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Table 5 Global judgements from DevPICv2 Section 3

From: Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)

Appointment

Rater

Does the recruiter consistently convey a position of equipoise and what evidence do you have to suggest this?

Is the P in equipoisea and what evidence do you have to suggest this?

Does the patient accept randomisation as a means to determine treatmenta and what evidence do you have to support this?

Is there evidence that the patient is sufficiently informed by the end of the consultation to make an informed decision and what evidence do you have to support this?

1

1

Y

Unclear

Unclear

Unclear

2

Y

Y

Y

Y

2

1

N

Unclear

Unclear

N

2

N

Y

Unclear

N

3

1

Y

Y

Unclear

Y

2

Y

Y

Y

Y

4

1

N

Unclear

N

N

2

N

Unclear

N

N

5

1

Y

Unclear

N

Unclear

2

N

Unclear

N

Unclear

6

1

Y

Y

Y

Y

2

Y

Y

Y

Y

  1. aat the point of decision-making about participation or at the end of the appointment
  2. Y = Yes, N = No, Unclear = insufficient evidence to make this judgement