Required knowledge 149 4 Test-management pathway: Tests are part of test-management pathway: A guideline panel member understands that tests are part of a test-management pathway.b Test evaluation concepts: (In case the guideline development situation demands:) a guideline panel member can recall that tests are evaluated using the following concepts: analytical performance, clinical performance, clinical effectiveness, cost-effectiveness, and broader impactc [38]. Clinical effectiveness of testing: A guideline panel member understands that the clinical effectiveness (desirable and undesirable health effects) of testing is determined by evaluating the test-management pathway. Direct and indirect evaluation: A guideline panel member can recall that a test-management pathway can be evaluated directly (in a diagnostic randomised controlled trial with sufficient follow-up to reach a change in people-important outcomes) and indirectly if direct evidence is lacking. Indirect evaluation of a test-management pathway includes assessment of all components of the testmanagement pathway. Certainty assessment: A guideline panel member can recall that evaluation of a test-management pathway includes assessment of the certainty of the evidence of the (components of the) pathway. Balance of desirable and undesirable consequences: A guideline panel member understands that evaluation of a test-management pathway includes consideration of the balance between desirable and undesirable consequences related to the test. Modelling: A guideline panel member can recall that desirable and undesirable consequences related to the test should be balanced by modelling. Target population: Pre-test probability: A guideline panel member understands that each target population has a (specific) pre-test probability (related to the context and setting in which the test is performed)d of having a certain condition (e.g. a disease) [39]. Test: Purpose: Tests can be used for different purposes: screening or surveillance, risk assessment, classification and staging, diagnosis, treatment decisions, treatment monitoring, and estimating prognosis [34]. A guideline panel member is able to formulate the purpose of the test of interest. Role: New tests can have four main roles: replacement of a test, triage, add-on or parallel/combined [34]. A guideline panel member is able to formulate the role of the test of interest. Test burden: A guideline panel member is able to formulate burden, side effects and societal costs related to the test of interest. Test result: Test accuracy as informative step: A guideline panel member understands that, in the absence of direct evidence, evaluation of the clinical performance/test accuracy is an informative and essential step to be able to determine the impact of a test on people-important outcomes. Clinical performance in target population: A guideline panel member understands that clinical performance/test accuracy depends on the target population (including context and setting) in which the test is used and evaluated.e Post-test probability: A guideline panel member can recall that the post-test probability of having a certain condition depends on the pre-test probability and the test result. Threshold for test-positivity: A guideline panel member can recall that a cut-off point of a certain test result determines the threshold for test positivity (i.e., the test result deviates from normal), and that changing the threshold for test positivity affects sensitivity and specificity (in opposite direction) as well as management following the test results. This may relate to over- and underdiagnosis [40]. Test results: A guideline panel member understands that test results can be true positive, true negative, false positive, false negative and inconclusive (neither positive, nor negative). In guideline development, it is important to focus on these outcomes rather than sensitivity and specificity. Incorrect classification: A guideline panel member understands that false positive and false negative test results are related to incorrect classification of (not) having the condition of interest.
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