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

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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 languageEnglish
Article number484
JournalTrials
Volume16
Early online date27 Oct 2015
DOIs
Publication statusPublished - 2015

Fingerprint

Clinical Protocols
Informed Consent
Randomized Controlled Trials
Research
Outcome Assessment (Health Care)
Delphi Technique
Ethics Committees
Surveys and Questionnaires
Nurses
Interviews

Keywords

  • core outcome set
  • consensus methods
  • stakeholders
  • informed consent

Cite this

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title = "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 = "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.",
keywords = "core outcome set, consensus methods, stakeholders, informed consent",
author = "Kate Gillies and Vikki Entwistle and Treweek, {Shaun P} and Cynthia Fraser and Williamson, {Paula R} and Campbell, {Marion K}",
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.",
year = "2015",
doi = "10.1186/s13063-015-1011-8",
language = "English",
volume = "16",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

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T1 - Evaluation of interventions for informed consent for randomised controlled trials (ELICIT)

T2 - protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

AU - Gillies, Kate

AU - Entwistle, Vikki

AU - Treweek, Shaun P

AU - Fraser, Cynthia

AU - Williamson, Paula R

AU - Campbell, Marion K

N1 - 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.

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

KW - core outcome set

KW - consensus methods

KW - stakeholders

KW - informed consent

U2 - 10.1186/s13063-015-1011-8

DO - 10.1186/s13063-015-1011-8

M3 - Article

VL - 16

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 484

ER -