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公开(公告)号：US5251126A
公开(公告)日：1993-10-05
申请号：US605400
申请日：1990-10-29
申请人： Michael G. Kahn , Dijia Huang , Stephen A. Bussmann , Steve B. Cousins , Charlene A. Abrams , James C. Beard
发明人： Michael G. Kahn , Dijia Huang , Stephen A. Bussmann , Steve B. Cousins , Charlene A. Abrams , James C. Beard
CPC分类号： G01N35/00871 , G06F19/3487 , A61B5/14532 , G01N2035/00108 , G01N2035/00881 , G06F19/322 , G06F19/3456 , G06F19/363 , Y10S128/923
摘要： An automated diabetes data interpretation method is provided which combines symbolic and numeric computing approaches in order to identify and highlight key clinical findings in the patient's self-recorded diabetes data. The patient data, including blood glucose levels and insulin dosage levels, recorded by a diabetic patient over a period of time by means of a glucose meter or the like, is initially downloaded into a central processing system such as a personal computer. The accepted diabetes data is subsequently processed to (a) identify insulin dosage regimens corresponding to predefined significant changes in insulin dosage which are found to be sustained for at least a predefined segment of the overall data collection period, (b) identify statistically significant changes in blood glucose levels resulting across adjacent ones of the identified insulin regimen periods, and (c) identify clinically significant changes in blood glucose levels from within the identified statistically significant glucose level changes. The results of the diabetes data processing are generated in the form of a comprehensive yet easily understandable data interpretation report highlighting the processing results, including details pertaining to the identified insulin regimens and the associated clinically significant changes in glucose levels.
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公开(公告)号：US07444293B1
公开(公告)日：2008-10-28
申请号：US09974781
申请日：2001-10-10
IPC分类号： G06Q50/00
CPC分类号： G06Q50/24 , G06F19/00 , G06Q50/22 , G16H10/20 , Y10S707/99945
摘要： Structure and methodology for reducing risk of protocol ambiguities that could lead to operational failures in the conduct of clinical trials. Roughly described, an analyst encodes the features of a protocol into a highly structured, formal model created specifically to capture issues that tend to cause operational difficulties. The process forces the analyst to look for specific parameters in the text version of the protocol. The system creates a database of the protocol as encoded, and can display the protocol schema as a graphical network of protocol events and temporal links. In one aspect, the database includes an object class into which an analyst encodes descriptions of operational uncertainties. The system can display the network in graphical-visual form, with a human-perceptible indication of objects that have operational uncertainties associated therewith. Advantageously, the formal protocol model includes slots for encoding temporal constraints among protocol events.
摘要翻译： 用于降低协议模糊度风险的结构和方法，这可能导致临床试验进行中的操作失败。 大致描述，分析师将协议的特征编码成一个高度结构化的正式模型，专门用于捕获容易导致操作困难的问题。 该过程强制分析人员在协议的文本版本中查找特定参数。 该系统创建协议的数据库编码，并可以将协议模式显示为协议事件和时间链接的图形网络。 在一个方面，数据库包括对象类，分类器对其进行编码操作不确定性的描述。 该系统可以以图形视觉形式显示网络，具有与之相关的具有操作不确定性的对象的人为可察觉的指示。 有利地，正式协议模型包括用于协议协议事件之间的时间约束的时隙。
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公开(公告)号：US08533008B2
公开(公告)日：2013-09-10
申请号：US12505860
申请日：2009-07-20
IPC分类号： G06Q50/00
CPC分类号： G06F19/363 , G06F19/00 , G06F19/325 , G06F19/3481 , G06Q50/24 , G16H10/20 , G16H15/00
摘要： Meta-models are made available to clinical trial protocol designers. A meta-model includes a list of preliminary patient eligibility attributes appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model in a protocol database. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Sponsors and individual clinical sites have controlled access to the protocols. Study sites make reference to the protocol database in order to perform patient eligibility screening. Once a patient is enrolled into a study, the protocol database indicates to the clinician what workflow tasks are to be performed at each patient visit.
摘要翻译： Meta模型可用于临床试验方案设计人员。 元模型包括适用于特定疾病类别的初步患者资格属性的列表。 协议设计者选择适当的元模型，并在协议数据库中选择的元模型内编码临床试验方案，包括资格和患者工作流程。 所产生的协议数据库与其他协议的数据库一起存储在协议数据库的库中。 赞助商和个人临床站点已经控制了对协议的访问。 研究网站参考协议数据库，以进行患者资格筛选。 一旦患者参加了研究，协议数据库向临床医生指示在每次病人访问时将执行哪些工作流任务。
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公开(公告)号：US08504380B2
公开(公告)日：2013-08-06
申请号：US10454954
申请日：2003-06-05
IPC分类号： G06Q10/00
CPC分类号： G06F19/363 , G06F17/30011 , G06F19/00 , G06F19/324 , G06Q10/067 , G06Q50/22 , G16H10/20
摘要： Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. Alter all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.
摘要翻译： 粗略地描述，用户在结构化临床试验协议数据库中实例化协议元素，然后从它们中抽出开发一个或多个协议相关文档。 该系统帮助用户通过参考先前与类似协议相关联的任务的历史数据库来选择在研究期间执行的任务。 该系统自动从数据库中的协议元素生成复杂的内容，并且可以在文档的不同位置呈现不同的协议元素的重叠集合。 该系统可以自动提供指示文档方面的建议，该方面仍然需要完成，或突出显示赞助机构认为对文档类型重要的其他问题。 更改所有协议元素在协议数据库中实例化，然后可以用于驱动研究的大多数下游方面的操作。
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公开(公告)号：US20090313048A1
公开(公告)日：2009-12-17
申请号：US12505860
申请日：2009-07-20
CPC分类号： G06F19/363 , G06F19/00 , G06F19/325 , G06F19/3481 , G06Q50/24 , G16H10/20 , G16H15/00
摘要： Clinical trials are defined, managed and evaluated according to an overall end-to-end system. The central authority creates protocol meta-models and makes them available to clinical trial protocol designers. Each meta-model includes a short list of preliminary patient eligibility attributes which are appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Sponsors and individual clinical sites have controlled access to the protocols. Study sites make reference to the pertinent protocol databases to which they have access in the protocol database library in order to perform patient eligibility screening. Once a patient is enrolled into a study, the protocol database indicates to the clinician what tasks are to be performed at each patient visit. These tasks can include both patient management tasks and data management tasks. The workflow graph advantageously also instructs the proper time for the clinician to obtain a patient's informed consent. The system reports patient progress to study sponsors, who can then monitor the progress of the trial, and to a central authority which can then generate performance metrics. Advantageously, a common controlled medical terminology database is used by all components of the system.
摘要翻译： 临床试验根据整体端到端系统进行定义，管理和评估。 中央机构创建协议元模型，使其可用于临床试验协议设计者。 每个元模型包括适用于特定疾病类别的初步患者资格属性的简短列表。 协议设计人员选择适当的元模型，并在选定的元模型中编码临床试验方案，包括资格和患者工作流程。 所产生的协议数据库与其他协议的数据库一起存储在协议数据库的库中。 赞助商和个人临床站点已经控制了对协议的访问。 研究网站参考协议数据库中可访问的相关协议数据库，以便进行病人资格筛选。 一旦患者参加了研究，协议数据库向临床医生指示在每次病人访问中要执行的任务。 这些任务可以包括患者管理任务和数据管理任务。 工作流程图有利地还指示临床医生获得患者知情同意的适当时间。 该系统报告患者进展情况，以研究赞助者，然后可以监测试验的进展情况，然后监控中央机构，然后可以生成性能指标。 有利地，系统的所有组件使用公共受控医学术语数据库。
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