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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.