General introduction 13 1 General introduction This introduction chapter guides through the various pillars that are essential for addressing challenges in guideline development and healthcare related testing in practice. It sets the rationale for this thesis, outlining and bringing together the worlds of guideline development, testing in practice, and test evaluation in research to finally arrive at the aim of this thesis and the research questions. Guidelines Guidelines, including clinical practice guidelines and public health guidelines, are documents providing recommendations intended to optimize patient care. They are developed using a systematic review of the available evidence and an analysis of benefits and harms of alternative care options. To be regarded as trustworthy according to the Institute of Medicine, guidelines should: - be based on a systematic review of the existing evidence; - be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups; - consider important patient subgroups and patient preferences, as appropriate; - be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest; - provide a clear explanation of the logical relationships between alternative care options and health outcomes; - provide ratings of both the quality of evidence and the strength of recommendations; and - be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations [1]. Guideline development follows a clear process, which is crucial for acceptance and implementation. The first step concerns an analysis of problems to be addressed, the identification of the specific topic, target group(s) and target population of the guideline. Next, a guideline panel (also known as a guideline development group/committee) is established, consisting of representatives from all relevant professional groups, patient/consumer/people representatives and methodologists. Following that, the scope of the guideline is defined including the formulation of key questions that need to be addressed. After that, a draft guideline is developed. This process includes a series of steps, in which available guidelines are reviewed, scientific evidence is identified and critically assessed, and relevant expertise and experience is considered, after which draft recommendations are formulated. Next, the draft guideline is disseminated to all relevant stakeholders and target groups for
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