Which outcomes related to RCT informed consent matter to stakeholders?
Research type
Research Study
Full 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
IRAS ID
170140
Contact name
Katie Gillies
Contact email
Sponsor organisation
University of Aberdeen/NHS Grampian
Duration of Study in the UK
2 years, 0 months, 5 days
Research summary
This project aims to develop a core outcome set (COS) for the evaluation of interventions intended to improve informed consent for RCTs. COS are standardised sets of outcomes that represent the minimum outcomes that should be measured in a clinical trial (or a particular condition or topic area).
Various intervention have been developed that aim to improve informed consent to RCTs. However, there is a lack of consistency regarding which outcomes are measured, how they are measured (i.e. which tool is used) and when they are measured (i.e. timing). This creates problems for individual studies but also when trying to analyse studies alongside one another. There is also a lack of clarity regarding which outcomes matter (to whom) and why, which is critical when considering these interventions are targeted at potential trial participants. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified.
This project aims to employ methods that have been used in other COS projects. In brief, a systematic review will be conducted to identify outcomes already measured; interviews with stakeholders (potential participants (i.e. patients), trialists, research nurses, ethics committee chairs, researchers) to explore their views on the which outcomes matter; a survey to reach agreement on the most important outcomes; and a final meeting to determine the final COS. Stakeholder participants will be identified through existing registers or organisations and contacted via gatekeepers.
Development of a COS in this context should allow a more valid assessment of interventions aimed at improving informed consent and produce more consistent results from trials which can then be combined together to produce more meaningful results. The importance of including a range of stakeholders, to have their voices heard on what matters most to them, is central to this work.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0375
Date of REC Opinion
26 Feb 2015
REC opinion
Further Information Favourable Opinion