Table 2 Trial appreciation.
HAMLET (n = 28) (n (%)) | PAIS (n = 30) (n (%)) | p Value | |
---|---|---|---|
Was the information provided clear to you?* | |||
Yes | 27 (96) | 14 (47) | <0.001 |
No | 0 (0) | 1 (3) | |
Don't know | 1 (4) | 15 (50) | |
Did you perceive the outcome of treatment allocation as a matter of life or death?* | |||
Yes | 23 (82) | 10 (33) | 0.001 |
No | 4 (14) | 16 (54) | |
Don't know | 1 (4) | 4 (13) | |
Do you have negative feelings about the informed consent procedure?* | |||
Yes | 9 (32) | 1 (3) | 0.014 |
No | 18 (64) | 28 (94) | |
Don't know | 1 (4) | 2 (3) | |
Do you feel that the question for participation and randomisation was acceptable at that moment? | |||
Yes | 19 (68) | 16 (54) | 0.40 |
No | 4 (14) | 4 (13) | |
Don't know | 5 (18) | 10 (33) | |
Were you capable of deciding about participation?* | |||
Yes | 17 (61) | 13 (43) | 0.018 |
No | 8 (29) | 4 (14) | |
Don't know | 3 (10) | 13 (43) | |
Did you feel participation was voluntary? | |||
Yes | 18 (65) | 23 (77) | 0.18 |
No | 8 (28) | 3 (10) | |
Don't know | 2 (7) | 4 (13) | |
Do you regret having given permission? | |||
Yes | 3 (11) | 0 (0) | 0.12 |
No | 23 (82) | 25 (83) | |
Don't know | 2 (7) | 5 (17) | |
Are you glad with the treatment your relative received? | |||
Yes | 14 (50) | 19 (63) | 0.17 |
No | 5 (18) | 7 (23) | |
Don't know | 9 (32) | 4 (13) | |
Would you have preferred the doctor having taken the responsibility for treatment choices? | |||
Yes | 11 (39) | 6 (20) | 0.12 |
No | 15 (54) | 17 (57) | |
Don't know | 2 (7) | 7 (23) | |
Would you have preferred the doctor having taken the responsibility for study participation? | |||
Yes | 3 (11) | 0 (0) | 0.063 |
No | 21 (75) | 20 (67) | |
Don't know | 4 (14) | 10 (33) | |
Would you approve participation again under similar circumstances? | |||
Yes | 17 (61) | 20 (67) | 0.78 |
No | 2 (7) | 1 (3) | |
Don't know | 9 (32) | 9 (30) | |
How do you feel about being interviewed again? | |||
Positive | 23 (82) | 23 (77) | 0.49 |
Negative | 3 (11) | 2 (7) | |
Neutral | 2 (7) | 5 (17) |
HAMLET, Hemicraniectomy After Middle cerebral artery infarction with Life‐threatening Edema Trial; PAIS, Paracetamol (Acetaminophen) In Stroke trial.
*Statistically significant difference between HAMLET and PAIS.