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