JP2015099163A - 試験方法の臨床的等価を判定するためのシステムおよび方法 - Google Patents
試験方法の臨床的等価を判定するためのシステムおよび方法 Download PDFInfo
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- JP2015099163A JP2015099163A JP2015033417A JP2015033417A JP2015099163A JP 2015099163 A JP2015099163 A JP 2015099163A JP 2015033417 A JP2015033417 A JP 2015033417A JP 2015033417 A JP2015033417 A JP 2015033417A JP 2015099163 A JP2015099163 A JP 2015099163A
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
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- Public Health (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Automatic Analysis And Handling Materials Therefor (AREA)
Abstract
【解決手段】レポートは、修正済みの平均差プロット、変動性図、偏りの信頼区間、および区間のプロットを含むことができる。グラフィカルユーザインターフェースは、基準方法または機器および評価方法または機器に関連付けられたデータを識別可能にするために提供される。基準方法における変動レベルが決定される。評価方法または機器と基準方法または機器との間で観察される偏りが算出される。偏りの信頼区間が算出される。評価方法または機器と基準方法または機器との間の偏りが、基準方法における変動レベルに対して比較され、評価方法または機器が基準方法または機器と臨床的に等価であるかどうかに関する結果を含むレポートが生成される。
【選択図】図3
Description
302 観察内容(対照)を記録
304 評価方法を実行
306 観察内容(評価)を記録
308 統計分析プログラムを開始
310 データを識別
312 計算タイプを選択
314 所望の出力を選択
316 計算を開始
318 等価を判定およびレポート
320 選択した出力を生成
Claims (1)
- 評価試験方法が基準試験方法と臨床的に等価であるかどうかを判定する方法であって、
複数のソースから取得した複数の試験体を用意するステップであって、前記複数のソースの各々について、複数の基準試験体と、1つの評価試験体とを用意するステップと、
前記複数のソースの各々について、前記複数の基準試験体に対する基準試験方法の結果を取得するステップと、
前記複数のソースの各々について、前記評価試験体に対する評価試験方法の結果を取得するステップと、
前記複数のソースの各々について、2つの基準試験体に対する前記基準試験方法の結果の間の差を計算し、前記計算された差を前記基準試験方法の結果の平均値で除算し、および、前記複数のソースの各々について除算された差を平均することにより、前記基準試験方法の変動のレベルを計算するステップと、
前記複数のソースの各々について、前記基準試験方法の結果と、前記評価試験方法の結果との差を平均することにより、前記基準試験方法と前記評価試験方法との間の偏りを計算するステップと、
前記計算された変動のレベルおよび前記計算された偏りに基づいて、信頼区間を計算するステップと、
前記計算された信頼区間が所定の範囲内にある場合に、前記評価試験方法が前記基準試験方法と等価であると判定するステップと、
前記基準試験方法の結果、前記評価試験方法の結果、前記平均の偏り、前記変動のレベル、および等価の判定を一部に含むレポートを生成するステップと、
前記生成されたレポートをコンピュータの表示装置に表示するステップと
を備え、
前記基準試験方法において使用される試験体および前記評価試験方法において使用される試験体は同一のソースからのものであることを特徴とする方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/096,102 | 2002-03-13 | ||
US10/096,102 US7440856B2 (en) | 2002-03-13 | 2002-03-13 | System and method for determining clinical equivalence of test methods |
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JP2013205120A Division JP2014016363A (ja) | 2002-03-13 | 2013-09-30 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
Publications (2)
Publication Number | Publication Date |
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JP2015099163A true JP2015099163A (ja) | 2015-05-28 |
JP6224018B2 JP6224018B2 (ja) | 2017-11-01 |
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Application Number | Title | Priority Date | Filing Date |
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JP2003068965A Pending JP2004037449A (ja) | 2002-03-13 | 2003-03-13 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
JP2011025235A Pending JP2011090014A (ja) | 2002-03-13 | 2011-02-08 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
JP2013205120A Pending JP2014016363A (ja) | 2002-03-13 | 2013-09-30 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
JP2015033417A Expired - Lifetime JP6224018B2 (ja) | 2002-03-13 | 2015-02-23 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
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JP2003068965A Pending JP2004037449A (ja) | 2002-03-13 | 2003-03-13 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
JP2011025235A Pending JP2011090014A (ja) | 2002-03-13 | 2011-02-08 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
JP2013205120A Pending JP2014016363A (ja) | 2002-03-13 | 2013-09-30 | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
Country Status (5)
Country | Link |
---|---|
US (2) | US7440856B2 (ja) |
EP (1) | EP1345155A3 (ja) |
JP (4) | JP2004037449A (ja) |
AU (1) | AU2003200983B8 (ja) |
CA (1) | CA2421571C (ja) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
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US20050004767A1 (en) * | 2003-04-30 | 2005-01-06 | Green Sol F. | Method and system for validating changes in medical practice, procedures and product choice |
US7440856B2 (en) * | 2002-03-13 | 2008-10-21 | Becton, Dickinson And Company | System and method for determining clinical equivalence of test methods |
WO2004099914A2 (en) * | 2003-04-30 | 2004-11-18 | Becton, Dickinson And Company | Extranet service site and method for using same |
US8296732B2 (en) * | 2007-03-23 | 2012-10-23 | Sas Institute Inc. | Computer-implemented systems and methods for analyzing product configuration and data |
US8087001B2 (en) * | 2007-06-29 | 2011-12-27 | Sas Institute Inc. | Computer-implemented systems and methods for software application testing |
US8506622B2 (en) * | 2009-04-17 | 2013-08-13 | Medtronic Vascular, Inc. | Mobile external coupling for branch vessel connection |
KR20220016377A (ko) * | 2020-07-31 | 2022-02-09 | 주식회사 바이오크 | 추적관찰 데이터 신뢰도 부여 방법 |
Citations (3)
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US6125297A (en) * | 1998-02-06 | 2000-09-26 | The United States Of America As Represented By The United States National Aeronautics And Space Administration | Body fluids monitor |
JP2013205120A (ja) * | 2012-03-27 | 2013-10-07 | Osaka City Univ | 電力計測装置 |
JP2014016363A (ja) * | 2002-03-13 | 2014-01-30 | Becton Dickinson & Co | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
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JPS61213674A (ja) * | 1985-03-19 | 1986-09-22 | Toshiba Corp | 自動化学分析装置 |
US4858154A (en) * | 1986-04-07 | 1989-08-15 | Coulter Electronics, Inc. | Interlaboratory quality assurance program |
JP2828609B2 (ja) * | 1994-09-22 | 1998-11-25 | 株式会社エイアンドティー | 臨床検査分析装置 |
US6678669B2 (en) * | 1996-02-09 | 2004-01-13 | Adeza Biomedical Corporation | Method for selecting medical and biochemical diagnostic tests using neural network-related applications |
US6556951B1 (en) * | 1997-11-26 | 2003-04-29 | The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services | System and method for intelligent quality control of a process |
WO1999054724A1 (en) * | 1998-04-22 | 1999-10-28 | Imaging Research Inc. | Process for evaluating chemical and biological assays |
JP2000187037A (ja) * | 1998-12-24 | 2000-07-04 | Sysmex Corp | 精度管理機能を備えた試料分析装置 |
US6041788A (en) * | 1999-01-04 | 2000-03-28 | Shen; Liji | Method of evaluating drug effect in a multiple dose clinical trial |
DE60013303T2 (de) * | 1999-06-17 | 2005-09-22 | Amersham Biosciences Niagara Inc., St. Catharines | Verfahren zum entfernen systematischer fehler und abweichungen und zum abschätzen zufälliger fehler in chemischen und biologischen testverfahren |
US6434511B1 (en) * | 1999-09-28 | 2002-08-13 | General Electric Company | Processor and method for determining the statistical equivalence of the respective mean values of two processes |
JP2001124757A (ja) * | 1999-10-29 | 2001-05-11 | Meidensha Corp | 3態窒素分析システムにおけるシステムの自己診断方法 |
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EP1428021A4 (en) * | 2001-08-24 | 2007-04-11 | Bio Rad Laboratories | BIOMETRIC QUALITY CONTROL METHOD |
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2002
- 2002-03-13 US US10/096,102 patent/US7440856B2/en not_active Expired - Lifetime
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2003
- 2003-03-10 CA CA2421571A patent/CA2421571C/en not_active Expired - Lifetime
- 2003-03-12 AU AU2003200983A patent/AU2003200983B8/en not_active Expired
- 2003-03-13 EP EP03251543A patent/EP1345155A3/en not_active Ceased
- 2003-03-13 JP JP2003068965A patent/JP2004037449A/ja active Pending
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2011
- 2011-02-08 JP JP2011025235A patent/JP2011090014A/ja active Pending
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2013
- 2013-09-30 JP JP2013205120A patent/JP2014016363A/ja active Pending
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2015
- 2015-02-23 JP JP2015033417A patent/JP6224018B2/ja not_active Expired - Lifetime
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US6125297A (en) * | 1998-02-06 | 2000-09-26 | The United States Of America As Represented By The United States National Aeronautics And Space Administration | Body fluids monitor |
JP2014016363A (ja) * | 2002-03-13 | 2014-01-30 | Becton Dickinson & Co | 試験方法の臨床的等価を判定するためのシステムおよび方法 |
JP2013205120A (ja) * | 2012-03-27 | 2013-10-07 | Osaka City Univ | 電力計測装置 |
Also Published As
Publication number | Publication date |
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JP6224018B2 (ja) | 2017-11-01 |
JP2004037449A (ja) | 2004-02-05 |
EP1345155A2 (en) | 2003-09-17 |
US20090248315A1 (en) | 2009-10-01 |
AU2003200983B8 (en) | 2010-03-25 |
JP2014016363A (ja) | 2014-01-30 |
EP1345155A3 (en) | 2006-03-08 |
US7440856B2 (en) | 2008-10-21 |
CA2421571A1 (en) | 2003-09-13 |
AU2003200983A1 (en) | 2003-12-18 |
AU2003200983B2 (en) | 2009-11-26 |
CA2421571C (en) | 2015-01-27 |
AU2003200983A8 (en) | 2010-04-29 |
US8160818B2 (en) | 2012-04-17 |
US20030172712A1 (en) | 2003-09-18 |
JP2011090014A (ja) | 2011-05-06 |
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