram showing an example of a determination method of a plural type in a preliminary examination, and a judgment method (4), a table (10), a judgment method, and a method (a standard of 132466.doc • 43-200917148, a method of judging, The determination method (4) indicates an example of the high-standard determination method. The determination method in the example is a method in which a plurality of types of screening diagnoses are combined and subjected to preliminary examination. The specific meaning of the determination method and the The determination methods (4) to (4) shown in Fig. 1G of '4 are the same. In the present embodiment, the low standard determination method (4) uses the following method: a plurality of implementations of the amount of money to be excluded, and the implementation of the inspection is determined. The high-standard judgment method (4) uses the following method: a plurality of times the application of the determination of the cut-off value β is determined to determine the implementation of the present examination. Further, the middle-standard judgment method (8) in the middle of the above two determination methods is the same as the present embodiment. In the method (b) of Fig. 13, the method of excluding and determining the diagnosis is performed plural times.
圖1 6係預備檢診中的複數種類之判定法之其他例的示 圖m⑷表示低標準判定法之例,判定法⑻表示中 才不準判疋法之例’又,判定法⑷表示高標準判定法之例。 本實&例中之判疋法成為將兩種類之筛選診斷組合而進行 預備檢診時之敎法。關於該等判定法之具體内容,與第 1實施形態中圖11所示之判定法⑷〜(C)相同。 本實㈣中’低標準判定法⑷使用如下方法··進行應用 有截斷值α1的除外診斷1、及應用㈣斷值CX2的除外診斷2 該兩種類之除外診斷,對本檢診之實施進行判定。又,高 :準判定法⑷使用如下方法:進行應用有截斷值β1的確: 診斷1、及應用彳截斷值β2的確定診斷2該兩種類之確定珍 斷對本檢θ之實施進行判定。又,上述兩個判定法之中 1的中‘準判疋法(b)係與本實施形態的圖13之判定法⑷ 132466.doc • 44· 200917148 相同’使用實施有-種類之除外診斷及—種類之確定診斷 該兩種類之沴斷的方法。 本發明之檢診資訊管理系統及管理方法並非限於上述實 施形態及構成例,其可進行各種變形。例如,對於檢診資 訊管理系統之具體的硬體構成,可使用各種構成,而並非 限於圖1所示之構成。 又,在對預備檢診準備複數種類之判定法時,上述構成 例中設為三種類,但亦可為準備兩種類或者四種類以上之 判定法的構成。又,如上所述,若無需複數種類之判定 法’則亦可構成為準備除外診斷與確定診斷加以組合的一 種類之判定法。又,關於各個判定法之具體内容,除圖 1 3圖1 5、圖! 6所不之例以夕卜還使用各種判定法。 又,對於檢診儲存資料而言,於上述實施例中,關於圖 5所不之疾病風險之推定’根據過去的檢診資料等,按性 別、年代、時期等條件確認羅病率之資料並計算上述推定 f病率,但例如圖12所示,亦可預先準備按性別、年代、 等的羅病率之表以作為檢診儲存資料。 此處’對第i實施形態之檢轸資訊管理系統而言,管理 判斷機構於判定資訊記憶機構中,記憶有在對本檢診之實 =仃匈定之預備檢診中,判定標準不同的複數種類之判 2、及用以從上述複數種類之判定法中選擇適用於受試 之構定法之選擇條件’並且採用具有判定法選擇機構 料、:,該判定法選擇機構參照受試驗者之檢診資訊資 5者儲存有檢診中複數個受試驗者之資料的檢診儲存 132466.doc -45· 200917148 貝料之至少一者,根據選擇條件’對於預備檢診,於複數 種類之判定法中選擇適用於受試驗者之判定法。 又’第1實施形態之檢診資訊管理方法可採用如下構 成;於管理判斷步驟中,包括判定法選擇步驟,該判定法 選擇步驟在對本檢診之實施進行判定之預備檢診中,使用 預先準備的判定標準不同之複數種類之判定法、及用以從 上述複數種類之判定法中選擇適用於受試驗者之判定法之 選擇條件,並參照受試驗者之檢診資訊資料、或者儲存有 檢診中複數個受試驗者之資料的檢診儲存資料之至少一 者,根據選擇條件,對於預備檢診,於複數種類之判定法 中選擇適用於受試驗者之判定法。 此處,管理系統較好的是,除檢診資訊資料庫以外,還 具備檢診資訊輸入機構,其用於以下情況:在含有取得受 試驗者之斷層圖像並進行診斷的圖像診斷之本檢診中的本 檢診資訊之輸入,及在含有於圖像診斷前所進行的篩選診 斷之預備檢診中的預備檢診資訊之輸入。 又,管理系統較好的是,管理判斷機構具有檢診實施判 定機構,其根據應用判定法選擇機構中選擇之判定法所進 行的預備檢診之結果,對本檢診之實施進行判定。同樣 地,管理方法較好的{,管理判斷步驟包括檢診實施判定 步驟,其根據應用判定法選擇步驟中選擇之判定法所進行 的預備檢診之結果,對本檢診之實施進行判定。藉此,可 對受試驗者適當地進行檢診實施之管理。 關於對預備檢診所準備之判定標準不同的判定法,較好 132466.doc -46- 200917148 的疋,預備檢診中之複數種類之判定法包括:第丨判定 法,其係在應用著眼於檢查之靈敏度所設定之截斷值以來 判斷陽性或者陰性之篩選診斷中進行# $ ;以&第2判定 法,其係在應用著眼於檢查之特異度所設定之截斷值0來 判斷1%性或者陰性之筛選診斷中進行判定。 ^ 又,較好的是,預備檢診中之複數種類之判定法包括第 3判定法,其係將如下篩選診斷加以組合而進行判定, 即,應用著眼於檢查之靈敏度所設定之截斷值以來判斷陽 性或陰性之筛選診斷、以及應用著眼於檢查之特異度所設 疋之截斷值β來判斷陽性或陰性之篩選診斷。 又,關於對受试驗者的預備檢診中之判定法之選擇,管 理系統可採用如下構成:判定法選擇機構參照從檢診資I 資料抽出的前一次之檢診結果資訊,選擇適用於受試驗者 之判定法。同樣地,管理方法可採用如下構成:判定法選 擇步驟參照從檢診資訊資料抽出的前一次之檢診結果資 訊’選擇適用於受試驗者之判定法。 又,管理系統可採用如下構成:判定法選擇機構參照從 檢診儲存資料所導出的疾病風險之推定資訊,選擇適用於 欠忒驗者之判定法。同樣地,管理方法可採用如下構成: 判定法選擇步驟參照從檢診儲存資料所導出的疾病風險之 推定資訊,選擇適用於受試驗者之判定法。 第2實施形態之檢診資訊管理系統中,管理判斷機構具 有檢診實施判定機構,該檢診實施判定機構根據應用判定 法所進行的預備檢診之結果,對本檢診之實施進行判定, 132466.doc -47- 200917148 預備檢診中之判定法採用如下判定法之構成:將應用著眼 於檢查之靈敏度所設定之截斷值α來判斷陽性或陰性之診 斷即除外診斷、及應用著眼於檢查之特異度所設定之截斷 值β來判斷陽性或陰性之診斷即確定診斷加以組合而進行 判定。 又,第2實施形態之檢診資訊管理方法中,管理判斷步 驟具有檢診實施判定步驟,其根據應用判定法所進行的預 備檢診之結果,對本檢診之實施進行判定,預備檢診中之 判定法採用如下判定法之構成:將應用著眼於檢查之靈敏 度所設定之截斷值α來判斷陽性或陰性之診斷即除外診 斷、及應用著眼於檢查之特異度所設定之截斷值β來判斷 陽性或陰性之診斷即確定診斷加以組合而進行判定。 此處,管理系統較好的是,除檢診資訊資料庫以外,還 具備檢診資訊輸入機構,其用於以下情況:在含有取得受 試驗者之斷層圖像並進行診斷的圖像診斷之本檢診中的本 檢診資訊之輸入、及在含有於圖像診斷前所進行的篩選診 斷之預備檢診中的預備檢診資訊之輸入。 關於對預備檢診所準備之判定法,預備檢診中之判定法 可採用如下構成:根據除外診斷之結果中的陽性/陰性、 及確定診斷之結果中的陽性/陰性之組合,對本檢診之實 施進行判定。藉此,可對本檢診之實施適當地進行判定。 或者,預備檢診中之判定法可採用如下構成:使用複數 次除外診斷作為除外診斷,使用複數次確定診斷作為確定 診斷,並且根據複數次除外診斷之結果中的所有陽性/ 一 132466.doc •48· 200917148 部分陽陽•陰性/所有陰性、及複數次確定診斷之結果中 的所有陽性/一部陽性•陰性/所有陰性之組合,對本檢診 之實施進行判定。如此,藉由分別複數次使用除外診斷及 確定診斷,可提高對本檢診實施之判定精度。 產業上之可利用性 本發明可用作能夠對受試驗者有效地進行檢診、降低其 診斷費用之檢診資訊管理系統及檢診資訊管理方法。 【圖式簡單說明】 圖1係表示檢診資訊管理系統之一實施形態之構成的方 塊圖。 圖2係表示檢診資訊管理方法之基本概念之流程圖。 圖3係表示檢診資訊管理方法之一例之流程圖。 圖4係表示檢診資訊資料之判定法之選擇方法的流程 圖。 圖5係表示檢診儲存資料之判定法之選擇方法的流程 圖。 圖6係表示適用於篩選診斷之截斷值之設定方法的流程 圖。 圖7係表示篩選診斷之靈敏度及特異度之示圖。 圖8(a)〜圖8(b)係表示除外診斷中之截斷值α之設定方法 的示圖。 圖9(a)〜圖9(b)係表示確定診斷中之截斷值β之設定方法 的示圖。 圖10(a)〜圖10(c)係表示預備檢診中之複數種類之判定法 132466.doc -49- 200917148 之一例的示圖。 定法 圖11 (a)〜圖11 (c)係表示預備檢診中之複數種_之判 之其他例的不圖。 圖12係表示作為檢診儲存資料所準備的罹病率表之示 圖。 ’、 圖13(a)〜圖13(b)係表示將除外診斷與確定診斷組合之判 定法之例圖。 圖14係表示檢診資訊管理方法之一例的流程圖。 圖15(a)〜圖l5(c)係預備檢診中之複數種類之判定法之一 例的示圖。 圖1 6(a)〜圖丨6(c)係預備檢診中之複數種類之判定法的其 他例示圖。 【主要元件符號說明】 1A 檢診資訊管理系統 10 檢诊資訊管理裝置 11 檢診資料輸入控制部 12 管理資訊輸出控制部 15 管理判斷部 16 檢診實施判定部 17 判定資訊記憶部 18 判定法選擇部 20 檢診資料庫 21 檢診資訊資料庫 22 檢診儲存資料庫 132466.doc -50. 200917148 50 輸入部 51 輸入裝置 52 外部I/F 53 外部裝置 60 輸出部 61 顯示裝置 62 印刷裝置 132466.doc -51Fig. 16 is a diagram showing another example of the determination method of the plural type in the preliminary examination. (4) indicates an example of the low standard judgment method, and the judgment method (8) indicates that the method is not allowed to judge the method. Further, the judgment method (4) indicates high. An example of a standard judgment method. The method of judging in this example is a method of combining two types of screening diagnoses for preliminary examination. The details of these determination methods are the same as the determination methods (4) to (C) shown in Fig. 11 in the first embodiment. In the present (4), the 'low standard judgment method (4) uses the following method: • Exclusion diagnosis with the cutoff value α1 and the application (4) Exclusion diagnosis of the cutoff value CX2 2 The exclusion diagnosis of the two types is used to determine the implementation of this test. . Further, the high: quasi-judgment method (4) uses the following method: the application of the cutoff value β1 is confirmed: Diagnosis 1, and the determination of the application of the cutoff value β2. 2 The determination of the two types of determinations determines the implementation of the test θ. Further, the middle 'quasi-determination method (b) of 1 of the above two determination methods is the same as the determination method (4) 132466.doc • 44· 200917148 of FIG. 13 of the present embodiment. - Determination of the type of diagnosis of the two types of methods. The medical examination information management system and management method of the present invention are not limited to the above-described embodiments and configuration examples, and various modifications can be made. For example, various configurations may be used for the specific hardware configuration of the diagnostic information management system, and are not limited to the configuration shown in Fig. 1. In addition, in the case of preparing a plurality of types of determinations for the preliminary examination, three types of the above-described configuration examples are used, but it is also possible to prepare two or four types of determination methods. Further, as described above, if a plurality of types of determination methods are not required, it is also possible to configure one type of determination method in which the exclusion diagnosis and the determination diagnosis are combined. In addition, as for the specific content of each judgment method, in addition to Figure 1 3 Figure 15, Figure! In the case of 6 cases, various judgment methods are also used. In addition, in the above-mentioned embodiment, in the above-mentioned embodiment, the estimation of the risk of disease in the case of FIG. 5 is based on the past examination data, etc., and the information on the disease rate is confirmed according to the conditions of sex, age, time, and the like. The above-mentioned estimated f disease rate is calculated. However, as shown in FIG. 12, a table of sex rates by sex, age, and the like may be prepared in advance as a check-up storage data. Here, in the inspection information management system of the i-th embodiment, the management judgment means stores, in the judgment information memory mechanism, a plurality of types in which the judgment criteria are different in the preliminary examination of the inspection. The judgment 2 and the selection condition for selecting the configuration method suitable for the test from the above-mentioned plural types of determination methods, and using the selection method to select the mechanism material:: the determination method selection mechanism refers to the examination of the subject The information resource 5 stores the examination and storage of the data of a plurality of subjects in the examination. 132466.doc -45· 200917148 At least one of the materials, according to the selection condition, for the preliminary examination, in the judgment of the plural type Choose the judgment method that applies to the subject. Further, the inspection information management method according to the first embodiment may have the following configuration; and the management determination step includes a determination method selection step for using the advance inspection in the preliminary examination for determining the execution of the examination. a determination method of a plurality of types of judgment criteria to be prepared, and a selection condition for selecting a judgment method applicable to a subject from the plurality of types of judgment methods, and referring to the examiner's examination information, or storing At least one of the examination and storage data of the plurality of subjects in the examination, according to the selection condition, selects a judgment method applicable to the subject in the plural type of determination method for the preliminary examination. Here, the management system preferably has a check-in information input unit in addition to the check-up information database, and is used in the case of image diagnosis including obtaining a tomographic image of a subject and performing diagnosis. The input of the medical examination information in this examination and the input of the preliminary examination information in the preliminary examination including the screening diagnosis performed before the image diagnosis. Further, in the management system, the management judging means preferably has a check-up execution judging means for judging the execution of the test based on the result of the preliminary check conducted by the judging method selected by the application judging method selection means. Similarly, the management method is better. {The management judging step includes a check-up execution judging step for judging the execution of the test based on the result of the preliminary check conducted by the judging method selected in the application decision-making selection step. Thereby, the subject can be appropriately managed for the examination and implementation. Regarding the judgment method for the different judgment criteria for the preparatory examination clinic, it is better to use the method of judging the plural types in the preliminary examination, including the third judgment method, which is applied to examine the application. The screening diagnosis determined by the sensitivity is determined to be 1% in the screening diagnosis for judging positive or negative. The determination is made in the negative screening diagnosis. Further, it is preferable that the determination method of the plural type in the preliminary examination includes the third determination method, which combines the following screening diagnoses, that is, the application is based on the cutoff value set by the sensitivity of the examination. A screening diagnosis that judges positive or negative, and a cut-off value β set by the specificity of the examination to determine a positive or negative screening diagnosis. Further, regarding the selection of the determination method in the preliminary examination of the subject, the management system may be configured such that the selection method refers to the information of the previous examination result extracted from the medical examination I data, and the selection is applied to The judgment of the subject. Similarly, the management method may be configured as follows: the determination method selection step refers to the judgment method applied to the subject by referring to the previous examination result information extracted from the examination information. Further, the management system may be configured such that the determination method selection mechanism refers to the estimation information of the disease risk derived from the examination and storage data, and selects the determination method applicable to the under-reviewer. Similarly, the management method may be configured as follows: The determination method selection step refers to the estimation information of the disease risk derived from the examination and storage data, and selects the determination method applicable to the subject. In the medical examination information management system according to the second embodiment, the management determination unit includes a diagnosis execution determination unit that determines the execution of the examination based on the result of the preliminary examination performed by the application determination method, 132466 .doc -47- 200917148 The judgment method in the preliminary examination adopts the following judgment method: the diagnosis is judged by using the cutoff value α set by the sensitivity of the examination to judge the positive or negative diagnosis, and the application is focused on the examination. The cut-off value β set by the specificity is determined by judging whether the diagnosis is positive or negative, that is, the diagnosis is determined and combined. Further, in the inspection information management method according to the second embodiment, the management determination step includes a diagnosis execution determination step of determining the execution of the examination based on the result of the preliminary examination performed by the application determination method, and preparing for the examination. The determination method adopts a configuration in which the judgment is made by using the cutoff value α set by the sensitivity of the inspection to determine the diagnosis of the positive or negative diagnosis, and the cutoff value β set by the specificity of the inspection. A positive or negative diagnosis is determined by combining the diagnoses. Here, the management system preferably has a check-in information input unit in addition to the check-up information database, and is used in the case of image diagnosis including obtaining a tomographic image of a subject and performing diagnosis. The input of the medical examination information in this examination and the input of the preliminary examination information in the preliminary examination including the screening diagnosis performed before the image diagnosis. With regard to the judgment method for the preparation of the preparatory examination clinic, the judgment method in the preliminary examination may be constituted by the combination of the positive/negative in the result of the exclusion diagnosis and the positive/negative in the result of the determination of the diagnosis. The implementation is judged. Thereby, the judgment of the implementation of this examination can be appropriately determined. Alternatively, the determination method in the preliminary examination may be constituted by using a plurality of exclusion diagnoses as the exclusion diagnosis, using the plurality of determination diagnoses as the determination diagnosis, and all the positives in the results of the multiple exclusion diagnosis/one 132466.doc • 48· 200917148 The combination of all positive/one positive•negative/all negative in the results of partial Yangyang•negative/all negative and multiple confirmed diagnosis determines the implementation of this test. In this way, by using the exclusion diagnosis and the determination of the diagnosis multiple times, the accuracy of the determination of the examination can be improved. Industrial Applicability The present invention can be used as a medical information management system and a medical examination information management method capable of effectively performing a diagnosis on a subject and reducing the diagnosis cost thereof. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a block diagram showing the configuration of an embodiment of a medical examination information management system. Fig. 2 is a flow chart showing the basic concept of the management information management method. Fig. 3 is a flow chart showing an example of a method of managing a medical examination information. Fig. 4 is a flow chart showing a method of selecting a judgment method for the inspection information. Fig. 5 is a flow chart showing a method of selecting a judgment method for reviewing stored data. Fig. 6 is a flow chart showing a method of setting a cutoff value suitable for screening diagnosis. Figure 7 is a graph showing the sensitivity and specificity of the screening diagnosis. 8(a) to 8(b) are diagrams showing a method of setting the cutoff value α in the exclusion diagnosis. Fig. 9 (a) to Fig. 9 (b) are diagrams showing a method of setting the cutoff value ? in the diagnosis. Fig. 10 (a) to Fig. 10 (c) are diagrams showing an example of a plural type of determination method 132466.doc -49 - 200917148 in the preliminary examination. The method of Fig. 11 (a) to Fig. 11 (c) is a diagram showing another example of the judgment of the plural types in the preliminary examination. Fig. 12 is a view showing a ricket rate table prepared as a check-up storage material. Figs. 13(a) to 13(b) are diagrams showing an example of a combination of the exclusion diagnosis and the determination diagnosis. Fig. 14 is a flow chart showing an example of a method of managing a medical examination information. Fig. 15 (a) to Fig. 15 (c) are diagrams showing an example of the determination method of the plural type in the preliminary examination. Fig. 16 (a) to Fig. 6 (c) are other illustrations of the determination method of the plural types in the preliminary examination. [Description of main component symbols] 1A Inspection information management system 10 Inspection information management device 11 Inspection data input control unit 12 Management information output control unit 15 Management determination unit 16 Inspection execution determination unit 17 Determination information storage unit 18 Determination method selection Department 20 Inspection database 21 Inspection information database 22 Inspection storage database 132466.doc -50. 200917148 50 Input unit 51 Input device 52 External I/F 53 External device 60 Output unit 61 Display device 62 Printing device 132466. Doc -51
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JP2007170731A JP2009009396A (en) | 2007-06-28 | 2007-06-28 | Medical examination information management system and management method |
JP2007170739A JP5191693B2 (en) | 2007-06-28 | 2007-06-28 | Screening information management system and management method |
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CN105011933A (en) * | 2014-04-25 | 2015-11-04 | 朴永根 | Health medical examination method including detailed examination information |
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WO2019176960A1 (en) * | 2018-03-13 | 2019-09-19 | 富士フイルム株式会社 | Medical examination management device, medical examination management method and program |
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JPH03111976A (en) * | 1989-09-26 | 1991-05-13 | Olympus Optical Co Ltd | Inspection data processor |
JP2000099605A (en) * | 1998-09-24 | 2000-04-07 | Fujitsu Ltd | Health examination information analysis server and network health information system |
JP2001067423A (en) * | 1999-08-30 | 2001-03-16 | Sanyo Electric Co Ltd | Medical examination data processor |
JP2003233678A (en) * | 2002-02-07 | 2003-08-22 | Nippon Telegr & Teleph Corp <Ntt> | Health care system and method therefor |
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CN105011933A (en) * | 2014-04-25 | 2015-11-04 | 朴永根 | Health medical examination method including detailed examination information |
CN105011933B (en) * | 2014-04-25 | 2016-08-24 | 朴永根 | Comprise the health examination method of detailed inspection information |
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