Proportion of spontaneous recall of trial items* |
Name of drug | 6 (19) | 12 (40) | 1 (6) | 4 (24) |
Effect of drug | 6 (19) | 9 (30) | 0 (0) | 4 (24) |
Placebo controlled design | 10 (31) | 13 (43) | 1 (6) | 12 (71) |
Double blind design | 4 (13) | 6 (20) | 0 (0) | 7 (41) |
Privacy | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Side effects | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Route of administration | 3 (9) | 2 (7) | 2 (12) | 2 (12) |
Voluntary participation | 2 (6) | 3 (10) | 0 (0) | 3 (18) |
Withdrawal possible | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Duration of trial | 1 (3) | 0 (0) | 0 (0) | 0 (0) |
| | | | |
Proportion of correct answer to questions on trial design†
|
Did you participate in a study? | | | | |
Yes | 14 (38) | 24 (80) | 4 (24) | 12 (70) |
No | 12 (38) | 6 (20) | 2 (11) | 3 (18) |
Don’t know | 6 (19) | 0 (0) | 11 (65) | 2 (12) |
| | | | |
What was effect of the drug? | | | | |
Correct | 6 (19) | 14 (47) | 0 (0) | 6 (35) |
Incorrect | 3 ( 9 ) | 4 (13) | 1 (6) | 3 (18) |
Don’t know | 23 (72) | 12 (40) | 16 (94) | 8 (47) |
| | | | |
What proportion of participants was given in the study drug? |
One half | 7 (22) | 11 (37) | 1 (6) | 7 (41) |
Any other proportion | 1 (3) | 3 (10) | 2 (12) | 2 (12) |
Don’t know | 24 (75) | 16 (53) | 14 (82) | 8 (47) |
| | | | |
Did you receive information about risks and benefits? |
Yes | 8 (25) | 19 (64) | 0 (0) | 12 (70) |
No | 2 (6) | 2 (7) | 1 (6) | 3 (18) |
Don’t know | 22 (69) | 9 (29) | 16 (94) | 2 (12) |
| | | | |
Who had access to the case record forms? |
Correct | 4 (13) | 9 (30) | 1 (6) | 2 (12) |
Incorrect | 5 (15) | 10 (33) | 1 (6) | 7 (41) |
Don’t know | 23 (72) | 11 (37) | 15 (88) | 8 (47 |
| | | | |
What were possible side effects of the study drug? |
Correct | 2 (6) | 5 (17) | 1 (6) | 5 (29) |
Incorrect | 2 (6) | 4 (13) | 0 (0) | 3 (18) |
Don’t know | 28 (88) | 21 (70) | 16 (94) | 9 (53) |
| | | | |
Was participation obligatory? | | | | |
No | 19 (59) | 23 (77) | 0 (0) | 16 (94) |
Yes | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Don’t know | 13 (41) | 7 (23) | 17 (100) | 1 (6) |
| | | | |
Was withdrawal after consent possible? |
Yes | 8 (25) | 15 (50) | 1 (6) | 6 (35) |
No | | | | |
Don’t know | | | | |
| | | | |
Answers to questions about opinions‡ |
Was everything clear to you? | | | | |
Yes | 8 (25) | 20 (65) | 1 (6) | 11 (65) |
No | 4 (13) | 4 (12) | 1 (6) | 5 (29) |
Don’t know | 20 (62) | 7 (23) | 15 (88) | 1 (6) |
| | | | |
Was staff available to answer any questions? |
Yes | 9 (28) | 9 (31) | 0 (0) | 9 (53) |
No, no-one was available to answer questions | 0 (0) | 3 (10) | 0 (0) | 9 (53) |
Don’t know | 15 (47 | 6 (21) | 16 (94) | 0 (0) |
Had no questions | 8 (25) | 11 (38) | 1 (6) | 8 (47) |
| | | | |
In retrospect, had you wanted more information? |
Yes | 4 (13) | 6 (20) | 0 (0) | 3 (18) |
No | 16 (49) | 19 (63) | 1 (6) | 14 (32) |
Don’t know | 12 (38) | 5 (17) | 16 (94) | 0 (0) |
| | | | |
Did you receive written information? |
Yes | 3 (9) | 13 (43) | 0 (0) | 9 (53) |
No | 8 (25) | 10 (34) | 1 (6) | 5 (29) |
Don’t know | 21 (66) | 7 (23) | 16 (94) | 3 (18) |
| | | | |
Did you read the written information? | | | | |
Yes | 3 (9) | 13 (43) | 0 (0) | 8 (47) |
No | 0 (0) | 0 (0) | 0 (0) | 1 (6) |
Don’t know | 21 (66) | 8 (27) | 16 (94) | 3 (18) |
| | | | |
Did you feel participation was voluntary? | | | | |
Yes | 16 (50) | 23 (77) | # | 15 (88) |
No | 0 (0) | 0(0) | # | 1 (6) |
Don’t know | 16 (50) | 7 (23) | # | 1 (6) |
| | | | |
Were you capable of deciding about participation? |
Yes | 9 (28) | 23 (78) | # | 16 (94) |
No | 7 (22) | 3 (9) | # | 1 (6) |
Don’t know | 16 (50) | 4 (13) | # | 0 (0) |
| | | | |
Do you think the informed consent procedure should be changed? |
Yes | 3 (9) | 12 (41) | 0 (0) | 4 (24) |
No | 7 (22) | 14 (45) | 0 (0) | 12 (70) |
Don’t know | 22 (69) | 4 (14) | 17 (100) | 1 (60) |
| | | | |
Would you participate again? | | | | |
Yes | 31 (97) | 28 (93 | 16 (94) | 16 (94) |
No | 1 (3) | 2 (7) | 1 (6) | 1 (6) |
Don’t know | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| | | | |
How readable was the written information? |
Easy to read | 29 (91) | 28 (94) | 16 (93) | 17 (100) |
Hard to read | 2 (6) | 1 (3) | 0 (0) | 0 (0) |
Neutral | 1 (3) | 1 (3) | 1 (7) | 0 (0) |
| | | | |
How do you assess participation in retrospect? | | | | |
Positive | 25 (78) | 24 (80) | 17 (100) | 14 (82) |
Negative | 0 (0) | 1 (3) | 0 (0) | 0 (0) |
Neutral | 7 (22) | 5 (17) | 0 (0) | 3 (18) |