Abstract
BackgroundA variety of systems have been developed to grade evidence and develop recommendations based on the available evidence. However, development of guidelines for medical tests is especially challenging given the typical indirectness of the evidence; direct evidence of the effects of testing on patient important outcomes is usually absent. We compared grading systems for medical tests on how they use evidence in guideline development.MethodsWe used a systematic strategy to look for grading systems specific to medical tests in PubMed, professional guideline websites, via personal correspondence, and handsearching back references of key articles. Using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument as a starting point, we defined two sets of characteristics to describe these systems: methodological and process ones. Methodological characteristics are features relating to how evidence is gathered, appraised, and used in recommendations. Process characteristics are those relating to the guideline development process. Data were extracted in duplicate and differences resolved through discussion.ResultsTwelve grading systems could be included. All varied in the degree to which methodological and process characteristics were addressed. Having a clinical scenario, identifying the care pathway and/or developing an analytical framework, having explicit criteria for appraising and linking indirect evidence, and having explicit methodologies for translating evidence into recommendations were least frequently addressed. Five systems at most addressed these, to varying degrees of explicitness and completeness. Process wise, features most frequently addressed included involvement of relevant professional groups (8/12), external peer review of completed guidelines (9/12), and recommendations on methods for dissemination (8/12). Characteristics least often addressed were whether the system was piloted (3/12) and funder information (3/12).ConclusionsFive systems for grading evidence about medical tests in guideline development addressed to differing degrees of explicitness the need for and appraisal of different bodies of evidence, the linking of such evidence, and its translation into recommendations. At present, no one system addressed the full complexity of gathering, assessing and linking different bodies of evidence.
Highlights
A variety of systems have been developed to grade evidence and develop recommendations based on the available evidence
The highest available evidence comes from high quality systematic reviews of randomized controlled trials that document the effect on patient important outcomes, such as mortality, morbidity, or functional health [3,4]
Twelve grading systems [15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31] were identified for inclusion, two of which—Evaluation of Genomic Applications in Practice and Prevention initiative (EGAPP) and National Institute for Health and Clinical Excellence (NICE)’s Diagnostic Assessment Programme (DAP)—were specific to medical tests [22,26]
Summary
A variety of systems have been developed to grade evidence and develop recommendations based on the available evidence. Panels often grade the quality of the available evidence [1] Such an approach of systematically evaluating the evidence and developing recommendations can reduce bias and provide transparency to the guideline development process with benefits to both guideline developers and their target audiences [1]. Guideline panels may be interested in producing guidelines to address the use of tests for testing disease susceptibility and risk stratification, for staging a disease, monitoring its course for treatment selection, and for surveillance after treatment In these applications, diagnostic test accuracy data may not always be the most informative expression of test performance [6,7]
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