Table 2 Phase 2 outcome measures, constructs, and questions

CUE-R 2 (26 questions)

 Feasibility

Consent mode & decision

2

Extent infographic was used

1

Ease of use of infographic

2

Acceptability of infographic

1

3

 Effectiveness

Trial-related knowledge

4

Extent standard consent documents were used

1

Ease of use of consent documents

2

Satisfaction with information received

1

2

Desire for further information

1

Confidence in consent decision

1

Demographics

5

Research coordinator CRF (15 questions)

 Feasibility

Consent mode & decision

3

Duration of consent encounter

1

Successful implementation of infographic

4

Ease of use of infographic

1

 Effectiveness

Satisfaction with consent encounter

1

Number & difficulty of questions asked

1

1

Perception of patient/SDM comprehension

1

Perception of patient/SDM satisfaction

1

Perception of patient/SDM confidence

1