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. 2011 Jun 10:6:62.
doi: 10.1186/1748-5908-6-62.

Application of GRADE: making evidence-based recommendations about diagnostic tests in clinical practice guidelines

Jonathan Hsu  1 , Jan L Brożek, Luigi Terracciano, Julia Kreis, Enrico Compalati, Airton Tetelbom Stein, Alessandro Fiocchi, Holger J Schünemann
Affiliations

Application of GRADE: making evidence-based recommendations about diagnostic tests in clinical practice guidelines

Jonathan Hsu et al. Implement Sci. .

Abstract

Background: Accurate diagnosis is a fundamental aspect of appropriate healthcare. However, clinicians need guidance when implementing diagnostic tests given the number of tests available and resource constraints in healthcare. Practitioners of health often feel compelled to implement recommendations in guidelines, including recommendations about the use of diagnostic tests. However, the understanding about diagnostic tests by guideline panels and the methodology for developing recommendations is far from completely explored. Therefore, we evaluated the factors that guideline developers and users need to consider for the development of implementable recommendations about diagnostic tests.

Methods: Using a critical analysis of the process, we present the results of a case study using the Grading of Recommendations Applicability, Development and Evaluation (GRADE) approach to develop a clinical practice guideline for the diagnosis of Cow Milk Allergy with the World Allergy Organization.

Results: To ensure that guideline panels can develop informed recommendations about diagnostic tests, it appears that more emphasis needs to be placed on group processes, including question formulation, defining patient-important outcomes for diagnostic tests, and summarizing evidence. Explicit consideration of concepts of diagnosis from evidence-based medicine, such as pre-test probability and treatment threshold, is required to facilitate the work of a guideline panel and to formulate implementable recommendations.

Discussion: This case study provides useful guidance for guideline developers and clinicians about what they ought to demand from clinical practice guidelines to facilitate implementation and strengthen confidence in recommendations about diagnostic tests. Applying a structured framework like the GRADE approach with its requirement for transparency in the description of the evidence and factors that influence recommendations facilitates laying out the process and decision factors that are required for the development, interpretation, and implementation of recommendations about diagnostic tests.

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Figures

Figure 1
Figure 1
General process followed for developing clinical practice guideline on diagnostic tests.
See this image and copyright information in PMC

References

    1. Tatsioni A, Zarin DA, Aronson N, Samson DJ, Flamm CR, Schmid C, Lau J. Challenges in Systematic Reviews of Diagnostic Technologies. Annals of Internal Medicine. 2005;142:1048–1055. - PubMed
    1. Leeflang MMG, Deeks JJ, Gatsonis C, Bossuyt PMM. Systematic Reviews of Diagnostic Test Accuracy. Annals of Internal Medicine. 2008;149:889–897. - PMC - PubMed
    1. Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Bossuyt P, Chang S, Muti P, Jaeschke R, Guyatt GH. GRADE: assessing the quality of evidence for diagnostic recommendations. Evidence Based Medicine. 2008;13:162–163. - PubMed
    1. Schunemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, Williams JW Jr, Kunz R, Craig J, Montori VM, Bossuyt P, Guyatt GH. GRADE Working Group. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336:1106–1110. doi: 10.1136/bmj.39500.677199.AE. - DOI - PMC - PubMed
    1. Fiocchi A, Brozek J, Schünemann H, Bahna SL, von Berg A, Beyer K, Bozzola M, Bradsher J, Compalati E, Ebisawa M, Guzmán MA, Li H, Heine RG, Keith P, Lack G, Landi M, Martelli A, Rancé F, Sampson H, Stein A, Terracciano L, Vieths S. World Allergy Organization (WAO) Special Committee on Food Allergy. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) Guidelines. World Allergy Organization Journal. 2010;3:57–161. doi: 10.1097/WOX.0b013e3181defeb9. - DOI - PMC - PubMed