[GA25-04] Thresholds for responder analyses of complex scales in benefit assessments – the 15% approach

In 2020, IQWiG published a new procedure for determining relevance thresholds for responder analyses of complex scales, in particular patient-reported outcomes (PROs), for the first time and has since applied this procedure (15% threshold). The aim of this general commission is to bring together the methodological principles and definitions published in various places regarding the “15% threshold” in a single document and, alongside the European health technology assessment, to make them accessible to a wider readership. In addition, more detailed information on the approach and the empirical basis used at the time is provided.