Table 4.
Items included in the COnSiDER core outcome set
| How the proxy makes the decision | |
| Whether the proxy decision-maker: | |
| Makes a decision that fits with the person’s own values, wishes, and preferences (values congruence) | |
| Is able to determine the person’s own values, wishes and preferences about the choices | |
| Is clear about which risks/side-effects of the study would matter most to the person | |
| Is clear about which benefits from the study would matter most to the person | |
| Is clear about which benefits or risks/side-effects from the study would be more important to the person (balancing benefits and risks) | |
| Experiences of decision-making in this context | |
| Whether the proxy decision-maker: | |
| Feels it was the right decision | |
| Feels satisfied with the decision | |
| Feels that they had enough time to make a decision | |
| Feels that the decision process was good (regardless of the outcome) | |
| Is comfortable with the decision | |
| Feels that the decision was a wise one | |
| Feels that they have enough support from others to make a decision | |
| Personal characteristics that influence the decision | |
| Whether the proxy decision-maker: | |
| Recognises that a decision needs to be made (choice awareness) | |
| Has been informed about the purpose of the study, procedures, risks and benefits | |
| Has been informed about their role in making the decision | |
| Understands that the person’s own values, wishes, and preferences affect the decision | |
| Understands the information needed to make the decision (objective understanding) | |
| Feels that they understand the information well enough to make the decision (subjective understanding) | |
| Recognises they do not have enough information about the views of the person to represent their views | |
| Feels confident in their knowledge to make a decision | |
| Feels confident to make a decision | |
| Feels able and has the opportunity to ask questions | |
| Feels able to express their opinion about each choice | |
| Feels as involved in the decision as they want to be | |
| Feels prepared to make the decision | |
| Is ready to make a decision | |
| Feels that they can delay their decision if they feel that they need more time |