Checkpoint checklist for ADaM submission package and SAS Macros for package validation / 中国临床药理学与治疗学

FDA clearly provides the rules for drug submission and requires that all the studies which are suitable in electronic format should follow CDISC standard.Due to the detailed contents of submission package,it's always a big challenge to submission institution and staff.It usually costs a lot of time for company or member to complete the validation before submission to FDA.Based on the ADaM submission package,this paper gives a clear picture of validation checkpoint checklist.For every checkpoint,it will see and find the ways to automatically validate through SAS macros or tools.So that it will decrease the manual checking workload,saving the time and shorten the submission period.

Toma de decisiones inteligente a partir de registros médicos almacenados en CDA-HL7 / Intelligent decision-making from medical records stored on the CDA-HL7

Debido al incremento exponencial de la información almacenada en las organizaciones, la Sociedad de la Información está siendo superada por la necesidad de nuevos métodos capaces de procesar la información y asegurar su uso productivo. Esto se hace lógicamente extensible a los centros hospitalarios, a partir del uso extendido de las Historias Clínicas en formato electrónico. Disponer de información sistematizada, gestionarla de forma eficiente y segura es esencial para garantizar mejores prácticas en salud. A esto se le añade la necesidad de soportar estándares que permitan el intercambio entre las instituciones de salud; específicamente HL7 se ha convertido en uno de los más utilizados debido a que proporciona el intercambio a partir del metalenguaje XML. En este trabajo se propone una metodología para el descubrimiento de conocimiento implícito en Historias Clínicas en formato semi-estructurado utilizando el contenido y la estructura de los mismos. Los principales resultados son: (1) La metodología para el agrupamiento de Historias Clínicas; (2) La interpretación de los resultados del agrupamiento para asistir la toma de decisiones diagnósticas; (3) La implementación del estándar HL7, para la manipulación de documentos médicos a partir de CDA(AU)

Due to the exponential increase of stored information the organizations, the information society is being overtaken by the need for new methods capable of processing information and ensuring its productive use. This is logically extended to the hospitals, from the widespread use of clinical histories in electronic format. To have systematized information, manage it efficiently and securely is essential to ensure better health practices. In addition, there is the need for standards to support the exchange among health institutions; specifically hl7 has become one of the most widely used because it provides the exchange from xml. In this paper is presented a methodology for the discovery of implicit knowledge in medical records with semi-structured format, using their content and structure. The main results are: (1) the methodology for the clustering of medical records; (2) the interpretation of the results of the clustering to assist diagnostic decision-making; (3) the implementation of the hl7 standard for handling medical records from CDA(AU)

Research and Design of Medical Data Integration Platform / 世界科学技术-中医药现代化

In this paper, through in-depth study on characteristics of hospital information system (HIS) construction and requirements of medical data integration, and combined with the medical data straits of heterogeneity, multi-source, complexity, dynamic growth, etc., the problem of information exchange in different systems was aimed to solved, in order to realize medical data sharing among internal systems in hospital.Based on Extensible Markup Language (XML), public data model was described by XML Schema technology. Global and local medical data were queried using XQuery technology. The results showed that a medical data integration platform based on HL7 standard and the middleware technologies were proposed. It was concluded that the platform shielded the heterogeneity of underlying medical data by middleware technology. It finally realized the global query and transparent access of medical data in HIS for users.

Study on XML based Data Collection Planning of Traditional Chinese Medicine Clinical Medicine / 世界科学技术-中医药现代化

This study was aimed to discuss possible problems in the data collection process of traditional Chinese medicine (TCM) clinical medicine and to propose appropriate solutions. Based on analysis of clinical data features and data collection demands among 20 TCM clinical research bases, reference were made on key technologies of the Electronic Medical Records' integration and sharing, to propose the solution of TCM clinical data collection. The re-sults showed that proposing the metadata and data entities synchronized intersecting strategy, analyzing key points on this strategy, and proposing appropriate solutions, found the technical processes of the TCM clinical data collec-tion. It was concluded that the analysis and solution on key points of TCM clinical data collection provided the basis and the reference to data collection issues of TCM clinical research base.

XML schema for writing ISO 15189: 2007 - Compliant SOPs for clinical laboratory examinations.

Standard Operating Procedures are generally hard copy text documents at clinical laboratories. Due to wider access to computer based technology, Standard Operating Procedures are increasingly kept in electronic form allowing easier and wider access to its users. Such electronic form of Standard Operating Procedures are generally in plain text form or some form of word-processor document. Such presentation-centric documents are difficult to append and revise and access online. Development of Standard Operating Procedures based on eXtended Markup Language(XML) can rectify these difficulties by separating data from its presentation. This study analyses requirements of IS/ISO:15189 and NABL, India for writing examination Standard Operating Procedures and develops appropriate schema for validation of Standard Operating Procedures for clinical laboratory examinations.

Development of Clinical Contents Model Markup Language for Electronic Health Records / 대한의료정보학회지

OBJECTIVES: To develop dedicated markup language for clinical contents models (CCM) to facilitate the active use of CCM in electronic health record systems. METHODS: Based on analysis of the structure and characteristics of CCM in the clinical domain, we designed extensible markup language (XML) based CCM markup language (CCML) schema manually. RESULTS: CCML faithfully reflects CCM in both the syntactic and semantic aspects. As this language is based on XML, it can be expressed and processed in computer systems and can be used in a technology-neutral way. CONCLUSIONS: CCML has the following strengths: it is machine-readable and highly human-readable, it does not require a dedicated parser, and it can be applied for existing electronic health record systems.

Research on the Ways of Medical Record Information Storage / 医学信息学杂志

The paper introduces storage ways of medical record information with both advantages and disadvantages, including data-base way, portfolio in order way, XML way, and the combination between XML and database. Comparison says that the combined way is the better way which harmonizes the structure and retrieval efficiency.

Arden Syntax as a standard expression language for medical knowledge / 대한의료정보학회지

The Arden Syntax is a language for expressing computable medical decisions. It was developed and published under the direction of Health Level Seven, Inc (HL7), and is a standard of the American National Standards Institute (ANSI). It is used to construct executable Medical Logic Modules (MLMs) that represent individual clinical decisions. The authors introduced brief explanation of the Arden Syntaxand gave an example to help readers understand it with easy. Although Arden Syntax is the HL7 standard, there are problems related to the adoption of Arden Syntax as the standard tool for describing medical logic: the curly-braces problem, and the compiler problem. GELLO as well as virtual Medical Record based on the HL7 Reference Information Model (RIM) may provide solutions to the former problem. The latter problem would be resolved by introducing XML based expression of Arden Syntax, the ArdenML: the next generation of Arden Syntax. Unfortunately, Korean hospital information systems are not yet ready to adopt clinical decision support system including Arden Syntax. However, when Arden Syntax version 3.0 (ArdenML) with Korean rule-base engines is introduced into the hospital information system, it would be easier to build up clinical decision support system in Korea.

Parsing KEGG XML Files to Find Shared and Duplicate Compounds Contained in Metabolic Pathway Maps: A Graph-Theoretical Perspective

The basic graph layout technique, one of many visualization techniques, deals with the problem of positioning vertices in a way to maximize some measure of desirability in a graph. The technique is becoming critically important for further development of the field of systems biology. However, applying the appropriate automatic graph layout techniques to the genomic scale flow of metabolism requires an understanding of the characteristics and patterns of duplicate and shared vertices, which is crucial for bioinformatics software developers. In this paper, we provide the results of parsing KEGG XML files from a graph-theoretical perspective, for future research in the area of automatic layout techniques in biological pathway domains.

PhactaManager: A Clinical Trial Management System Incorporating an XML Layer as a Database-Independent Processing Platform / 대한의료정보학회지

OBJECTIVE: Clinical trials are the most time-consuming and expensive part of the drug development process. Clinical Trial Management Systems (CTMSs) help sponsors of clinical trials manage all aspects of planning, performance, and reporting. Most conventional systems provide data processing functions using database management system (DBMS) procedures, which cause DBMS dependency problems. Thus, it is hard to handle the system by researchers who are unfamiliar with database. It is also difficult to share Electronic Case Report Forms (eCRFs) between institutions because conventional systems rely on specific software. METHODS: PhactaManager was developed for solving these problems by introducing an XML Layer in the application tier using an Entity-Attribute-Value model in the database tier. RESULTS: PhactaManager is a three-tier clinical trial management system that has an XML layer. The XML Layer provides a common DBMS independent eCRF document processing platform. Also we developed XML based eCRF Grammar to describe eCRF documents. The XML data elements described by eCRF grammar was constitute to eCRF by PhactaDesigner which an eCRF document design program. CONCLUSION: We achieved DBMS independency by implementing the XML Layer in PhactaManager. The Development of the eCRF Grammar enables the standardization of eCRF design, data correction and data sharing in multicenter clinical trial.

The Interchange of Radiological Reports Using Clinical Document Architecture Standards / 대한의료정보학회지

OBJECTIVE: We developed a Clinical Document Architecture(CDA) Generator module based on CDA standard for the interchange of radiological reports. METHODS: This paper describes CDA standard, the template of radiological report, CDA Generator module, and the Web-form report using an Extensible Stylesheet Language(XSL) style-sheet. And the CDA Generator module is integrated into a existing Picture Archiving Communication System(PACS) Viewer. RESULTS: Radiological reports based on CDA standard are used to interchange between different health institutions, and also presented in an Extensible Markup Language (XML) compatible web browser. CONCLUSION: The proposed module and concept in this paper may be a utility in improving health care delivery and can also be used to integrate with other Digital Imaging and Communication in Medicine(DICOM) Structured Report (SR) compliant PACS systems.

Implementation of Device Independent ECG Reporting System Using Web Development Framework / 대한의료정보학회지

OBJECTIVE: We developed a Cocoon framework-based device independent electrocardiogram(ECG) Reporting System in order to support such various web devices as desktop Personal Computer(PC), Personal Digital Assistants(PDA) and SmartPhone. METHODS: ECG Reporting System, built in the Cocoon framework, consists of modules of ECG Report Module and ECG Image Module. Two modules publish the applied ECG Report to each different templates according to the requesting device. The method of framework-based development in this paper features a reduction of development costs and the robust stability of system. RESULTS: The medical staff may require patient ECG information in ubiquitous healthcare environment, ECG Reporting System supports their correct judgment and expeditious response by servicing ECG report of the patient according to the requesting device. CONCLUSION: The proposed system and concept in this paper may be a good solution for developing the point of care service system supporting various mobile devices.

A METHOD OF REALIZING THE VISUAL REPOSITORY BASE ON SVG STANDARD / 药物分析学报

This paper demonstrates that the visual and graphical repository can be established through extending the SVG standard, introducing C# script and customizing component into repository. The graphical system, which uses the technique of Visual Studio.Net, supports the secondary object-oriented development. It allows the user to not only add all kinds of component objects, but also add properties and functions for the object. In addition, the graphical system has a very good property of customization. It supports the C# script and the zoom in/zoom out of pictures. The file formats used in this system are XML and SVG.

A XML-based Model for Integration of Individual Health Information / 대한의료정보학회지

OBJECTIVE: For disease prevention and health promotion, it is important that individual health information is managed continuously and can be retrieved easily when necessary. We propose a model for integrated management of diverse individual health information that is generated and managed in heterogeneous Health Information System(HIS)s at hospitals or health centers. METHODS: We use XML and relational database together to represent the health information structurally and manage it flexibly. In order to show the effectiveness of our method, we developed a prototype of Intermediate System for integration and analysed the result. RESULTS: The Intermediate System for integration provides the schema of health information, represents the information in forms of XML strings by the subjects, and stores each XML string as one field of relational database. In each heterogeneous HIS, there is an adaptor that transforms the health information into XML according to the schema. The messages for transmission between each HIS and Intermediate System are represented in XML. CONCLUSION: The experimental study shows that using relational database and XML together provides a flexible, extensible and structured way of representing complex, dynamic, structurally-variant and large-scale information, on the premise that the database tables are partitioned or distributed according to the status of server.

Development of a network management platform for medical equipment maintenance / 医疗卫生装备

XML dynamic swapper of network data applied, a network management platform for medial equipment maintenance is developed, which is based on hospital LAN communication. J2EE-based multiplayer B/S structure is adopted. With the platform, routine management, malfunction declaration, maintenance service and data totaling can be carried out effectively.

Web-based Paper Submission Management System of The Korean Society of Medical Informatics / 대한의료정보학회지

The scientific societies have provided with important resources of scientific research products, archived in journals and proceedings. Use of advanced information technology would benefit the scientific information management processes. Korean Society of Medical Informatics (KOSMI) has developed a web-based and XML-enabled paper submission management system since 2002. This paper describes KOSMI's a web-based paper submission management system which manages the processes of submitting, reviewing and distributing papers online. We demonstrate in the paper management system XML (eXtensible Markup Language) technology which is an emerging standard for information exchange on the World Wide Web. One user's request, the management program generates an electronic document in an XML format, which can be systematically managed via standardized way of modern information processing. We believe that the current effort will facilitate more scientific information exchange in a standard format and enhance the lead of knowledge-based information society.

HL7 message processing technology based on XML / 医疗卫生装备

Information integration of heterogeneous systems needs implementing to meet the communication requirements of all subsystems of Hospital Information System (HIS). The solution is to introduce Health Level Seven (HL7), an international medical information exchange standard. With extensible Markup Language (XML) as the message-encoding manner, HL7 version 3 follows the object-oriented methodology. Based on the message system of HL7 version 3, this paper introduces an XML-based message processing technology and then testifies its feasibility.

Lucene-based Full-text Retrieval System of Electronic Care Record / 医疗卫生装备

Objective To research a more effective method of full-text retrieval of electronic care record (ECR), which avails clinical work, medical research and ECR management. Methods Based on full -text retrieval by keyword, by changing the form of ECR with XML,a full-text retrieval system of ECR based on Lucene was built. Results The system testing showed that the precision ratio of ECR retrieval was raised. Conclusion The full-text retrieval system of ECR meets the design requirements and the function needs.

Hospital Information Exchange System Using XML Document / 대한의료정보학회지

Recently many domestic hospitals computerize and automatize the process to manage their own medical data. These medical data should be shared among the departments in the hospital and be held in common in case of patients transfers or references to the remote hospitals. However, there is no simple method to share data among the management systems to be shared due to their heterogeneous platforms. Schema sharing with systems and standard format data transfer could be a solution. In this paper, we propose HIES(Hospital Information Exchange System), which uses XML as a standard medical data transfer method. HIES uses XML, which is currently recognized as the standard of electronic documents, for integrating and managing heterogeneous and distributed medical data. Information Sharing Manager to maintain consistent schema information for heterogeneous database systems in hospital systems as well as Image Compression/Partition Manager for efficient image data transfer and reemergence among the systems are implemented.

Development of a Generic Data Form Authoring Program Based on XML/XSL Technology: XML/XSL-based Generic Form Editor / 대한의료정보학회지

The World Wide Web provides the means for theintegration of clinical computer systems. Extensible Markup Language (XML) and Extensible Stylesheet Language (XSL) are newly developed and standardized Internet protocols. Development of custom data entry forms requires significant programming resources in clinical information system development and management. Visual design tools and a modifiable, template-driven approach may facilitate this process. However, these approaches generally require the predefinition of data form element types. This paper describes an XML/XSL-based technology enabling post hoc definition of elementary and composite data entry form element types.