Mariska Tuut

Summary 249 Summary This thesis describes research in the field of guideline development, more specifically the development of guidelines for healthcare related testing, with the aim of facilitating and improving the process of developing guidelines recommendations about testing. This summary outlines the separate chapters of the thesis and highlights the conclusions. Chapter 1 provides the general introduction to the thesis. It sets out the rationale for the thesis by introducing the topic and its components, emphasizing their importance and challenges, and defining the aim and research questions. Guidelines, including clinical practice and public health guidelines, are documents that provide recommendations to enhance healthcare. The development of guidelines follows a clear process that includes systematic reviewing of available evidence and analysis of the benefits and harms of alternative care options, within a guideline panel of experts and representatives from key affected groups. Many organisations worldwide have adopted the GRADE approach, which emphasises the importance of certainty of evidence for clinically relevant differences in people-important outcomes. This approach pays specific attention to guideline development on healthcare related testing, taking into account the indirect link between testing and people-important outcomes, and emphasising the importance of consideration of false positive, false negative and inconclusive test results on people-important outcomes. Although the general competencies and knowledge required for guideline development are known, specific knowledge for creating testing guidelines has, to our knowledge, not yet been established. The purpose of testing is to improve or prevent deterioration of people-important outcomes. People-important outcomes are components of people’s (health) status following an intervention, and are used to assess effectiveness. Unlike treatment, testing usually does not have an immediate impact on people-important outcomes, although there are some exceptions. This implies that a series of steps, such as treatment, must be taken to move from testing to people-important outcomes. Testing in healthcare can serve various purposes, including screening, surveillance, risk classification, diagnosis, staging, treatment triage, prognosis, and follow-up. To assess the value of a test, various aspects should be considered. These include the analytic performance, clinical performance, clinical effectiveness, cost-effectiveness, and the broader impact of the test. Defining the role of a new test relative to existing tests, such as triage or add-on, is also critical.

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