Results of the questionnaire used in the study
| Patient consented | Relative consented | |||
|---|---|---|---|---|
| Answer by patient (n=37) | Answer by relative (n=30) | Answer by patient (n=17) | Answer by relative (n=17) | |
| Values are n (%) of patients or relatives who recalled the item spontaneously and correctly. | ||||
| *The numbers are patients or relatives who recall the item spontaneously and correctly; percentages are given in parentheses. | ||||
| # Does not apply because relative consented. | ||||
| †The numbers are patients or relatives who recalled the item, items are abbreviated versions of the original in Dutch. | ||||
| ‡The numbers are patients or relatives who mentioned the item, percentages are given in parentheses. Items are abbreviated versions of the original questions in Dutch. | ||||
| 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) |