Table 4

Comprehension of the informed consent stratified by education attainment

Question and correct answerBasic education (n=22)Less than high school (n=15)High school diploma (n=25)University degree (n=14)p Value
1. Are you participating in a clinical trial?
 Yes (%)12 (55)7 (47)17 (68)11 (79)0.25
2. Which study have you been enrolled in?
 Reporting the right name of the study or some key details about the study (%)02 (13)6 (24)5 (36)0.03
3. What is the name of the treatment?
 Indicating the correct name of the study drug (%)1 (4)3 (20)7 (28)7 (50)0.02
4. Are there some benefits from participating in this study?
 No; benefits in term of increasing scientific knowledge; or unknown benefits (%)1 (4)1 (7)4 (16)4 (29)0.17
5. If there are benefits, which are they?
 Benefits in term of increasing scientific knowledge (%)0/72/4 (50)3/12 (25)3/9 (33)0.26
6. What are the risks?
 Side effects from study drug; the study drug may not stop the tumour; do not know (%)8 (36)3 (20)10 (40)7 (50)0.39
7. What are the possible adverse events?
 Listing some of the possible side effects (%)6 (27)4 (27)12 (48)9 (64)0.08
8. Do you know the procedures of the study?
 Yes; at least in part (%)9 (41)3 (20)12 (48)10 (71)0.046
9. How many visits are required for the purpose of this clinical trial?
 Reporting the number of visits required for the purpose of the clinical trial (%)2 (9)1 (7)5 (20)4 (29)0.29
10. Did you have additional procedures compared with the standard treatment for your cancer?
 Yes (%)1 (4)1 (7)6 (24)8 (57)0.0009
11. If yes, list the additional procedures
 Listing at least some of the additional procedures (%)1/1(100)1/1 (100)5/6 (83)7/8(87)0.9
12. Were blood samples requested by the study?
 Yes (%)8 (36)3 (20)14 (56)9 (64)0.05
13. Should you have not participated in this study, what treatment would you have received?
 Listing the name of the standard treatment (%)1 (5)3 (20)7 (28)9 (64)0.001
14. Do all the patients enrolled in this clinical trial receive the same medical treatment?
 No (%)01 (7)3 (12)4 (29)0.052
Number of correct answers (median (IQR))1 (0;4)1 (0;3)5 (0;8)8 (2;11)0.004
  • Data are presented as number of correct answers with proportion of responders in parentheses. Comparison between the four groups was performed by χ2 test, Fisher's exact test, or Kruskal Wallis test as appropriate.