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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)