Required knowledge 161 4 Possible required knowledge components ↓ Role in guideline panel Health care provider Health care consumer Methodologist Guideline panel chair Cost-effectiveness analysis of a test is the evaluation of the balance between patient relevant outcomes and costs due to the introduction of a test The broader impact of a test refers to consequences of introducing or using a test beyond clinical effectiveness and cost-effectiveness (e.g., acceptability, implementability) Clinical practice guideline development Clinical practice guideline development about the value of a medical test starts with the definition of a clinical or health question. In the formulation of the question the proposed role (triage, add-on, replacement) of the medical test is described, the test-treatment pathway is outlined, and the patient relevant outcomes are determined Content expertise about the test and disease of interest is necessary Diagnostic accuracy can be considered a surrogate outcome for patient relevant outcomes All steps of the test-treatment pathway should be systematically and critically assessed, starting with the evaluation of diagnostic accuracy Specific methods (e.g., search filters, risk of bias tools, meta-analysis techniques, reporting standards) should be used for conducting systematic reviews of diagnostic test accuracy False negative and false positive results should be interpreted in terms of patient relevant outcomes The certainty of the evidence should be assessed. This includes test accuracy, effects of the test (direct benefit, adverse effects, burden), natural course of the disease of interest, effect of management guided by test results, the link between test results and management decisions, and the overall certainty of the evidence Desirable and undesirable consequences of a medical test should be balanced (by formal or informal modelling)
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