[Development of a tool for structuring and reflecting data on harms with consumer health information (SCHADEN Tool)]

The aim of evidence-based health information and decision aids is to help users with making decisions that are consistent with their personal values and preferences. Information on harms of interventions can be especially challenging due to gaps in the evidence ecosystem and special communication requirements. The aim of this project was to develop a tool that assists creators in the communication of harms of interventions. The project group in the Patient Information and Participation Working Group of the Network for Evidence-Based Medicine (EbM Network) included creators from different fields including science, journalism, patient information, and consumer protection. Starting with the discussion of case studies, the SCHADEN tool was developed in an iterative process over a period of two years, during which twelve video conferences, several small group meetings, and two congress workshops were held. The draft of the tool was put up for discussion via the EbM network as part of a public consultation phase and later finalized. In four sections, nine key questions, and 29 detailed questions the tool reflects the full development process and comprises both a short version and a comprehensive manual. It serves as a reflection instrument that makes necessary decisions explicit, supports documentation and provides methodological assistance. The tool recognizes that the development of health information or decision aids may differ in terms of resources and formats with different requirements and objectives. The SCHADEN tool is intended to supplement existing standards such as the Good Practice Guidelines for Health Information and the Guideline Evidence-based Health Information.