Total (N = 214) | Acute coronary syndrome subgroup (n = 158)* | Acute stroke subgroup (n = 54)* | |
---|---|---|---|
What was the scope of the trial information and how was it delivered to trial participants?** | |||
all-embracing information, verbal + written*** | 53.3% | 47.5% | 70.4% |
abbreviated information, verbal and written | 38.8% | 41.8% | 29.6% |
all-embracing verbal + abbreviated written information*** | 15.0% | 14.6% | 13.0% |
abbreviated verbal + all-embracing written information*** | 10.7% | 12.0% | 7.4% |
abbreviated verbal information only | 4.2% | 4.4% | 3.7% |
proxy consent (by guardianship court) only | 0.0% | 0.0% | 0.0% |
Did you additionally seek consent of participants' relative(s), if available? | |||
yes, always | 18.3% | 9.5% | 44.4% |
yes, sometimes | 43.7% | 41.4% | 48.1% |
rarely or exceptionally | 25.3% | 32.5% | 5.6% |
never | 12.7% | 16.6% | 1.9% |
Following enrolment, did you inform participants' relative(s), if available, about their trial participation? | |||
yes, always | 54.2% | 43.0% | 87.0% |
yes, sometimes | 33.7% | 41.8% | 11.1% |
rarely or exceptionally | 9.8% | 12.7% | 1.9% |
never | 2.3% | 2.5% | 0.0% |
Did the involvement of a participant's relative(s) influence the time necessary to obtain informed consent? | |||
yes, delayed | 55.6% | 55.1% | 57.4% |
yes, shortened | 6.6% | 6.3% | 7.4% |
no influence | 29.4% | 27.8% | 35.2% |
not applicable (no involvement) | 8.4% | 10.8% | 0.0% |
How do patients react to a trial proposal in an emergency condition? | |||
positively/somewhat positively | 65.7% | 61.1% | 77.8% |
equal proportions for positive and negative responses | 29.1% | 33.8% | 16.7% |
negatively/somewhat negatively | 1.0% | 1.3% | 0.0% |
uncertain | 4.2% | 3.8% | 5.5% |
Is an emergency (conscious) patient able to understand the nature of the trial and consciously decide whether or not to participate? | |||
always/most often | 32.3% | 31.7% | 33.3% |
some patients are able | 46.7% | 43.0% | 59.3% |
no or few patients are able | 17.3% | 20.9% | 5.6% |
uncertain | 3.7% | 4.4% | 1.8% |
How much of the verbal information received by the patient is really understood? | |||
all/almost all | 32.9% | 33.8% | 31.5% |
some | 58.2% | 58.6% | 55.5% |
almost none | 1.9% | 2.5% | 0.0% |
uncertain | 7.0% | 5.1% | 13.0% |
How much of the written trial information does an emergency patient actually read? | |||
all/almost all | 14.5% | 13.3% | 18.5% |
some | 62.1% | 62.0% | 61.1% |
almost none | 19.2% | 21.5% | 13.0% |
uncertain | 4.2% | 3.2% | 7.4% |
The amount of information supposed to be given to patient was, in general: | |||
too comprehensive | 80.4% | 85.4% | 64.8% |
adequate in regard to the patient's condition | 17.7% | 13.3% | 31.5% |
too brief | 0.0% | 0.0% | 0.0% |
uncertain | 1.9% | 1.3% | 3.7% |
How does a trial proposal to an emergency patient affect their trust in the physician? | |||
increases trust | 26.3% | 27.4% | 24.1% |
neither increases nor decreases trust | 48.3% | 49.0% | 46.3% |
decreases trust | 9.9% | 10.2% | 9.2% |
uncertain | 15.5% | 13.4% | 20.4% |
Does informing a participant's relative(s) about their trial participation make sense at all? | |||
yes | 68.1% | 63.3% | 83.0% |
no | 12.7% | 14.6% | 5.7% |
uncertain | 19.2% | 22.1% | 11.3% |
Which of the following models of informed consent in emergency settings would be the best? | |||
all-embracing information (like non-emergency trials), verbal and written*** | 14.0% | 11.4% | 22.2% |
abbreviated information, verbal and written + abbreviated consent form, with obligatory all-embracing written consent to continue the trial once the participant's status has sufficiently improved (ICH GCP-based)*** | 78.0% | 81.7% | 66.7% |
abbreviated oral information + only verbal consent, with obligatory all-embracing written consent to continue the trial once the participant's status has sufficiently improved (currently unrealistic under national regulations)*** | 7.5% | 6.3% | 11.1% |
other model | 0.5% | 0.6% | 0.0% |