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Table 5 Factors associated with low comprehension scores of QuIC Part A items

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

  A4. Experimental nature of study A8.Potential risks or discomforts A9. Benefit to self A13. Compensation
Quite disagree* Unsure Totally agree P Quite disagree* Unsure Totally agree P Quite disagree Unsure Totally agree* P Quite disagree Unsure Totally agree* P
Medical centres
  Site A 3.5% 7.1% 12.7% 0.54 3.0% 6.5% 13.8% 0.009 5.7% 8.7% 8.9% 0.927 0.8% 6.5% 16.0% <0.0001
  Site B 1.1% 3.3% 5.4% 2.7% 4.1% 3.0% 3.2% 3.5% 3.0% 2.2% 6.0% 1.6%
  Site C 6.5% 9.2% 22.2% 4.3% 14.3% 19.2% 9.2% 14.6% 14.1% 7.6% 21.7% 8.7%
  Site D 3.0% 4.1% 8.9% 3.5% 6.8% 5.7% 3.8% 7.0% 5.1% 1.6% 9.8% 4.6%
  Site E 0.8% 3.0% 9.2% 0.8% 4.6% 7.8% 4.1% 5.1% 4.1% 3.0% 7.3% 2.7%
Prior knowledge: had you known about “RCTs” before you took part in J-START?
  Yes 6.2% 9. 8% 13.0% 0.002 5.4% 10.5% 13.0% 0.266 6.5% 11.9% 10.5% 0.613 4.1% 16.0% 8.9% 0.629
  No 8.7% 16.8% 45.5% 8.9% 25.7% 36.5% 19.5% 27.0% 24.6% 11.1% 35.2% 24.7%
Prior knowledge: had you known about J-START before the informed consent?
  Yes 6.5% 7.1% 12.5% 0.003 3.5% 8.7% 13.8% 0.703 6.2% 11.4% 8.4% 0.529 4.1% 13.8% 8.1% 0.851
  No 8.4% 19.5% 46.1% 10.8% 27.6% 35.7% 19.7% 27.6% 26.8% 11.1% 37.4% 25.5%
Helpfulness of media: Educational video was an aid to understanding J-START
  Yes 9.8% 19.8% 44.2% 0.538 9.5% 24.6% 39.5% 0.003 19.2% 27.0% 27.3% 0.517 9.2% 35.5% 29.0% 0.001
  No 1.1% 1.4% 4.1% 0.3% 4.3% 2.2% 1.4% 3.5% 1.9% 1.1% 4.3% 1.1%
  Unsure 4.1% 5.4% 10.3% 4.6% 7.3% 7.8% 5.4% 8.4% 6.0% 4.9% 11.4% 3.5%
Evaluations of the verbal delivery of the information: I had sufficient opportunity to ask questions
  Yes 14.1% 23.9% 51.8% 0.411 14.1% 30.8% 44.9% 0.025 25.1% 33.5% 31.1% 0.023 13.3% 44.4% 32.0% 0.049
  No 0.8% 2.7% 6.8% 0.3% 5.4% 4.6% 0.8% 5.4% 4.1% 1.9% 6.8% 1.6%
Evaluations of the verbal delivery of the information: I had enough time to understand information
  Yes 9.8% 17.9% 40.7% 0.828 9.2% 21.6% 37.6% 0.007 18.1% 25.7% 24.6% 0.729 9.2% 32.8% 26.3% 0.013
  No 5.2% 8.7% 17.9% 5.1% 14.6% 11.9% 7.8% 13.2% 10.5% 6.0% 18.4% 7.3%
Evaluations of the verbal delivery of the information: Did you find it easy to say no?
  Yes 11.7% 18.7% 45.0% 0.409 10.5% 25.4% 39.5% 0.137 22.4% 25.7% 27.3% 0.001 13.0% 36.0% 26.3% 0.043
  No 3.3% 7.9% 13.6% 3.8% 10.8% 10.0% 3.5% 13.2% 7.8% 2.2% 15.2% 7.3%
  1. *Correct answer. J-START, Japan STrategic Anti-cancer Randomized controlled Trial; RCT, randomized controlled trial.