Table 4 Questionnaire on participants’ impression of the informed consent process
Item | Categories | N | % |
|---|---|---|---|
Prior knowledge | |||
Did you know about “RCTs” before participating in J-START? | Yes | 108 | 28.7 |
No | 268 | 71.3 | |
Did you know about J-START before the informed consent procedure? | Yes | 97 | 25.8 |
No | 279 | 74.2 | |
Helpfulness of media | |||
Did the information leaflet help you understand J-START? | Helpful | 266 | 70.7 |
Unsure | 62 | 16.5 | |
No | 48 | 12.8 | |
Did the educational video help you understand J-START? | Helpful | 277 | 73.7 |
Unsure | 25 | 6.7 | |
No | 74 | 19.7 | |
Evaluations of the verbal delivery of the information during the informed consent procedure | |||
Did the research staff confirm your understanding? | Yes | 346 | 92.0 |
Unsure | 17 | 4.5 | |
No | 9 | 2.4 | |
Missing | 4 | 1.1 | |
Did you need further information? | Yes | 10 | 2.7 |
Unsure | 58 | 15.4 | |
No | 299 | 79.5 | |
Missing | 9 | 2.4 | |
I had sufficient opportunity to ask questions | Yes | 338 | 89.9 |
Unsure | 14 | 3.7 | |
No | 20 | 5.3 | |
Missing | 4 | 1.1 | |
I had enough time to understand information | Yes | 259 | 68.9 |
Unsure | 102 | 27.1 | |
No | 12 | 3.2 | |
Missing | 3 | 0.8 | |
Did you find it easy to refuse participation? | Yes | 285 | 75.8 |
Unsure | 60 | 16.0 | |
No | 23 | 6.1 | |
Missing | 8 | 2.1 | |