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