Step-by-step guide 207 6 Appendix 3. Updated step-by-step guide for developing a testmanagement pathway Steps Signalling questions People (Setting & Timing) In whom is testing considered? Define the eligibility criteria: in which persons is testing considered? Define healthcare setting Consider personal characteristics, setting, referral patterns, previous test results. Are we interested in a particular age, sex or gender? Have the persons been referred from another setting? Were other tests performed? In what setting will the persons be tested? (population screening program, general practitioners practice, physiotherapy practice, hospital, etc.) Should subgroups be considered? Index test Which test or testing strategy is considered? Define measurand Primary purpose of the index test Define measurement platform or assay(s) The guideline panel will have to be specific enough in the description of the test that is considered. What is the measurand (the physical quantity or property that is being measured)? What is the primary purpose of testing (screening, diagnostic, prognostic, predictive, monitoring, etc.) What is the role of the test relative to other tests (triage, replacement, add-on, parallel/combined) Is a combination of tests or specific testing strategy considered? (multimarker score, sequence of tests, etc.) What is the burden associated with the test (efforts to undergo the test, adverse effects, complications, costs, etc.) Are there any feasibility considerations? (resource requirements, training, storage, transport, etc.) Are there any acceptability considerations? (patients values and preferences, equity, costs, etc.) What platform or which kind of assay is used for the measurand? 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
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