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

Katie Gillies* (Corresponding Author), Paula R Williamson, Vikki A Entwistle, Heidi Gardner, Shaun Treweek, Marion K Campbell

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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 RCTs (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: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition.

CONCLUSION: The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an RCT. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders.

REGISTRATION: COMET database - http://www.comet-initiative.org/Studies/Details/595.

Original languageEnglish
Pages (from-to)14-22
Number of pages9
JournalJournal of Clinical Epidemiology
Volume137
Early online date26 Feb 2021
DOIs
Publication statusE-pub ahead of print - 26 Feb 2021

Keywords

  • Informed consent
  • clinical trials
  • Core outcome set

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