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Table 2 Example information items identified from Delphi survey and patient information leaflet review and included in prototype decision-aid development

From: Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework

  Section Item
A The decision support tool development process Finding out what information potential participants need to prepare them to discuss trial participation
The decision support tool was tested out with recruiters who are actively engaged in discussing trials with potential participants.
B Providing information about trial participation and standard care The decision (i.e., trial participation or not) that needs to be considered is adequately described.
The decision support tool presents information about the advantages/benefits of trial participation.
The decision support tool presents information about the advantages/benefits of non-participation.
The decision support tool explains that taking part in the trial is voluntary.
C Presenting information on the likelihood (i.e., chance) of receiving different treatments The decision support tool presents textual information (i.e., information in words) on the chances of receiving specific treatments. For example, for a trial of surgery versus medical treatment, you have a 1 in 2 chance of getting surgery if you take part in the trial or 100% chance of getting medical treatment if you do not take part in the trial.
The decision support tool provides more than one way of explaining the chances (e.g., words, numbers and diagrams).
The decision support tool presents information about advantages and disadvantages of trial participation that includes the likelihood that they will happen.
D Determining what matters to participants The decision support tool describes the features of trial participation and standard care to help participants imagine what it is like to experience these options. For example, “Surgery A may result in pain in your right knee. People who experience this pain may find it hard to move around following surgery”.
The decision support tool asks participants to think about which advantages and disadvantages of trial participation and standard care matter most to them.
E Using stories from other participants The decision support tool provides stories of other participants’ experiences of deciding to participate (or not) in a trial.
The decision support tool provides stories that represent a range of experiences (positive and negative) of taking part (or not) in a trial.
F Decision guidance The decision support tool provides a step-by-step way to make a decision about trial participation (e.g., by using a list or worksheet that outlines the steps or by developing the decision support tool in such a way that it guides the participant through the decision).
G Disclosing conflicts of interest The decision support tool reports who is organising and funding the research.
The decision support tool contains details of who has reviewed (from both a scientific and ethical perspective) the trial.
H Balancing the presentation of options The advantages and disadvantages of trial options and standard care are presented with equivalent detail (e.g., using similar fonts, order, and display of statistical information).
I Using plain language The information is written at a level that can be understood by at least half of the participants for whom it is intended.
The information provides ways other than reading (e.g., audio, video, or in-person discussion) to help participants understand information.
J Basing included information on up-to-date scientific information The decision support tool describes the quality of the scientific evidence (e.g., quality of research studies).
The decision support tool uses evidence taken from studies on participants that are similar to the participants who would use the information (e.g., age and gender).