Mariska Tuut

Step-by-step guide 191 6 Background Guidelines aim to support decision making in healthcare practice[1]. The ultimate goal of a guideline is to improve or sustain health outcomes that are considered important from the perspective of the target population of the guidelines, so-called peopleimportant outcomes, such as mortality and quality of life. A set of key questions define the scope of the guideline. Answers to such questions are based on systematic reviews of the evidence, combined with clinical expertise, and patients’ or consumers’ values and preferences. These are subsequently translated to guideline recommendations by the guideline panel [2]. The key questions include specific components, such as the population of interest, the intervention of interest and people-important outcomes [3]. In healthcare, tests can provide additional information about the past, current or future state of a person. The information may be relevant for diagnostic, prognostic, screening, monitoring, treatment (options), or other purposes [4]. Testing in itself usually has no direct effect on a patient/person’s health status. In addition, healthcare related tests are rarely used in isolation. They are typically included in a testmanagement pathway in which the information from testing is used to guide further actions [5-7]. The incremental value of test information will depend on population characteristics (e.g., features, symptoms, context and setting), test characteristics (e.g. sensitivity and specificity), management options following the test result and their downstream consequences on people-important outcomes [8]. The chain of these elements, starting from the testing process and ending in people-important outcomes is called the test-management pathway. Different terms can be used for pathways that link testing to further clinical actions and people-important outcomes, such as test-treatment pathway, diagnostic pathway, clinical pathway, and analytical framework. In our study, we use the term ‘testmanagement pathway’ to be as inclusive as possible. Additionally, we prefer to use the term 'guidelines’, rather than ‘clinical practice guidelines’ so as to also include the public health domain. We also use the term ‘test’, ‘instead of ‘diagnostic test’, to include other purposes and settings of testing and test strategies [9]. Currently, the dominant source of evidence about testing most often comes from studies evaluating test performance, such as diagnostic accuracy [10]. Consequently, most guideline recommendations on testing are based on evidence concerning test accuracy only [11]. While having the best available estimates of a test’s clinical sensitivity and specificity is desirable, it is not sufficient for deciding whether testing should be recommended for use. Accuracy measures can help in estimating how many

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