Appl Clin Inform 2010; 01(04): 408-418
DOI: 10.4338/ACI-2010-04-RA-0024
Research Article
Schattauer GmbH

Registers for networked medical research in Germany

Situation and prospects
J. Stausberg
1   Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians-Universität München, Germany
,
U. Altmann
2   Institut für Medizinische Informatik, Justus-Liebig-Universität Giessen, Germany
,
G. Antony
3   Kompetenznetz Parkinson, Marburg, Germany
,
J. Drepper
4   TMF – Technology, Methods, and Infrastructure for Networked Medical Research (acknowledged non-profit association), Berlin, Germany
,
U. Sax
5   Universitätsmedizin Göttingen, Germany
,
A. Schütt
4   TMF – Technology, Methods, and Infrastructure for Networked Medical Research (acknowledged non-profit association), Berlin, Germany
› Institutsangaben
Weitere Informationen

Correspondence to:

Prof. Dr. med. Jürgen Stausberg
Ludwig-Maximilians-Universität München
Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE)
Marchioninistraße 15, D-81377 München
Germany
Telefon: +49 89 7095-7499   
Fax: +49 89 7095-7491   

Publikationsverlauf

received: 28. April 2010

accepted: 06. August 2010

Publikationsdatum:
16. Dezember 2017 (online)

 

Summary

Background: Several disease specific registers are operated by members of the ‘TMF – Technology, Methods, and Infrastructure for Networked Medical Research’, an umbrella organization of research networks in Germany.

Objective: To describe the coverage and the current state as well as financial and organizational issues of registers operated by member networks of the TMF, to identify their requirements and needs, and to recommend best practice models.

Methods: A survey with a self-completion questionnaire including all 55 TMF member networks was carried out in winter 2007/2008. Interviews focusing on technological issues were conducted and analyzed in summer 2009 with a convenience sample of 10 registers.

Results: From 55 TMF member networks, 11 provided information about 14 registers. Six registers address diseases of the circulatory system with more than 150,000 registered patients. The interviews revealed a typical setting of “research registers”. Research registers are an important mean to generate hypotheses for clinical research, to identify eligible patients, and to share data with clinical trials. Concerning technical solutions, we found a remarkable heterogeneity. The analysis of the most efficient registers revealed a structure with five levels as best practice model of register management: executive, operations, IT-management, software, hardware.

Conclusion: In the last ten years, the TMF member networks established disease specific registers in Germany mainly to support clinical research. The heterogeneity of organizational and technical solutions as well as deficits in register planning motivated the development of respective recommendations. The TMF will continue to assist the registers in quality improvement.


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Conflict of interest

The authors do not declare any conflicts of interest.

  • References

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  • 2 Brooke EM. The current and future use of registers in health information systems. Geneva: World Health Organization,; 1974
  • 3 Mathis S, Wild C. Register für klinische und gesundheitsökonomische Fragestellungen: Einsatzbereiche von kardiovaskulären, wirbelsäulenspezifischen und neurologischen Registern und Good Practice Strategien für die Arbeit mit Registern. HTA_Projektbericht #11, 2008. Wien: Ludwig Boltzmann Institut für Health Technology Assessment,; 2008
  • 4 Gladman DD, Menter A. Introduction/overview on clinical registries. Ann Rheum Dis 2005; 64 (II) ii101-ii102.
  • 5 Bestehorn K. Medical Registries. Med Klin 2005; 100: 722-728 [in German].
  • 6 Leiner F, Haux R. Systematic planning of clinical documentation. Methods of Information in Medicine 1996; 35: 25-34.
  • 7 Wegscheider K. Medical registries. Benefits and limitations. Bundesgesundheitsbl - Gesundheitsforsch -Gesundheitsschutz 2004; 47: 416-421 [in German].
  • 8 Gliklich R, Dreyer N. eds. Registries for Evaluating Patient Outcomes: A User’s Guide. AHRQ Publication No. 07-EHC001-1, April 2007.
  • 9 Newton J, Garner S. Disease registers in England. A report commissioned by the Department of Health Policy Research Programme in support of the White Paper entitled Saving Lives: Our Healthier Nation. Oxford: Institute of Health Sciences, University of Oxford; 2002
  • 10 Pommerening K. et al. Integrating eHealth and medical research: The TMF data protection scheme. In: Blobel B, Pharow P, Zvarova J, Lopez D. (Eds.): eHealth: Combining Health Telematics, Telemedicine, Biomedical Engineering and Bioinformatics to the Edge. Aka, Berlin: 2008: 5-10.
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  • 15 Ohmann C, Kuchinke W. Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration. Methods Inf Med. 2009; 48: 45-54.
  • 16 Raftery J, Roderick P, Stevens A. Potential use of routine databases in health technology assessment. Health Technology Assessment. 2005 9: (20)
  • 17 Roovers JP. Registries: what level of evidence do they provide?. Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18: 1119-1120.
  • 18 Arts DG, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework. J Am Med Inform Assoc 2002; 9: 600-611.
  • 19 Silver FL. et al. International experience in stroke registries: lessons learned in establishing the Registry of the Canadian Stroke Network. Am J Prev Med. 2006; 31: S235-S237.
  • 20 Evans SM, Bohensky M, Cameron PA, McNeil J. A survey of Australian clinical registries: can quality of care be measured?. Intern Med J. 2009 Oct 7. [Epub ahead of print].
  • 21 ISO/IEC 20000. Information technology - Service management. 2005-12-15. Geneva: ISO,; 2005

Correspondence to:

Prof. Dr. med. Jürgen Stausberg
Ludwig-Maximilians-Universität München
Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE)
Marchioninistraße 15, D-81377 München
Germany
Telefon: +49 89 7095-7499   
Fax: +49 89 7095-7491   

  • References

  • 1 Dreyer NA, Garner S. Registries for robust evidence. JAMA 2009; 302: 790-791.
  • 2 Brooke EM. The current and future use of registers in health information systems. Geneva: World Health Organization,; 1974
  • 3 Mathis S, Wild C. Register für klinische und gesundheitsökonomische Fragestellungen: Einsatzbereiche von kardiovaskulären, wirbelsäulenspezifischen und neurologischen Registern und Good Practice Strategien für die Arbeit mit Registern. HTA_Projektbericht #11, 2008. Wien: Ludwig Boltzmann Institut für Health Technology Assessment,; 2008
  • 4 Gladman DD, Menter A. Introduction/overview on clinical registries. Ann Rheum Dis 2005; 64 (II) ii101-ii102.
  • 5 Bestehorn K. Medical Registries. Med Klin 2005; 100: 722-728 [in German].
  • 6 Leiner F, Haux R. Systematic planning of clinical documentation. Methods of Information in Medicine 1996; 35: 25-34.
  • 7 Wegscheider K. Medical registries. Benefits and limitations. Bundesgesundheitsbl - Gesundheitsforsch -Gesundheitsschutz 2004; 47: 416-421 [in German].
  • 8 Gliklich R, Dreyer N. eds. Registries for Evaluating Patient Outcomes: A User’s Guide. AHRQ Publication No. 07-EHC001-1, April 2007.
  • 9 Newton J, Garner S. Disease registers in England. A report commissioned by the Department of Health Policy Research Programme in support of the White Paper entitled Saving Lives: Our Healthier Nation. Oxford: Institute of Health Sciences, University of Oxford; 2002
  • 10 Pommerening K. et al. Integrating eHealth and medical research: The TMF data protection scheme. In: Blobel B, Pharow P, Zvarova J, Lopez D. (Eds.): eHealth: Combining Health Telematics, Telemedicine, Biomedical Engineering and Bioinformatics to the Edge. Aka, Berlin: 2008: 5-10.
  • 11 Nonnemacher M, Weiland D, Neuhäuser M, Stausberg J. Adaptive management of data quality in cohort studies and registers: proposal for a guideline. Acta Informatica Medica 2007; 15: 225-230.
  • 12 Drolet BC, Johnson KB. Categorizing the world of registries. Journal of Biomedical Informatics 2008; 41: 1009-1020.
  • 13 Winter A. et al. Integrated Information Systems for Translational Medicine. Meth Inf Med 2007; 46: 601-607.
  • 14 Dugas M. et al. Single source information systems to connect patient care and clinical research. Stud Health Technol Inform. 2009; 150: 61-65.
  • 15 Ohmann C, Kuchinke W. Future developments of medical informatics from the viewpoint of networked clinical research. Interoperability and integration. Methods Inf Med. 2009; 48: 45-54.
  • 16 Raftery J, Roderick P, Stevens A. Potential use of routine databases in health technology assessment. Health Technology Assessment. 2005 9: (20)
  • 17 Roovers JP. Registries: what level of evidence do they provide?. Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18: 1119-1120.
  • 18 Arts DG, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework. J Am Med Inform Assoc 2002; 9: 600-611.
  • 19 Silver FL. et al. International experience in stroke registries: lessons learned in establishing the Registry of the Canadian Stroke Network. Am J Prev Med. 2006; 31: S235-S237.
  • 20 Evans SM, Bohensky M, Cameron PA, McNeil J. A survey of Australian clinical registries: can quality of care be measured?. Intern Med J. 2009 Oct 7. [Epub ahead of print].
  • 21 ISO/IEC 20000. Information technology - Service management. 2005-12-15. Geneva: ISO,; 2005