Step-by-step guide 199 6 Outcome(s) of interest What is the ultimate goal to achieve, avoid or simplify in people in whom testing is considered? Define the anticipated or desired impact of testing on downstream (people-important) outcomes Define the how the index test results can guide (clinical) management decisions Guideline panels will likely need an introduction on how to define these outcomes. What are the (crucial and important) people-important outcomes that ultimately matter? How may the index test help to improve, avoid, simplify or these outcome(s)? Linking outcomes to testing How will testing guide further healthcare actions or patient management? Link (positive, negative, failed, inconclusive, continuous) test results to management options and people-important outcomes Testing in itself rarely leads to the desired outcomes. What management options are available after testing, to achieve, avoid, or simplify the people-important outcomes mentioned under c? What management options may follow the following test results: - For dichotomized test results: positive test result - For dichotomized test results: negative test result - For continuous test results: actual test results - Failed tests - Inconclusive test results What is the target condition or target event? (this may be a disease or disease stage) What are the consequences of false positive and false negative tests results on people-important outcomes? Comparator What is the alternative to testing? Define the existing pathway or the one that would be in place if the index test under (b) was not available This refers to the ‘C’ in the PICO framework, the comparator. The comparator may be the standard of care. What is currently being done to achieve, avoid or simplify the people-important outcome(s) mentioned under c? What type of information guides or would guide management if we did not or do not have the index test results? Explicit step-by-step guidance on how to actually derive such pathways is limited in the existing guidance. So far, we have not been able to identify studies reporting on the experience of users applying these approaches. Test-management pathways and concepts have been presented earlier as a tool for setting the scene and framing the question(s) in a guideline development or test accuracy review process [13, 16-18]. The AHRQ and the USPSTF refer to the development of such pathways as a guide to help in formulating specific key questions [16, 17]. Both organizations use the term ‘Analytical Framework’, which they use both for intervention related questions and for test-related questions as a way of going from a more ambiguous initial claim to a specific answerable guideline or review question. The Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy uses the term ‘Clinical pathway’ to outline how
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