Please use this identifier to cite or link to this item:
https://doi.org/10.1186/s13063-015-1011-8
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 | Authors: | Gillies, K Entwistle, V Treweek, S.P Fraser, C Williamson, P.R Campbell, M.K |
Keywords: | anxiety Article clinical protocol consensus core outcome set decision making Delphi study human informed consent mental capacity outcome assessment practice guideline prospective study qualitative analysis randomized controlled trial (topic) reliability self report systematic review attitude to health comprehension Delphi study ethics health personnel attitude methodology patient selection personnel procedures psychology randomized controlled trial (topic) research subject Attitude of Health Personnel Comprehension Consensus Delphi Technique Health Knowledge, Attitudes, Practice Humans Informed Consent Patient Selection Randomized Controlled Trials as Topic Research Design Research Personnel Research Subjects |
Issue Date: | 2015 | Citation: | 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 (1) : 484. ScholarBank@NUS Repository. https://doi.org/10.1186/s13063-015-1011-8 | Rights: | Attribution 4.0 International | 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. © 2015 Gillies et al. | Source Title: | Trials | URI: | https://scholarbank.nus.edu.sg/handle/10635/180881 | ISSN: | 17456215 | DOI: | 10.1186/s13063-015-1011-8 | Rights: | Attribution 4.0 International |
Appears in Collections: | Elements Staff Publications |
Show full item record
Files in This Item:
File | Description | Size | Format | Access Settings | Version | |
---|---|---|---|---|---|---|
10_1186_s13063-015-1011-8.pdf | 551.73 kB | Adobe PDF | OPEN | None | View/Download |
This item is licensed under a Creative Commons License