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[Manual for Methods and Use of Routine Practice Data for Knowledge Generation].

Monika Klinkhammer-Schalke1,2, Thomas Kaiser3, Christian Apfelbacher4

  • 1Tumorzentrum Regensburg, Institut für Qualitätssicherung und Versorgungsforschung, Universität Regensburg, Regensburg.

Gesundheitswesen (Bundesverband Der Arzte Des Offentlichen Gesundheitsdienstes (Germany))
|September 22, 2020
PubMed

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Summary

Routine practice data, particularly from health registers, offers valuable insights for healthcare research. Standardized methods are needed for data consolidation, verification, and application to ensure high-quality evidence generation.

Area of Science:

  • Health Services Research
  • Medical Informatics
  • Data Science

Background:

  • Growing interest in utilizing existing healthcare data, especially from health registers.
  • Insufficient standardization and transparent presentation of methodological procedures for routine practice data.
  • Establishment of an ad hoc commission by the German Network for Health Services Research (DNVF) for routine practice data utilization.

Purpose of the Study:

  • To address the need for standardized and transparent methodologies in using routine practice data.
  • To develop a method guide for the appropriate use of care-related data.
  • To clarify the terminology, advocating for "routine practice data" over Real World Data (RWD) and Real World Evidence (RWE).

Main Methods:

  • Review of existing concepts and guidelines for generating and evaluating care-related data.

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  • Analysis of best practice examples, particularly from oncology register data.
  • Development of a methodological manual for routine practice data.
  • Main Results:

    • Identified a lack of clear quality requirements and structured procedures for data consolidation, verification, and methodological application.
    • Demonstrated the potential of register data in oncology for guideline evaluation and deriving recommendations.
    • Proposed "routine practice data" as a more effective term than RWD/RWE to emphasize research quality.

    Conclusions:

    • There is a critical need to revise inconsistent requirements and develop a comprehensive method guide for routine practice data.
    • Standardized methods are essential for high-quality research using routine practice data, including register-based studies.
    • The proposed manual aims to enhance the transparent and effective use of routine practice data for evidence generation.