Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): developing a core outcome set

Kate Gillies, Cynthia Fraser, Vikki Entwistle, Shaun Treweek, Paula Williamson, Marion Campbell* (Corresponding Author)

*Corresponding author for this work

Research output: Contribution to journalConference articlepeer-review

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Abstract

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks, or benefits, associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on ‘understanding’ of trial information and recruitment to the parent study. Yet there is a lack of clarity regarding whether these are the ‘right’ outcomes to measure and which outcomes matter (to whom) and why.
Original languageEnglish
Article numberP53
Number of pages1
JournalTrials
Volume16
Issue numberSupplement 2
DOIs
Publication statusPublished - 16 Nov 2015
Event3rd International Clinical Trials Methodology Conference - Glasgow, United Kingdom
Duration: 16 Nov 201517 Nov 2015

Keywords

  • Systematic Literature Review
  • Informed Consent Process
  • Healthcare Intervention
  • Systematic Methodology
  • Delphi Study

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