Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study.

ABSTRACT:

Background

300 million operations and procedures are performed annually across the world, all of which require a patient's informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy.

Methods

The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration- https://www.comet-initiative.org/Studies/Details/1024 ). Participants from all key stakeholder groups took part in the process, inc

SUBMITTER: Convie LJ 

PROVIDER: S-EPMC9364552 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature