Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Kate Gillies; Vikki Entwistle; Shaun P Treweek; Cynthia Fraser; Paula R Williamson; Marion K Campbell

doi:10.1186/s13063-015-1011-8

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

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

^*Corresponding author for this work

University of Liverpool

Research output: Contribution to journal › Article › peer-review

21 Citations (Scopus)

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Abstract

BACKGROUND: 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 the 'understanding' of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified.

METHODS/DESIGN: The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes.

DISCUSSION: The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area.

Original language	English
Article number	484
Journal	Trials
Volume	16
Early online date	27 Oct 2015
DOIs	https://doi.org/10.1186/s13063-015-1011-8
Publication status	Published - 2015

Bibliographical note

Acknowledgements
This work was supported by personal fellowship award (to KG) from the Medical Research Council’s Strategic Skills Methodology programme. The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. PW is funded by a UK Medical Research Council Hub for Trials Methodology Research Network grant G0800792. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Chief Scientist Office, MRC or the Department of Health.

Keywords

core outcome set
consensus methods
stakeholders
informed consent

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Evaluation of interventions for informed consent for randomised controlled trials (ELICIT)
© 2015 Gillies et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Marion Campbell
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Chair in HSRU
- Institute of Applied Health Sciences
Person: Academic
Kate Gillies
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Personal Chair
- Institute of Applied Health Sciences
Person: Academic, Academic Related - Research
Shaun Treweek
- School of Medicine, Medical Sciences & Nutrition, Health Services Research Unit (HSRU) - Chair in Health Services Research
- Institute of Applied Health Sciences
Person: Academic

Cite this

Gillies, K., Entwistle, V., Treweek, S. P., Fraser, C., Williamson, P. R., & Campbell, M. K. (2015). Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials, 16, Article 484. https://doi.org/10.1186/s13063-015-1011-8

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. / Gillies, Kate (Corresponding Author); Entwistle, Vikki ; Treweek, Shaun P et al.
In: Trials, Vol. 16, 484, 2015.

Research output: Contribution to journal › Article › peer-review

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Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Abstract

Bibliographical note

Keywords

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Profiles

Marion Campbell

Kate Gillies

Shaun Treweek

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