Grading quality of evidence and strength of recommendations in clinical practice guidelines: Part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies

Authors

  • J. L. Brożek,

    1. Department of Epidemiology, Italian National Cancer Institute Regina Elena, Rome, Italy
    2. Department of Medicine, Jagiellonian University School of Medicine, Krakow, Poland
    Search for more papers by this author
  • E. A. Akl,

    1. Department of Medicine and Family Medicine, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, NY, USA
    Search for more papers by this author
  • R. Jaeschke,

    1. Department of Medicine, McMaster University, Hamilton, ON, Canada
    Search for more papers by this author
  • D. M. Lang,

    1. Allergy/Immunology Section, Asthma Center Respiratory Institute, Cleveland Clinic, Cleveland, OH, USA
    Search for more papers by this author
  • P. Bossuyt,

    1. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands
    Search for more papers by this author
  • P. Glasziou,

    1. Centre for Evidence-Based Medicine, Department of Primary Health Care, University of Oxford, Oxford, United Kingdom
    Search for more papers by this author
  • M. Helfand,

    1. Portland Veterans Administration Medical Center and Department of Medicine, Oregon Health & Science University, Portland, OR, USA
    Search for more papers by this author
  • E. Ueffing,

    1. Centre for Global Health, Institute of Population Health, University of Ottawa, Ottawa, ON, Canada
    Search for more papers by this author
  • P. Alonso-Coello,

    1. Iberoamerican Cochrane Center, Servicio de Epidemiología Clínica y Salud Pública, Hospital de Sant Pau, Barcelona, Spain
    2. Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Spain
    Search for more papers by this author
  • J. Meerpohl,

    1. German Cochrane Centre, Institute of Medical Biometry and Medical Informatics, University Hospital Freiburg, Freiburg, Germany
    2. Division of Pediatric Hematology & Oncology, Department of Pediatrics, University Hospital Freiburg, Freiburg, Germany
    Search for more papers by this author
  • B. Phillips,

    1. Centre for Reviews and Dissemination, University of York, York, United Kingdom
    Search for more papers by this author
  • A. R. Horvath,

    1. Department of Clinical Chemistry, University of Szeged, Szeged, Hungary
    Search for more papers by this author
  • J. Bousquet,

    1. Service des Maladies Respiratoires, Hôpital Arnaud de Villeneuve, INSERM, Montpellier, France
    Search for more papers by this author
  • G. H. Guyatt,

    1. Department of Medicine, McMaster University, Hamilton, ON, Canada
    2. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada
    Search for more papers by this author
  • H. J. Schünemann,

    1. Department of Medicine and Family Medicine, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, NY, USA
    2. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada
    Search for more papers by this author
  • for the GRADE Working Group

    1. Department of Epidemiology, Italian National Cancer Institute Regina Elena, Rome, Italy
    Search for more papers by this author

Holger J. Schünemann, MD, PhD
Department of Clinical Epidemiology and Biostatistics
Faculty of Health Sciences
McMaster University
1200 Main Street W
Hamilton, ON
Canada

Abstract

The GRADE approach to grading the quality of evidence and strength of recommendations provides a comprehensive and transparent approach for developing clinical recommendations about using diagnostic tests or diagnostic strategies. Although grading the quality of evidence and strength of recommendations about using tests shares the logic of grading recommendations for treatment, it presents unique challenges. Guideline panels and clinicians should be alert to these special challenges when using the evidence about the accuracy of tests as the basis for clinical decisions. In the GRADE system, valid diagnostic accuracy studies can provide high quality evidence of test accuracy. However, such studies often provide only low quality evidence for the development of recommendations about diagnostic testing, as test accuracy is a surrogate for patient-important outcomes at best. Inferring from data on accuracy that using a test improves outcomes that are important to patients requires availability of an effective treatment, improved patients’ wellbeing through prognostic information, or – by excluding an ominous diagnosis – reduction of anxiety and the opportunity for earlier search for an alternative diagnosis for which beneficial treatment can be available. Assessing the directness of evidence supporting the use of a diagnostic test requires judgments about the relationship between test results and patient-important consequences. Well-designed and conducted studies of allergy tests in parallel with efforts to evaluate allergy treatments critically will encourage improved guideline development for allergic diseases.

Ancillary