Questionnaire

Informed consent in clinical trials (ICICT)
General information (to be completed by interviewer at study coordinating centre)
1. Name of interviewer:
2. Date of interview:
3. Department:
4. Name of parent study:
5. Date of signature of informed consent for parent study:
6. Duration of follow-up in parent study	/ / months
7. Participation in parent study:
ongoing
ended (date) .....................
8. Could not complete the questionnaire for one of the following reasons:
deceased
unconscious
not found
declined
Part 1. Patient information (to be completed by interviewer during face-to-face interview with the patient subject)
9. Primary diagnosis:
10. Sex:
11. Age:
12. Situation:
married
single
widowed
divorced
13. Number of children:
14. McCabe index:	1	2	3
15. Type of illness resulting in inclusion in the parent study:
chronic
acute
16. Prognosis:
vital
functional
Person who signed the consent (patient or proxy) (to be completed by interviewer during face-to-face interview with the patient subject)
17. Understanding of the French language:
very good or good
average
poor or very poor
18. Literacy:
primary school
high school/college
university
Part 2. Parent study (to be completed by interviewer from information obtained at the study coordinating center or from the parent study coordinator)
18. Type of study (several answers may apply):
diagnostic
therapeutic
with individual benefit to the patient
without individual benefit to the patient
other
19. Sponsor:
industry
research institution (public or private not for profit)
hospital
other
20. Preliminary inclusion phase:
yes
no
21. Where is the patient during the most of the parent study:
in a hospital
in a clinical investigation centre
at home or in an ambulatory setting
both
22. Participation in the parent study results in additional:
clinic visits
hospital admissions
tests or procedures:
imaging
blood tests
endoscopies
biopsies
other
nothing
Part 3. General questions about research protocols (to be completed by interviewer during face-to-face interview with the patient subject)
23. How would you describe your participation (several answers)?
Trial	Yes n = 21 (8%)
Experiment	Yes n = 9 (3%)
Research	Yes n = 104 (37%)
Protocol	Yes n = 89 (32%)
Study	Yes n = 63 (23%)
24. When you were offered to participate in (parent study) did you understand that you could decide not to participate?
yes	n = 265 (95%)
no	n = 14 (5%)
25. Did you receive this information?
Orally	n = 84 (30%)
Written documentation	n = 9 (3%)
Both	n = 163 (58%)
Not sure	n = 23 (8%)
26. How was your consent recorded?
Written	n = 57 (20%)
Oral	n = 10 (4%)
Both	n = 212 (76%)
27. Do you have a copy of your written informed consent form?
yes	n = 212 (76%)
no	n = 57 (20%)
not sure	n = 10 (4%)
28. Were you given an information document?
yes	n = 104 (37%)
no	n = 163 (58%)
not sure	n = 12 (4%)
29. Do you have a copy of this document?
yes	n = 212 (76%)
no	n = 57 (20%)
not sure	n = 10 (4%)
30. Who gave you explanations about the parent’s study (several answers possible)?
Hospital physician	n = 222 (80%)
Nurse	n = 113 (40%)
Patients and patients’ associations	n = 24 (9%)
Family	n = 56 (20%)
31. What was the time interval between receiving information about the disease and the parent study and signature of informed consent forms?
none
Immediately	n = 83 (30%)
Same day	n = 36 (13%)
Later	n = 144 (52%)
Not sure	n = 16 (6%)
32. Were you alone with the physician or did a third party assist you?
Alone	n = 138 (49%)
Third party − medical team	n = 45 (16%)
Third party − family	n = 66 (24%)
Third party − both	n = 9 (3%)
Not sure	n = 21 (8%)
33. Were you satisfied by the information received (on parent study)?
Sufficient	n = 221 (79%)
Insufficient	n = 47 (17%)
Not sure	n = 11 (4%)
34. I will read a series of statement which can be true or false:
When you enter a protocol:
	True	False	Not sure
You must finish	63 (23%)	203 (73%)	13 (5%)
You may withdraw when you want	228 (82%)	34 (12%)	17 (6%)
It depends, you must talk to the physician	118 (42%)	142 (51%)	19 (7%)
Suppose that you had decided not to participate (in parent study), do you think that would have made any difference to your usual medical management?
yes	n = 36 (13%)
no	n = 243 (87%)
35. Compared with usual care would you say that participating in a research protocol results for you in (referred to equipoise):
More risk	n = 31 (11%)
Identical risk	n = 145 (52%)
Less risk	n = 58 (22%)
Not sure	n = 45 (16%)
36. Compared with usual care would you say that participating in a research protocol (referred to equipoise):
Increases your chance of cure	n = 152 (54%)
Gives equal chance of cure	n = 90 (32%)
Decreases you chance of cure	n = 4 (1%)
Not sure	n = 33 (13%)
37. I will read a series of statements that may represent reasons to participate in a research protocol. I would like you to tell me whether, for you, these reasons were important, not important, or not relevant.
	Important	Not important	Not relevant
For the advancement of research, of medicine	249 (89%)	24 (9%)	6 (2%)
To benefit others	222 (80%)	45 (16%)	12 (4%)
To benefit from the best treatment (*)	193 (69%)	44 (16%)	42 (15%)
Because I trust my physician	161 (58%)	74 (27%)	44 (16%)
To benefit from more gentle care	149 (53%)	81 (29%)	49 (18%)
Because the treatment is not available otherwise	98 (35%)	74 (27%)	107 (38%)
Because there is no choice	67 (24%)	67 (24%)	145 (52%)
Because it is interesting, out of curiosity	60 (22%)	142 (51%)	77 (28%)
Because I know other persons who did it	12 (4%)	24 (9%)	243 (87%)
38. Did you receive information?
	Orally	Written	Both	Not sure
About the aim of the study	89 (32%)	23 (8%)	91 (33%)	76 (27%)
About the benefits for yourself	101 (36%)	15 (5%)	63 (23%)	100 (36%)
About the risks	60 (22%)	24 (9%)	78 (28%)	117 (41%)
About insurance	2 (1%)	38 (14%)	9 (3%)	230 (82%)
About time period	74 (27%)	20 (7%)	120 (43%)	65 (23%)
About what study changes regarding normal care 69 (25%)	7 (3%)	57 (20%)	146 (52%)
About what happens when you want to stop	47 (17%)	18 (7%)	54 (19%)	160 (57%)
About the ethic committee agreement	15 (5%)	26 (9%)	16 (6%)	222 (80%)
About biomedical research	9 (3%)	48 (17%)	19 (7%)	203 (73%)
Regarding respect for anonymity	71 (25%)	42 (15%)	79 (28%)	87 (31%)
Regarding other important issues	3 (1%)	0	2 (1%)	274 (98%)
39. If you need information or need asking questions about the study protocol, do you think it will be
Easy to have any additional information	n = 228 (82%)
Not very easy to have any additional information	n = 30 (11%)
Difficult to have any additional information	n = 21 (8%)
QUIZ
40. Do you know the word “placebo”?	Yes n = 202 (72%)
41. Which of the following statements are true or false?
	True	False	Not sure
Placebo is a well-known but not very efficient drug	8 (4%)	178 (88%)	16 (8%)
Is the old treatment	3 (2%)	184 (91%)	15 (7%)
Is a medication without any active effect	175 (87%)	12 (6%)	15 (7%)
42. Do you know the word “randomize” or “randomization”?	Yes n = 73 (26%)
43. Which of the following statements are true or false?
	True	False	Not sure
It’s a medical test	2 (1%)	52 (19%)	225 (81%)
It’s a lottery	41 (15%)	11 (4%)	227 (81%)
It’s an experiment	12 (4%)	40 (14%)	227 (81%)
Part 4. Specific questions (on parent study)
44. The main purpose of the study is:
A treatment	n = 147 (53%)
A diagnostic procedure	n = 114 (41%)
Not sure	n = 18 (6%)
45. Who decided on the treatment you received (during parent study)?
Concerned 147 patients
Your physician	n = 20 (14%)
Random allocation	n = 20 (14%)
The manufacturer	n = 7 (5%)
A scientific board	n = 4 (3%)
Not sure	n = 96 (65%)
46. Questions about the study medication
Do you know what the study medication is?	Yes n = 122 (83%)
What is it for?	Correct n = 130 (88%)
47. Is it compared to another treatment?
Yes	n = 61 (41%)
No	n = 63 (43%)
Not sure	n = 23 (16%)
48. Do you know which treatment you are taking for this study?
Yes	n = 29 (20%)
No	n = 32 (22%)
Not sure	n = 86 (59%)
49. Do you think that your physician knows which medication you are taking?
Yes	n = 39 (27%)
No	n = 22 (15%)
Not sure	n = 86 (59%)
If the parent study concerns a diagnostic procedure (concerned 114 patients)
50. Do you know what the study procedure is?
Yes	n = 89 (78%)
No	n = 25 (22%)
51. Do you know what it is used for?	Yes n = 97 (86%)
52. Do you know whether this procedure is compared to another?
Yes	n = 18 (16%)
No	n = 78 (68%)
Not sure	n = 18 (16%)
To be completed by the interviewer
53. Level of patient understanding of the informed consent process
Excellent/good	n = 232 (83%)
Moderate	n = 47 (17%)