Table 2.
Evaluation of understanding and satisfaction of the informed consent process at study initiation
| Cohort 1 | Cohort 2 | ||
|---|---|---|---|
| Absolute number of patients (percentage) | Absolute number of patients (percentage) | Absolute risk difference (95% CI) | |
| Setting of the informed consent process | |||
| How many conversations did you have with your doctor before signing the informed consent form? | N = 80 | N = 89 | |
| One | 41 (50%) | 47 (53%) | − 1.6% (− 16.3%; + 13.2%) |
| Two | 30 (38%) | 26 (29%) | + 8.39% (− 5.8%; + 22.1%) |
| More than two | 9 (11%) | 16 (18%) | − 6.7% (− 17.4%; + 4.3%) |
| How much time did you need to read the informed consent material? | N = 82 | N = 75 | |
| Up to 15 min | 33 (40%) | 28 (38%) | + 2.91% (− 12.2%; + 17.7%) |
| 15–30 min | 21 (26%) | 31 (41%) | − 15.7% (− 29.7%; − 0.98%) |
| 30–60 min | 14 (17%) | 4 (5%) | + 11.75% (+ 1.7%; + 21.84) |
| More than 60 min | 5 (6%) | 4 (5%) | + 0.76% (− 7.6%; + 8.8%) |
| I did not read it | 6 (7%) | 8 (11%) | − 3.35% (− 13.2%; + 5.95%) |
| No answer | 3 (4%) | 0 (0%) | + 3.7% (− 1.8%; + 10.2%) |
| I read the informed consent material completely | N = 82 | N = 89 | |
| Rather or fully agree | 61 (74%) | 53 (60%) | + 14.8% (+ 0.7%; + 28.1%) |
| Partially agree | 9 (11%) | 20 (22%) | − 11.5% (− 22.5%; − 0.14%) |
| Rather not agree or do not agree at all | 12 (15%) | 16 (18%) | − 3.34% (− 14.4%; + 8.0%) |
| I just wanted to sign the informed consent form | N = 81 | N = 87 | |
| Rather or fully agree | 9 (11%) | 25 (29%) | − 17.6% (− 29.1%; − 5.5%) |
| Partially agree | 9 (11%) | 17 (19%) | − 8.4% (− 19.3%; + 2.7%) |
| Rather not agree or do not agree at all | 63 (78%) | 45 (52%) | + 26.1% (+ 11.6%; + 38.94) |
| I received a lot of additional information through (study) nurses | N = 72 | N = 87 | |
| Rather or fully agree | 33 (46%) | 14 (17%) | + 29.7% (+ 15.5%; + 42.8%) |
| Partially | 28 (39%) | 21 (24%) | + 14.6% (+ 0.3%; + 28.7%) |
| Rather not agree or do not agree at all | 11 (15%) | 52 (60%) | − 44.5% (− 56.2%; − 30.0%) |
| Comprehension | |||
| The consent form was easy to understand | N = 80 | N = 84 | |
| Rather or fully agree | 56 (70%) | 60 (72%) | − 1.4% (− 15.2%; + 12.3%) |
| Partially | 18 (22%) | 18 (21%) | + 1.1% (− 11.5%; + 13.8%) |
| Rather not agree or do not agree at all | 6 (8%) | 6 (7%) | + 0.4% (− 8.2%; + 9.2%) |
| I had to ask a lot of questions to understand the informed consent form | N = 81 | N = 82 | |
| Rather or fully agree | 9 (11%) | 8 (9%) | + 1.4% (− 8.4%; + 11.2%) |
| Partially agree | 19 (24%) | 19 (23%) | + 0.3% (− 12.6%; + 13.2%) |
| rather not agree or do not agree at all | 53 (65%) | 55 (68%) | − 1.6% (− 15.9%; + 12.7%) |
| There were many incomprehensible words in the text | N = 75 | N = 82 | |
| Rather or fully agree | 12 (16%) | 11 (13%) | + 2.6% (− 8.6%; + 14.1%) |
| Partially agree | 21 (28%) | 28 (34%) | − 6.2% (− 20.1%; + 8.3%) |
| Rather not agree or do not agree at all | 42 (56%) | 43 (53%) | + 3.6% (− 11.8%; + 18.7%) |
| The consent form was well structured | N = 73 | N = 82 | |
| Rather or fully agree | 53 (73%) | 62 (76%) | − 3.0% (− 16.8%; + 10.6%) |
| Partially agree | 19 (26%) | 17 (21%) | + 5.3% (− 7.9%; + 18.6%) |
| Rather not agree or do not agree at all | 1 (1%) | 3 (3%) | − 2.3% (− 8.9%; + 4.2%) |
| I know the purpose of the trial | N = 82 | Not applicable | |
| Rather or fully agree | 73 (89%) | ||
| Partially agree | 7 (9%) | ||
| Rather not agree or do not agree at all | 2 (2%) | ||
| The therapy goal was clearly discussed with me | Not applicable | N = 88 | |
| Rather or fully agree | 66 (75%) | ||
| Partially agree | 16 (18%) | ||
| Rather not agree or do not agree at all | 6 (7%) | ||
| Satisfaction | |||
| I felt reassured after the informed consent | N = 77 | N = 88 | |
| Rather or fully agree | 15 (12%) | 43 (48.5%) | − 29.4% (− 42.0%; − 15.0% |
| Partially | 36 (28%) | 30 (34%) | + 12.7% (− 2.3%; + 26.9%) |
| Rather not agree or do not agree at all | 26 (20%) | 15 (17.5%) | + 16.7% (+ 3.5%; + 29.6%) |
| Chances and risks were well presented | N = 74 | N = 89 | |
| Rather or fully agree | 53 (72%) | 67 (75%) | − 3.7% (− 17.3%; + 9.7%) |
| Partially | 19 (25%) | 16 (18%) | + 7.7% (− 4.9%; + 20.5%) |
| rather not agree or do not agree at all | 2 (3%) | 6 (7%) | − 4.0%; (− 11.5%; + 3.51%) |
| It was important to me to be informed about all side effects | N = 76 | N = 88 | |
| Rather or fully agree | 53 (70%) | 74 (84%) | − 14.4% (− 27.0%; − 1.5%) |
| Partially agree | 12 (16%) | 11 (13%) | + 3.3% (− 7.4%; + 14.5%) |
| Rather not agree or do not agree at all | 11 (14%) | 3 (3%) | + 11.1% (+ 2.3%; + 20.9%) |
| The doctor took enough time to explain everything | N = 82 | N = 89 | |
| Rather or fully agree | 80 (98%) | 76 (85%) | + 12.2% (+ 3.7%; + 21.1%) |
| Partially | 1 (1%) | 9 (10%) | − 8.9% (− 17.0%; − 1.8%) |
| Rather not agree or do not agree at all | 1 (1%) | 4 (5%) | − 3.3% (− 9.9%; + 2.8%) |
| I had enough time to overthink my agreement to therapy | N = 82 | N = 84 | |
| Rather or fully agree | 65 (79%) | 65 (77%) | + 1.9% (− 10.7%; + 14.3%) |
| Partially agree | 8 (10%) | 10 (12%) | − 2.15% (− 76.6; − 54.6%) |
| Rather not agree or do not agree at all | 9 (11%) | 9 (11%) | + 0.26% (− 12.0%; + 7.7%) |
| Retrospectively, the informed consent displayed things decently | N = 43 | ||
| Fully agree | 22 (52%) | ||
| Rather agree | 16 (37%) | ||
| Partially | 3 (7%) | ||
| Rather not agree | 1 (2%) | ||
| Do not agree at all | 1 (2%) | ||
| Retrospectively, I am satisfied with the information I received | N = 43 | ||
| Fully agree | 20 (47%) | ||
| Rather agree | 19 (44%) | ||
| Partially | 3 (7%) | ||
| Rather not agree | 1 (2%) | ||
| Do not agree at all | 0 (0%) | ||
| I would have liked more information after all | N = 43 | ||
| Fully agree | 3 (7%) | ||
| Rather agree | 4 (9%) | ||
| Partially | 11 (26%) | ||
| Rather not agree | 15 (35%) | ||
| Do not agree at all | 10 (23%) | ||
| The therapy proceeded in the same way as the informed consent talk anticipated | N = 43 | ||
| Fully agree | 19 (44%) | ||
| Rather agree | 17 (40%) | ||
| Partially | 6 (14%) | ||
| Rather not agree | 1 (2%) | ||
| Do not agree at all | 0 (0%) | ||