Table 2.
Evaluation of understanding and satisfaction of the informed consent process at study initiation and 6 months later (follow-up)
| Study initiation | |
|---|---|
| How much time was between the informed consent talk and therapy start? (n = 80) | Absolute number of patients (percentage) |
| Up to 1 day | 17 (21%) |
| Up to 1 week | 44 (55%) |
| More than 1 week | 19 (24%) |
| How was the information presented? (n = 88) | |
| Oral only | 24 (27%) |
| Only by written material | 0 (0%) |
| Both orally and by written material | 64 (73%) |
| Were different therapy options discussed? (n = 89) | |
| Yes | 46 (52%) |
| No | 39 (43%) |
| I do not remember | 4 (5%) |
| How many conversations did you have with your doctor before signing the informed consent form? (n = 89) | |
| One | 47 (53%) |
| Two | 26 (29%) |
| More than two | 16 (18%) |
| I had enough time to overthink my agreement to therapy (n = 84) | |
| Fully agree | 38 (45%) |
| Rather agree | 27 (32%) |
| Partially | 10 (12%) |
| Rather not agree | 6 (7%) |
| Do not agree at all | 3 (4%) |
| How long did the oral explanation about the planned therapy take? (n = 89) | |
| Up to 5 min | 1 (1%) |
| Up to 10 min | 10 (12%) |
| Up to 15 min | 12 (13%) |
| 15–30 min | 38 (43%) |
| 30–60 min | 20 (22%) |
| More than 60 min | 8 (9%) |
| How much time did you need to read the informed consent material? (n = 75) | |
| Up to 15 min | 28 (38%) |
| 15–30 min | 31 (41%) |
| 30–60 min | 4 (5%) |
| More than 60 min | 4 (5%) |
| I did not read it | 8 (11%) |
| I read the informed consent material completely (n = 89) | |
| Fully agree | 30 (34%) |
| Rather agree | 23 (26%) |
| Partially | 20 (22%) |
| Rather not agree | 9 (10%) |
| Do not agree at all | 7 (8%) |
| The aim of the therapy was clearly discussed during the informed consent process (n = 88) | |
| Fully agree | 35 (40%) |
| Rather agree | 31 (35%) |
| Partially | 16 (18%) |
| Rather not agree | 4 (5%) |
| Do not agree at all | 2 (2%) |
| The consent form was easy to understand (n = 84) | |
| Fully agree | 29 (35%) |
| Rather agree | 31 (37%) |
| Partially | 18 (21%) |
| Rather not agree | 4 (5%) |
| Do not agree at all | 2 (2%) |
| I had to ask a lot of questions to understand the informed consent form (n = 82) | |
| Fully agree | 2 (2%) |
| Rather agree | 6 (7%) |
| Partially | 19 (23%) |
| Rather not agree | 35 (43%) |
| Do not agree at all | 20 (25%) |
| There were many incomprehensible words in the text (n = 82) | |
| Fully agree | 3 (3%) |
| Rather agree | 8 (10%) |
| Partially | 28 (34%) |
| Rather not agree | 26 (32%) |
| Do not agree at all | 17 (21%) |
| I just wanted to sign the informed consent form (n = 87) | |
| Fully agree | 5 (6%) |
| Rather agree | 20 (23%) |
| Partially | 17 (19%) |
| Rather not agree | 20 (23%) |
| Do not agree at all | 25 (29%) |
| I felt reassured after the informed consent (n = 88) | |
| Fully agree | 11 (12.5%) |
| Rather agree | 32 (36%) |
| Partially | 30 (34%) |
| Rather not agree | 11 (12.5%) |
| Do not agree at all | 4 (5%) |
| Chances and risks were well presented (n = 89) | |
| Fully agree | 31 (35%) |
| Rather agree | 36 (40%) |
| Partially | 16 (18%) |
| Rather not agree | 6 (7%) |
| Do not agree at all | 0 (0%) |
| It was important to me to be informed about all side effects (n = 88) | |
| Fully agree | 53 (60%) |
| Rather agree | 21 (24%) |
| Partially | 11 (13%) |
| Rather not agree | 2 (2%) |
| Do not agree at all | 1 (1%) |
| The doctor took enough time to explain everything (n = 89) | |
| Fully agree | 51 (57%) |
| Rather agree | 25 (28%) |
| Partially | 9 (10%) |
| Rather not agree | 3 (4%) |
| Do not agree at all | 1 (1%) |
| Follow up | |
| 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%) |