SP2.1.8 Informed consent – Are we appropriately assessing the process?

Abstract Aims There is no standardised measure of the validity consent. Over 300 million invasive procedures take place globally each year. This study aims to define a core outcome set (COS) for informed consent therapy. Methods A prospective mixed method was undertaken in line with published protocol and COS developed accordance Core Outcome Measures Effectiveness Trials (COMET) methodology. included systematic review outcomes studies consent, semi-structured interviews prioritisation using 2-round modified Delphi technique. Two consensus webinars were used ratify inclusion final COS. Results 36 domains valid identified by review. 41 conducted key stakeholders (with significant patient involvement) 164 participants from stakeholder groups across 8 countries completed Round 1 125 round 2. 11 40 met “consensus in” criteria, 6 meeting all groups. These directly other 5 that some but not discussed webinars. 9 defined Conclusion first research into It defines what are most important process step forward standardising research.