150 Chapter 4 Interpreting false positives/negatives: A guideline panel member is able to interpret false positive and false negative test results in terms of people-important outcomes. Testing reflects moment: A guideline panel member understands that the test result relates to the moment in time when the test was taken, meaning that test results can vary over time within a person. Interpretation of test results & subsequent management: Management following testing: A guideline panel member understands that a test can lead to additional tests and/or treatment and/or other management, depending on the test result. Link between test result and management: A guideline panel member understands that not all patients with a specific test result get the recommended management. Management burden: A guideline panel member is able to formulate the burden, side effects and societal costs of the management of interest. Impact on people-important outcomes: Testing aim: A guideline panel member understands that the principle aim of a test is to improve people-important outcomes and/or to reduce deterioration of people-important outcomes. Direct and indirect impact of management: A guideline panel member understands that management following a test result may directly or indirectly affect people-important outcomes. Management effectiveness: A guideline panel member understands that management following a test result may or may not be effective in the improvement or prevention of deterioration of peopleimportant outcomes. Footnotes: a. Several experts are involved in guideline development: healthcare professionals who have expertise on the guideline topic of interest, healthcare consumers who have experience in the guideline topic of interest, methodologists who have expertise on guideline methodology and chairs leading the guideline panel. In this document, a guideline panel member refers to healthcare professionals and healthcare consumers in a guideline panel. b. This relates to the assumption that a test is performed in a certain context, and is usually followed by actions, such as clinical management, self-management, or watchful waiting. c. The ability to correctly detect or monitor a measurand is called the analytical performance of a test; This is evaluated by parameters such as trueness, validity, imprecision, limits of detection and crossreactivity. The ability to correctly classify those with and without the target condition is called the clinical performance of a test (also called test accuracy or diagnostic accuracy); this can be determined by comparing the index test (test of interest) with a reference test (also called reference standard) and is evaluated in a 2x2 table in which people with and without the target condition are classified according to their test result and parameters such as sensitivity and specificity, true positives, true negatives, false positives, false negatives, and inconclusive results. The ability of a test to improve people-important outcomes is called the clinical effectiveness of a test (also called clinical utility). The clinical effectiveness is determined by evaluating the testmanagement pathway. The evaluation of the balance between a change in people-important outcomes and costs due to the introduction of a test is called the cost-effectiveness of a test. The evaluation of consequences of introducing or using a test beyond clinical effectiveness and costeffectiveness is called the broader impact of a test. This is evaluated by parameters such as acceptability (including robustness of a test in practice), feasibility and implementability. d. The pre-test probability is the proportion of people in the population at risk who have the condition of interest at a specific time or time interval, i.e., the point prevalence or the period prevalence of the condition of interest. Pre-test probabilities may be estimated from routine data, practice data or clinical judgement. e. Test characteristics (such as sensitivity and specificity) vary between populations.
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