4.2 Progress report of subproject 2

Transcription

1 4.2 Progress report of subproject 2 Project title: Project leaders: Telematics and computer-based quality management in a communication network for malignant lymphomas Dr. Barbara Heller Prof. Dr. Markus Löffler Universität Leipzig Institut für Medizinische Informatik, Statistik und Epidemiologie Liebigstr. 27 D Leipzig Phone: +49 (0) /104 Fax: +49 (0) heller@imise.uni-leipzig.de, loeffler@imise.uni-leipzig.de Summary Subproject 2 drafts and installs information technology concepts and tools for the Competence Network Malignant Lymphomas in order to support data and information flow between research and applied health care. Within the report s timeframe, the project focused on the implementation of a central communication service as well as on establishing a communication network. The realization of the communication network requires the partners integration. This process was initiated by integrating the reference centres for pathology (subproject 3). Since the other main aspect of the project is quality assurance, computer-based tools for quality assurance in clinical trial management are being developed. To coordinate the clinical trial groups cooperative efforts, the combined working group has been continued. Criteria and methods for quality assurance have been developed and their implementation has begun. Furthermore, cooperation concerning the development of quality management with other national medical networks as well as international cooperation with experts for malignant lymphoma have been initiated Results and ongoing activities Communication services and data exchange To ensure the productive operation of information technology (IT) in the Leipzig communication centre, integration of the three study trial centres and the reference pathologies have been continued. The Competence Network s data server is backed up regularly, according to the data backup provisions that are integrated into the IT security concept. Moreover, the measures defined within the IT security concept have been implemented incrementally. Annual Report Competence Network Malignant Lymphomas

2 Furthermore, in the framework of IT security a DNS service has been put into operation within the internal network of the Leipzig communication centre. Communication facilities are being established at the Competence Network s partners, based on their IT infrastructure, to enable data and information exchange. The concept for data exchange between reference pathologists and clinical trial centres has been mostly implemented and the necessary review by the official data security officers has been completed. The final approval is expected to be soon available. Information services / Content management system This project s objective is the integration of standardized information tools for clinical trials. Therefore a concept has been developed in consideration of the precise requirements, which have been specified collaboratively by the partners. The professional content management system (CMS) VIP, obtained in 2001, has been upgraded to version 8.1, and the data updated as necessary. Furthermore, the software tools for constructing a data dictionary (Onto-Builder) and the treatment management tool (Onco-Workstation) have been integrated into the content management system. Quality management This project tends to the quality management procedures of the Competence Network s clinical trials. So far, content definition and computer-based support for SOPs have been the focus. The development of quality standards for quality assurance protocols has been improved as well. Up to April 2003 about 15% of SOPs have been brought into consensus between the participating study groups and are expected to be approved by the board of the Competence Network. The current topic in the development of evaluation methods for clinical trial quality is the quality of documented data. Together with the network assistants, a comparison between selected CRF (case report form) data and corresponding source data has been initiated as a measure of current data quality. The results will be the basis for a decision on the necessity of monitoring. A third project of the working group for quality management (WG-QM) is the harmonisation of CRFs and clinical definitions. A first step towards CRF harmonisation, focusing on term definitions, was finished in A second step, focusing on the CRF layout, was initiated. The harmonisation of clinical definitions was expanded to an international cooperation of experts for malignant lymphoma, coordinated by Bruce Cheson (National Cancer Institute, USA) and the WG-QM (Beate Pfistner, Cologne) in To advance the computer-based support of SOPs, the first version of the web-based SOP Management Tool (SOP-Creator) has been implemented. The SOP-Creator contains the following functions: (1) Creation and quality assurance of SOPs using the editorial tool Annual Report Competence Network Malignant Lymphomas

3 VIP'HTML client, extended with a SOP-specific component; (2) Administration of SOPs on the CMS VIP platform with central data storage, version administration, reference administration, access control and quality assurance cycle; (3) SOP distribution using style sheets as Web (HTML) and printable (PDF) documents. Biometrical, knowledge-based data dictionary The web-based software tool for constructing a data dictionary (Onto-Builder), developed in 2001, has been introduced in the Competence Network Malignant Lymphomas. Therefore the following documents have been produced: Guideline for the Construction of Medical Terms, and Onto-Builder Handbook Part I: the Construction of Medical Terms. Furthermore, the construction of the data dictionary (input of content) and the analysis of terms and their definitions are underway. To manage the harmonization process of terms and definitions a user concept has been generated, which includes solutions for access control and quality assurance Cooperation within the network The cooperation with other subprojects is very important for the central subproject 2, especially regarding the partners integration. Due to positive experience with regular meetings, subproject 2 will continue to run telematic workshops once or twice a year. At the telematic workshop, representatives of involved projects meet, discuss and try to reach a consensus regarding aims, progress of the work, results, future directions and communication and integration concepts. Cooperation with subproject 1: The working package Conception and Realisation of a Central Information Service involves close cooperation with the Competence Network s Central Office (subproject 1). The Central Office collects the content and prepares it for presentation. Subproject 2 conceives and implements informational concepts and tools for the information service s construction based on the partners agreed requirements. In April 2003, training for editors was held, prepared and organized by subproject 1 and subproject 2. The participants (staff of the Competence Network Malignant Lymphomas) received training in the maintenance of website content using the editorial tool VIP'HTML client. Cooperation with subproject 3: The close cooperation with the reference centres for lymph node pathology (subproject 3) has been continued. As agreed with the cooperation partners, the staff of SP3 in Leipzig designed the central pathology database server and is in charge of it. In addition, there is a close cooperation between SP3 and the staff of SP2 with regard to data security and interfaces with the databases on clinical trials. Annual Report Competence Network Malignant Lymphomas

4 Cooperation with subproject 5: In cooperation with SP5, the contents of the therapy guide for malignant lymphomas are presented within the web information service. Quality management: The working group organised quality management workshops. Members of the working group are the network s three quality managers of the study groups DSHNHL, GLSG, DHSG as well as representatives of interested subprojects (SP1, SP3, SP5, SP10), the network assistants (SP1) and external representatives (e.g. the Coordinating Centres for Clinical Trials in Cologne and Leipzig). There is a close cooperation with the four network assistants with respect to the harmonisation of CRFs Other cooperation Cooperation within the telematic platform (TMF) Within the working group System Components for Medical Research and Clinical Trials the following projects have been initiated and are being operated by subproject 2: Conception, construction and operation of information and communication portals on the basis of content management systems (Dec Dec 2003), Systems validation in clinical trials generation of a validation guideline for the Coordinating Centres of Clinical Trials and other networks (Oct 2002 July 2003). Cooperation with other competence networks A cooperation with the Competence Network Paediatric Oncology and Haematology for development of SOPs and the integration of the treatment management tool (Onco- Workstation) has been initiated. International cooperation In cooperation with members of the Intergruppo Italiano Linfomi (IIL) the proposal Implementation of IT-based Measures for Quality Assurance has been submitted within the European Platform for the Conquest of Lymphomas (EPCOL) to the 6th Framework Programme of the European Commission. Concerning international interest in the harmonisation of clinical definitions and statistical trial parameters the group for International Harmonisation of Trial Parameters for Malignant Lymphoma was initiated in December This group is coordinated by Bruce Cheson (National Cancer Institute, USA) and the WG-QM (represented by Beate Pfistner). Several subgroups of international experts for specific topics, e.g. remission criteria and Annual Report Competence Network Malignant Lymphomas

5 involved field radiation, have been initiated. For the discussion of definitions, an electronic platform and regular meetings are planned. The number of joint trials for malignant lymphoma is increasing in Europe. To improve and harmonise quality in clinical trials on the European level, the WG-QM is participating as a coordinator for the subproject "Quality Management in the EPCOL proposal Publications Heller, B., Herre, H. 2003: Ontological Categories in GOL, in press Hatje H., Speer R., Heller B., Noack F., Stein H., Hogrefe D., Feller A.C., Hummel M.: Lymphknotenreferenzzentren: Aktuelle Online Studienpatienten- und Materialdatenbank. In: Telemedizinführer Deutschland, Ausgabe 2003, S Pfistner, B., Mehl, C., Klöss, M., Löffler, M., Herrmann-Frank, A. für das Kompetenznetz Maligne Lymphome: Übergreifende Strukturen im Kompetenznetz Maligne Lymphome am Beispiel des Qualitätsmanagements. Monatszeitschrift Kinderheilkunde 2002, 150 (10): Pfistner, B., Klöss, M., Mehl, C.: Quality standards and quality assurance. Onkologie 2002, 25 (Suppl 4): 914A Further objectives for the current funding period Communication services and data exchange In the current funding period the tasks of the communication centre in Leipzig are (1) routine operations, (2) the implementation of the IT security safeguards described in the security concept, (3) the gradual integration of further partners (the CLL study centre, the reference centre for radiotherapy (SP4), the office of the network of private practices (SP5), and (4) the technical integration of applications (e.g. therapy management tools (SP2), an image database with zoom server (SP3)) into the communication network with the objective to enhance the information and communication services offered in the network. IT security management (1) The objective of the study centres in Cologne, Leipzig, and Munich is to elaborate their own IT-security concepts according to the model of the communication centre in Leipzig. Further IT-security concepts will be elaborated in cooperation with the study centres of the communication centre. (2) A second objective is the long-term maintenance of the intended security level on the basis of the elaborated IT security concept. (3) A certificate of a third party, e.g. the Bundesamt für Sicherheit in der Informationstechnik (BSI), shall confirm the security level reached in order to document the security reliability for outside persons. Annual Report Competence Network Malignant Lymphomas

6 Information services The objective of this aspect of the project is the routine operation and the extension of the integrated information service up to a comprehensive information and communication portal with support for different communities (personnel of the clinical trials, doctors, scientists, patients etc.), standard portal functionalities (e.g. client, user homepages, groupware, public key infrastructure), and ongoing specific information services and applications (e.g. therapy management tools, material databases, databases for histological pictures). Treatment management tool The objective during this one-year project is the evaluation and refinement of the tool in about 5 selected hospitals and private practices. This is necessary in order to gain experience for the widespread use of the tool on a broad health care level. This shall also be fostered by the integration of single modules into the information and communication portal. The main focus is the implementation of all measures that are necessary for a fully productive operation. Among these are the refinements of the modules to account for the evaluation results from the test installation, the support and the maintenance of the tool, and the contents (e.g. customizing the documentation module to local conditions). The only new software development is the updatemodule that enables local installations to copy new versions of the programme code and the protocols of the clinical trials from the central server. Quality management The objective is to complete the SOP system, to supplement the collection of term definitions, to implement quality management measures in the study centres, and to continually monitor the quality level in the study centres. In addition, the gradual introduction of the tools (the SOP management tool, the data dictionary) is planned into the management process of clinical trials of the participating study groups. Another objective is the functional extension of the SOP-Creator (for convenient SOP administration and improved handling through user-orientated SOP presentation) as well as the realisation of a semantically well-founded data dictionary (availability of a consistent term basis in the context of clinical trials for different document types, configuration for the use in computer-based applications). A novel objective of interdisciplinary quality management is to determine whether and how the use of clinical trial management software with electronic CRFs in clinical trials provides an improvement in quality and productivity. Annual Report Competence Network Malignant Lymphomas