Thank you for your interest in the ELICIT study.
In this study we aim to find out about how we should evaluate the impact of interventions to improve decisions about trial participation. This is in order to develop an agreed set of standards for the evaluation of interventions which improve decisions about participating in randomised trials.
We would like to develop an agreed set of standards for the evaluation of interventions which improve informed consent in randomised trials. An intervention is something that aims to make a change and is tested through research. For example, changing the wording on a participant information sheet, giving training to researchers about giving information to potential participants during the consent process, using other aids to help decision-making about taking part in a trial, would all be described as interventions to improve informed consent.
The study is in three rounds and if you agree to take part you will be asked to respond to all three parts. Completion of each round will take about 10 minutes. The study will be conducted entirely online.
This questionnaire is the first of three rounds of the survey. We would like you to complete this questionnaire within three weeks (by 07/06/19).
Once we have received responses to this first round questionnaire, we will collect together and summarise the results and prepare the second round questionnaire.
It is very important that you complete the questionnaires in all three rounds. The reliability of the results will not be as good if people drop out of the study before the end. If people drop out because they feel their opinions are in the minority/majority, the final results will overestimate/underestimate how much people agreed on this topic.
All responses will be anonymous. However, to help us track completion of each round we would like you to initially register using your email address. Upon registration you will be allocated a study number which will be used to process your data anonymously.
To register and access the survey, please click the 'Register' button below.
If at any time you would like to discuss this Delphi survey, please contact: Dr Katie Gillies at the University of Aberdeen, email@example.com, 01224 438159.
How and why this study has been designed
This study focuses on core outcome sets. If you are not familiar with core outcome sets, please watch this 3 minute video to find out what core outcome sets are, and how they can be used by researchers: https://youtu.be/Hpmtk4v5xpA.
Core outcome sets represent the minimum that should be measured and reported in all clinical trials of treatments for a specific condition. This project will adapt methods which have been previously used in projects developing core outcome sets for assessment of clinical treatments, so that we can develop core outcome sets for aspects of trial methodology.
Currently there is no core outcome set that can be used in tests of interventions to improve informed consent in randomised trials, which makes it harder to compare the effects of different interventions. In this study we aim to find out which outcomes are important for the evaluation of interventions to improve decisions about trial participation.
How was the list of outcomes generated?
We have carried out a thorough search (called a systematic review) of previous studies about informed consent, to identify which outcomes have been measured. We have also interviewed with stakeholders who each had some interest in trial participation, decision making and/or the ethics of recruitment to research studies. These stakeholders included patients and advocates, trialists, research nurses, social scientists and ethicists with an interest in trials and/or informed consent, and psychologists with an interest in communication research. Both the systematic review and the interviews have enabled us to produce a list of outcomes that you will see later on in the survey.
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All DelphiManager data is stored on a secure server in the University of Liverpool data centre. For more informatation please contact firstname.lastname@example.org