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Das GRADE-System

Ein internationaler Ansatz zur Vereinheitlichung der Graduierung von Evidenz und Empfehlungen in Leitlinien

The GRADE System. An international approach to standardize the graduation of evidence and recommendations in guidelines

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Zusammenfassung

Leitlinien haben sich für Ärzte und Patienten zu einer wichtigen Stütze bei diagnostischen und therapeutischen Entscheidungen entwickelt. Um die aktuell verfügbaren methodischen Konzepte der Leitlinienentwicklung zu harmonisieren und die große Heterogenität und oft mangelnde Transparenz existierender Systeme zu überwinden, hat die GRADE (Grading of Recommendations, Assessment, Development and Evaluation) Working Group, eine internationale Kollaboration von Leitlinienentwicklern, Klinikern und Methodikern, die vorhandenen Konzepte weiterentwickelt. Zentrale Bestandteile des GRADE-Systems sind die Unterscheidung zwischen der Qualität der Evidenz und der Stärke einer Empfehlung, die gleichzeitige Betrachtung von Nutzen und Schaden einer Intervention, die Fokussierung auf patientenrelevante Endpunkte, die Abbildung von inhärenten Wertvorstellungen einer Empfehlung und die Integration von Überlegungen zum Ressourcenverbrauch. Unter Berücksichtigung dieser Kriterien werden mit dem GRADE-System starke und abgeschwächte Empfehlungen abgegeben. International befürworten zahlreiche Leitlinienorganisationen und medizinische Fachgesellschaften das System und haben es für die Erstellung der eigenen Leitlinien übernommen.

Abstract

Clinical practice guidelines have become an important source of information to support clinicians in the management of individual patients. However, current guideline methods have limitations that include the lack of separating the quality of evidence from the strength of recommendations. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) working group, an international collaboration of guideline developers, methodologists, and clinicians have developed a system that addresses these shortcomings. Core elements include transparent methodology for grading the quality of evidence, the distinction between quality of the evidence and strength of a recommendation, an explicit balancing of benefits and harms of health care interventions, an explicit recognition of the values and preferences that underlie recommendations. The GRADE system has been piloted in various practice settings to ensure that it captures the complexity involved in evidence assessment and grading recommendations while maintaining simplicity and practicality. Many guideline organizations and medical societies have endorsed the system and adopted it for their guideline processes.

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Danksagung

Die Autoren bedanken sich bei Frau PD Dr. Ina Kopp, AWMF, Monika Lelgemann, HTA Zentrum in der Universität Bremen und Prof. Dr. Dr. Günter Ollenschläger, Ärztliches Zentrum für Qualität in der Medizin, für die kritische Durchsicht und die hilfreichen Kommentare zum Manuskript.

Interessenkonflikt

Regina Kunz ist Mitglied der GRADE Working Group. Sie erhielt Honorare für Vorträge und Workshops über Leitlinienentwicklung und für Tätigkeiten im Bereich der evidenzbasierten Medizin, die auf Forschungskonten eingezahlt und darüber verwaltet wurden.

Holger Schünemann ist Mitglied der GRADE Working Group. Er erhielt keine persönlichen Honorare von kommerziellen Sponsoren, die in Zusammenhang mit GRADE stehen. Forschungsgelder und Honorare für Vorträge und Workshops zur Methodik der Entwicklung von evidenzbasierten Leitlinien und zu Forschungsmethodik wurden auf Forschungskonten eingezahlt.

Bernard Burnand: Es bestehen keine Interessenkonflikte.

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Authors and Affiliations

  1. Basel Institut für Klinische Epidemiologie, Universitätsspital Basel, Hebelstrasse 19, 4031, Basel, Schweiz

    R. Kunz

  2. Unité d’évaluation des soins, Institut universitaire de médecine sociale et préventive IUMSP, Lausanne, Schweiz

    B. Burnand

  3. Department of Epidemiology, Italian National Cancer Institute „Regina Elena“, Rom, Italien

    H.J. Schünemann

Authors
  1. R. Kunz
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  2. B. Burnand
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  3. H.J. Schünemann
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Correspondence to R. Kunz.

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Kunz, R., Burnand, B. & Schünemann, H. Das GRADE-System. Internist 49, 673–680 (2008). https://doi.org/10.1007/s00108-008-2141-9

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  • DOI: https://doi.org/10.1007/s00108-008-2141-9

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