Table 4.
Scores of objective and subjective comprehension on the different comprehension domains (ranging from 0 = no comprehension to 100 = full comprehension), in the intention to treat analysis without replacement of missing data
| Original informed consent form | Modified informed consent form | P | |
|---|---|---|---|
| (n = 204) | (n = 198) | ||
| Objective comprehension total score | 72.5 (9.6) | 72.3 (10.0) | 0.83 |
| Notion of experimentation | 75.7 (21.8) | 78.7 (20.8) | 0.19 |
| Study objective | 65.7 (18.9) | 65.6 (19.6) | 0.89 |
| Methodology | 72.1 (13.7) | 70.8 (14.3) | 0.44 |
| Benefits/risks and constraints | 61.0 (18.6) | 60.9 (17.1) | 0.81 |
| Legal obligations | 65.5 (23.9) | 68.1 (22.7) | 0.27 |
| Subject protection | 83.5 (13.5) | 82.1 (15.7) | 0.58 |
| Subjective comprehension total score | 87.7 (13.4) | 87.6 (15.3) | 0.40 |
| Notion of experimentation | 92.4 (17.4) | 90.8 (20.3) | 0.75 |
| Study objective | 90.8 (19.6) | 91.4 (17.4) | 0.98 |
| Methodology | 87.6 (17.2) | 87.9 (17.6) | 0.92 |
| Benefits/risks and constraints | 89.5 (16.9) | 88.5 (19.5) | 0.98 |
| Legal obligations | 77.9 (25.2) | 76.7 (26.3) | 0.78 |
| Subject protection | 93.5 (14.1) | 93.8 (15.7) | 0.33 |
Data are given as mean (SD).