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Table 4 Questionnaire on participants’ impression of the informed consent process

From: Participants’ understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START

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
  1. J-START, Japan STrategic Anti-cancer Randomized controlled Trial; RCT, randomized controlled trial.