Skip to main content

Table 2 Results of the non-inferiority tests

From: Time-to-event versus ten-year-absolute-risk in cardiovascular risk prevention – does it make a difference? Results from the Optimizing-Risk-Communication (OptRisk) randomized-controlled trial

a. For all variables for which high values are favorable, the upper limit of one-sided 95% CI is relevant)

Test-score

Mean (std) Emoticons

Mean (std) TTE

Max. Score

Non-inferiority margin ε

Upper limit of one-sided 95% CI

Non-inferiority confirmed

Effect size (Cohen’s d)

PEF-FB 9

Total score (primary outcome)

81.88 (20.58)

83.57 (18.12)

100

10

2.12

yes

0.09

Risk perception*

4.06 (2.344)

5.22 (2.83)

10

1

−0.659

Yes, even superiority

0.45

Importance of avoiding a CV event

8.84 (2.39)

9.06 (1.95)

10

1

0.19

yes

0.10

Accessibility

Total Score

18,10 (1,835)

17,78 (2,598)

16

1.6

0.74

yes

−0.14

Subscore “comprehensibility”

4.69 (0.52)

4.56 (0.719)

4

0.4

0.245

yes

−0.21

Subscore “usefulness”

4.57 (0.598)

4.43 (0.74)

4

0.4

0.268

yes

−0.21

Subscore “seriousness”

4.4 (0.669)

4.46 (0.75)

4

0.4

0.074

yes

0.08

Subscore “intuitive accessibility”

4,40 (0.79)

4,34 (0.78)

4

0.4

0.195

yes

−0.08

PDMS-D

total score

72,32 (19.57)

73.57 (19.89)

40

4

2.6

yes

0.06

subscore preparation for decision-making

74.34 (19.08)

74.74 (19.3)

40

4

3.29

yes

0.02

subscore preparation for GP consultation

68.91 (24.0)

70.5 (25.0)

40

4

3.16

yes

0.06

b. For all variables for which high values are not favorable, the lower limit of one-sided 95% CI is relevant

Test-score

Mean (std) Emoticons

Mean (std) TTE

Max. score

Limit of equivalence

lower limit of one-sided 95% CI

Non-inferiority confirmed

Effect size (Cohen’s d)

DCS Total score

15.38 (13.96)

14,77 (12.36)

100

−10

−2.0

yes

−0.05

Informed Subscore

16,84 (17.79)

16.23 (16.01)

100

−10

−2.64

yes

−0.04

Values Clarity Subscore

14.81 (16.71)

13.64 (13.96)

100

−10

−1.76

yes

−0.08

Support Subscore

16,19 (15.93)

17,43 (16.45)

100

−10

−4.4

yes

0.08

Uncertainty subscore

15,57 (17.02)

14,73 (15.69)

100

−10

−2.27

yes

−0.05

Effective decision subscore

13.66 (15.85)

13.74 (15.31)

100

−10

−3.07

yes

0.00

  1. DCS: Decisional Conflict Scale, high score stands for high level of decisional conflict
  2. PEF-FB 9 Shared decision-making questionnaire, 9 items; high score stands for high level of patient involvement
  3. CV cardiovascular, PDMS-D Preparation for Decision-Making Scale – German version, GP general practitioner
  4. *Risk perception is significantly higher in the TTE illustration group compared to the emoticons (p < 0.005)