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Methods Inf Med 2007; 46(05): 601-607
DOI: 10.1160/ME9063
Paper
Schattauer GmbH

Integrated Information Systems for Translational Medicine[*]

A. Winter
1   University of Leipzig, Institute of Medical Informatics, Statistics and Epidemiology, Leipzig, Germany
,
G. Funkat
1   University of Leipzig, Institute of Medical Informatics, Statistics and Epidemiology, Leipzig, Germany
,
A. Haeber
2   University of Applied Sciences, Zwickau, Germany
,
C. Mauz-Koerholz
3   University of Halle/Wittenberg, University Clinic and Polyclinic for Child and Adolescent Medicine, Halle, Germany
,
K. Pommerening
4   University of Mainz, Institute of Medical Biostatistics, Epidemiology, and Informatics, Mainz, Germany
,
S. Smers
5   Leipzig University Medical Center, Department for Information Management, Leipzig, Germany
,
J. Stausberg
6   University of Duisburg-Essen, Institute for Medical Informatics, Biometry and Epidemiology, Essen, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
22 January 2018 (online)

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Summary

Objectives: Translational medicine research needs a two-way information highway between ‘bedside’ and ‘bench’. Unfortunately there are still weak links between successfully integrated information roads for bench, i.e. research networks, and bedside, i.e. regional or national health information systems. The question arises, what measures have to be taken to overcome the deficiencies.

Methods: It is examined how patient care-related costs of clinical research can be separated and shared by health insurances, whether quality of patient care data is sufficient for research, how patient identity can be maintained without conflict to privacy, how care and research records can be archived, and how information systems for care and research can be integrated.

Results: Since clinical trials improve quality of care, insurers share parts of the costs. Quality of care data has to be improved by introducing minimum basic data sets. Pseudonymization solves the conflict between needs for patient identity and privacy. Archiving patient care records and research records is similar and XML and CDISC can be used. Principles of networking infrastructures for care and research still differ. They have to be bridged first and harmonized later.

Conclusions: To link information systems for care (bed) and for research (bench) needs technical infrastructures as well as economic and organizational regulations.

Keywords

Translational medicine - health information systems - research networks - patient identification - finance

* The paper is based on an interdisciplinary session at the 2006 annual conference of the German Association for Medical Informatics, Statistics and Epidemiology (www.gmds2006.de) in Leipzig, Germany, and an invited talk at the 2006 annual conference of the Japan Association of Medical Informatics (http://jcmi2006.med.hokudai.ac.jp/), Sapporo, Japan.


 

  • References

  • 1 European Union. Innovative Medicines Initiative. http://ec.europa.eu/research/fp6/index_en.cfm?p=1_innomed last access 2006-10-20.
    PubMedGoogle Scholar
  • 2 European Federation of Pharmaceutical Industries and Associations. Creating biomedical R&D leadership for Europe to benefit patients and society. http://ec.europa.eu/research/fp6/p1/innovative-medicmes/pdfVision_en.pdf last access 2006-10-19.
    PubMedGoogle Scholar
  • 3 Marincola FM. Translational Medicine: A two-wayroad. J Transl Med 2003; 1 (01) 1.
    CrossrefPubMedGoogle Scholar
  • 4 Brouwers MC, Haynes RB, Jadad AR, Hayward RS, Padunsky JA, Yang JL. Evidence-based health care and the Cochrane Collaboration. Clin Perform Qual Health Care 1997; 5 (04) 195-201.
    PubMedGoogle Scholar
  • 5 Winter AF, Ammenwerth E, Bott OJ, Brigl B, Buchauer A, Gräber S. et al. Strategic Information Management Plans: The Basis for Systematic Information Management in Hospitals. Yearbook of Medical Informatics.. Stuttgart: Schattauer; 2003: 431-441.
    Google Scholar
  • 6 Gulliford M, Naithani S, Morgan M. What is “continuity of care”?. J Health Serv Res Policy 2006; 11 (04) 248-250.
    CrossrefPubMedGoogle Scholar
  • 7 Holm T, Lassen JF, Husted SE, Christensen P, Heickendorff L. A randomized controlled trial of shared care versus routine care for patients receiving oral anticoagulant therapy. J Intern Med 2002; 252 (04) 322-331.
    CrossrefPubMedGoogle Scholar
  • 8 Winter A, Brigl B, Wendt T. Modeling Hospital Information Systems (Part 1): The Revised Three-Layer Graph-Based Meta Model 3LGM2 . Methods Inf Med 2003; 42 (05) 544-551.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 9 Haux R. Health information systems – past, present, future. Int J Med Inform 2006; 75 3-4 268-281.
    CrossrefPubMedGoogle Scholar
  • 10 Kuhn KA, Wurst SHR, Bott OJ, Giuse DA. Expanding the Scope of Health Information Systems. Haux R, Kulikowski C. IMIA Yearbook of Medical Informatics 2006. Methods Inf Med 2006; 45 Suppl 1.. Stuttgart: Schattauer; 2006: 43-52.
    Google Scholar
  • 11 Turisco F, Keogh D, Stubbs C, Glaser J, Crowley Jr WF. Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment. J Investig Med 2005; 53 (08) 425-433.
    CrossrefPubMedGoogle Scholar
  • 12 Bauer U, Niggemeyer E, Lange PE. The competence network for congenital heart defects. Networking instead of isolated efforts for optimized research and care. Med Klin (Munich) 2006; 101 (09) 753-758.
    CrossrefPubMedGoogle Scholar
  • 13 Avidan A, Weissman C, Sprung CL. An internet web site as a data collection platform for multicenter research. Anesth Analg 2005; 100 (02) 506-511.
    CrossrefPubMedGoogle Scholar
  • 14 Unutzer J, Choi Y, Cook IA, Oishi S. Aweb-based data management system to improve care for depression in a multicenter clinical trial. Psychiatr Serv 2002; 53 (06) 671-673 678.
    CrossrefPubMedGoogle Scholar
  • 15 Telematikplattformfür Medizinische Forschungsnetze e.V Anetwork for networks – Infrastructure for networked medical research. http://www.tmf-ev.de/site/EN/int/about_tmf/c_about.php last access 2007-03-08.
    PubMedGoogle Scholar
  • 16 Winter A, Brigl B, Wendt T. Modeling Hospital Information Systems (Part 1): The Revised Three-Layer Graph-Based Meta Model 3LGM2 . Haux R, Kulikowski C. IMIA Yearbook of Medical Informatics 2005: Ubiquitous Health Care Systems.. Stuttgart: Schattauer; 2005: 363-370.
    Google Scholar
  • 17 Hübner-Bloder G, Ammenwerth E, Brigl B, Winter A. Specification of a reference model for the domain layerofa hospital information system. Stud Health Technol Inform 2005; 116: 497-502.
    PubMedGoogle Scholar
  • 18 Wendt T, Häber A, Brigl B, Winter A. Modeling Hospital Information Systems (Part 2): Using the 3LGM2 Tool for Modeling Patient Record Management. Methods Inf Med 2004; 43 (03) 256-267.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 19 Haux R. Individualization, globalization and health – about sustainable information technologies and the aim of medical informatics. Int J Med Inform 2006; 75 (12) 795-808.
    CrossrefPubMedGoogle Scholar
  • 20 Kaatsch P, Blettner M, Spix C, Jurgens H. Follow up of long-term survivors after childhood cancer in Germany. Klin Paediatr 2005; 217 (03) 169-175.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 21 Korholz D, Claviez A, Hasenclever D, Kluge R, Hirsch W, Kamprad F. et al. The concept of the GPOH-HD 2003 therapy study for pediatric Hodgkin’s disease: evolution in the tradition of the DAL/GPOH studies. Klin Padiatr 2004; 216 (03) 150-156.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 22 Dieckmann K, Potter R, Wagner W, Prott F J, Hornig-Franz I, Rath B. et al. Up-front centralized data review and individualized treatment proposals in a multicenter pediatric Hodgkin’s disease trial with 71 participating hospitals: the experience of the German-Austrian pediatric multicenter trial DAL-HD-90. Radiother Oncol 2002; 62 (02) 191-200.
    CrossrefPubMedGoogle Scholar
  • 23 Creutzig U, Jurgens H, Herold R, Gobel U, Henze G. Concepts of the Society of Paediatric Oncology and Haematology (GPOH) and the German Competence Network in Paediatric Oncology and Haematology for the quality controlled development inpaediatric oncology. Klin Padiatr 2004; 216 (06) 379-383.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 24 ICH harmonised tripartite guideline: guideline for good clinical practice. 8. Essential documents for the conduct of a clinical trial. J Postgrad Med 2001; 47 (04) 264-267.
    PubMedGoogle Scholar
  • 25 ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice. J Postgrad Med 2001; 47 (03) 199-203.
    PubMedGoogle Scholar
  • 26 ICH Harmonised Tripartite Guideline: guideline for good clinical practice. J Postgrad Med 2001; 47 (02) 121-130.
    PubMedGoogle Scholar
  • 27 Health Level Seven Inc. Clinical Data Interchange Standards Consortium Inc. HL7 and CDISC Mark First Anniversary of Renewed Associate Charter Agreement, Joint Project Result from Important Healthcare-Clinical Research Industry Collaboration. http://www.hl7.org/documentcenter/public/pressreleases/20051012b.pdf last access 2007-04-01.
    PubMedGoogle Scholar
  • 28 Swart E. Good practice of secondary data analysis. J Public Health 2005; 13: 175.
    CrossrefPubMedGoogle Scholar
  • 29 Iezzoni LI. Risk adjustment for measuring health care outcomes.. Chicago, Illinois: Health Administration Press; 2003
  • 30 Dietzel GT. The electronic health card as atool for seamless care. German activities to implement telematics. Stud Health Technol Inform 2003; 96: 213-217.
    PubMedGoogle Scholar
  • 31 Mikkelsen G, Aasly J. Concordance of information in parallel electronic and paper based patient records. Int J Med Inform 2001; 63 (03) 123-131.
    CrossrefPubMedGoogle Scholar
  • 32 Iezzoni LI. Assessing quality using administrative data. Annals of Internal Medicine 1997; 127: 666-674.
    CrossrefPubMedGoogle Scholar
  • 33 Knaup P, Garde S, Merzweiler A, Graf N, Schilling F, Weber R. et al. Towards shared patient records: an architecture for using routine data for nationwide research. Int J Med Inform 2006; 75 3-4 191-200.
    CrossrefPubMedGoogle Scholar
  • 34 Graubner B. Orthopedic basic documentation: requirements ofdiagnostic statistics and results in Goettingen university clinics. Z Orthop Ihre Grenzgeb 1989; 127 (04) 437-444.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 35 Stausberg J, Nonnemacher M, Weiland D, Antony G, Neuhauser M. Management of data quality-development of a computer-mediated guideline. Stud Health Technol Inform 2006; 124: 477-482.
    PubMedGoogle Scholar
  • 36 Noumeir R, Lemay A, Lina JM. Pseudonymization of Radiology Data for Research Purposes. J Digit Imaging 2006; Epub ahead of print.
    PubMedGoogle Scholar
  • 37 Glock J, Herold R, Pommerening K. Personal identifiers in medical research networks: Evaluation of the personal identifier generator in the Competence Network Pediatric Oncology and Haematology. GMS Med Inform Biom Epidemiol. 2006 2. 02 Doc06.
    PubMedGoogle Scholar
  • 38 Hoffmann W, Latza U, Terschuren C. Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP) – revised version after evaluation. Gesundheitswesen 2005; 67 (03) 217-225.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 39 Kurth B, Hense H, Hoffmann W. Leitlinien und Empfehlungen zur Sicherung von Guter Epidemiologischer Praxis (GEP). http://www.dgepi.de/doc/Empfehlungen.doc last access 2006-04-06.
    PubMedGoogle Scholar
  • 40 Dujat C, Schmücker P, Haux R, Winter A. Digital Optical Archiving of Medical Records in Hospital Information Systems – A Practical Approach towards the Electronic Patient Record?. Methods Inf Med 1995; 34 (05) 489-497.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 41 Hollerbach A, Brandner R, Bess A, Schmucker R, Bergh B. Electronically signed documents in health care – analysis and assessment of data formats and transformation. Methods Inf Med 2005; 44 (04) 520-527.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 42 Kuchinke W, Wiegelmann S, Verplancke P, Ohmann C. Extended cooperation in clinical studies through exchange of CDISC metadata between different study software solutions. Methods Inf Med 2006; 45 (04) 441-446.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 43 Bess A, Brandner R. Deduction of principles on long-term conservation of electronically signed documents by multi professional analyses. Stud Health Technol Inform 2003; 95: 130-135.
    PubMedGoogle Scholar
  • 44 Dolin RH, Alschuler L, Boyer S, Beebe C, Behlen FM, Biron PV. et al. HL7 Clinical Document Architecture, Release 2. J Am Med Inform Assoc 2006; 13 (01) 30-39.
    CrossrefPubMedGoogle Scholar
  • 45 Fraunhofer Gesellschaft zur Förderung der Angewandten Forschung. D2D Technisches Handbuch. Technisches Handbuch des Kommunikationskonzeptes für patientenbezogene medizinische Daten. Kassenärztliche Vereinigung Nordrhein (KVNo). Version 4.01. http://kvno.arzt.de/importiert/d2d_habu_soft.pdf last access 2006-04-01.
    PubMedGoogle Scholar
  • 46 Klein A, Ganslandt T, Brinkmann L, Spitzer M, Ueckert F, Prokosch HU. Experiences with an Interoperable Data Acquisition Platform for Multi-Centric Research Networks Based on HL7 CDA. AMIA Annu Symp Proc 2006: 986.
    PubMedGoogle Scholar
  • 47 Klein A, Prokosch H-U, Ganslandt T. Experiences with an Interoperable Data Acquisition Platform for Multi-Centric Research Networks Based on HL7 CDA. Methods Inf Med 2007; 46: 580-585.
    Article in Thieme ConnectPubMedGoogle Scholar