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 |
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| Authors: | J. L. Bro&# ek,E. A. Akl,R. Jaeschke,D. M. Lang,P. Bossuyt,P. Glasziou,M. Helfand,E. Ueffing,P. Alonso-Coello,J. Meerpohl,B. Phillips,A. R. Horvath,J. Bousquet,G. H. Guyatt,H. J. Schü nemann,for the GRADE Working Group |
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| Affiliation: | Department of Epidemiology, Italian National Cancer Institute Regina Elena, Rome, Italy;;Department of Medicine, Jagiellonian University School of Medicine, Krakow, Poland;;Department of Medicine and Family Medicine, School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, NY, USA;;Department of Medicine, McMaster University, Hamilton, ON, Canada;;Allergy/Immunology Section, Asthma Center Respiratory Institute, Cleveland Clinic, Cleveland, OH, USA;;Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands;;Centre for Evidence-Based Medicine, Department of Primary Health Care, University of Oxford, Oxford, United Kingdom;;Portland Veterans Administration Medical Center and Department of Medicine, Oregon Health &Science University, Portland, OR, USA;;Centre for Global Health, Institute of Population Health, University of Ottawa, Ottawa, ON, Canada;;Iberoamerican Cochrane Center, Servicio de Epidemiología Clínica y Salud Pública, Hospital de Sant Pau, Barcelona, Spain;;Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Spain;;German Cochrane Centre, Institute of Medical Biometry and Medical Informatics, University Hospital Freiburg, Freiburg, Germany;;Division of Pediatric Hematology &Oncology, Department of Pediatrics, University Hospital Freiburg, Freiburg, Germany;;Centre for Reviews and Dissemination, University of York, York, United Kingdom;;Department of Clinical Chemistry, University of Szeged, Szeged, Hungary;;Service des Maladies Respiratoires, Hôpital Arnaud de Villeneuve, INSERM, Montpellier, France;;Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada |
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| 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. |
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| Keywords: | clinical practice guidelines diagnosis evidence based medicine grading |
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