Mariska Tuut

Step-by-step guide 193 6 design such a test-management pathway aimed at guideline developers. The intention was that such a guide would assist guideline developers in formulating focused questions and evidence-based recommendations on testing. Methods General methodology This project was based on a developmental design with a co-creative strategy. The initial creation of the step-by-step guide and the first phase of user testing were part of the DECIDE project, a 5-year project from January 2011 to December 2015, co-funded by the European Commission under the Seventh Framework Programme. Its objective was to build on the work of the GRADE Working Group to develop and evaluate methods for the dissemination of guidelines, including the evaluation of evidence and the development of recommendations about healthcare related tests [22]. Finalisation of the step-by-step guide and additional user testing was conducted in 2023. The authors who participated in the pilot testing and user testing sessions are all researchers in the field of test evaluation and/or guideline development. They do not currently hold any active healthcare provider roles. Firstly, the project team drafted a number of signalling questions per PICO element. Secondly, the step-by-step guide was co-created with two experts in the field and underwent user-testing with experts in the field and guideline panel members. This approach was selected to ensure comprehensive consideration of all relevant aspects. The Standards for Reporting Qualitative Research (SRQR) have been used to guide reporting of the research [23]. Development of the step-by-step guide for creating a test-management pathway The initial project team (GG, MML, PMB, MWL) selected the Population – Index test – Comparator – Outcome (PICO) elements as a starting point [24]. Using these elements and handbooks as basis (Agency for Healthcare Research and Quality, US Preventive Services Task Force, Cochrane handbook (for diagnostic test accuracy), GRADE for Diagnosis), the project team proposed a number of signalling questions for each PICO element, also based on their own expertise and experience in guideline development and study design [13, 16-18]. The aim of these questions was to facilitate guideline panel members in identifying issues that may need consideration when positioning the test of interest in its proposed pathway. The draft step-by-step guide was co-created in 2014 with one diagnostic test accuracy systematic reviewer and one guideline methodologist (MKT) within the project team. With these experts, the test-management

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