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Table 4 Items included in the COnSiDER core outcome set

From: Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

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