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). |