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Table 2 Characteristics of trials and sample recruitment appointments

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

Trial

Development of DevPICv1 N = 17

Phase 1 evaluation N = 6 (DevPICv1)

Phase 2 evaluation N = 6 (DevPICv2)

CLASS

CHEMORAD

ProtecT

POUT

CSAW

OPTIMA

ACST II

OPTIMA

ProtecT

N appointments

6

3

8

3

2

1

2

2

2

Blinded category

Appt ID:1–6

   

Less good

3.

Good

1. 2.

Less good

4.

Good

5.

Less good

6.

Good

-

Less good

2.

Good

1.

Less good

4.

Good

3.

Less good

5.

Good

6.

Cancer (Y/N)

N

Y

Y

Y

N

Y

N

Y

Y

Surgical arm (Y/N)

Y

Y

Y

N

Y

N

Y

N

Y

N of trial arms

2

2

3

2

3

2

2

2

3

Recruiter

 Surgeon

5

1

1

N/A

2

N/A

2

N/A

0

 Oncologist

N/A

2

0

3

N/A

1

N/A

2

0

 Nurse

1

0

7

0

0

0

0

0

2

Outcome for trial participation

Yes, No or Undecideda

N = 0

N = 0

N = 5

No = 2

No = 1

N = 1

N = 0

No = 0

N = 1

Y = 0

Y = 0

Y = 2

Y = 1

Y=0

Y=0

Yes = 1

Y = 0

Y = 1

Undecided = 6

Undecided = 3

Undecided = 1

Undecided =0

Undecided =1

Undecided =0

Undecided = 1

Undecided =2

Undecided =0

Length of consultation

Mean:13 m 49 s

Range: 8 m 58 s–16 m 22 s

Mean:30 m 46 s

Range: 25 m 30s–37 m 55 s

Mean:58 m 24 s

Range: 14 m 43 s–1 h 48 m 24 s

39 m 58 s

26 m 43 s

33 m 19 s

16 m 50s

24 m 01 s

31 m 10s

20 m 22 s

14 m 26 s

1 h 06 m 27 s

22 m 13 s

18 m 44 s

43 m 02 s

Length of time to rate (min)

N/A

163 m

169 m

120 m

75 m

94 m

81 m

73 m

55

51 m

54 m

39 m

65 m

Mean time to rate (min)

N/A

117 m

56 m

  1. aUndecided = outcome agreed was further time to consider participation and/or another appointment to discuss participation further. All participants were providing consent for themselves
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Trials

ISSN: 1745-6215