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