An international core outcome set for evaluating interventions to improve informed consent to clinical trials: The ELICIT Study.

ABSTRACT:

Objective

To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in randomized controlled trials (of healthcare interventions), the ELICIT Study.

Study design

International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting.

Results

The literature review and stakeholder interviews (n = 25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n = 79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: th

SUBMITTER: Gillies K 

PROVIDER: S-EPMC8485845 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature